Letrozole pretreatment prior to medical termination of pregnancy: a systematic review.

PubMed

Nash, Christopher M; Philp, Lauren; Shah, Prakesh; Murphy, Kellie E

2018-06-01

The purpose of this systematic review was to evaluate the efficacy of pretreatment with letrozole prior to either a first- or second-trimester medical termination of pregnancy. We searched letrozole, femara, aromatase inhibitors, abortifacient agents, termination of pregnancy and labor induction in MEDLINE, EMBASE, Cochrane Database, Google Scholar and PubMed from inception of each database until September 2015 with no language limitation. A systematic review of all randomized controlled trials (RCTs) was performed where women received either letrozole and misoprostol or placebo and misoprostol for termination of pregnancy. The primary outcome was complete abortion rate, defined as complete evacuation of the products of conception from the uterus. Relative risk with 95% confidence intervals was used to report data. Our systematic review identified 7 studies; 4 RCTs were included in the review. Two RCTs evaluated terminations of pregnancy up to 9 weeks' gestation, while 2 evaluated terminations over 9 weeks' gestation. For each gestational age group, one trial supported an increase in complete abortion rate, while the other showed no difference, with letrozole and misoprostol compared with placebo and misoprostol. Time-to-abortion interval for terminations up to 9 weeks' gestation was not improved with the addition of letrozole to misoprostol. For terminations over 9 weeks' gestation, one trial supported and one trial refuted a decrease in time-to-abortion interval with letrozole and misoprostol. Similarly, for each gestational age group, one study supported a decrease and one study showed no difference in rate of dilation and curettage (D&C) with letrozole and misoprosol. Medication side effects were similar between both treatment groups. There was significant heterogeneity between the trials, and therefore, the results were not meta-analyzed. Some studies and trials report better outcomes (i.e., complete abortion rates, time-to-abortion and D&C rates) in women exposed to letrozole and misoprostol compared to placebo and misoprostol, while other trials demonstrate no difference. Further research exploring letrozole pretreatment prior to medical abortion is required. This systematic review demonstrated that a combination of letrozole and misoprostol increased the rate of complete abortion compared to misoprostol alone in some studies but not in others; additional well-designed RCT's are needed. Copyright © 2017 Elsevier Inc. All rights reserved.

Rethinking WHO guidance: review of evidence for misoprostol use in the prevention of postpartum haemorrhage

PubMed Central

Chu, Christina S; Brhlikova, Petra; Pollock, Allyson M

2012-01-01

This article describes and critically appraises clinical trials assessing misoprostol effectiveness in preventing primary postpartum haemorrhage (PPH) in home and community settings in low- and middle-income countries. Of 172 identified studies of misoprostol use in labour only six fulfilled the inclusion criteria. All trials used 600μg misoprostol in the intervention arm; three assessed misoprostol alongside components of active management of the third-stage labour (AMTSL), two used expectant management of labour and one allowed birth attendants to choose management practice. The three AMTSL studies showed no significant differences in PPH incidence or referral to higher centres and only one study showed significant decrease in severe PPH using misoprostol. One expectant management study and the choice of management by birth attendants study found significant decreases in PPH incidence with misoprostol. All studies showed significantly increased risk of shivering with misoprostol. Studies were biased by use of alternative uterotonics in the control arm, confounding management practices, and subjective assessment and, with one exception, exclusion of high-risk women. PPH incidence fell in both the control and intervention groups in both the landmark papers that informed the World Health Organization (WHO) decision to admit misoprostol to the Essential Medicines List. This suggests factors other than misoprostol use are crucial. Current evidence does not support misoprostol use in home and community settings in low- and middle-income countries for PPH prevention. WHO should rethink its recent decision to include misoprostol on the Essential Medicines List. PMID:22907551

Misoprostol use during the third stage of labor.

PubMed

Joy, S D; Sanchez-Ramos, L; Kaunitz, A M

2003-08-01

To systematically review the efficacy of misoprostol compared with placebo or other uterotonics in preventing maternal morbidity associated with the third stage of labor. We identified, retrieved, evaluated, abstracted data, and assessed the quality of all published studies (from January 1996 to May 2002) which assessed misoprostol's efficacy in minimizing uterine blood loss during the third stage of labor. Seventeen studies included 28170 subjects; of these, approximately one-half received misoprostol with the remainder receiving either a placebo or another uterotonic agent. An estimate of the odds ratio (OR) and risk difference for dichotomous outcomes was calculated using a random- and fixed-effects model. Continuous outcomes were pooled using a variance-weighted average of within-study difference in means. In assessing studies comparing misoprostol with placebo, those who received oral misoprostol had a decreased risk of needing additional uterotonics (OR 0.64, 95% confidence interval 0.46, 0.90). Compared with placebo, use of misoprostol was associated with an increased risk for shivering and pyrexia. In contrast, in studies comparing misoprostol with oxytocin, oxytocin was associated with significantly lower rates of postpartum hemorrhage, maternal shivering and pyrexia. In studies comparing misoprostol with Syntometrine, misoprostol was associated with higher rates of the need for additional uterotonic agent as well as shivering. Misoprostol was inferior to oxytocin and other uterotonics with regard to any of the third stage of labor outcomes assessed. However, when compared to placebo, misoprostol had a decreased risk of needing additional uterotonics. Thus, in less-developed countries where administration of parenteral uterotonic drugs may be problematic, misoprostol represents a reasonable agent for the management of the third stage of labor. Additional randomized clinical trials examining objective outcome measures (i.e. need for blood transfusion or 10% hemoglobin change) may further define benefits and risks of misoprostol use during the third stage of labor.

Labour induction at term--a randomised trial comparing Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone.

PubMed

Matonhodze, Baron B; Hofmeyr, G Justus; Levin, Jonathan

2003-05-01

To compare three methods of labour induction. Randomised controlled trial. Academic hospitals in Johannesburg, South Africa. Women with intact membranes due for induction of labour. Randomised, sealed opaque envelopes were used to allocate women to labour induction with extra-amniotic Foley catheter/titrated oral misoprostol solution (N = 174), titrated oral misoprostol solution alone (N = 176), or vaginal dinoprostone (N = 176). Misoprostol was dissolved in water and 20-40 g was given 2-hourly. These were failure to deliver vaginally within 24 hours, additional measures for induction or augmentation of labour, analgesia, and maternal and fetal complications. In the Foley catheter group, misoprostol was required in all but 1 case. Failure to deliver vaginally within 24 hours was similar for the three groups (79/174 v. 70/176 v. 70/176 respectively). Labour augmentation, caesarean section and instrumental delivery were used somewhat more frequently in the Foley/misoprostol group than in the misoprostol alone group, but these differences were not statistically significant. More analgesia was used in the Foley catheter/misoprostol group than in the misoprostol group (64/172 v. 46/175). Side-effects and neonatal complications were similar for the three groups. Use of extra-amniotic Foley catheter placement showed no measurable benefits over the use of oral misoprostol alone, or vaginal dinoprostone.

A randomized trial of misoprostol and oxytocin for induction of labor: safety and efficacy.

PubMed

Kramer, R L; Gilson, G J; Morrison, D S; Martin, D; Gonzales, J L; Qualls, C R

1997-03-01

To compare the safety and efficacy of misoprostol and oxytocin for induction of labor. One hundred thirty women requiring induction of labor were randomized to receive either intravenous oxytocin or 100 micrograms misoprostol, administered intravaginally every 4 hours until labor was established. Compared with women receiving oxytocin, a greater percentage of women in the misoprostol group had Bishop scores of 3 or less (58 versus 38%, P < .05). Nonetheless, the median induction-to-delivery interval was significantly shorter (585 versus 885 minutes, P < .001) in the misoprostol group. Women in the misoprostol group were more likely to deliver vaginally within 24 hours of the start of induction (77 versus 55%, P < .002). Epidural analgesia was used more frequently in women receiving oxytocin than in those receiving misoprostol (73 versus 50%, P = .025). The total percentage of cesarean deliveries was not significantly different, although the percentage of cesarean deliveries for dystocia was lower in the misoprostol group (8 versus 21%, P = .02). Uterine tachysystole was significantly more common (70 versus 11%, P < .001) and hospital charges significantly less with misoprostol. Compared with oxytocin for labor induction, misoprostol results in a shorter induction-to-delivery interval, a reduction in the rate of cesarean delivery for dystocia, and a decreased use of epidural analgesia. Uterine tachysystole is significantly more common with the use of misoprostol.

Prostaglandins for preventing postpartum haemorrhage.

PubMed

Tunçalp, Özge; Hofmeyr, G Justus; Gülmezoglu, A Metin

2012-08-15

Prostaglandins have mainly been used for postpartum haemorrhage (PPH) when other measures fail. Misoprostol, a new and inexpensive prostaglandin E1 analogue, has been suggested as an alternative for routine management of the third stage of labour. To assess the effects of prophylactic prostaglandin use in the third stage of labour. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (7 January 2011). We updated this search on 25 May 2012 and added the results to the awaiting classification section. Randomised trials comparing a prostaglandin agent with another uterotonic or no prophylactic uterotonic (nothing or placebo) as part of management of the third stage of labour. The primary outcomes were blood loss 1000 mL or more and the use of additional uterotonics. Two review authors independently assessed eligibility and trial quality and extracted data. We included 72 trials (52,678 women). Oral or sublingual misoprostol compared with placebo is effective in reducing severe PPH (oral: seven trials, 6225 women, not totalled due to significant heterogeneity; sublingual: risk ratio (RR) 0.66; 95% confidence interval (CI) 0.45 to 0.98; one trial, 661 women) and blood transfusion (oral: RR 0.31; 95% CI 0.10 to 0.94; four trials, 3519 women).Compared with conventional injectable uterotonics, oral misoprostol was associated with higher risk of severe PPH (RR 1.33; 95% CI 1.16 to 1.52; 17 trials, 29,797 women) and use of additional uterotonics, but with a trend to fewer blood transfusions (RR 0.84; 95% CI 0.66 to 1.06; 15 trials; 28,213 women). Additional uterotonic data were not totalled due to heterogeneity. Misoprostol use is associated with significant increases in shivering and a temperature of 38º Celsius compared with both placebo and other uterotonics. Oral or sublingual misoprostol shows promising results when compared with placebo in reducing blood loss after delivery. The margin of benefit may be affected by whether other components of the management of the third stage of labour are used or not. As side-effects are dose-related, research should be directed towards establishing the lowest effective dose for routine use, and the optimal route of administration.Neither intramuscular prostaglandins nor misoprostol are preferable to conventional injectable uterotonics as part of the management of the third stage of labour especially for low-risk women; however, evidence has been building for the use of oral misoprostol to be effective and safe in areas with low access to facilities and skilled healthcare providers and future research on misoprostol use in the community should focus on implementation issues.

Introducing medication abortion into public sector facilities in KwaZulu-Natal, South Africa: an operations research study.

PubMed

Blanchard, Kelly; Lince-Deroche, Naomi; Fetters, Tamara; Devjee, Jaymala; de Menezes, Ilundi Durão; Trueman, Karen; Sudhinaraset, May; Nkonko, Errol; Moodley, Jack

2015-10-01

Examine the feasibility of introducing mifepristone-misoprostol medication abortion into existing public sector surgical abortion services in KwaZulu-Natal, South Africa. Cohort study of women offered medication or surgical abortion in a larger medication abortion introduction study. The sample included 1167 women seeking first-trimester abortion at four public sector facilities; 923 women at ≤9 weeks' gestation were eligible for medication abortion. Women who chose medication abortion took 200 mg of mifepristone orally at the facility and 800 mcg of misoprostol buccally (or vaginally if they anticipated or experienced problems with buccal administration) 48 h later at home, based on international research and global safe abortion guidelines. Women who chose surgical abortion received 600 mg of misoprostol sublingually or vaginally on the day of their procedure followed by manual vacuum aspiration 4 h later. Main outcome measures included proportion of eligible women who chose each method, proportion with complete abortion and proportion reporting adverse events. Ninety-four percent of eligible women chose medication abortion. No adverse events were reported by women who chose surgical abortion; 3% of women in the medication abortion group reported adverse events and 0.4% reported a serious adverse event. Seventy-six percent of women received a family planning method at the facility where their received their abortion, with no difference based on procedure type. Medication abortion patients were significantly more likely to report they would choose this method again (94% vs. 78%, p<.001) and recommend the method to a friend (98% vs. 84%, p<.001). Medication abortion was successfully introduced with low and acceptable rates of adverse events; most women at study facilities chose this option. Mifepristone-misoprostol medication abortion was successfully integrated into public sector surgical abortion services in South Africa and was chosen by a large majority of women who were eligible and offered choice of early termination method; access to medication abortion should be expanded in South Africa and other similar settings. Copyright © 2015 Elsevier Inc. All rights reserved.

Comparative Study of Oral and Vaginal Misoprostol for Induction of Labour, Maternal and Foetal Outcome

PubMed Central

Komala, Kambhampati; Reddy, Meherlatha; Quadri, Iqbal Jehan; B., Suneetha; V., Ramya

2013-01-01

Background: Misoprostol is a new promising agent for cervical ripening and induction of labour .The ideal dose, route and frequency of administration of misoprostol are still under investigation. Although, vaginal application of misoprostol has been validated as a reasonable mean of induction, there is a patient resistance to digital examination and there is a risk of ascending infection. For this reason, oral administration of misoprostol for cervical ripening and labour induction has been tried. Aims and Objectives: To compare 50μg of oral misoprostol versus 25μg of intravaginal misoprostol for induction of labour at term and maternal, foetal outcomes. Methods: Two hundred women who were at term, with indication for induction of labour and Bishop scores of ≤5 were randomly assigned to receive misoprostol 50μg or 25μg intravaginal, every 4-6 hours, for a maximum of 5 doses. In either group, pregnant females with inadequate uterine contractions despite being given maximum 5 doses of misoprostol, were augmented using oxytocin. The primary outcome measure was time-interval from induction to vaginal delivery and vaginal delivery rate within 24 hours. Results: The median induction to vaginal delivery time in oral group (12.92h) and vaginal group (14.04 h) was not significant. Oral misoprostol resulted in more number of vaginal deliveries as compared to vaginal misoprostol (94% as compared to 86%), which was not significant. There was a significantly higher incidence of uterine tachysystole in the vaginal group, as compared to oral group. There were no significant differences between the groups with respect to oxytocin augmentation, caesarean section rate, analgesic requirement and neonatal outcome. Conclusion: Oral misoprostol is as efficacious as vaginal misoprostol because of shorter induction delivery interval, lower caesarean section rates, and lower incidence of failed induction rates. Lower incidence of foetal distress and easy intake are observed if the drug is administered orally. PMID:24551660

Advance distribution of misoprostol for prevention of postpartum hemorrhage (PPH) at home births in two districts of Liberia

PubMed Central

2014-01-01

Background A postpartum hemorrhage prevention program to increase uterotonic coverage for home and facility births was introduced in two districts of Liberia. Advance distribution of misoprostol was offered during antenatal care (ANC) and home visits. Feasibility, acceptability, effectiveness of distribution mechanisms and uterotonic coverage were evaluated. Methods Eight facilities were strengthened to provide PPH prevention with oxytocin, PPH management and advance distribution of misoprostol during ANC. Trained traditional midwives (TTMs) as volunteer community health workers (CHWs) provided education to pregnant women, and district reproductive health supervisors (DRHSs) distributed misoprostol during home visits. Data were collected through facility and DRHS registers. Postpartum interviews were conducted with a sample of 550 women who received advance distribution of misoprostol on place of delivery, knowledge, misoprostol use, and satisfaction. Results There were 1826 estimated deliveries during the seven-month implementation period. A total of 980 women (53.7%) were enrolled and provided misoprostol, primarily through ANC (78.2%). Uterotonic coverage rate of all deliveries was 53.5%, based on 97.7% oxytocin use at recorded facility vaginal births and 24.9% misoprostol use at home births. Among 550 women interviewed postpartum, 87.7% of those who received misoprostol and had a home birth took the drug. Sixty-three percent (63.0%) took it at the correct time, and 54.0% experienced at least one minor side effect. No serious adverse events reported among enrolled women. Facility-based deliveries appeared to increase during the program. Conclusions The program was moderately effective at achieving high uterotonic coverage of all births. Coverage of home births was low despite the use of two channels of advance distribution of misoprostol. Although ANC reached a greater proportion of women in late pregnancy than home visits, 46.3% of expected deliveries did not receive education or advance distribution of misoprostol. A revised community-based strategy is needed to increase advance distribution rates and misoprostol coverage rates for home births. Misoprostol for PPH prevention appears acceptable to women in Liberia. Correct timing of misoprostol self-administration needs improved emphasis during counseling and education. PMID:24894566

Advance distribution of misoprostol for prevention of postpartum hemorrhage (PPH) at home births in two districts of Liberia.

PubMed

Smith, Jeffrey Michael; Baawo, Saye Dahn; Subah, Marion; Sirtor-Gbassie, Varwo; Howe, Cuallau Jabbeh; Ishola, Gbenga; Tehoungue, Bentoe Z; Dwivedi, Vikas

2014-06-04

A postpartum hemorrhage prevention program to increase uterotonic coverage for home and facility births was introduced in two districts of Liberia. Advance distribution of misoprostol was offered during antenatal care (ANC) and home visits. Feasibility, acceptability, effectiveness of distribution mechanisms and uterotonic coverage were evaluated. Eight facilities were strengthened to provide PPH prevention with oxytocin, PPH management and advance distribution of misoprostol during ANC. Trained traditional midwives (TTMs) as volunteer community health workers (CHWs) provided education to pregnant women, and district reproductive health supervisors (DRHSs) distributed misoprostol during home visits. Data were collected through facility and DRHS registers. Postpartum interviews were conducted with a sample of 550 women who received advance distribution of misoprostol on place of delivery, knowledge, misoprostol use, and satisfaction. There were 1826 estimated deliveries during the seven-month implementation period. A total of 980 women (53.7%) were enrolled and provided misoprostol, primarily through ANC (78.2%). Uterotonic coverage rate of all deliveries was 53.5%, based on 97.7% oxytocin use at recorded facility vaginal births and 24.9% misoprostol use at home births. Among 550 women interviewed postpartum, 87.7% of those who received misoprostol and had a home birth took the drug. Sixty-three percent (63.0%) took it at the correct time, and 54.0% experienced at least one minor side effect. No serious adverse events reported among enrolled women. Facility-based deliveries appeared to increase during the program. The program was moderately effective at achieving high uterotonic coverage of all births. Coverage of home births was low despite the use of two channels of advance distribution of misoprostol. Although ANC reached a greater proportion of women in late pregnancy than home visits, 46.3% of expected deliveries did not receive education or advance distribution of misoprostol. A revised community-based strategy is needed to increase advance distribution rates and misoprostol coverage rates for home births. Misoprostol for PPH prevention appears acceptable to women in Liberia. Correct timing of misoprostol self-administration needs improved emphasis during counseling and education.

Umbilical vein injection of misoprostol versus normal saline for the treatment of retained placenta: intrapartum placebo-controlled trial.

PubMed

Rajab, Sheelan S; Alalaf, Shahla K

2014-01-21

The third stage of labour may be complicated by retained placenta, which should be managed promptly because it may cause severe bleeding and infection, with a potentially fatal outcome. This study evaluated the effectiveness of umbilical vein injection of misoprostol for the treatment of retained placenta in a hospital setting. This hospital-based placebo-controlled trial was conducted at the Maternity Teaching Hospital, Erbil City, Kurdistan region, Northern Iraq from April 2011 to February 2012. The inclusion criteria were: gestational age of at least 28 weeks, vaginal delivery, and failure of the placenta to separate within 30 minutes after delivery of the infant despite active management of the third stage of labour. Forty-six women with retained placentas were eligible for inclusion. After informed consent was obtained, the women were alternately allocated to receive umbilical vein injection of either 800 mcg misoprostol dissolved in 20 mL of normal saline (misoprostol group) or 20 mL of normal saline only (saline group). The women were blinded to the group allocation, but the investigator who administered the injection was not. The trial was registered by the Research Ethics Committee of Hawler Medical University. After umbilical vein injection, delivery of the placenta occurred in 91.3% of women in the misoprostol group and 69.5% of women in the saline group, which was not a significant difference between the two groups. The median vaginal blood loss from the time of injection until delivery of the placenta was significantly less in the misoprostol group (100 mL) than in the saline group (210 mL) (p value < 0.001). Umbilical vein injection of misoprostol is an effective treatment for retained placenta, and reduces the volume of vaginal blood loss with few adverse effects. Current Controlled Trial HMU: N252.1.2011.

Umbilical vein injection of misoprostol versus normal saline for the treatment of retained placenta: intrapartum placebo-controlled trial

PubMed Central

2014-01-01

Background The third stage of labour may be complicated by retained placenta, which should be managed promptly because it may cause severe bleeding and infection, with a potentially fatal outcome. This study evaluated the effectiveness of umbilical vein injection of misoprostol for the treatment of retained placenta in a hospital setting. Methods This hospital-based placebo-controlled trial was conducted at the Maternity Teaching Hospital, Erbil City, Kurdistan region, Northern Iraq from April 2011 to February 2012. The inclusion criteria were: gestational age of at least 28 weeks, vaginal delivery, and failure of the placenta to separate within 30 minutes after delivery of the infant despite active management of the third stage of labour. Forty-six women with retained placentas were eligible for inclusion. After informed consent was obtained, the women were alternately allocated to receive umbilical vein injection of either 800 mcg misoprostol dissolved in 20 mL of normal saline (misoprostol group) or 20 mL of normal saline only (saline group). The women were blinded to the group allocation, but the investigator who administered the injection was not. The trial was registered by the Research Ethics Committee of Hawler Medical University. Results After umbilical vein injection, delivery of the placenta occurred in 91.3% of women in the misoprostol group and 69.5% of women in the saline group, which was not a significant difference between the two groups. The median vaginal blood loss from the time of injection until delivery of the placenta was significantly less in the misoprostol group (100 mL) than in the saline group (210 mL) (p value < 0.001). Conclusion Umbilical vein injection of misoprostol is an effective treatment for retained placenta, and reduces the volume of vaginal blood loss with few adverse effects. Clinical Trial Registration Current Controlled Trial HMU: N252.1.2011 PMID:24444360

Dose and side effects of sublingual misoprostol for treatment of postpartum hemorrhage: what difference do they make?

PubMed Central

2012-01-01

Background Shivering and fever are common side effects of misoprostol. An unexpectedly high rate of fever above 40°C was documented among Ecuadorian women given treatment with 800mcg of sublingual misoprostol to manage postpartum hemorrhage (PPH) (36%). Much lower rates have been reported elsewhere (0-9%). Methods From February to July 2010, an open-label pilot study was conducted in Quito, Ecuador to determine whether a lower dose--600mcg sublingual misoprostol--would result in a lower incidence of high fever (≥40°C). Rates of shivering and fever with 600mcg sublingual regimen were compared to previously documented rates in Ecuador following PPH treatment with 800mcg sublingual misoprostol. Results The 600mcg dose resulted in a 55% lower rate of high fever compared with the 800mcg regimen (8/50; 16% vs. 58/163; 36%; relative risk 0.45 95% CI 0.23-0.88). Only one woman had severe shivering following the 600mcg dose compared with 19 women in the 800mcg cohort (2% vs. 12%; relative risk 0.17 (0.02-1.25)). No cases of delirium/altered sensorium were reported with the 600mcg dose and women’s assessment of severity/tolerability of shivering and fever was better with the lower dose. Conclusions 600mcg sublingual misoprostol was found to decrease the occurrence of high fever among Ecuadorian women when given to treat PPH. This study however was not powered to examine the efficacy of this treatment regimen and cannot be recommended at this time. Future research is needed to confirm whether other populations, outside of Quito, Ecuador, experience unusually high rates of elevated body temperature following sublingual administration of misoprostol for treatment of PPH. If indeed similar trends are found elsewhere, larger trials to confirm the efficacy of lower dosages may be justified. Trial Registration Clinical trials.gov, Registry No. NCT01080846 PMID:22769055

Dose and side effects of sublingual misoprostol for treatment of postpartum hemorrhage: what difference do they make?

PubMed

León, Wilfrido; Durocher, Jill; Barrera, Gustavo; Pinto, Ernesto; Winikoff, Beverly

2012-07-07

Shivering and fever are common side effects of misoprostol. An unexpectedly high rate of fever above 40°C was documented among Ecuadorian women given treatment with 800mcg of sublingual misoprostol to manage postpartum hemorrhage (PPH) (36%). Much lower rates have been reported elsewhere (0-9%). From February to July 2010, an open-label pilot study was conducted in Quito, Ecuador to determine whether a lower dose--600mcg sublingual misoprostol--would result in a lower incidence of high fever (≥40°C). Rates of shivering and fever with 600mcg sublingual regimen were compared to previously documented rates in Ecuador following PPH treatment with 800mcg sublingual misoprostol. The 600mcg dose resulted in a 55% lower rate of high fever compared with the 800mcg regimen (8/50; 16% vs. 58/163; 36%; relative risk 0.45 95% CI 0.23-0.88). Only one woman had severe shivering following the 600mcg dose compared with 19 women in the 800mcg cohort (2% vs. 12%; relative risk 0.17 (0.02-1.25)). No cases of delirium/altered sensorium were reported with the 600mcg dose and women's assessment of severity/tolerability of shivering and fever was better with the lower dose. 600mcg sublingual misoprostol was found to decrease the occurrence of high fever among Ecuadorian women when given to treat PPH. This study however was not powered to examine the efficacy of this treatment regimen and cannot be recommended at this time. Future research is needed to confirm whether other populations, outside of Quito, Ecuador, experience unusually high rates of elevated body temperature following sublingual administration of misoprostol for treatment of PPH. If indeed similar trends are found elsewhere, larger trials to confirm the efficacy of lower dosages may be justified. Clinical trials.gov, Registry No. NCT01080846.

Comparison of Mifepristone Followed by Misoprostol with Misoprostol Alone for Treatment of Early Pregnancy Failure: A Randomized Double-Blind Placebo-Controlled Trial.

PubMed

Sinha, Priya; Suneja, Amita; Guleria, Kiran; Aggarwal, Richa; Vaid, Neelam B

2018-02-01

To compare the efficacy and safety of mifepristone followed by misoprostol with misoprostol alone in the management of early pregnancy failure (EPF). A randomized double-blind placebo-controlled clinical trial. Ninety-two women with EPF ≤12 weeks were recruited and randomly allocated to receive either mifepristone 200 mg ( n  = 46) or placebo ( n  = 46). Forty-eight hours later, patients in both the groups were given 800 µg misoprostol per-vaginum. If no expulsion occurred within 4 h, repeat doses of 400 µg misoprostol were given orally at 3-hourly interval to a maximum of 2 doses in women ≤9 weeks by scan and 4 doses in women >9 weeks by scan. Pre-treatment of misoprostol with mifepristone significantly increased the complete abortion rate (86.7 vs. 57.8%, p  = 0.009) and, hence, reduced the need for surgical evacuation (13.3 vs. 42.2%, p  = 0.002), induction to expulsion interval (4.74 ± 2.24 vs. 8.03 ± 2.77 h, p  = 0.000), mean number of additional doses of misoprostol required (0.68 vs. 1.91, p  = 0.000), and side effects. Use of mifepristone prior to misoprostol in EPF significantly improves the efficacy and reduces the side effects of misoprostol alone.

How often and under which circumstances do Mexican pharmacy vendors recommend misoprostol to induce an abortion?

PubMed

Lara, Diana; García, Sandra G; Wilson, Kate S; Paz, Francisco

2011-06-01

Misoprostol was used by women across Mexico to induce abortion even before 2007, when first-trimester abortion was legalized in Mexico City. Pharmacy vendors' misoprostol recommendation practices across subregions of Mexico after abortion legalization warrant examination. Overall, 192 pharmacies in four regions of Mexico were randomly selected and visited by simulated clients presenting three scenarios (a young woman, an adult woman and a male partner). Bivariate and multivariate analyses were used to explore associations between pharmacy, vendor and client characteristics and drug access. In 558 encounters with simulated clients, 78% of vendors provided information about misoprostol-18% recommended it spontaneously and 60% recommended it only after the client asked specifically for the drug. Fifteen percent of vendors recommended a potentially effective misoprostol dosing regimen. Mexico City-based pharmacies and those in the Central region were significantly less likely than those in the North region to require a prescription to sell misoprostol (odds ratios, 0.2 and 0.3, respectively). Independent pharmacies and those from low-?income areas were significantly more likely to sell misoprostol by the pill than chain pharmacies and those in medium-income areas (3.2 and 2.7, respectively). Access to misoprostol is influenced by neighborhood socioeconomic level, pharmacy location and pharmacy type. The frequently inaccurate and incomplete information provided to clients about using misoprostol for abortion suggests the need to improve pharmacy vendor training in medication abortion options and to develop ways to directly inform women about misoprostol use.

Postpartum hemorrhage prevention in Nepal: a program assessment.

PubMed

Rajbhandari, Swaraj Pradhan; Aryal, Kamal; Sheldon, Wendy R; Ban, Bharat; Upreti, Senendra Raj; Regmi, Kiran; Aryal, Shilu; Winikoff, Beverly

2017-06-05

In 2009, the Nepal Ministry of Health and Population launched a national program for prevention of postpartum hemorrhage (PPH) during home births that features advance distribution of misoprostol to pregnant women. In the years since, the government has scaled-up the program throughout much of the country. This paper presents findings from the first large-scale assessment of the effectiveness of the advance distribution program. Data collection was carried out in nine districts and all three ecological zones. To assess knowledge, receipt and use of misoprostol, household interviews were conducted with 2070 women who had given birth within the past 12 months. To assess supply and provision of misoprostol, interviews were conducted with 270 Female Community Health Volunteers (FCHVs) and staff at 99 health facilities. Among recently delivered women, only 15% received information about misoprostol and 13% received misoprostol tablets in advance of delivery. Yet 87% who received advance misoprostol and delivered at home used it for PPH prevention. Among FCHVs, 96% were providing advance misoprostol for PPH prevention; however 81% had experienced at least one misoprostol stock out within the past year. About one-half of FCHVs were providing incomplete information about the use of misoprostol; in addition, many did not discuss side effects, how to recognize PPH or where to go if PPH occurs. Among health facilities, just one-half had sufficient misoprostol stock, while 95% had sufficient oxytocin stock, at the time of this assessment. In Nepal, women who receive advance misoprostol are both willing and able to use the medication for PPH prevention during home births. However the supply and personnel challenges identified raise questions about scalability and impact of the program over the long-term. Further assessment is needed.

Misoprostol dose-related shivering and pyrexia in the third stage of labour. WHO Collaborative Trial of Misoprostol in the Management of the Third Stage of Labour.

PubMed

Lumbiganon, P; Hofmeyr, J; Gülmezoglu, A M; Pinol, A; Villar, J

1999-04-01

To select the misoprostol dose to be used in a large multicentre randomised trial comparing misoprostol with oxytocin in the routine management of the third stage of labour. Randomised pilot trial, double-blinded with the use of double placebos. Two of the nine hospitals that will participate in the main multicentre trial. The hospitals were located in Johannesburg, South Africa and Khon Kaen, Thailand. Women during second stage of labour about to be delivered vaginally. The trial had three arms: misoprostol 400 microg versus misoprostol 600 microg versus intramuscular oxytocin 10 IU. Each group received an injection and three tablets immediately after the birth of the baby. Shivering and pyrexia rates were the main outcome measures. Data on other side effects and characteristics of the third stage of labour were also collected. Side effects were noted as none, mild, moderate or severe. Both shivering and pyrexia (temperature > 38 degrees C) were most common in the 600 microg misoprostol group (28% and 7.5% for shivering and pyrexia, respectively) compared with 400 microg misoprostol (19% and 2%), and the oxytocin group (12.5% and 3%). The increase in shivering in the misoprostol 600 microg group was due primarily to a higher rate of moderate shivering. None of the women had a temperature > 40 degrees C. There were no increases in severe side effects and other adverse events in the misoprostol 600 microg group. When used in the management of the third stage of labour oral misoprostol is associated with an increase in the rate of moderate shivering and pyrexia which seems to be dose-related. Based on the results of this pilot trial, the Steering Committee has decided to use 600 microg misoprostol in the main trial, comparing it with oxytocin, in order to achieve higher effectiveness.

Instability of misoprostol tablets stored outside the blister: a potential serious concern for clinical outcome in medical abortion.

PubMed

Berard, Veronique; Fiala, Christian; Cameron, Sharon; Bombas, Teresa; Parachini, Mirella; Gemzell-Danielsson, Kristina

2014-01-01

Misoprostol (Cytotec) is recognised to be effective for many gynaecological indications including termination of pregnancy, management of miscarriage and postpartum haemorrhage. Although not licensed for such indications, it has been used for these purposes by millions of women throughout the world. Misoprostol tablets are most often packaged as multiple tablets within an aluminium strip, each within an individual alveolus. When an alveolus is opened, tablets will be exposed to atmospheric conditions. To compare the pharmaco technical characteristics (weight, friability), water content, misoprostol content and decomposition product content (type A misoprostol, type B misoprostol and 8-epi misoprostol) of misoprostol tablets Cytotec (Pfizer) exposed to air for periods of 1 hour to 720 hours (30 days), to those of identical non exposed tablets. Four hundred and twenty (420) tablets of Cytotec (Pfizer) were removed from their alveoli blister and stored at 25°C/60% relative humidity. Water content, and misoprostol degradation products were assayed in tablets exposed from 1 to 720 hours (30 days). Comparison was made with control tablets (N=60) from the same batch stored in non-damaged blisters. Statistical analyses were carried out using Fisher's exact test for small sample sizes. By 48 hours, exposed tablets demonstrated increased weight (+4.5%), friability (+1 300%), and water content (+80%) compared to controls. Exposed tablets also exhibited a decrease in Cytotec active ingredient dosage (-5.1% after 48 hours) and an increase in the inactive degradation products (+25% for type B, +50% for type A and +11% for 8-epi misoprostol after 48 hours) compared to controls. Exposure of Cytotec tablets to 'typical' European levels of air and humidity results in significant time-dependent changes in physical and biological composition that could impact adversely upon clinical efficacy. Health professionals should be made aware of the degradation of misoprostol with inappropriate storage of misoprostol tablets.

Instability of Misoprostol Tablets Stored Outside the Blister: A Potential Serious Concern for Clinical Outcome in Medical Abortion

PubMed Central

Berard, Veronique; Fiala, Christian; Cameron, Sharon; Bombas, Teresa; Parachini, Mirella; Gemzell-Danielsson, Kristina

2014-01-01

Introduction Misoprostol (Cytotec) is recognised to be effective for many gynaecological indications including termination of pregnancy, management of miscarriage and postpartum haemorrhage. Although not licensed for such indications, it has been used for these purposes by millions of women throughout the world. Misoprostol tablets are most often packaged as multiple tablets within an aluminium strip, each within an individual alveolus. When an alveolus is opened, tablets will be exposed to atmospheric conditions. Objective To compare the pharmaco technical characteristics (weight, friability), water content, misoprostol content and decomposition product content (type A misoprostol, type B misoprostol and 8-epi misoprostol) of misoprostol tablets Cytotec (Pfizer) exposed to air for periods of 1 hour to 720 hours (30 days), to those of identical non exposed tablets. Methods Four hundred and twenty (420) tablets of Cytotec (Pfizer) were removed from their alveoli blister and stored at 25°C/60% relative humidity. Water content, and misoprostol degradation products were assayed in tablets exposed from 1 to 720 hours (30 days). Comparison was made with control tablets (N = 60) from the same batch stored in non-damaged blisters. Statistical analyses were carried out using Fisher’s exact test for small sample sizes. Results By 48 hours, exposed tablets demonstrated increased weight (+4.5%), friability (+1 300%), and water content (+80%) compared to controls. Exposed tablets also exhibited a decrease in Cytotec active ingredient dosage (−5.1% after 48 hours) and an increase in the inactive degradation products (+25% for type B, +50% for type A and +11% for 8-epi misoprostol after 48 hours) compared to controls. Conclusion Exposure of Cytotec tablets to ‘typical’ European levels of air and humidity results in significant time-dependent changes in physical and biological composition that could impact adversely upon clinical efficacy. Health professionals should be made aware of the degradation of misoprostol with inappropriate storage of misoprostol tablets. PMID:25502819

Treatment of retained placenta with misoprostol: a randomised controlled trial in a low-resource setting (Tanzania).

PubMed

van Beekhuizen, Heleen J; Pembe, Andrea B; Fauteck, Heiner; Lotgering, Fred K

2009-10-23

Retained placenta is one of the common causes of maternal mortality in developing countries where access to appropriate obstetrical care is limited. Current treatment of retained placenta is manual removal of the placenta under anaesthesia, which can only take place in larger health care facilities. Medical treatment of retained placenta with prostaglandins E1 (misoprostol) could be cost-effective and easy-to-use and could be a life-saving option in many low-resource settings. The aim of this study is to assess the efficacy and safety of sublingually administered misoprostol in women with retained placenta in a low resource setting. Multicentered randomised, double-blind, placebo-controlled trial, to be conducted in 5 hospitals in Tanzania, Africa. Women with retained placenta, at a gestational age of 28 weeks or more and blood loss less than 750 ml, 30 minutes after delivery of the newborn despite active management of third stage of labour. Trial Entry & Randomisation & Study Medication: After obtaining informed consent, eligible women will be allocated randomly to the treatment groups using numbered envelopes that will be randomized in variable blocks containing identical capsules with either 800 microgram of misoprostol or placebo. The drugs will be given sublingually. The women, maternal care providers and researchers will be blinded to treatment allocation. 117 women, to show a 40% reduction in manual removals of the placenta (p = 0.05, 80% power). The randomization will be misoprostol: placebo = 2:1. PRIMARY STUDY OUTCOME: Expulsion of the placenta without manual removal. Secondary outcome is the number of blood transfusions. This is a protocol for a randomized trial in a low resource setting to assess if medical treatment of women with retained placenta with misoprostol reduces the incidence of manual removal of the placenta. Current Controlled Trials ISRCTN16104753.

Rectal misoprostol in management of retained placenta: a contradictory result.

PubMed

Pongsatha, Saipin; Tongsong, Theera

2011-05-01

Retained placenta is one of the common problems in obstetric practice. The most common procedure to manage cases with retained placenta is manual removal of placenta (MROP) under general anesthesia. Recent data indicates that misoprostol may be helpful in decreasing the rate of MROP. To assess the efficacy of rectal misoprostol in women with delayed placental separation. A descriptive, retrospective cohort was conducted. All pregnant women with retained placenta longer than 30 minutes after fetal delivery, either in second or third trimester that received 800 mcg rectal misoprostol were included in the present study. Successful treatment was defined as spontaneous placental expulsion within 30 minutes after rectal misoprostol administration. The rate of spontaneous placental expulsion within 30 minutes after misoprostol administration was very low, only three out of 20 cases (15%). High dose rectal misoprostol does not give a promising result in cases of retained placenta. It is ineffective to facilitate placental separation in cases of retained placenta and does not seem to decrease the rate of MROP.

Feasibility of assessing the safety and effectiveness of menstrual regulation medications purchased from pharmacies in Bangladesh: a prospective cohort study.

PubMed

Footman, Katharine; Scott, Rachel; Taleb, Fahmida; Dijkerman, Sally; Nuremowla, Sadid; Reiss, Kate; Church, Kathryn

2018-02-01

To assess the feasibility of following up women who purchase mifepristone+misoprostol or misoprostol-only from pharmacies in order to measure the safety and effectiveness of self-administration of menstrual regulation. A prospective cohort study followed women purchasing mifepristone+misoprostol or misoprostol-only from pharmacies in Bangladesh. Participants were recruited by pharmacy workers either in person or indirectly via the purchaser of the drugs. End users were contacted by phone 2 weeks after recruitment, screened and interviewed. Study recruitment rates by pharmacy workers were low (30%, 109 of 642 women informed about the study), but 2-week follow-up rates were high (87%). Of the 109 end users interviewed, 87 purchased mifepristone+misoprostol and 20 misoprostol-only, while 2 women did not know what drugs they had purchased. Mean self-reported number of weeks of pregnancy was 5.7 weeks. Information provision by pharmacy workers was inadequate (40.4% received none, 8.7% received written information or pictures). A total of 80.5% of mifepristone+misoprostol users were sold the correct regimen versus 9 out of 20 misoprostol-only users. A total of 68.8% did not report experiencing any complications (70.0% misoprostol-only; 69.0% mifepristone+misoprostol users, p=1.0). A total of 94.3% of mifepristone+misoprostol users and 75% of misoprostol-only users reported that they were not pregnant at day 15 (p=.020). However, 7.3% of all users sought additional treatment. Challenges in assessing outcomes of self-managed menstrual regulation medications purchased from pharmacies must be overcome through further development of this methodology. Interventions are urgently needed to ensure that women have access to correct dosages, accurate information and necessary referrals. This paper assesses the outcomes of women who self-manage menstrual regulation medications purchased from pharmacies. The methodology requires further development, but our study provides preliminary positive evidence on the safety and effectiveness of self-management despite low information provision from pharmacy workers. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Early pregnancy termination with intravaginally administered sodium chloride solution-moistened misoprostol tablets: historical comparison with mifepristone and oral misoprostol.

PubMed

Jain, J K; Meckstroth, K R; Mishell, D R

1999-12-01

The purpose of this study was to compare the abortifacient effect of intravaginally administered moistened misoprostol tablets with that of the combination regimen of mifepristone and oral misoprostol. One hundred women at

Double-blind randomized controlled trial comparing misoprostol and oxytocin for management of the third stage of labor in a Nigerian hospital.

PubMed

Musa, Abdulkarim O; Ijaiya, Munir'deen A; Saidu, Rakiya; Aboyeji, Abiodun P; Jimoh, Abiodun A; Adesina, Kikelomo T; Abdul, Ishaq F

2015-06-01

To compare the efficacy of oral misoprostol with that of oxytocin for active management of the third stage of labor (AMTSL). A double-blind randomized control trial was undertaken at a center in Ilorin, Nigeria, between January and June 2013. Every other eligible patient (in the first stage of labor at term, to have a spontaneous vaginal delivery, and no/low risk of postpartum hemorrhage [PPH]) were randomly assigned with computer-generated random numbers to receive oral misoprostol (600μg) plus placebo injection or oral placebo plus oxytocin injection (1mL of 10IU) in the third stage of labor. The primary outcome was amount of blood loss during delivery. Mean postpartum blood loss was 325.85±164.72mL in the 100 patients given misoprostol and 303.95±163.33mL in the 100 patients given oxytocin (P=0.391). PPH (≥500mL blood loss) was recorded in 15 (15.0%) patients given misoprostol and 14 (14.0%) given oxytocin (P=0.841). Shivering, pyrexia, and diarrhea were all significantly more common in the misoprostol group (P<0.01 for all). The efficacy of oral misoprostol was similar to that of intramuscular oxytocin. Adverse effects associated with misoprostol were transient and self-limiting. Thus, oral misoprostol is efficacious and a good alternative to oxytocin for AMTSL. Pan African Clinical Trials Registry:PACTR201407000825227. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

A double-blind, randomized, placebo-controlled trial of misoprostol and routine uterotonics for the prevention of postpartum hemorrhage.

PubMed

Fawole, Adeniran O; Sotiloye, Oladapo S; Hunyinbo, Kehinde I; Umezulike, Augustine C; Okunlola, Michael A; Adekanle, Daniel A; Osamor, Jonathan; Adeyanju, Olusoji; Olowookere, Olufemi O; Adekunle, Adeyemi O; Singata, Mandisa; Mangesi, Lindeka; Hofmeyr, George J

2011-02-01

To assess the effects of 400-μg sublingual misoprostol plus routine uterotonics on postpartum hemorrhage. A double-blind, placebo-controlled, randomized study was performed. After delivery of the child, eligible women received routine uterotonics and were randomly allocated to receive 400-μg misoprostol or placebo sublingually. The primary outcome measure was blood loss of at least 500 mL within 1 hour of taking the trial tablets. In total, 672 women received misoprostol and 673 received placebo. The baseline data were similar for both groups. Misoprostol plus routine uterotonics reduced postpartum blood loss, but the effect was not significant for blood loss of at least 500 mL (relative risk [RR] 0.96; 95% confidence interval [CI], 0.63-1.45) or blood loss of at least 1000 mL (RR 0.50; 95% CI, 0.15-1.66). Misoprostol also reduced the need for non-routine oxytocin, manual removal of the placenta, and hysterectomy, but these differences were not significant either. Misoprostol was associated with pyrexia and moderate/severe shivering. There was no death in either group. Misoprostol plus routine uterotonics resulted in modest reductions of blood loss in the third stage of labor, but the effects did not reach statistical significance. Larger studies are recommended. Copyright © 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Contraction frequency after administration of misoprostol in obese versus nonobese women.

PubMed

Stefely, Erin; Warshak, Carri R

2018-04-30

To examine impact of obesity on contraction frequency following misoprostol. Our hypothesis is that an increased volume of distribution reduces the bioavailability of misoprostol and may be an explanation for reduced efficacy. We examined the contraction frequency as a surrogate marker for bioavailability of misoprostol. We compared the rate of contractions at five time intervals in 313 subjects: prior to administration, and at four intervals post administration. We compared number of contractions in obese versus nonobese. As a planned secondary analysis, we then compared the rate of change in contractions per hour at four time intervals: a repeated measures analysis to compare the rate of change in contractions per hour over the 5-hour window controlling for race (White versus non-White) and parity (primiparous versus multiparous). General linear model and repeated measures analysis were conducted to report the parameter estimates, least square means, difference of least square means, and p values. Nonobese women presented with more contractions at baseline, 7 ± 5 versus 4 ± 5 c/h, p < .001. At all four time intervals after misoprostol administration obese women had fewer contractions per hour. The rate of change in contraction frequency after administration found obese women had a lower rate of increase in contraction frequency over the course of all four hours. We found a least squares means estimate (c/h): first hour (-0.87), p = .08, second hour (-2.43), p = .01, third hour (-1.80), p = .96, and fourth hour (-2.98), p = .007. Obese women have a lower rate of contractions per hour at baseline and at four intervals after misoprostol administration. In addition, the rate of change in the increase in contractions/hour also was reduced in obese women versus nonobese women. This suggests a lower bioavailability of misoprostol in women with a larger volume of distribution which would likely impact the efficacy of misoprostol in obese women when given the same dose of misoprostol. It is unknown if higher misoprostol dosing would increase efficacy of misoprostol in obese women.

Misoprostol Reverse Hippocampal Neuron Cyclooxygenase-2 Downstream Signaling Imbalance in Aluminum-Overload Rats

PubMed Central

Guo, Yuanxin; Lei, Wenjuan; Wang, Jianfeng; Hu, Xinyue; Wei, Yuling; Ji, Chaonan; Yang, Junqing

2016-01-01

Although COX-2 inhibition in animal models of neurodegenerative diseases has shown neuroprotection, recent studies have revealed some serious side effects (ulcers, bleeding, fatal cerebrovascular diseases etc.) and the limited benefits of COX-2 inhibitors. A more focused approach is necessary to explore the therapeutic effect of the COX downstream signaling pathway in neurological research. The aim of this study was to explore the alterations of the PGES-PGE2-EP signal pathway and the effect of misoprostol on neurodegeneration by chronic aluminum-overload in rats. Adult rats were treated by intragastric administration of aluminum gluconate. The PGE2 content and expression of PGES and EPs in the hippocampi of rats were detected using ELISA, q-PCR and Western blot analysis, respectively. The content of malondialdehyde (MDA) and the activity of superoxide dismutase (SOD) in the rat hippocampi were also detected. The misoprostol treatment dose-dependently improved spatial learning and memory function as well as healing after hippocampal neuron damage induced by chronic aluminum-overload in rats. Meanwhile, the administration of misoprostol resulted in a decrease in the PGE2 level and down-regulation of the mPGES-1, EP2 and EP4 expression levels, while there was a dose-dependent up-regulation of EP3 expression. These results suggest that misoprostol possesses a neuroprotective property, and the mechanism involves affecting the EP3 level and reducing the endogenous production of PGE2 through a negative feedback mechanism, increasing the EP3 expression level, decreasing the EP2 and EP4 expression levels, and rebuilding the mPGES-1-PGE2-EP1-4 signal pathway balance. In this way, misoprostol has a counteractive effect on oxidant stress and inflammation in the central nervous system. The PGES-PGE2-EPs signaling pathway is a potential therapeutic strategy for treating neurodegeneration in patients. PMID:27033056

Randomized Double Masked Trial of Zhi Byed 11, a Tibetan Traditional Medicine, Versus Misoprostol to Prevent Postpartum Hemorrhage in Lhasa, Tibet

PubMed Central

Miller, Suellen; Tudor, Carrie; Thorsten, Vanessa; Nyima; Kalyang; Sonam; Lhakpen; Droyoung; Quzong, Karma; Dekyi, Tsering; Hartwell, Ty; Wright, Linda L.; Varner, Michael W.

2009-01-01

The objective of this study was to compare a Tibetan traditional medicine (the uterotonic Zhi Byed 11 [ZB11]) to oral misoprostol for prophylaxis of postpartum hemorrhage (PPH). We conducted a double-blind randomized controlled trial at three hospitals in Lhasa, Tibet, People’s Republic of China. Women (N = 967) were randomized to either ZB11 or misoprostol groups. Postpartum blood loss was measured in a calibrated blood collection drape. The primary combined outcome was incidence of PPH, defined as measured blood loss (MBL) ≥ 500 mL, administration of open label uterotonics, or maternal death. We found that the rate of the combined outcome was lower among the misoprostol group (16.1% versus 21.8% for ZB11; P = .02). Frequency of PPH was lower with misoprostol (12.4% versus 17.4%; P = .02). There were no significant differences in MBL > 1000 mL or mean or median MBL. Fever was significantly more common in the misoprostol group (P = .03). The rate of combined outcome was significantly lower among women receiving misoprostol. However, other indices of obstetric hemorrhage were not significantly different. PMID:19249659

Administration of misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage in homebirths in Pakistan: a randomised placebo-controlled trial.

PubMed

Mobeen, N; Durocher, J; Zuberi, Nf; Jahan, N; Blum, J; Wasim, S; Walraven, G; Hatcher, J

2011-02-01

to determine if misoprostol is safe and efficacious in preventing postpartum haemorrhage (PPH) when administered by trained traditional birth attendants (TBA) at home deliveries. a randomised, double-blind, placebo-controlled trial. Chitral, Khyber Pakhtunkhwa Province, Pakistan. a total of 1119 women giving birth at home. from June 2006 to June 2008, consenting women were randomised to receive 600 microg oral misoprostol (n = 534) or placebo (n = 585) after delivery to determine whether misoprostol reduced the incidence of PPH (≥ 500 ml). the primary outcomes were measured blood loss ≥ 500 ml after delivery and drop in haemoglobin >2 g/dl from before to after delivery. oral misoprostol was associated with a significant reduction in the rate of PPH (≥ 500 ml) (16.5 versus 21.9%; relative risk 0.76, 95% CI 0.59-0.97). There were no measurable differences between study groups for drop in haemoglobin >2 g/dl (relative risk 0.79, 95% CI 0.62-1.02); but significantly fewer women receiving misoprostol had a drop in haemoglobin >3 g/dl, compared with placebo (5.1 versus 9.6%; relative risk 0.53, 95% CI 0.34-0.83). Shivering and chills were significantly more common with misoprostol. There were no maternal deaths among participants. postpartum administration of 600 microg oral misoprostol by trained TBAs at home deliveries reduces the rate of PPH by 24%. Given its ease of use and low cost, misoprostol could reduce the burden of PPH in community settings where universal oxytocin prophylaxis is not feasible. Continual training and skill-building for TBAs, along with monitoring and evaluation of programme effectiveness, should accompany any widespread introduction of this drug.

Sublingual misoprostol for management of empty sac or missed miscarriage: The first two years' experience at a metropolitan Australian hospital.

PubMed

Mcgee, Therese M; Diplock, Hayley; Lucewicz, Ania

2016-08-01

Misoprostol management of miscarriage is only now becoming widely used in Australia. To review the efficacy, safety and the popularity of outpatient sublingual misoprostol in empty sac/missed miscarriage management over its first two years of availability in a metropolitan Australian hospital. A retrospective cohort review was undertaken of women choosing sublingual misoprostol 600 μg (three tablets) × three doses for miscarriage management. Principal outcomes assessed were miscarriage resolution without the need for curettage and complications. Additionally, the relative popularity of misoprostol versus surgery by place of birth and over time, and the return of pregnancy tissue for histology were analysed. Between 1 December 2012 and 30 November 2014, 279 women chose sublingual misoprostol for nonurgent miscarriage management, while 420 chose surgery (40 and 60%, respectively). Of the misoprostol cohort, 269 had complete data; 239 of 269 (88.8%) had resolution without curettage, nine (3.3%) had acute curettage, 21 (7.8%) had nonacute curettage, 30 (11.15%) had unplanned emergency department presentation, 11 (4.1%) had unplanned admission, three (1.1%) had blood transfusion and one (0.4%) had an infection requiring admission. Misoprostol was as popular with Australian-born as overseas-born women; 53.5% of patients returned histopathology specimens; one (0.7%) demonstrated partial hydatidiform mole. Outpatient management of missed/empty gestational sac miscarriage using sublingual misoprostol is associated with a high rate of avoiding curettage and the low rate of complication. It is equally popular with Australian-born and overseas-born women. Just over 50% returned pregnancy tissue for analysis. © 2016 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Diclofenac/misoprostol: novel findings and their clinical potential.

PubMed

Shield, M J

1998-05-01

The new class of antiinflammatory and analgesic drugs, the selective cyclooxygenase (COX-2) inhibitors, which promise to be devoid of the types of toxicity associated with nonsteroidal antiinflammatory drugs (NSAID), especially adverse gastrointestinal effects, are under clinical trial but are not yet available for use. All NSAID, including those most recently introduced, exhibit nonselectivity of action, producing therapeutic blood levels that inhibit constitutive COX-1 and deplete tissue protective prostaglandins. Among NSAID, the diclofenac/misoprostol combination (Arthrotec) is unique in possessing an active component, misoprostol, to help prevent NSAID induced gastrointestinal damage. Ulcer damage and associated serious complications probably represent only the tip of the iceberg in relation to clinically significant side effects associated with the use of NSAID. In this context, metaanalysis of 8 large multicenter studies reported here has shown that patients taking NSAID show a mean decrease in hemoglobin over 4 - 12 weeks' assessment, with some 10-20% of patients exhibiting clinically significant decreases (> or = 1 g/dl) early in treatment. Patients taking diclofenac/misoprostol showed significantly less of a decline in hemoglobin and up to 50% fewer clinically significant decreases than patients receiving diclofenac alone. The misoprostol component of diclofenac/misoprostol may also help to restore homeostasis in tissues other than the gut. Inhibition of the activity or release of various tissue damaging agents and inflammatory cytokines, e.g., thromboxane and interleukin 1, are described, as are in vivo animal studies that have revealed synergistic or potentiating analgesic and antiinflammatory activities between misoprostol and NSAID, particularly diclofenac. Clinical studies in postsurgical dental pain in more than 500 patients have now shown enhanced analgesia, with greater relief over a longer period, for the diclofenac/misoprostol combination compared with diclofenac alone. The relevance of these findings to pain and inflammation control in arthritis is discussed. Enhanced control of morning stiffness provided by diclofenac/misoprostol, possibly also the result of misoprostol/diclofenac synergy, is also reported, and the development of an objective system that measures 24 hour ambulatory activity is described. Using this Numact recorder, improved mobility in patients receiving diclofenac 75 mg/misoprostol 200 microg was observed compared with patients treated with diclofenac 75 mg slow release. Further studies are being performed employing magnetic resonance imaging both to assess antiinflammatory effects in joint soft tissue architecture and to assess whether the synergistic stimulatory effects of diclofenac and misoprostol on human osteoarthritic cartilage that have been reported in vitro are clinically evident. A growing body of evidence supports the view that the diclofenac/misoprostol combination provides an improved therapeutic ratio over diclofenac alone, not only by improving gastrointestinal safety but also by enhancing analgesic/antiinflammatory effects.

Efficacy of misoprostol for the treatment of postpartum hemorrhage: current knowledge and implications for health care planning.

PubMed

Prata, Ndola; Weidert, Karen

2016-01-01

A myriad of interventions exist to treat postpartum hemorrhage (PPH), ranging from uterotonics and hemostatics to surgical and aortic compression devices. Nonetheless, PPH remains the leading cause of maternal mortality worldwide. The purpose of this article is to review the available evidence on the efficacy of misoprostol for the treatment of primary PPH and discuss implications for health care planning. Using PubMed, Web of Science, and GoogleScholar, we reviewed the literature on randomized controlled trials of interventions to treat PPH with misoprostol and non-randomized field trials with controls. We discuss the current knowledge and implications for health care planning, especially in resource-poor settings. The treatment of PPH with 800 μg of misoprostol is equivalent to 40 IU of intravenous oxytocin in women who have received oxytocin for the prevention of PPH. The same dose might be an option for the treatment of PPH in women who did not receive oxytocin for the prevention of PPH and do not have access to oxytocin for treatment. Adding misoprostol to standard uterotonics has no additional benefits to women being treated for PPH, but the beneficial adjunctive role of misoprostol to conventional uterotonics is important in reducing intra- and postoperative hemorrhage during cesarean section. Misoprostol is an effective uterotonic agent in the treatment of PPH. Clinical guidelines and treatment protocols should be updated to reflect the current knowledge on the efficacy of misoprostol for the treatment of PPH with 800 μg sublingually.

Oral misoprostol versus oxytocin in the management of the third stage of labour.

PubMed

Parsons, Steven M; Walley, Robert L; Crane, Joan M G; Matthews, Kay; Hutchens, Donna

2006-01-01

To compare the effects of oral misoprostol 800 mug with intramuscular oxytocin 10 IU in routine management of the third stage of labour. This randomized controlled trial was performed in a rural district hospital in Ghana, West Africa, and enrolled women in labour with anticipated vaginal delivery and no known medical contraindication to prostaglandin administration. Women were randomized to receive oral misoprostol 800 mug or intramuscular oxytocin 10 IU. Blood samples were taken to determine hemoglobin concentration before delivery and at 12 hours post partum. Treatment was administered at delivery of the anterior shoulder. The primary outcome was the change in hemoglobin concentration from before to after delivery. Secondary outcomes included other measures of blood loss and presumed medication side effects. In total, 450 women were enrolled in the study. Their baseline characteristics were similar. There was no significant difference between the groups in the change in hemoglobin concentration (misoprostol 1.07 g/dL and oxytocin 1.00 g/dL). The only significant secondary outcomes were shivering (80.7% with misoprostol vs. 3.6% with oxytocin) and pyrexia (11.4% with misoprostol, none with oxytocin). Routine use of oral misoprostol 800 microg appears to be as effective as 10 IU parenteral oxytocin in minimizing blood loss during the third stage of labour, as determined by change in hemoglobin concentration. Misoprostol appears to be a safe, inexpensive, and effective uterotonic for use in rural and remote areas, where intravenous oxytocin may be unavailable.

A phase III randomized, placebo-controlled, double-blind study of misoprostol rectal suppositories to prevent acute radiation proctitis in patients with prostate cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hille, Andrea; Schmidberger, Heinz; Hermann, Robert M.

2005-12-01

Purpose: Acute radiation proctitis is the most relevant complication of pelvic radiation and is still mainly treated supportively. Considering the negative impact of acute proctitis symptoms on patients' daily activities and the potential relationship between the severity of acute radiation injury and late damage, misoprostol was tested in the prevention of acute radiation-induced proctitis. Methods and Materials: A total of 100 patients who underwent radiotherapy for prostate cancer were entered into this phase III randomized, placebo-controlled, double-blind study with misoprostol or placebo suppositories. Radiation-induced toxicity was evaluated weekly during radiotherapy using the Common Toxicity Criteria. Results: Between the placebo andmore » the misoprostol groups, no significant differences in proctitis symptoms occurred: 76% of patients in each group had Grade 1 toxicity, and 26% in the placebo group and 36% in the misoprostol group had Grade 2 toxicity. No differences were found in onset or symptom duration. Comparing the peak incidence of patients' toxicity symptoms, significantly more patients experienced rectal bleeding in the misoprostol group (p = 0.03). Conclusion: Misoprostol given as a once-daily suppository did not decrease the incidence and severity of radiation-induced acute proctitis and may increase the incidence of acute bleeding.« less

Preventive Efficacy and Safety of Rebamipide in Nonsteroidal Anti-Inflammatory Drug-Induced Mucosal Toxicity

PubMed Central

Kim, Jeong Ho; Park, Soo-Heon; Cho, Chul-Soo; Lee, Soo Teik; Yoo, Wan-Hee; Kim, Sung Kook; Kang, Young Mo; Rew, Jong Sun; Park, Yong-Wook; Lee, Soo Kon; Lee, Yong Chan; Park, Won; Lee, Don-Haeng

2014-01-01

Background/Aims The use of proton pump inhibitors or misoprostol is known to prevent the gastrointestinal complications of nonsteroidal anti-inflammatory drugs (NSAIDs). Rebamipide is known to increase the mucosal generation of prostaglandins and to eliminate free oxygen radicals, thus enhancing the protective function of the gastric mucosa. However, it is unknown whether rebamipide plays a role in preventing NSAID-induced gastropathy. The aim of this study was to determine the effectiveness of rebamipide compared to misoprostol in preventing NSAID-induced gastrointestinal complications in patients requiring continuous NSAID treatment. Methods We studied 479 patients who required continuous NSAID treatment. The patients were randomly assigned to groups that received 100 mg of rebamipide three times per day or 200 μg of misoprostol three times per day for 12 weeks. The primary endpoint of the analysis was the occurrence rate of gastric ulcers, as determined by endoscopy after 12 weeks of therapy. Results Of the 479 patients in the study, 242 received rebamipide, and 237 received misoprostol. Ultimately, 44 patients (18.6%) withdrew from the misoprostol group and 25 patients (10.3%) withdrew from the rebamipide group. There was a significant difference in withdrawal rate between the two groups (p=0.0103). The per protocol analysis set was not valid because of the dropout rate of the misoprostol group; thus, the intention to treat (ITT) analysis set is the main set for the efficacy analysis in this study. After 12 weeks, the occurrence rate of gastric ulcers was similar in the rebamipide and misoprostol groups (20.3% vs 21.9%, p=0.6497) according to ITT analysis. In addition, the therapeutic failure rate was similar in the rebamipide and misoprostol groups (13.6% vs 13.1%, p=0.8580). The total severity score of the gastrointestinal symptoms was significantly lower in the rebamipide group than in the misoprostol group (p=0.0002). The amount of antacid used was significantly lower in the rebamipide group than in the misoprostol group (p=0.0258). Conclusions Rebamipide can prevent gastric ulcers when used with NSAIDs and can decrease the gastrointestinal symptoms associated with NSAID administration. When the possibility of poor compliance and the potential adverse effects of misoprostol are considered, rebamipide appears to be a clinically effective and safe alternative. PMID:25071901

Preventive efficacy and safety of rebamipide in nonsteroidal anti-inflammatory drug-induced mucosal toxicity.

PubMed

Kim, Jeong Ho; Park, Soo-Heon; Cho, Chul-Soo; Lee, Soo Teik; Yoo, Wan-Hee; Kim, Sung Kook; Kang, Young Mo; Rew, Jong Sun; Park, Yong-Wook; Lee, Soo Kon; Lee, Yong Chan; Park, Won; Lee, Don-Haeng

2014-07-01

The use of proton pump inhibitors or misoprostol is known to prevent the gastrointestinal complications of nonsteroidal anti-inflammatory drugs (NSAIDs). Rebamipide is known to increase the mucosal generation of prostaglandins and to eliminate free oxygen radicals, thus enhancing the protective function of the gastric mucosa. However, it is unknown whether rebamipide plays a role in preventing NSAID-induced gastropathy. The aim of this study was to determine the effectiveness of rebamipide compared to misoprostol in preventing NSAID-induced gastrointestinal complications in patients requiring continuous NSAID treatment. We studied 479 patients who required continuous NSAID treatment. The patients were randomly assigned to groups that received 100 mg of rebamipide three times per day or 200 μg of misoprostol three times per day for 12 weeks. The primary endpoint of the analysis was the occurrence rate of gastric ulcers, as determined by endoscopy after 12 weeks of therapy. Of the 479 patients in the study, 242 received rebamipide, and 237 received misoprostol. Ultimately, 44 patients (18.6%) withdrew from the misoprostol group and 25 patients (10.3%) withdrew from the rebamipide group. There was a significant difference in withdrawal rate between the two groups (p=0.0103). The per protocol analysis set was not valid because of the dropout rate of the misoprostol group; thus, the intention to treat (ITT) analysis set is the main set for the efficacy analysis in this study. After 12 weeks, the occurrence rate of gastric ulcers was similar in the rebamipide and misoprostol groups (20.3% vs 21.9%, p=0.6497) according to ITT analysis. In addition, the therapeutic failure rate was similar in the rebamipide and misoprostol groups (13.6% vs 13.1%, p=0.8580). The total severity score of the gastrointestinal symptoms was significantly lower in the rebamipide group than in the misoprostol group (p=0.0002). The amount of antacid used was significantly lower in the rebamipide group than in the misoprostol group (p=0.0258). Rebamipide can prevent gastric ulcers when used with NSAIDs and can decrease the gastrointestinal symptoms associated with NSAID administration. When the possibility of poor compliance and the potential adverse effects of misoprostol are considered, rebamipide appears to be a clinically effective and safe alternative.

Balancing the efficacy and safety of misoprostol: a meta-analysis comparing 25 versus 50 micrograms of intravaginal misoprostol for the induction of labour.

PubMed

McMaster, K; Sanchez-Ramos, L; Kaunitz, A M

2015-03-01

The optimal dose of misoprostol for the induction of labour remains uncertain. To compare the efficacy and safety of 25 versus 50 micrograms of intravaginal misoprostol tablets for the induction of labour and cervical ripening. We performed electronic and manual searches to identify relevant randomised trials. The efficacy outcomes assessed were rates of vaginal delivery within 24 hours, delivery within one dose, and oxytocin augmentation, and interval to delivery. The safety outcomes assessed were incidences of tachysystole, hyperstimulation, caesarean delivery, cesarean delivery for non-reassuring fetal heart rate (FHR), operative vaginal delivery, abnormal 5-minute Apgar score, abnormal cord gas values, admission to a neonatal intensive care unit (NICU), and meconium passage. Thirteen studies (1945 women) were included. Relative risk (RR) and 95% confidence intervals (CI) were calculated using fixed-effects and random-effects models. We found that 25 micrograms was less efficacious, with lower rates of delivery after one dose (RR 0.59; 95% CI 0.39-0.88) and vaginal delivery within 24 hours (RR 0.88; 95% CI 0.79-0.96), and with increased rates of oxytocin augmentation (RR 1.54, 95% CI 1.36-1.75). We noted an improved safety profile with 25 micrograms, however, with decreased rates of tachysystole (RR 0.46; 95% CI 0.35-0.61), hyperstimulation (RR 0.5; 95% CI 0.31-0.78), caesarean deliveries for non-reassuring FHR (RR 0.67; 95% CI 0.52-0.87), NICU admissions (RR 0.63; 95% CI 0.4-0.98), and meconium passage (RR 0.65; 95% CI 0.45-0.96). Although 50 micrograms of intravaginal misoprostol may be more efficacious, safety concerns make the 25-microgram dose preferable. © 2014 Royal College of Obstetricians and Gynaecologists.

A randomized trial of hospital vs home self administration of vaginal misoprostol for medical abortion.

PubMed

Shrestha, A; Sedhai, L B

2014-01-01

A combination of mifepristone followed after 24 hrs by misoprostol has proved a safe and effective abortifacient for termination of early pregnancy. Home use of misoprostol for medical abortion is still controversial in many countries including ours where women's literacy rate is low. Particularly in developing countries, this method markedly decreased the hospital visit which would be beneficial to patients and hospital staff. To see whether the home self administration of vaginal misoprostol was equally effective as administered by trained staff in terms of successful termination of early pregnancy. Secondary outcomes were bleeding and pain duration during medical abortion, side effects, reason for termination of pregnancy and women's acceptability of the procedure. One hundred and eighty eight women requesting medical abortion with pregnancy less than 63 days gestation were randomized into two groups either self administration of vaginal misoprostol (800 mcg) at home or hospital administration 24 hours after oral 200 mg mifepristone. Ultrasound was performed after 14 days to confirm complete abortion. The overall success rate was similar in two groups: 89.13% on home group Vs 86.9% in hospital group. Eleven out of 18 women (61.1%) having incomplete abortion had successful termination after 2nd dose misoprostol( 400 mcg). None of the women had continued pregnancy. Multigravida had slightly higher risk of failure (R.R: 1.04). Home self administration of vaginal misoprostol was safe and effective for early termination of medical abortion and was acceptable. Use of extra dose of misoprostol has advantage of higher completion rate of abortion.

Intraumbilical injection of three different uterotonics in the management of retained placenta.

PubMed

Harara, Rany; Hanafy, Sherif; Zidan, Mahmoud Saad Alsayed; Alberry, Medhat

2011-09-01

The aim of this work was to compare the effect of intraumbilical injection of three different uterotonic solutions in the management of retained placenta. This study was conducted in Ain-Shams University Maternity Hospital, Cairo, Egypt. A total of 78 women with retained placenta (>30 min after delivery of the fetus) were included in the study and subdivided into three groups. Each group was injected with a different type of uterotonic into the umbilical vein after clamping it using the Pipingas technique. Uterotonics used were either 20 IU oxytocin dissolved in 30 mL saline (n=26), ergometrine 0.2 mg dissolved in 30 mL saline (n=27) or misoprostol 800 µg dissolved in 30 mL saline (n=25). The overall success rate of spontaneous placental separation within 30 min after intraumbilical injection of uterotonics was 56/78 (71.79%). The success rate was higher with misoprostol when compared to oxytocin and ergometrine but the difference was not significant (20/25 [80%], 19/26 [73.08%], 17/27 [62.96%], respectively, P>0.05). The injection-to-separation interval was significantly shorter in the misoprostol group than in the oxytocin and ergometrine groups (7.0±2.2 min, 13.14±3.76 min, 22.5±4.37 min, respectively, P<0.001). Intraumbilical injection of uterotonics, namely oxytocin, ergometrine and dissolved misoprostol in saline, are closely effective in the management of retained placenta, with misoprostol being slightly more effective. This method may have a role in minimizing the need for manual removal of the placenta and its adverse sequelae. © 2011 The Authors. Journal of Obstetrics and Gynaecology Research © 2011 Japan Society of Obstetrics and Gynecology.

Oral or vaginal misoprostol administration for induction of labor: a randomized, double-blind trial.

PubMed

Adair, C D; Weeks, J W; Barrilleaux, S; Edwards, M; Burlison, K; Lewis, D F

1998-11-01

To compare the efficacy and vaginal birth intervals after intravaginal or oral misoprostol for labor induction. One hundred seventy-eight women were randomized to one of two double-blind groups: 1) oral misoprostol 200 microg and one-half tablet placebo intravaginal or 2) oral placebo tablet and one-half tablet of a 100-microg misoprostol intravaginal (dose 50 microg). Doses were repeated every 6 hours until labor was established (maximum of three doses). Ninety-three subjects were assigned to oral misoprostol and 85 to intravaginal administration. Oral administration was accompanied by significantly shorter intervals to the onset of uterine contractility (133+/-78 minutes versus 168+/-93, P < .01) but a higher incidence of abnormal uterine contractile activity (tachysystole 38.7% versus 20.0%, P < .01; hyperstimulation syndrome 44.1% versus 21.2%, P < .01). No adverse maternal or neonatal outcomes were noted, nor were there differences in cesarean delivery rates or total lengths of labor. Oral administration of 200 microg misoprostol has similar efficacy to intravaginal administration of 50 microg but is associated with more frequent abnormal uterine contractility.

Outcome of misoprostol and oxytocin in induction of labour

PubMed Central

Acharya, Trishna; Devkota, Ramesh; Bhattarai, Bimbishar; Acharya, Radha

2017-01-01

Background: Induction of labour is the process of initiating the labour by artificial means from 24 weeks of gestation. The main aim of this study is to find out the maternal and foetal outcomes after induction of labour with misoprostol and oxytocin beyond 37 weeks of gestation. Methods: This was a hospital-based observational study carried out at Paropakar Maternity and Women’s Hospital, Nepal. Misoprostol of 25 µg was inserted in posterior fornix of vagina or oxytocin infusion was started from 2.5 units on whom induction was decided. Maternal and foetal/neonatal outcomes were observed. Collected data were analysed using SPSS and MS Excel. Results: General induction rate was found to be 7.2%. In this study, post-term pregnancy was found to be the most common reason for induction of labour. Analysis of onset of labour led to the finding that mean onset of labour was much rapid in oxytocin (6.6 h) than misoprostol (13.6 h). However, there is similarity in induction–delivery interval in both groups. Overall, the rate of normal delivery and caesarean section was found to be 64.9% and 33.2%, respectively. Similarly, normal delivery within 12 h was seen in 18.4% of the patients given with misoprostol and 43.5% in oxytocin group. Foetal distress was found as the most common reason for caesarean section. The overall occurrence of maternal complication was found to be similar in misoprostol and oxytocin groups, nausea/vomiting being the most common (36.7%) complication followed by fever (24.1%). Besides this, the most common neonatal complication found in overall cases was meconium stained liquor (49.2%). Conclusion: It was found that misoprostol was used most frequently for induction of labour compared to oxytocin. The onset of labour was found to be rapid in oxytocin than misoprostol. However, the occurrence of side effects was found to be similar in both misoprostol and oxytocin groups. PMID:28540049

Should oral misoprostol be used to prevent postpartum haemorrhage in home-birth settings in low-resource countries? A systematic review of the evidence.

PubMed

Hundley, V A; Avan, B I; Sullivan, C J; Graham, W J

2013-02-01

Using misoprostol to prevent postpartum haemorrhage (PPH) in home-birth settings remains controversial. To review the safety and effectiveness of oral misoprostol in preventing PPH in home-birth settings. The Cochrane Library, PubMed, and POPLINE were searched for articles published until 31 March 2012. Studies, conducted in low-resource countries, comparing oral misoprostol with a placebo or no treatment in a home-birth setting. Studies of misoprostol administered by other routes were excluded. Data were extracted by two reviewers and independently checked for accuracy by a third. The quality of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. Data were sythesised and meta-analysis was performed where appropriate. Ten papers describing two randomised and four non randomised trials. Administration of misoprostol was associated with a significant reduction in the incidence of PPH (RR 0.58, 95% CI 0.38-0.87), additional uterotonics (RR 0.34, 95% CI 0.16-0.73), and referral for PPH (RR 0.49, 95% CI 0.37-0.66). None of the studies was large enough to detect a difference in maternal mortality, and none reported neonatal mortality. Shivering and pyrexia were the most common side effects. The finding that the distribution of oral misoprostol through frontline health workers is effective in reducing the incidence of PPH could be a significant step forwards in reducing maternal deaths in low-resource countries. However, given the limited number of high-quality studies in this review, further randomised controlled trials are required to confirm the association, particularly in different implementation settings. Adverse effects have not been systematically captured, and there has been limited consideration of the potential for inappropriate or inadvertent use of misoprostol. Further evidence is needed to inform the development of implementation and safety guidelines on the routine availability of misoprostol. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

Civil Society Organizations and medicines policy change: a case study of registration, procurement, distribution and use of misoprostol in Uganda.

PubMed

Atukunda, Esther Cathyln; Brhlikova, Petra; Agaba, Amon Ganafa; Pollock, Allyson M

2015-04-01

Misoprostol use for postpartum haemorrhage (PPH) has been promoted by Civil Society Organizations (CSOs) since the early 2000s. Yet, CSOs' role in improving access to misoprostol and shaping health policy at global and national levels is not well understood. We document the introduction of misoprostol in Uganda in 2008 from its registration, addition to treatment guidelines and national Essential Medicines List (EML), to its distribution and use. We then analyse the contribution of CSOs to this health policy change and service provision. Policy documents, procurement data and 82 key informant interviews with government officials, healthcare providers, and CSOs in four Ugandan districts of Kampala, Mbarara, Apac, Bundibugyo were collected between 2010 and 2013. Five key CSOs promoted and accelerated the rollout of misoprostol in Uganda. They supported the registration of misoprostol with the National Drug Authority, the development of clinical guidelines, and the piloting and training of health care providers. CSOs and National Medical Stores were procuring and distributing misoprostol country-wide to health centres two years before it was added to the clinical guidelines and EML of Uganda and in the absence of good evidence. The evidence suggests an increasing trend of misoprostol procurement and availability over the medicine of choice, oxytocin. This shift in national priorities has serious ramifications for maternal health care that need urgent evaluation. The absence of clinical guidelines in health centres and the lack of training preclude rational use of misoprostol. CSOs shifted their focus from the public to the private sector, where some of them continue to promote its use for off-label indications including induction of labour and abortion. There is an urgent need to build capacity to improve the robustness of the national and local institutions in assessing the safety and effectiveness of all medicines and their indications in Uganda. Copyright © 2015 Elsevier Ltd. All rights reserved.

Side effects of oral misoprostol for the prevention of postpartum hemorrhage: results of a community-based randomised controlled trial in rural India.

PubMed

Patted, Shobhana S; Goudar, Shivaprasad S; Naik, Vijaya A; Bellad, Mrutyunjaya B; Edlavitch, Stanley A; Kodkany, Bhalchandra S; Patel, Ashlesha; Chakraborty, Hrishikesh; Derman, Richard J; Geller, Stacie E

2009-01-01

To investigate the side effects of 600 microg oral misoprostol given for the mother and the newborn to prevent postpartum hemorrhage (PPH). One thousand six hundred twenty women delivering at home or subcentres in rural India were randomised to receive misoprostol or placebo in the third stage of labour. Women were evaluated for shivering, fever, nausea, vomiting and diarrhea at 2 and 24 h postpartum. Newborns were evaluated within 24 h for diarrhea, vomiting and fever. Symptoms were graded as absent, mild-to-moderate or severe. Women who received misoprostol had a significantly greater incidence of shivering (52%vs. 17%, p < 0.001) and fever (4.2%vs. 1.1%, p < 0.001) at 2 h postpartum compared with women who received placebo. At 24 h, women in the misoprostol group experienced significantly more shivering (4.6%vs. 1.4%, p < 0.001) and fever (1.4%vs. 0.4%, p < 0.03). There were no differences in nausea, vomiting or diarrhea between the two groups. There were no differences in the incidence of vomiting, diarrhea or fever for newborns. Misoprostol is associated with a significant increase in postpartum maternal shivering and fever with no side effects for the newborn. Given its proven efficacy for the prevention of PPH, the benefits of misoprostol are greater than the associated risks.

Reduction of aspirin-induced fecal blood loss with low-dose misoprostol tablets in man

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cohen, M.M.; Clark, L.; Armstrong, L.

Misoprostol (SC-29333), a synthetic prostaglandin E1 methyl ester analog, was given simultaneously with acetylsalicylic acid in a double-blind, placebo-controlled randomized prospective study of 32 healthy human male subjects. Fecal blood loss was measured for eight days using the /sup 51/Cr-labeled red blood cell technique. Aspirin (650 mg qid) and misoprostol (25 micrograms qid) or placebo were given during days 3, 4, and 5. There was a significant (P less than 0.05) increase in median blood loss (modified Friedman test) from 0.81 to 6.05 ml/day in the aspirin with placebo group (N = 16). Median blood loss was increased (from 0.75more » to 3.75 ml/day) in the aspirin with misoprostol group (N = 16), but this was significantly less (Mann-Whitney U test, P less than 0.01) than the placebo group. Mean serum salicylate concentrations in the placebo and misoprostol groups were similar (7.8 and 6.8 micrograms/ml, respectively). There were no significant changes in laboratory values in any of the subjects studied, nor were any major side-effects encountered. This study demonstrates that oral misoprostol reduces aspirin-induced gastrointestinal bleeding even when administered simultaneously and at a dose level below its threshold for significant acid inhibition. This indicates a potential role for misoprostol in the prevention of gastric mucosal damage in selected patients.« less

A comparative study of DA-9601 and misoprostol for prevention of NSAID-associated gastroduodenal injury in patients undergoing chronic NSAID treatment.

PubMed

Lee, Oh Young; Kang, Dae-Hwan; Lee, Dong Ho; Chung, Il-Kwun; Jang, Jae Young; Jang, Jae-Young; Kim, Jin-Il; Cho, Jin-Woong; Rew, Jong-Sun; Lee, Kang-Moon; Kim, Kyoung Oh; Choi, Myung-Gyu; Lee, Sang-Woo; Lee, Soo-Teik; Kim, Tae-Oh; Shin, Yong-Woon; Seol, Sang-Yong

2014-10-01

Misoprostol is reported to prevent non-steroidal anti-inflammatory drug (NSAID)-associated gastroduodenal complications. There is, however, limited information regarding the efficacy of DA-9601 in this context. We performed a comparative study on the relative efficacy of DA-9601 and misoprostol for prevention of NSAID-associated complications. In this multicenter, double-blinded, active-controlled, stratified randomized, parallel group, non-inferiority trial, 520 patients who were to be treated with an NSAID (aceclofenac, 100 mg, twice daily) over a 4-week period were randomly assigned to groups for coincidental treatment with DA-9601 (60 mg, thrice daily) (236 patients for full analysis) or misoprostol (200 μg, thrice daily) (242 patients for full analysis). [corrected]. The primary endpoint was the gastric protection rate, and secondary endpoints were the duodenal protection rate and ulcer incidence rate. Endpoints were assessed by endoscopy after the 4-week treatment period. Drug-related adverse effects, including gastrointestinal (GI) symptoms, were also compared. At week 4, the gastric protection rates with DA-9601 and misoprostol were 81.4 % (192/236) and 89.3 % (216/242), respectively. The difference between the groups was -14.2 %, indicating non-inferiority of DA-9601 to misoprostol. Adverse event rates were not different between the two groups; however, the total scores for GI symptoms before and after administration were significantly lower in the DA-9601 group than in the misoprostol group (-0.2 ± 2.8 vs 1.2 ± 3.2; p < 0.0001). DA-9601 is as effective as misoprostol in preventing NSAID-associated gastroduodenal complications, and has a superior adverse GI effect profile.

Shortening the induction delivery interval with prostaglandins: a randomized controlled trial of solo or in combination

PubMed Central

Mahendru, Rajiv; Yadav, Shweta

2011-01-01

Objective To compare the efficacy and safety of misoprostol alone with dinoprostone followed by misoprostol, all inserted intravaginally in induction of labor at term and the obstetrical outcome. Material and Methods A pilot study comprising 111 primigravidae, >37 gestational weeks with singleton pregnancy in cephalic presentation having an unfavorable Bishop score admitted for labor induction, were considered and randomly allocated into two groups. In group I (n=55) with intravaginal 25mcg misoprostol 4 hourly (six doses at the most) and and group II (n=56), with dinoprostone 0.5mg followed eight hours later by 25mcg misoprostol induction to vaginal delivery time was found to be significantly different, being 14.8 h in group-I and shorter in group-II with a mean of 11.6 h. Vaginal delivery rates within 12 h (groups-I and −II: 47.2%, as compared to 60.7%, respectively) were found to be higher with dinoprostone-misoprostol induction, as well as vaginal delivery rates in 24 h, 80.0% and 91.1%. The need for oxytocin augmentation was more frequent in the misoprostol than in the dinoprostone-misoprostol group, (61.8%, and 39.3%), and all these observations were statistically significant. Abnormal foetal heart rate pattern occurred more frequently (18.2%) in group-I in contrast to 5.3% in group-II, as was the incidence rate of (18.2%) who had passage of meconium in group-I, this rate being significantly different from group-II having meconium passage in 3 cases, a rate of 5.3%. Conclusion Using dinoprostone followed by vaginal misoprostol is safe and effective for induction of labor with less need for oxytocin augmentation and shorter induction delivery interval. PMID:24591967

Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis.

PubMed

Lin, Monique G; Nuthalapaty, Francis S; Carver, Alissa R; Case, Ashley S; Ramsey, Patrick S

2005-09-01

To systematically review published data evaluating the comparative use of misoprostol with placebo/expectant management or oxytocin for labor induction in women with term (> or = 36 weeks of gestation) premature rupture of membranes. PubMed (1966-2005), Ovid (1966-2005), CINAHL, The Cochrane Library, ACP Journal Club, OCLC, abstracts from scientific forums, and bibliographies of published articles were searched using the following keywords: premature rupture of membranes, misoprostol, labor induction, and cervical ripening. Primary authors were contacted directly if the data sought were unavailable or only published in abstract form. Only randomized controlled trials evaluating the efficacy and safety of misoprostol in comparison with placebo or expectant management (n = 6) and oxytocin (n = 9) published in either article or abstract form were analyzed and included in the meta-analysis. Studies were reviewed independently by all authors. Meta-analysis was performed, and the relative risks (RRs) were calculated and pooled for each study outcome. Misoprostol, compared with placebo, significantly increased vaginal delivery less than 12 hours (RR 2.71, 95% confidence interval [CI] 1.87-3.92, P < .001). Misoprostol was similar to oxytocin with respect to vaginal delivery less than 24 hours (RR 1.07, 95% CI 0.88-1.31, P = .50) and less than 12 hours (RR 0.98, 95% CI 0.71-1.35, P = .90). Misoprostol was not associated with an increased risk of tachysystole, hypertonus, or hyperstimulation syndrome when compared with oxytocin and had similar risks for adverse neonatal and maternal outcomes. Misoprostol is an effective and safe agent for induction of labor in women with term premature rupture of membranes. When compared with oxytocin, the risk of contraction abnormalities and the rate of maternal and neonatal complications were similar among the 2 groups.

Second trimester medical abortion with mifepristone followed by unlimited dosing of buccal misoprostol in Armenia.

PubMed

Louie, Karmen S; Chong, Erica; Tsereteli, Tamar; Avagyan, Gayane; Abrahamyan, Ruzanna; Winikoff, Beverly

2017-02-01

The aim of the study was to assess the efficacy and acceptability of a regimen using mifepristone and buccal misoprostol with unlimited dosing for second trimester abortion in Armenia. Women seeking to terminate 13-22 week pregnancies were enrolled in the study. Participants swallowed 200 mg mifepristone in the clinic and were instructed to return to the hospital for induction 24-48 h later. During induction, women were given 400 μg buccal misoprostol every 3 h until the fetus and placenta were expelled. The abortion was considered a success if complete uterine evacuation was achieved without oxytocin or surgery. A total of 120 women with a median gestational age of 18 weeks participated in the study. All women began misoprostol induction around 24 h after taking mifepristone. Complete uterine evacuation was achieved in 119 (99.2%) women. The median induction-to-abortion interval was 10.3 h (range 4-17.4) with a mean of 9.5 ± 2.5 h. A median of four misoprostol doses (range 2-6) with a mean of 4 ± 1 misoprostol doses were administered. The induction-to-abortion interval, number of misoprostol doses, pain score and analgesia use increased as gestational age advanced. Acceptability of the method was high among both patients and providers. The medical abortion regimen of 200 mg mifepristone followed 24 h later by induction with 400 μg buccal misoprostol administered every 3 h, with no limit on the number of doses used for the termination of pregnancies of 13-22 weeks' gestation is an effective and acceptable option for women.

Effect of misoprostol on patients with aspirin-exacerbated respiratory disease undergoing aspirin challenge and desensitization.

PubMed

Walters, Kristen M; Simon, Ronald A; Woessner, Katharine M; Wineinger, Nathan E; White, Andrew A

2017-07-01

Prostaglandin E 2 (PGE 2 ) is an anti-inflammatory compound that inhibits 5-lipoxygenase activity. Diminished PGE 2 regulation in aspirin-exacerbated respiratory disease (AERD) leads to respiratory reactions on cyclooxygenase 1 inhibition. In vitro studies have found that exogenous PGE 2 stabilizes inflammatory mediator release. To examine whether misoprostol (oral prostaglandin E 1 analogue) use during aspirin challenge and desensitization might decrease the severity of aspirin-induced symptoms and make desensitization safer for patients with AERD. Forty-five patients undergoing aspirin challenge and/or desensitization were randomized to misoprostol (n = 30) or placebo (n = 15) and compared with a group of historical controls (n = 31). Misoprostol (200 μg) was administered at 30 minutes, 90 minutes, and 4 hours after the first dose of nasal ketorolac. Measured end points included change in forced expiratory volume in 1 second (FEV 1 ), peak nasal inspiratory flow rate (PNIF), number of treatments received for induced reactions, and adverse gastrointestinal effects. A difference in FEV 1 and PNIF reduction was detected between misoprostol and placebo (P = .03) and misoprostol and historical controls (P = .01), respectively, during nasal ketorolac challenge. No difference was detected among aspirin reactors. Among all reactors, no difference in magnitude was found for FEV 1 (P = .13) or PNIF (P = .07) reduction across all 3 groups. Total treatment requirement was similar (P = .14). Patients receiving misoprostol were more likely to report adverse gastrointestinal effects (P = .02). The addition of misoprostol to current aspirin challenge and/or desensitization protocols reveals no protective effect in reducing the intensity of nonsteroidal anti-inflammatory drug-induced symptoms and is not recommended based on the findings in this study. Copyright © 2017 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

High fever following postpartum administration of sublingual misoprostol.

PubMed

Durocher, J; Bynum, J; León, W; Barrera, G; Winikoff, B

2010-06-01

To explore what triggers an elevated body temperature of > or =40.0 degrees C in some women given misoprostol, a prostaglandin E1 analogue, for postpartum haemorrhage (PPH). Post hoc analysis. One tertiary-level hospital in Quito, Ecuador. A cohort of 58 women with a fever of above 40 degrees C following treatment with sublingual misoprostol (800 micrograms) for PPH. Side effects were documented for 163 Ecuadorian women given sublingual misoprostol to treat their PPH. Women's body temperatures were measured, and if they had a fever of > or =40.0 degrees C, measurements were taken hourly until the fever subsided. Temperature trends were analysed, and the possible physiological mechanisms by which postpartum misoprostol produces a high fever were explored. The onset, duration, peak temperatures, and treatments administered for cases with a high fever. Fifty-eight of 163 women (35.6%) treated with misoprostol experienced a fever of > or =40.0 degrees C. High fevers followed a predictable pattern, often preceded by moderate/severe shivering within 20 minutes of treatment. Body temperatures peaked 1-2 hours post-treatment, and gradually declined over 3 hours. Fevers were transient and did not lead to any hospitalisation. Baseline characteristics were comparable among women who did and did not develop a high fever, except for known previous PPH and time to placental expulsion. An unexpectedly high rate of elevated body temperature of > or =40.0 degrees C was documented in Ecuador following sublingually administered misoprostol. It is unclear why temperatures > or =40.0 degrees C occurred with a greater frequency in Ecuador than in other study populations using similar treatment regimens for PPH. Pharmacogenetic studies may shed further light on variations in individuals' responses to misoprostol.

High fever following postpartum administration of sublingual misoprostol

PubMed Central

Durocher, J; Bynum, J; León, W; Barrera, G; Winikoff, B

2010-01-01

Objective To explore what triggers an elevated body temperature of ≥40.0°C in some women given misoprostol, a prostaglandin E1 analogue, for postpartum haemorrhage (PPH). Design Post hoc analysis. Setting One tertiary-level hospital in Quito, Ecuador. Population A cohort of 58 women with a fever of above 40°C following treatment with sublingual misoprostol (800 micrograms) for PPH. Methods Side effects were documented for 163 Ecuadorian women given sublingual misoprostol to treat their PPH. Women’s body temperatures were measured, and if they had a fever of ≥40.0°C, measurements were taken hourly until the fever subsided. Temperature trends were analysed, and the possible physiological mechanisms by which postpartum misoprostol produces a high fever were explored. Main outcome measures The onset, duration, peak temperatures, and treatments administered for cases with a high fever. Results Fifty-eight of 163 women (35.6%) treated with misoprostol experienced a fever of ≥40.0°C. High fevers followed a predictable pattern, often preceded by moderate/severe shivering within 20 minutes of treatment. Body temperatures peaked 1–2 hours post-treatment, and gradually declined over 3 hours. Fevers were transient and did not lead to any hospitalisation. Baseline characteristics were comparable among women who did and did not develop a high fever, except for known previous PPH and time to placental expulsion. Conclusions An unexpectedly high rate of elevated body temperature of ≥40.0°C was documented in Ecuador following sublingually administered misoprostol. It is unclear why temperatures ≥40.0°C occurred with a greater frequency in Ecuador than in other study populations using similar treatment regimens for PPH. Pharmacogenetic studies may shed further light on variations in individuals’ responses to misoprostol. PMID:20406228

Side effects of oral misoprostol during the first 24 hours after administration in the third stage of labour.

PubMed

Lumbiganon, Pisake; Villar, José; Piaggio, Gilda; Gülmezoglu, A Metin; Adetoro, Lekan; Carroli, Guillermo

2002-11-01

To evaluate the side effects of 600 microg misoprostol orally during the first 24 hours after administration in the third stage of labour. Double blind randomised controlled trial. Tertiary care hospitals in Nigeria and Thailand. All women participating in the WHO Misoprostol trial in these two hospitals between January 1, 1999 and June 17, 1999. All women were followed up during the first 24 hours postpartum to evaluate the occurrence of shivering, nausea, vomiting, diarrhoea and other misoprostol-related side effects. Rates of shivering, nausea, vomiting, diarrhoea and pyrexia within 1 hour and in the intervals 2-6, 7-12, 13-18 and 19-24 hours after delivery. A total of 1686 women were enrolled. Women who received misoprostol had higher incidence than the oxytocin group of 'any' shivering in the first hour (RR 6.4, 95% CI 3.9 to 10.4) and the period covering 2-6 hours following delivery (RR 4.7, 95% CI 1.9 to 11.2). Pyrexia was also more common in the misoprostol group in both the same time intervals (RR 2.8, 95% CI 1.4 to 5.3 and RR 6.3, 95% CI 3.7 to 10.8, respectively). Diarrhoea was not present in the first hour in either group but appeared in the second time period (2-6 hours) and third time period (7-12 hours) more frequently in the misoprostol group than with oxytocin. The increased incidence of shivering and pyrexia that occurs with postpartum use of misoprostol persists up to 6 hours following delivery. Approximately 5% of women experience diarrhoea that starts after 1 hour and subsides within 12 hours.

Sublingual misoprostol and hyperpyrexia: case report with temperature curve.

PubMed

Tolefac, Paul Nkemtendong; Minkande, Jacqueline Ze

2017-07-26

Misoprostol has a wide range of applications in obstetrics and gynaecology. It is widely recommended by WHO, FIGO and ACOG for the treatment of postpartum haemorrhage due to it safety and cost-effectiveness. However, usage might be associated to hyperpyrexia and shivering. We present a 30 year old Cameroonian female gravida 1 para 1 who had a vaginal delivery at 40 weeks of gestation complicated by primary postpartum haemorrhage (PPH). PPH was managed by sublingual misoprostol that induced shivering and hyperpyrexia managed successfully with paracetamol and cooling. The occurrence of fever and shivering should be kept in mind when administering misoprostol for PPH.

[Illegal abortion with misoprostol in Guadeloupe].

PubMed

Manouana, M; Kadhel, P; Koffi, A; Janky, E

2013-04-01

The aim of this study was to describe the typical profile, and to assess the motivations of women who underwent illegal abortion with misoprostol in Guadeloupe (French West Indies). We conducted a 1-year prospective study on women who consulted after failure or complication of an illegal abortion with misoprostol. Fifty-two cases of illegal abortion with misoprostol were recorded. The most common profile was an unemployed woman, who was unmarried, foreign-born, had no medical insurance, and a low level of education; the median age was 28 (range 17 to 40). The justifications given were that the legal procedure was considered to be too slow, the young age of the woman, the ease of the self-medication procedure, a history of illegal abortion by misoprostol in the woman's country of origin, ignorance of the legal process, and financial and/or administrative problems. The problem of illegal abortion is probably underestimated in Guadeloupe and possibly France. This description of the profile of the population concerned and the justifications for choosing illegal abortion by misoprostol provides elements allowing better focus of education concerning abortion, contraception and family planning. Access to legal abortion centers should also be improved. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Off-label use of misoprostol in gynaecology

PubMed Central

Turner, JV; Agatonovic-Kustrn, S; Ward, HRG

2015-01-01

Clinical use of drugs is approved for specified clinical indication, route of administration, dose and population group. Off-label prescribing of a registered medicine occurs outside of these parameters and may be justified by pharmacology and physiology, as well as sufficient evidence from published clinical trials and reviews. Misoprostol and mifepristone in combination have recently been registered in Australia for medical termination of pregnancy in women of child-bearing age. There is good clinical evidence for efficacy and safety of misoprostol in uterine evacuation in both miscarriage and termination of pregnancy. The pharmacological effects of misoprostol on the uterus and clinical outcomes in both early miscarriage and abortion are comparable. Medical management of miscarriage with misoprostol in Australia is performed off-label. A woman presenting with first trimester miscarriage must be clearly informed that use of misoprostol in her case is for a non-approved indication. This raises the issue of inequity in her management compared with that of first trimester medical abortion, including being treated off-label and the potential cost of non-subsidised medication. The clinician must also be careful to use an evidence-based protocol that would withstand medicolegal challenge in the case of an adverse outcome. PMID:27729972

A randomized trial of misoprostol versus extra-amniotic sodium chloride infusion with oxytocin for induction of labor.

PubMed

Buccellato, C A; Stika, C S; Frederiksen, M C

2000-05-01

Our purpose was to compare the efficacy and safety of misoprostol and extra-amniotic sodium chloride infusion with oxytocin for induction of labor. This randomized trial compared two methods of labor induction in women requiring cervical ripening. One hundred twenty-three women undergoing labor induction with a Bishop score < or =5 were randomly selected to receive either misoprostol, 50 microg intravaginally every 4 hours, or extra-amniotic sodium chloride infusion. The primary outcome variable was the time interval from induction to vaginal delivery. Sixty-one women received extra-amniotic sodium chloride infusion and 62 women received misoprostol. The mean time interval from the start of induction to vaginal delivery was 15.0 +/- 5.0 hours and 16.5 +/- 7.2 hours for the extra-amniotic infusion and misoprostol groups, respectively (P, not significant). The cesarean delivery rate was not significantly different between the 2 groups (32.8% for the extra-amniotic infusion group; 19.4% for the misoprostol group). Maternal and neonatal outcomes were similar between the 2 groups. Both methods of induction are equally efficacious and result in similar maternal and neonatal outcomes.

Morphological, biochemical, histological, and ultrastructural protective effects of misoprostol on cisplatin induced-hepatotoxicity in adult male rats.

PubMed

Nasr, Ashraf Y

2013-12-01

To investigate the possible protective effect of misoprostol on cisplatin-induced hepatotoxicity. Four-equal sized groups (control, cisplatin-treated, misoprostol-treated, combined misoprostol, and cisplatin-treated) adult male Wistar rats (6 each) were used in this study. Body weight, liver weight, and liver weight/body weight ratio was calculated. Blood samples were obtained from the hearts of rats to determine the levels of total serum bilirubin (TSB), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and albumin. Liver specimens were prepared for both light and electron microscopes. The study was carried out between June 2012 and April 2013 at the Anatomy Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt, and the Department of Anatomy, Faculty of Medicine, King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia. A single cisplatin dose (7.5 mg/kg intraperitoneally) resulted in significant elevation of AST, ALT, and TSB serum levels, and a significant reduction of serum albumin level, body weight, liver weight, and liver weight/body weight ratio. A combination of misoprostol (200 ug/kg/day) with cisplatin improved most of the previous parameters. Examination of specimens by both light and electron microscopes revealed pericentral hepatic necrosis, periportal fibrosis, dilatation, and congestion of central vein and blood sinusoids, diminished glycogen content, degenerated mitochondria, vesicular dilated rough endoplasmic reticulum, and nuclear changes in cisplatin-treated rats. Oral intake of misoprostol with cisplatin improved many of these changes. The results indicate that misoprostol may have a protective effect on cisplatin-induced hepatotoxicity.

Side-effects of oral misoprostol in the third stage of labour--a randomised placebo-controlled trial.

PubMed

Hofmeyr, G J; Nikodem, V C; de Jager, M; Drakely, A

2001-05-01

Misoprostol, an inexpensive, stable, orally active prostaglandin analogue, has been suggested for use in the prevention of postpartum haemorrhage. Potential side-effects, however, need to be quantified. To compare the rate of postpartum shivering and pyrexia following oral misoprostol 600 micrograms and placebo. A double-blind placebo-controlled trial. Women in labour were randomly allocated to receive either misoprostol 600 micrograms orally or placebo after delivery. Conventional oxytocics were given immediately if blood loss was thought to be more than usual. Side-effects were recorded. Postpartum blood loss in the first hour was measured by collection in a special flat plastic bedpan. The labour ward of an academic hospital in Johannesburg, with 7,000 deliveries per annum. Shivering and pyrexia. The groups were well matched. Misoprostol use was associated with more shivering (44% versus 11%, relative risk (RR) 4.03, 95% confidence interval (CI) 2.85-5.70), pyrexia > or = 37.8 degrees C (38% v. 6%, RR 6.23, CI 3.89-9.97), 1-hour systolic blood pressure > or = 140 mmHg (33% v. 25%, RR 1.32, CI 1.03-1.70), and diastolic blood pressure > or = 90 mmHg (10.5% v. 3.0%, RR 3.44, CI 1.67-7.11). There were no other significant differences. The study was not designed to be large enough to assess a difference in blood loss > or = 1,000 ml (9% v. 9.7%, RR 0.93, CI 0.56-1.53). Possible effects on blood loss may have been obscured by the lesser use of additional oxytocics in the misoprostol group (14% v. 18%, RR 0.78, CI 0.54-1.13). This study has shown the association of postpartum oral misoprostol 600 micrograms with shivering, pyrexia and hypertension. The increased blood pressure, as for the trend towards increased abdominal pain, may be secondary to the uterotonic effect of misoprostol. Large randomised trials are needed to assess the effectiveness of misoprostol in the prevention of postpartum haemorrhage, against which the disadvantages demonstrated here can be weighed.

Prevention of postpartum hemorrhage at home birth in Afghanistan.

PubMed

Sanghvi, Harshadkumar; Ansari, Nasratullah; Prata, Ndola J V; Gibson, Hannah; Ehsan, Aftab T; Smith, Jeffrey M

2010-03-01

To test the safety, acceptability, feasibility, and effectiveness of community-based education and distribution of misoprostol for prevention of postpartum hemorrhage at home birth in Afghanistan. A nonrandomized experimental control design in rural Afghanistan. A total of 3187 women participated: 2039 in the intervention group and 1148 in the control group. Of the 1421 women in the intervention group who took misoprostol, 100% correctly took it after birth, including 20 women with twin pregnancies. Adverse effect rates were unexpectedly lower in the intervention group than in the comparison group. Among women in the intervention group, 92% said they would use misoprostol in their next pregnancy. In the intervention area where community-based distribution of misoprostol was introduced, near-universal uterotonic coverage (92%) was achieved compared with 25% coverage in the control areas. In Afghanistan, community-based education and distribution of misoprostol is safe, acceptable, feasible, and effective. This strategy should be considered for other countries where access to skilled attendance is limited.

Association between infection and fever in terminations of pregnancy using misoprostol: a retrospective cohort study.

PubMed

Nijman, Tobias A J; Voogdt, Kevin G J A; Teunissen, Pim W; van der Voorn, Patrick J Jp; de Groot, Christianne J M; Bakker, Petra C A M

2017-01-05

Fever is a well-known side effect of misoprostol, but clinically difficult to distinguish from an intra uterine infection. The aim of this study was to determine the incidence of fever in terminations of pregnancy (TOP) using misoprostol and to evaluate fever as indication of intra uterine infection. A retrospective cohort study was performed. Consecutive second trimester TOP with misoprostol between January 2008 and October 2012 were selected. We included 403 cases and determined the incidence of fever. To examine intra uterine infection as plausible cause of fever, pathological examination reports of placentas were reviewed for signs of infections. The incidence of fever was 42%. Logistic regression showed a dose dependent association between dosage misoprostol and degree of fever (OR 1.86; 95% CI: 1.3-2.7). There was no association between fever and epidural analgesia. Fever has a sensitivity of 55% and a specificity of 58% as a marker of intra uterine infection. The positive predictive value of fever for an intra uterine infection is 4% and the negative predictive value is 98%. Administration of misoprostol for the indication TOP is strongly associated with fever during labor. Fever is a poor predictor of intra uterine infection in the context of TOP.

Availability and provision of misoprostol and other medicines for menstrual regulation among pharmacies in Bangladesh via mystery client survey.

PubMed

Huda, Fauzia A; Ngo, Thoai D; Ahmed, Anisuddin; Alam, Anadil; Reichenbach, Laura

2014-02-01

To explore the availability and provision of misoprostol and other medicines for menstrual regulation (MR) among pharmacies in Bangladesh. Between March and November 2011, a cross-sectional study using mystery client visits was conducted among pharmacy workers in Dhaka and Gazipur Districts, Bangladesh. Mystery clients were trained to present 1 of 4 pre-developed situations to pharmacy workers to elicit information on the regimen, adverse effects, and complications of misoprostol use. Mystery clients visited 331 pharmacies. Among the 331 pharmacy workers, 45.8% offered the mystery clients misoprostol and/or other medicines for MR; 25.7% referred them to private clinics or hospitals. Only 7% recommended an effective regimen of misoprostol for MR; 65% suggested administering vaginal and oral misoprostol together. Overall, 72.4% did not provide any advice on complications; the remainder suggested visiting trained providers for complications. Counseling on excessive bleeding as a danger sign was provided by 46% of pharmacy workers. Most (94%) did not provide or refer for post-MR family planning. Pharmacy workers in urban Bangladesh are providing ineffective drugs and regimens for MR. A training package is needed to strengthen service delivery by providing accurate information, high-quality products, and referral mechanisms for women seeking MR through pharmacies. © 2013.

Misoprostol, an anti-ulcer agent and PGE2 receptor agonist, protects against cerebral ischemia.

PubMed

Li, Jun; Liang, Xibin; Wang, Qian; Breyer, Richard M; McCullough, Louise; Andreasson, Katrin

2008-06-20

Induction of COX-2 activity in cerebral ischemia results in increased neuronal injury and infarct size. Recent studies investigating neurotoxic mechanisms of COX-2 demonstrate both toxic and paradoxically protective effects of downstream prostaglandin receptor signaling pathways. We tested whether misoprostol, a PGE(2) receptor agonist that is utilized clinically as an anti-ulcer agent and signals through the protective PGE(2) EP2, EP3, and EP4 receptors, would reduce brain injury in the murine middle cerebral artery occlusion-reperfusion (MCAO-RP) model. Administration of misoprostol, at the time of MCAO or 2h after MCAO, resulted in significant rescue of infarct volume at 24 and 72h. Immunocytochemistry demonstrated dynamic regulation of the EP2 and EP4 receptors during reperfusion in neurons and endothelial cells of cerebral cortex and striatum, with limited expression of EP3 receptor. EP3-/- mice had no significant changes in infarct volume compared to control littermates. Moreover, administration of misoprostol to EP3+/+ and EP3-/- mice showed similar levels of infarct rescue, indicating that misoprostol protection was not mediated through the EP3 receptor. Taken together, these findings suggest a novel function for misoprostol as a protective agent in cerebral ischemia acting via the PGE(2) EP2 and/or EP4 receptors.

The added value of mifepristone to non-surgical treatment regimens for uterine evacuation in case of early pregnancy failure: a systematic review of the literature.

PubMed

van den Berg, Joyce; Gordon, Bernardus B M; Snijders, Marcus P M L; Vandenbussche, Frank P H A; Coppus, Sjors F P J

2015-12-01

Early pregnancy failure (EPF) is a common complication of pregnancy. Surgical intervention carries a risk of complications and, therefore, medical treatment appears to be a safe alternative. Unfortunately, the current medical treatment with misoprostol alone has complete evacuation rates between 53% and 87%. Some reports suggest that sequential treatment with mifepristone and misoprostol leads to higher success rates than misoprostol alone. To evaluate the added value of mifepristone to current non-surgical treatment regimens in women with EPF we performed a systematic literature search. Electronic databases were searched: PubMed, Cochrane Library, Current Controlled Trials, and ClinicalTrials.gov. Clinical studies, both randomised and non-randomised trials, reporting on the added value of mifepristone to current non-surgical treatment regimens in women with EPF were included. Data of sixteen studies were extracted using a data extraction sheet (based on the Cochrane Consumers and Communication Review Group's data extraction template). The methodological quality was assessed using the Cochrane Collaboration Risk of Bias tool. In five randomised and eleven non-randomised trials, success rates of sequential treatment with mifepristone and misoprostol in case of EPF varied between 52% and 95%. Large heterogeneity existed in treatment regimens and comparators between studies. The existing evidence is insufficient to draw firm conclusions about the added value of mifepristone to misoprostol alone. A sufficiently powered randomised, double blinded placebo-controlled trial is urgently required to test whether, in EPF, the sequential combination of mifepristone with misoprostol is superior to misoprostol only. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Sublingual misoprostol as an adjunct to oxytocin during cesarean delivery in women at risk of postpartum hemorrhage.

PubMed

Chaudhuri, Picklu; Majumdar, Arindam

2015-01-01

To evaluate whether a combination of misoprostol and oxytocin more effectively reduces blood loss during and after cesarean delivery than does oxytocin alone among women with known risk factors for postpartum hemorrhage (PPH). A prospective, randomized, double-blind, placebo-controlled trial was performed at a tertiary care center in Kolkata, India, between October 2012 and December 2013. Women were eligible if they were undergoing emergency cesarean under spinal anesthesia and were at high risk for PPH. Participants were randomly assigned (1:1) to receive 400 μg misoprostol or matched placebo sublingually after delivery of the newborn using a computer-generated random number sequence (block size eight). Participants and providers were masked to assignment. All participants received 20 IU oxytocin. The primary outcomes were intraoperative and postoperative blood loss. Both groups contained 198 women. Mean intraoperative blood loss was significantly lower in the misoprostol group (505.4±215.5 mL) than in the placebo group (587.3±201.5 mL; P<0.001). Mean postoperative blood loss was slightly lower in the misoprostol group (96.9±57.3 mL) than in the placebo group (103.4±58.4 mL; P=0.07). Shivering and pyrexia were more frequently associated with misoprostol (P<0.05 for both). Misoprostol as an adjunct to oxytocin seemed to more effectively reduce blood loss than did oxytocin alone. Clinical Trial Registry India:CTRI/2013/05/003645. Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Reduction in Infection-Related Mortality since Modifications in the Regimen of Medical Abortion

PubMed Central

Trussell, James; Nucatola, Deborah; Fjerstad, Mary; Lichtenberg, E Steve

2014-01-01

Background From 2001 to March 2006 Planned Parenthood health centers throughout the United States provided medical abortion by a regimen of oral mifepristone followed 24 to 48 hours later by vaginal misoprostol. In response to concerns about serious infections, in early 2006 Planned Parenthood changed the route of misoprostol administration to buccal and required either routine antibiotic coverage or universal screening and treatment for chlamydia; in July 2007, Planned Parenthood began requiring routine antibiotic coverage for all medical abortions. Methods We performed a retrospective analysis of Planned Parenthood cases assessing the rates of mortality caused by infection following medical abortion during a time period when misoprostol was administered vaginally (2001 through March 2006), as compared with the rate from April 2006 to the end of 2012 after a change to buccal administration of misoprostol and after initiation of new infection-reduction strategies. Results The mortality rate dropped significantly in the 81-month period after the joint change to 1) buccal misoprostol replacing vaginal misoprostol and 2) either sexually transmitted infection (STI) screening or routine preventative antibiotic coverage (15 month period) or universal routine preventative antibiotic coverage as part of the medical abortion (66 month period), from 1.37/100,000 to 0.00/100,000, p=0.013 (difference=1.37/100,000, 95% CI 0.47-4.03 per 100,000). Conclusion The infection-caused mortality rate following medical abortion declined by 100% following a change from vaginal to buccal administration of misoprostol combined with screen-and-treat or, far more commonly, routine antibiotic coverage. PMID:24405798

Different routes and forms of uterotonics for treatment of retained placenta: a randomized clinical trial.

PubMed

Maher, Mohammad Ahmed; Sayyed, Tarek Mohammad; Elkhouly, Nabih Ibrahim

2017-09-01

To compare between three different uterotonics (oxytocin, carbetocin and misoprostol) given via three different routes (intraumbilical, intravenous and sublingual, respectively) in reducing the need for manual removal of placenta (MROP). A randomized trial for cases with retained placenta 30 min following vaginal delivery. They received intraumbilical oxytocin, intravenous carbetocin or sublingual misoprostol. Main outcome measures were delivery of the placenta within 30 min following drug administration, and need for MROP. Secondary outcome measures were injection to placental delivery time, post-delivery hemoglobin, need for blood transfusion or additional uterotonics. The overall success rate was 66.7% (64/96), 71.3% (67/94) and 63.7% (58/91) for oxytocin, carbetocin and misoprostol groups, respectively (p > 0.05). When time needed to achieve placental delivery considered, a significant difference was observed with the shortest time for carbetocin (16.61 ± 3.76 min), then oxytocin (18.28 ± 3.34 min) and lastly misoprostol (23.00 ± 3.38 min) (p <0.001). Again, carbetocin group needed less additional uterotonics to achieve adequate uterine contractions (p <0.001). Although we aimed to exploit the advantage of certain drug over another, all seemed to have close efficacy but it would be important that further research should highlight availability, cost, ease of administration and storage requirements to determine which agent would best be used in this clinical scenario.

Potential Cost-Effectiveness of Prenatal Distribution of Misoprostol for Prevention of Postpartum Hemorrhage in Uganda

PubMed Central

Lubinga, Solomon J.; Atukunda, Esther C.; Wasswa-Ssalongo, George; Babigumira, Joseph B.

2015-01-01

Background In settings where home birth rates are high, prenatal distribution of misoprostol has been advocated as a strategy to increase access to uterotonics during the third stage of labor to prevent postpartum hemorrhage (PPH). Our objective was to project the potential cost-effectiveness of this strategy in Uganda from both governmental (the relevant payer) and modified societal perspectives. Methods and Findings To compare prenatal misoprostol distribution to status quo (no misoprostol distribution), we developed a decision analytic model that tracked the delivery pathways of a cohort of pregnant women from the prenatal period, labor to delivery without complications or delivery with PPH, and successful treatment or death. Delivery pathway parameters were derived from the Uganda Demographic and Health Survey. Incidence of PPH, treatment efficacy, adverse event and case fatality rates, access to misoprostol, and health resource use and cost data were obtained from published literature and supplemented with expert opinion where necessary. We computed the expected incidence of PPH, mortality, disability adjusted life years (DALYs), costs and incremental cost effectiveness ratios (ICERs). We conducted univariate and probabilistic sensitivity analyses to examine robustness of our results. In the base-case analysis, misoprostol distribution lowered the expected incidence of PPH by 1.0% (95% credibility interval (CrI): 0.55%, 1.95%), mortality by 0.08% (95% CrI: 0.04%, 0.13%) and DALYs by 0.02 (95% CrI: 0.01, 0.03). Mean costs were higher with prenatal misoprostol distribution from governmental by US$3.3 (95% CrI: 2.1, 4.2) and modified societal (by US$1.3; 95% CrI: -1.6, 2.8) perspectives. ICERs were US$191 (95% CrI: 82, 443) per DALY averted from a governmental perspective, and US$73 (95% CI: -86, 256) per DALY averted from a modified societal perspective. Conclusions Prenatal distribution of misoprostol is potentially cost-effective in Uganda and should be considered for national-level scale up for prevention of PPH. PMID:26560140

Social networks and health policy: the case of misoprostol and the WHO model essential medicine list.

PubMed

Millard, Colin; Brhlikova, Petra; Pollock, Allyson

2015-05-01

The WHO Essential Medicines List (EML) was established to help countries prioritise medicines according to their health care needs. Selection for the List is based on rigorous scrutiny of public health relevance, evidence on efficacy and safety, and comparative cost effectiveness. The WHO ideal is that a medicine and its efficacy are based on science, but in reality a medicine has a social life and the acceptance of a pharmaceutical intervention involves the interaction of a wide array of governmental and civil society organisations, and industry. Misoprostol is a medicine widely used for both abortion and prevention of postpartum haemorrhage in low income countries. Although the evidence for the latter is highly contested it was nevertheless added to the WHO EML in 2011. We use social network analysis to examine the social, political and economic field surrounding the WHO EML applications and health policy. We describe a chronology of the drug's use and of the applications to the WHO EML and carry out a social network analysis of the organisations and individuals involved in the applications, research and dissemination. The research identified a network of 238 organisations and individuals involved in the promotion of misoprostol for postpartum haemorrhage and present at the time of the WHO EML applications. There is a strong interdependency between the funding bodies, civil society organisations, researchers and clinician organisations. The research was part of an EU FP7 funded project on Accessing Medicines in Africa and South Asia (2010-2013). Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

Evaluation of effect of letrozole prior to misoprostol in comparison with misoprostol alone in success rate of induced abortion.

PubMed

Behroozi-Lak, T; Derakhshan-Aydenloo, S; Broomand, F

2018-03-01

Abortion, spontaneous or induced, is a common complication of pregnancy and exploration of available and safe regimens for medical abortion in developing countries seems crucial. The present study was aimed to assess the effect of letrozole in combination with misoprostol in women eligible for legal therapeutic abortion with gestational age ≤14weeks. This clinical randomized trial was conducted on 78 women who were candidate of medical abortion and eligible for legal abortion with gestational age ≤14 weeks that were randomly divided into two groups of case and controls. Case group received daily oral dose of 10mg letrozole for three days followed by vaginal misoprostol. In control group the patients received only vaginal misoprostol. The rate of complete abortion, induction-of-abortion time, and side-effects were assessed. Complete abortion was observed in 30 patients (76.9%) in case group and 9 (23.1%) cases were failed. In control group there was 16 (41.03%) complete abortions and 23 (58.97%) cases were failed to abort. Patients with gestational age of between 6 and 10 weeks did not show significant difference in both groups (P=0.134). Regarding pregnancy remnants there were significant differences between two groups (P=0.034). The time form admission to discharge in case groups were significantly shorter than those in control group (P=0.001). The indication for curettage in case group was significantly less than control group (P=0.001). A 3-day course of letrozole (10mg/daily) followed by misoprostol was associated with a higher complete abortion and lower curettage rates and reduction in time from admission to discharge in women with gestational age ≤14 weeks compared to misoprostol alone. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Exploring the feasibility of obtaining mifepristone and misoprostol from the internet.

PubMed

Murtagh, Chloe; Wells, Elisa; Raymond, Elizabeth G; Coeytaux, Francine; Winikoff, Beverly

2018-04-01

We aimed to document the experience of buying abortion pills from online vendors that do not require a prescription and to evaluate the active ingredient content of the pills received. We searched the internet to identify a convenience sample of websites that sold mifepristone and misoprostol to purchasers in the United States and attempted to order these products. We documented price, shipping time and other aspects of ordering. We sent the samples received to a testing laboratory that measured the amount of active ingredient in individual tablets. We identified 18 websites and ordered 22 products: 20 mifepristone-misoprostol combination products and 2 that contained only misoprostol. We received 18 combination products and the 2 misoprostol products from 16 different sites. No site required a prescription or any relevant medical information. The time between order and receipt of the 20 products ranged from 3 to 21 business days (median 9.5 days). The price for the 18 combination products ranged from $110 to $360, including shipping and fees; the products without mifepristone cost less. Chemical assays found that the 18 tablets labeled 200 mg mifepristone contained between 184.3 mg and 204.1 mg mifepristone, while the 20 tablets labeled 200 mcg misoprostol contained between 34.1 mcg and 201.4 mcg of the active ingredient. Obtaining abortion medications from online pharmaceutical websites is feasible in the United States. The mifepristone tablets received contained within 8% of the labeled amount of active agent. The misoprostol tablets all contained that compound but usually less than labeled. Given our findings, we expect that some people for whom clinic-based abortion is not easily available or acceptable may consider self-sourcing pills from the internet to be a rational option. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Prostaglandin E2 EP2 activation reduces memory decline in R6/1 mouse model of Huntington's disease by the induction of BDNF-dependent synaptic plasticity.

PubMed

Anglada-Huguet, Marta; Vidal-Sancho, Laura; Giralt, Albert; García-Díaz Barriga, Gerardo; Xifró, Xavier; Alberch, Jordi

2016-11-01

Huntington's disease (HD) patients and mouse models show learning and memory impairment even before the onset of motor symptoms. Deficits in hippocampal synaptic plasticity have been involved in the HD memory impairment. Several studies show that prostaglandin E2 (PGE2) EP2 receptor stimulates synaptic plasticity and memory formation. However, this role was not explored in neurodegenerative diseases. Here, we investigated the capacity of PGE2 EP2 receptor to promote synaptic plasticity and memory improvements in a model of HD, the R6/1 mice, by administration of the agonist misoprostol. We found that misoprostol increases dendritic branching in cultured hippocampal neurons in a brain-derived neurotrophic factor (BDNF)-dependent manner. Then, we implanted an osmotic mini-pump system to chronically administrate misoprostol to R6/1 mice from 14 to 18weeks of age. We observed that misoprostol treatment ameliorates the R6/1 long-term memory deficits as analyzed by the T-maze spontaneous alternation task and the novel object recognition test. Importantly, administration of misoprostol promoted the expression of hippocampal BDNF. Moreover, the treatment with misoprostol in R6/1 mice blocked the reduction in the number of PSD-95 and VGluT-1 positive particles observed in hippocampus of vehicle-R6/1 mice. In addition, we observed an increase of cAMP levels in the dentate ` of WT and R6/1 mice treated with misoprostol. Accordingly, we showed a reduction in the number of mutant huntingtin nuclear inclusions in the dentate gyrus of R6/1 mice. Altogether, these results suggest a putative therapeutic effect of PGE2 EP2 receptor in reducing cognitive deficits in HD. Copyright © 2016. Published by Elsevier Inc.

A randomized controlled trial on the value of misoprostol for the treatment of retained placenta in a low-resource setting.

PubMed

van Beekhuizen, Heleen J; Tarimo, Vincent; Pembe, Andrea B; Fauteck, Heiner; Lotgering, Fred K

2013-09-01

To evaluate the efficacy and safety of misoprostol among patients with retained placenta in a low-resource setting. A prospective, multicenter, randomized, double-blind, placebo-controlled trial was carried out in Tanzania between April 2008 and November 2011. It included patients who delivered at a gestational age of 28 weeks or more and had blood loss of 750 mL or less at 30 minutes after delivery. Sublingual misoprostol (800 μg) was compared with placebo as the primary treatment. Power analysis showed that 117 patients would be required to observe a reduction of 40% in the incidence of manual removal of the placenta (MRP; P=0.05, 80% power), the primary outcome. The secondary outcomes were blood loss and number of blood transfusions. Interim analysis after recruitment of 95 patients showed that incidence of MRP, total blood loss, and incidence of blood transfusions were similar in the misoprostol (MRP, 40%; blood loss, 803 mL; blood transfusion, 15%) and placebo (MRP, 33%, blood loss 787 mL, blood transfusion, 23%) groups. The trial was stopped because continuation would not alter the interim conclusion that misoprostol was ineffective. Treatment with misoprostol was found to have no clinically significant beneficial effect among women with retained placenta. Current Controlled Trials ISRCTN16104753. Copyright © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Efficacy and acceptability of a mifepristone-misoprostol combined regimen for early induced abortion among women in Mexico City.

PubMed

Peña, Melanie; Dzuba, Ilana G; Smith, Patricio Sanhueza; Mendoza, Luis Jorge Arellano; Bousiéguez, Manuel; Martínez, María Laura García; Polanco, Ranulfo Ríos; Villalón, Antonio Eduardo Flores; Winikoff, Beverly

2014-10-01

To evaluate the experience of women receiving mifepristone-misoprostol for early induced abortion in public sector facilities in the Federal District of Mexico City. An open-label prospective study was conducted with 1000 pregnant women who sought induced abortion with a pregnancy of up to 63days of gestation, as measured from the date of their last menstrual period. The study was conducted in three public sector healthcare facilities: two secondary level hospitals and one primary care clinic. Women ingested 200mg mifepristone on day 1, followed by 800μg buccal misoprostol 24hours later, and they returned for follow-up on day 8. The primary outcome was complete abortion without recourse to surgical intervention. A total of 971 women received mifepristone-misoprostol and were included in the analysis for efficacy of treatment. The overall efficacy of the combined medical abortion regimen studied was 97.3% (n=945); the success rate did not vary significantly by gestational age (95.9%-100%; P=0.449). Most women (n=922, 95.0%) had a successful induced abortion with only one dose of misoprostol. The combined mifepristone and buccal misoprostol regimen was found to be highly effective and acceptable among Mexican women. www.ClinicalTrials.gov: NCT00386282. Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Randomized double-blind placebo-controlled trial of buccal misoprostol to reduce the need for additional uterotonic drugs during cesarean delivery.

PubMed

Hernández-Castro, Flavio; López-Serna, Norberto; Treviño-Salinas, Emilio M; Soria-López, Juan A; Sordia-Hernández, Luis H; Cárdenas-Estrada, Eloy

2016-02-01

To determine whether buccal misoprostol during cesarean delivery in conjunction with active management of the third stage of labor reduces the need for additional uterotonic drugs. A double-blind, randomized, placebo-controlled trial was performed in Monterrey, Mexico, between February 2008 and December 2013. Eligible women had risk factors for uterine atony and were to undergo cesarean delivery under epidural block. Using a computer-generated sequence and blocks of six, patients were randomly assigned to receive 400μg misoprostol or 800μg placebo buccally after cord clamping. Both groups received an intravenous oxytocin infusion. The primary outcome was the need for additional uterotonic drugs. Analyses were performed per protocol. Patients, investigators, and data analysts were masked to group assignment. A total of 120 women were included in analyses (60 in each group). At least one additional uterotonic drug was required in 24 (40%) women in the placebo group versus 6 (10%) women in the misoprostol group (relative risk 0.16; 95% confidence interval 0.06-0.44). No adverse effects due to misoprostol were recorded. Buccal misoprostol during cesarean delivery reduced the need for additional uterotonic drugs to treat uterine atony. ClinicalTrials.gov:NCT01733329. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

A comparison of the Abortion Rights Mobilization and Population Council trials.

PubMed

Schaff, E A; Fielding, S L

2000-01-01

We compared the published results of the 1994-1995 Population Council (PC) trial to those from the 1996-1997 Abortion Rights Mobilization (ARM) trial to determine whether 200 mg mifepristone with 800 micrograms vaginal misoprostol is more effective and has fewer side effects than 600 mg mifepristone with 400 micrograms oral misoprostol. The complete medical abortion rate was lower in the PC trial than the ARM trial: 92% compared with 97% up to 49 days LMP (p < 0.05) and 83% versus 96% from 50 to 56 days LMP (p < 0.05). Nausea and vomiting were reported more frequently in the PC trial. The overall acceptability of the procedure was lower in the PC trial (88%) than in the ARM trial (94%), (p < 0.05). Mifepristone can be reduced from 600 to 200 mg when followed by vaginal misoprostol without loss of efficacy. Vaginal misoprostol extends the efficacy to 56 days LMP and is associated with less nausea and vomiting. Home use of misoprostol is safe and acceptable to women and decreases the number of required visits from three to two in most cases.

Misoprostol for tinnitus.

PubMed

Crinnion, C L; McCart, G M

1995-01-01

Practitioners should realize that further study of misoprostol in larger patient populations must be undertaken to determine its efficacy and safety in the treatment of tinnitus. Previous approaches to treating tinnitus have included carbamazepine, phenytoin, lidocaine, tocainide, flecainide acetate, alprazolam, and nortriptyline. Studies using lidocaine, nortriptyline, or alprazolam have shown encouraging results. The relative contribution of misoprostol remains to be seen; however, it may offer a new treatment option to patients who have experienced adverse effects or have contraindications to the pharmacologic agents currently available.

Training traditional birth attendants on the use of misoprostol and a blood measurement tool to prevent postpartum haemorrhage: lessons learnt from Bangladesh.

PubMed

Bell, Suzanne; Passano, Paige; Bohl, Daniel D; Islam, Arshadul; Prata, Ndola

2014-03-01

A consensus emerged in the late 1990s among leaders in global maternal health that traditional birth attendants (TBAs) should no longer be trained in delivery skills and should instead be trained as promoters of facility-based care. Many TBAs continue to be trained in places where home deliveries are the norm and the potential impacts of this training are important to understand. The primary objective of this study was to gain a more nuanced understanding of the full impact of training TBAs to use misoprostol and a blood measurement tool (mat) for the prevention of postpartum haemorrhage (PPH) at home deliveries through the perspective of those involved in the project. This qualitative study, conducted between July 2009 and July 2010 in Bangladesh, was nested within larger operations research, testing the feasibility and acceptability of scaling up community-based provision of misoprostol and a blood measurement tool for prevention of PPH. A total of 87 in-depth interviews (IDIs) were conducted with TBAs, community health workers (CHWs), managers, and government-employed family welfare visitors (FWVs) at three time points during the study. Computer-assisted thematic data analysis was conducted using ATLAS.ti (version 5.2). Four primary themes emerged during the data analysis, which all highlight changes that occurred following the training. The first theme describes the perceived direct changes linked to the two new interventions. The following three themes describe the indirect changes that interviewees perceived: strengthened linkages between TBAs and the formal healthcare system; strengthened linkages between TBAs and the communities they serve; and improved quality of services/service utilization. The data indicate that training TBAs and CHW supervisors resulted in perceived broader and more nuanced changes than simply improvements in TBAs' knowledge, attitudes, and practices. Acknowledgeing TBAs' important role in the community and in home deliveries and integrating them into the formal healthcare system has the potential to result in changes similar to those seen in this study.

Diclofenac and Misoprostol

MedlinePlus

... patients who have a high risk of developing stomach ulcers. Diclofenac is in a class of medications called ... you need to take an antacid during your treatment with diclofenac and misoprostol. You should not take ...

Prevention of postpartum haemorrhage by community-based auxiliary midwives in hard-to-reach areas of Myanmar: a qualitative inquiry into acceptability and feasibility of task shifting.

PubMed

Than, Kyu Kyu; Mohamed, Yasmin; Oliver, Victoria; Myint, Theingi; La, Thazin; Beeson, James G; Luchters, Stanley

2017-05-17

In Myanmar, postpartum haemorrhage is the leading cause of maternal mortality and contributes to around 30% of all maternal deaths. The World Health Organization recommends training and supporting auxiliary midwives to administer oral misoprostol for prevention of postpartum haemorrhage in resource-limited settings. However, use of misoprostol by auxiliary midwives has not formally been approved in Myanmar. Our study aimed to explore community and provider perspectives on the roles of auxiliary midwives and community-level provision of oral misoprostol by auxiliary midwives. A qualitative inquiry was conducted in Ngape Township, Myanmar. A total of 15 focus group discussions with midwives, auxiliary midwives, community members and mothers with children under the age of three were conducted. Ten key informant interviews were performed with national, district and township level health planners and implementers of maternal and child health services. All audio recordings were transcribed verbatim in Myanmar language. Transcripts of focus group discussions were fully translated into English before coding, while key informants' data were coded in Myanmar language. Thematic analysis was done using ATLAS.ti software. Home births are common and auxiliary midwives were perceived as an essential care provider during childbirth in hard-to-reach areas. Main reasons provided were that auxiliary midwives are more accessible than midwives, live in the hard-to-reach areas, and are integrated in the community and well connected with midwives. Auxiliary midwives generally reported that their training involved instruction on active management of the third stage of labour, including use of misoprostol, but not all auxiliary midwives reported using misoprostol in practice. Supportive reasons for task-shifting administration of oral misoprostol to auxiliary midwives included discussions around the good relationship and trust between auxiliary midwives and midwives, whereby midwives felt confident distributing misoprostol to auxiliary midwives. However, the lack of clear government-level written permission to distribute the drug was perceived as a barrier to task shifting. This study highlights the acceptability of misoprostol use by auxiliary midwives to prevent postpartum haemorrhage, and findings suggest that it should be considered as a promising intervention for task shifting in Myanmar.

Opening a door to safe abortion: international perspectives on medical abortifacient use.

PubMed

Pollack, A E; Pine, R N

2000-01-01

International experience compels us to revisit how we define and assess the safety and efficacy of medical abortifacients such as misoprostol. In some countries where safe abortion is neither accessible nor legal, even unsupervised, off-protocol use of misoprostol can provide women with a means to safely terminate pregnancy. This is due primarily to misoprostol-induced uterine contractions that cause bleeding, which in turn provides access to existing reasonable quality health services that would otherwise be unavailable. Several studies have suggested that an increase in the underground use of misoprostol in Brazil has already reduced serious complications from unsafe abortion. Thus, the availability of medical abortifacients combined with strengthened postabortion care services can legitimately be considered a public health success in countries in which safe abortion services do not exist and law reform is unlikely.

Sublingual misoprostol versus intramuscular oxytocin for prevention of postpartum hemorrhage in low-risk women.

PubMed

Chaudhuri, Picklu; Biswas, Jhuma; Mandal, Apurba

2012-02-01

To compare sublingual misoprostol with intramuscular oxytocin for prevention of postpartum hemorrhage (PPH) in low-risk vaginal birth. In a prospective, randomized, double-blind trial, 530 women without risk of PPH were randomly allocated to receive either 400 μg of misoprostol sublingually or 10 units of oxytocin intramuscularly within 1minute of delivery. The outcome measures were incidence of PPH, postpartum blood loss, drop in hemoglobin level in 24 hours, need for additional uterotonic drug, incidence of adverse effects, and need for blood transfusion. Student t, χ(2), Mann-Whitney U, and Fisher exact tests were used for comparison. Incidence of postpartum hemorrhage (≥ 500 mL) and postpartum blood loss in the misoprostol group were similar to those in the oxytocin group (6% versus 5.7%, P=0.85; 153 mL versus 146 mL, P=0.36). Shivering and pyrexia were encountered more often in the misoprostol than in the oxytocin group (shivering: 19% versus 0.8%, P<0.001, relative risk [RR] 0.86, 95% confidence interval [CI] 0.82-0.90; pyrexia: 2.3% versus 0%, P=0.03, RR 0.97, 95% CI 0.95-0.99). The efficacy of 400 μg of misoprostol administered sublingually was equivalent to that of 10 units of oxytocin given intramuscularly for prevention of PPH in low-risk vaginal delivery. Copyright © 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Sublingual misoprostol versus intravenous oxytocin in prevention of post-partum hemorrhage.

PubMed

Tewatia, Renu; Rani, Shikha; Srivastav, Usha; Makhija, Bela

2014-04-01

Post-partum hemorrhage (PPH) is the most common direct cause of maternal mortality and timely intervention can save many lives. To compare the effectiveness of sublingual misoprostol to intravenous oxytocin in preventing post-partum hemorrhage in low risk vaginal birth. One hundred patients with no risk factor for PPH were randomly allocated to receive 600 μg misoprostol administered sublingually or 10 IU of intravenous oxytocin immediately after the delivery of baby. Main outcome measures were post-partum blood loss, drop in hemoglobin in 24 h, duration of third stage of labor, and drug-related adverse effects. Mean age, parity and gestational age were similar in both groups. Mean blood loss was significantly lower in oxytocin group (114.28 ± 26.75 versus 149.50 ± 30.78 ml; p = 0.00). Drop in hemoglobin was 0.31 ± 0.16 versus 0.49 ± 0.21 g% (p = 0.01) in oxytocin and misoprostol group, respectively. Duration of third stage labor was shorter in oxytocin group (median 5 min, IQR: 4.5-5.5 versus 5.5 min, IQR: 5-6 min, p < 0.01). Although fever and shivering were common adverse effects with misoprostol but were not clinically significant. Intravenous oxytocin is more efficacious than sublingual misoprostol in preventing PPH in institutional deliveries.

Comparison of labour induction with misoprostol and dinoprostone and characterization of uterine response based on electrohysterogram.

PubMed

Benalcazar-Parra, Carlos; Monfort-Orti, Rogelio; Ye-Lin, Yiyao; Prats-Boluda, Gema; Alberola-Rubio, Jose; Perales, Alfredo; Garcia-Casado, Javier

2017-12-17

The objective of this study is to compare the uterine activity response between women administered dinoprostone (prostaglandin E2) and misoprostol (prostaglandin E1) for induction of labour (IOL) by analysing not only the traditional obstetric data but also the parameters extracted from uterine electrohysterogram (EHG). Two cohorts were defined: misoprostol (25-µg vaginal tablets; 251 women) and dinoprostone cohort (10 mg vaginal inserts; 249 women). All the mothers were induced by a medical indication of a Bishop Score < = 6. The misoprostol cohort was associated with a shorter time to achieve active labour (p = .017) and vaginal delivery (p = .009) and with a higher percentage of vaginal delivery in less than 24 h in mothers with a very unfavourable cervix score (risk ratio (RR): 1.41, IC95% 1.17-1.69, p = .002). Successful inductions with misoprostol showed EHG parameter values significantly higher than basal state for amplitude and pseudo Montevideo units (PMU) 60' after drug administration, while spectral parameters significantly increased after 150'. This response was not observed in failed inductions. In the successful dinoprostone group, the duration and number of contractions increased significantly after 120', PMU did so after 180', and no significant differences were found for spectral parameters, possibly due to the slower pharmacokinetics of this drug. Successful inductions of labour by misoprostol are associated with earlier effective contractions than in labours induced by dinoprostone.

Prevention of post-partum hemorrhage by rectal Misoprostol: A randomized clinical trial

PubMed Central

Firouzbakht, Mozhgan; Kiapour, Azadeh; Omidvar, Shabnam

2013-01-01

Background: Post-partum hemorrhage (PPH) is a common cause of maternal mortality in developing countries. This trial was conducted to study the effectiveness and safety of rectal misoprostol for PPH. Aim: To assess the effectiveness and safety of misoprostol and comparing with oxytocin for prevention of PPH. Materials and Methods: Women were randomized to receive either two 200 μg rectal misoprostol tablets (study group) or 20 units oxytocin in 1000 cc normal saline intravenously (control group). The outcomes were incidence of PPH, amount of blood loss, duration of labor, incidence of side effects, pre- and post-delivery hemoglobin, and use of additional uterotonics. Finding: The incidence of PPH was 12% in the study group and 10% in the control group (P > 0.05). No significant difference was observed between the groups hematocrit (P > 0.05). Other variables including severe PPH and duration of the third stage of labor were similar in both groups. Conclusion: Rectal misoprostol was as effective as intravenous oxytocin for preventing post-partum hemorrhage with the same incidence of side effects and is recommended to be use as an uterotonic agent to manage third stage of labor routinely. PMID:23633849

[The illegal market for gender-related drugs as portrayed in the Brazilian news media: the case of misoprostol and women].

PubMed

Diniz, Debora; Castro, Rosana

2011-01-01

This article analyzes how the Brazilian news media covers the illegal market for misoprostol, the main drug used to induce abortion. A total of 1,429 news stories were retrieved from 220 print and electronic media channels from 2004 to 2009. The analysis included 524 stories from 62 regional and national newspapers. Misoprostol appeared repeatedly in the news, but was usually approached from a criminal perspective, unlike abortion as a whole, which the Brazilian media routinely covers as a religious, political, and public health issue. Misoprostol is part of the illegal gender-related drug market, along with drugs for weight loss and erectile dysfunction and anabolic steroids. Sixty-four (12%) of the news stories told life histories of women who had aborted with misoprostol. The women's ages ranged from 13 to 46 years, and socioeconomic status was associated with different experiences with abortion. Three characters appeared in the women's abortion itineraries: girlfriends (confidantes), go-betweens, and physicians. Stories of late-stage abortion are confused with the criminal characterization of infanticide and provide the extreme cases in the media's narrative on abortion.

[Misoprostol: pathways, mediation and social networks for access to abortion using medication in the context of illegality in the State of Sao Paulo].

PubMed

Arilha, Margareth Martha

2012-07-01

The scope of this article is to discuss the commercialization and use of misoprostol for abortion purposes in the illegal contexts that still persist in Brazil. The information presented was collected through case studies conducted with two young women who aborted using medication - one successfully and one unsuccessfully - and two adult women who have close ties with women who used misoprostol. The study confirms the hypothesis that the diffusion and expansion of the use of misoprostol outside the hospital context is associated with the decision of women who seek lower costs, lower risks to their health and privacy. It also permits examination of the interpretation that this increase in consumption is linked to the inclusion of the medication in a set of goods that are illegally traded in Brazil, in different ways and in different contexts. As a result, women are exposed to different degrees of vulnerability depending directly on the steps taken, types of mediation used and social networks they belong to. These are the ways in which women and men obtain access to the use of misoprostol for abortion, the outcome of which may be successful or not.

Letrozole vs. Placebo Pretreatment in the Medical Management of First Trimester Missed Miscarriage: a Randomized Controlled Trial.

PubMed

Torky, Haitham A; Marie, Heba; ElDesouky, ElSayed; Gebreel, Samy; Raslan, Osama; Moussa, Asem A; Ahmad, Ali M; Zain, Eman; Mohsen, Mohamed N

2018-01-01

Misoprostol is used for the medical management of miscarriage as it is more effective in the early stages of pregnancy. Letrozole has an anti-estrogen effect and is used for the pretreatment of miscarriage with misoprostol. The aim of this study was compare the efficacy and safety of letrozole with placebo pretreatment in the medical management of first trimester missed miscarriage. This was a prospective randomized case-control study. Four hundred and thirty-eight women were randomly divided into two groups of 219; the placebo group received placebo tablets twice daily for 3 days, followed by 800 micrograms of misoprostol vaginally on the fourth day of enrolment, while the letrozole group received letrozole 10 mg twice daily for three days followed by 800 micrograms misoprostol administered vaginally. Symptoms and side effects were recorded, and the women advised to return to hospital if they experienced severe pain or bleeding or intolerable side effects and to report to hospital for a check-up one week after misoprostol administration. Ultrasound was done seven days after misoprostol administration to monitor outcomes. Surgical evacuation was carried out if medical management failed. There were significant differences between the two groups, with better outcomes found for the letrozole group in terms of rates of complete miscarriage, onset of vaginal bleeding, and interval between induction and onset of expulsion (p < 0.001). A higher rate of nausea and vomiting was reported for the letrozole group (p = 0.002). Differences between groups with regard to pre- and post-termination hemoglobin levels, fever, severe pain and severe bleeding needing evacuation were not statistically significant. Adding letrozole to misoprostol improves the success rate and decreases the interval between induction and expulsion in cases of first trimester miscarriage; however, nausea and vomiting is higher with letrozole.

Quality assessment of patient leaflets on misoprostol-induced labour: does written information adhere to international standards for patient involvement and informed consent?

PubMed Central

Clausen, Jette Aaroe; Rydahl, Eva

2016-01-01

Objectives The need for thorough patient information is increasing as maternity care becomes more medicalised. The aim was to assess the quality of written patient information on labour induction. In most Danish hospitals, misoprostol is the first-choice drug for induction in low-risk pregnancies. Misoprostol has been associated with adverse side effects and severe outcomes for mother and child and is not registered for obstetric use in Denmark. Setting Secondary care hospitals in Denmark. Data Patient information leaflets from all hospitals that used misoprostol as an induction agent by June 2015 (N=13). Design Patient leaflets were evaluated according to a validated scoring tool (International Patient Decision Aid Standards instrument, IPDAS), core elements in the Danish Health Act, and items regarding off-label use and non-registered medication. Two of the authors scored all leaflets independently. Outcome measures Women's involvement in decision-making, information on benefits and harms associated with the treatment, other justifiable treatment options, and non-registered treatment. Results Generally, the hospitals scored low on the IPDAS checklist. No hospitals encouraged women to consider their preferences. Information on side effects and adverse outcomes was poorly covered and varied substantially between hospitals. Few hospitals informed about precautions regarding outpatient inductions, and none informed about the lack of evidence on the safety of this procedure. None informed that misoprostol is not registered for induction or explained the meaning of off-label use or use of non-registered medication. Elements such as interprofessional consensus, long-term experience, and health authorities' approval were used to add credibility to the use of misoprostol. Conclusions Central criteria for patient involvement and informed consent were not met, and the patient leaflets did not inform according to current evidence on misoprostol-induced labour. Our findings indicate that patients receive very different, sometimes contradictory, information with potential ethical implications. Concerns should be given to outpatient inductions, where precise written information is of particular importance. PMID:27235300

Provision of menstrual regulation with medication among pharmacies in three municipal districts of Bangladesh: a situation analysis.

PubMed

Huda, Fauzia Akhter; Mahmood, Hassan Rushekh; Alam, Anadil; Ahmmed, Faisal; Karim, Farzana; Sarker, Bidhan Krishna; Al Haque, Nafis; Ahmed, Anisuddin

2018-02-01

The objective was to assess the provision of the combination of mifepristone-misoprostol for menstrual regulation (MR) in randomly selected urban pharmacies in Bangladesh. We conducted a cross-sectional survey among 553 pharmacy workers followed by 548 mystery client visits to the same pharmacies in 3 municipal districts during July 2014-December 2015. The survey found that 99% of pharmacy workers visited had knowledge of MR procedures but only two-thirds (67%) could state the legal time limit correctly; they mentioned misoprostol (86%) over mifepristone-misoprostol combination (78%) as a procedure of MR with medication (MRM); 36% reported knowing the recommended dosage of mifepristone-misoprostol combination; 70% reported providing information on effectiveness of the medicines; 50% reported recommending at least one follow-up visit to them; 63% reported explaining possible complications of using the medications; and 47% reported offering any post-MR contraception to their clients. In contrast, mystery client visits found that the mifepristone-misoprostol combination (69%) was suggested over misoprostol (51%) by the pharmacy workers; 54% provided the recommended dosage of mifepristone-misoprostol combination; 42% provided information on its effectiveness; 12% recommended at least one follow-up visit; 11% counseled on possible complications; and only 5% offered post-MR contraceptives to the mystery clients. We found knowledge gaps regarding recommended dosage for MRM and inconsistent practice in informing women on effectiveness, follow-up visits, possible complications and provision of post-MR contraceptives among the pharmacy workers, particularly during the mystery client visits. Pharmacy workers in Bangladesh need to be trained on legal time limits for MR services provision, on providing accurate information on disbursed medicine, and on proper referral mechanisms. A strong monitoring and regulatory system for pharmacy provision of MRM in pharmacies should be established. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.

PubMed

Derman, Richard J; Kodkany, Bhalchandra S; Goudar, Shivaprasad S; Geller, Stacie E; Naik, Vijaya A; Bellad, M B; Patted, Shobhana S; Patel, Ashlesha; Edlavitch, Stanley A; Hartwell, Tyler; Chakraborty, Hrishikesh; Moss, Nancy

2006-10-07

Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting. In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123. Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control. Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.

Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage: the MisoREST trial

PubMed Central

2013-01-01

Background Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol. Methods/Design The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization. Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients’ quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry. Discussion This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. Trial registration Dutch Trial Register: NTR3110 PMID:23638956

Poland syndrome associated with an aberrant subclavian artery and vascular abnormalities of the retina in a child exposed to misoprostol during pregnancy.

PubMed

Rosa, Rafael Fabiano Machado; Travi, Giovanni M; Valiatti, Fabiana; Zen, Paulo Ricardo Gazzola; Pinto, Louise Lapagesse; Kiss, Andrea; Graziadio, Carla; Paskulin, Giorgio Adriano

2007-06-01

Poland syndrome has been attributed to a process of vascular disruption, and exposure to misoprostol at 6-8 weeks of gestation has been shown to produce defects attributed to vascular disruption. Herein we report the first case of a patient with Poland syndrome associated with an aberrant subclavian artery and vascular abnormalities of the retina, whose mother used misoprostol during pregnancy. A White boy of 1 year and 7 months of age, whose mother used misoprostol during the second month of pregnancy, presented with bilateral epicanthal folds, aplasia of the sternocostal head of the pectoralis major muscle with a hypoplastic nipple on the right side, and asymmetry between the upper limbs. The results of an angiotomographic study showed the presence of an aberrant right subclavian artery. Ultrasonographic evaluation showed turbulence and a high peak in the diastolic velocity in both carotid arteries, suggesting stenosis. Ophthalmologic assessment disclosed an intense bilateral tortuosity of the retinal blood vessels, with arterialnarrowing and rarefaction of the retinal pigment epithelium. This case suggests that the mechanism of vascular disruption of misoprostol could be related to the aberrant subclavian artery and the observed Poland syndrome. His retinal findings are different from those in cases described thus far in the literature, and this pattern of anomaly has never been associated with a gestational exposure to misoprostol. The possibility of a relationship of the aberrant right subclavian artery and the pattern of blood flow verified in the carotid arteries with the eye fundus abnormalities could be causally related or simply coincidental.

Clinical Outcomes and Women's Experiences before and after the Introduction of Mifepristone into Second-Trimester Medical Abortion Services in South Africa.

PubMed

Constant, Deborah; Harries, Jane; Malaba, Thokozile; Myer, Landon; Patel, Malika; Petro, Gregory; Grossman, Daniel

2016-01-01

To document clinical outcomes and women's experiences following the introduction of mifepristone into South African public sector second-trimester medical abortion services, and compare with historic cohorts receiving misoprostol-only. Repeated cross-sectional observational studies documented service delivery and experiences of women undergoing second-trimester medical abortion in public sector hospitals in the Western Cape, South Africa. Women recruited to the study in 2008 (n = 84) and 2010 (n = 58) received misoprostol only. Those recruited in 2014 (n = 208) received mifepristone and misoprostol. Consenting women were interviewed during hospitalization by study fieldworkers with respect to socio-demographic information, reproductive history, and their experiences with the abortion. Clinical details were extracted from medical charts following discharge. Telephone follow-up interviews to record delayed complications were conducted 2-4 weeks after discharge for the 2014 cohort. The 2014 cohort received 200 mg mifepristone, which was self-administered 24-48 hours prior to admission. For all cohorts, following hospital admission, initial misoprostol doses were generally administered vaginally: 800 mcg in the 2014 cohort and 600 mcg in the earlier cohorts. Women received subsequent doses of misoprostol 400 mcg orally every 3-4 hours until fetal expulsion. Thereafter, uterine evacuation of placental tissue was performed as needed. With one exception, all women in all cohorts expelled the fetus. Median time-to-fetal expulsion was reduced to 8.0 hours from 14.5 hours (p<0.001) in the mifepristone compared to the 2010 misoprostol-only cohort (time of fetal expulsion was not recorded in 2008). Uterine evacuation of placental tissue using curettage or vacuum aspiration was more often performed (76% vs. 58%, p<0.001) for those receiving mifepristone; major complication rates were unchanged. Hospitalization duration and extreme pain levels were reduced (p<0.001), but side effects of medication were similar or more common for the mifepristone cohort. Overall satisfaction remained unchanged (95% vs. 91%), while other acceptability measures were higher (p<0.001) for the mifepristone compared to the misoprostol-only cohorts. The introduction of a combined mifepristone-misoprostol regimen into public sector second-trimester medical abortion services in South Africa has been successful with shorter time-to-abortion events, less extreme pain and greater acceptability for women. High rates of uterine evacuation for placental tissue need to be addressed.

Prevention of postpartum haemorrhage: cost consequences analysis of misoprostol in low-resource settings.

PubMed

Lang, Danielle L; Zhao, Fei-Li; Robertson, Jane

2015-11-23

While inferior to oxytocin injection in both efficacy and safety, orally administered misoprostol has been included in the World Health Organization Model List of Essential Medicines for use in the prevention of postpartum haemorrhage (PPH) in low-resource settings. This study evaluates the costs and health outcomes of use of oral misoprostol to prevent PPH in settings where injectable uterotonics are not available. A cost-consequences analysis was conducted from the international health system perspective, using data from a recent Cochrane systematic review and WHO's Mother-Baby Package Costing Spreadsheet in a hypothetical cohort of 1000 births in a mixed hospital (40% births)/community setting (60% births). Costs were estimated based on 2012 US dollars. Using oxytocin in the hospital setting and misoprostol in the community setting in a cohort of 1000 births, instead of oxytocin (hospital setting) and no treatment (community setting), 22 cases of PPH could be prevented. Six fewer women would require additional uterotonics and four fewer women a blood transfusion. An additional 130 women would experience shivering and an extra 42 women fever. Oxytocin/misoprostol was found to be cost saving (US$320) compared to oxytocin/no treatment. If misoprostol is used in both the hospital and community setting compared with no treatment (i.e. oxytocin not available in the hospital setting), 37 cases of PPH could be prevented; ten fewer women would require additional uterotonics; and six fewer women a blood transfusion. An additional 217 women would experience shivering and 70 fever. The cost savings would be US$533. Sensitivity analyses indicate that the results are sensitive to the incidence of PPH-related outcomes, drug costs and the proportion of hospital births. Our findings confirm that, even though misoprostol is not the optimum choice in the prevention of PPH, misoprostol could be an effective and cost-saving choice where oxytocin is not or cannot be used due to a lack of skilled birth attendants, inadequate transport and storage facilities or where a quality assured oxytocin product is not available. These benefits need to be weighed against the large number of additional side effects such as shivering and fever, which have been described as tolerable and of short duration.

No reduction of manual removal after misoprostol for retained placenta: a double-blind, randomized trial.

PubMed

van Stralen, Giel; Veenhof, Marieke; Holleboom, Cas; van Roosmalen, Jos

2013-04-01

To test the effect of 800 μg of misoprostol orally on the prevention of manual removal of retained placenta. Multicenter, double-blinded, placebo-controlled, randomized trial. One university and one non-university teaching hospital in the Netherlands. 99 women with retained placenta (longer than 60 min after childbirth) in the absence of postpartum hemorrhage. Eligible women were administered either 800 μg of misoprostol or placebo orally. Number of manual removals of retained placenta and amount of blood loss. Manual removal of retained placenta was performed in 50% of the women who received misoprostol and in 55% who received placebo (relative risk 0.91, 95% confidence interval 0.62-1.34). No difference in the amount of blood loss (970 vs. 1120 mL; p = 0.34) was observed between the two groups. Administration of 800 μg of oral misoprostol, one hour after childbirth, does not seem to reduce the number of manual removals of retained placentas. The time elapsing results in the delivery of 50% of the retained placentas at the expense of an increased risk of postpartum hemorrhage. © 2013 The Authors Acta Obstetricia et Gynecologica Scandinavica © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

Two medical abortion regimens for late first-trimester termination of pregnancy: a prospective randomized trial.

PubMed

Dalenda, Chelly; Ines, Najar; Fathia, Boudaya; Malika, Affes; Bechir, Zouaoui; Ezzeddine, Sfar; Hela, Chelly; Badis, Channoufi Mohamed

2010-04-01

Medical abortion regimens based on the use of either misoprostol alone or in association with mifepristone have shown high efficacy and excellent safety profile in early pregnancy abortion. However, no clear recommendation is available for late first-trimester termination of pregnancy. A prospective randomized controlled trial included 122 women seeking medical abortion at 9 to 12 weeks of gestation. Seventy-three patients were given a fixed protocol of 200 mg of mifepristone followed 48 h later by 400 mcg oral misoprostol (Group 1). The second group of 49 patients was administered 800-mcg intravaginal single-dose misoprostol (Group 2). This study sought to compare safety, efficacy and acceptability of these two nonsurgical abortion regimens. Fifty-nine (80.8%) women in Group 1 had complete abortion vs. 38 (77.4%) women in Group 2 (p=.66). Abdominal pain was observed significantly more often in Group 2 (35/49 (71.4%) vs. 32/73 (43.8%) in Group 1, p<.0001. Medical abortion was equally acceptable among the two groups [37/49 (75.5%) and 55/73 (75.7%), p=.89]. For late first-trimester termination, a single 800-mcg vaginal dose of misoprostol seems to be as effective as the mifepristone+misoprostol regimen, with acceptable side effects. Copyright 2010 Elsevier Inc. All rights reserved.

Association between gestational age and induction-to-abortion interval in mid-trimester pregnancy termination using misoprostol.

PubMed

Vitner, Dana; Deutsch, Michael; Paz, Yuri; Khatib, Nizar; Baltiter, Tania; Rosenberg, Shiran; Lowenstein, Lior

2011-06-01

The study was aimed to evaluate the effectiveness, outcome, and pain intensity of the vaginal administration of misoprostol for the induction of abortion between 13 and 24 gestational weeks. A retrospective study was conducted at our tertiary medical center from January 2006 to December 2009 on 122 consecutive women who underwent termination of pregnancy (TOP) in the mid-trimester. They were given 400 mcg of vaginal misoprostol every 6h, up to four doses. The induction-to-abortion interval and the level of pain experienced during the process were assessed. Success was defined by the fetus being expelled within 48 h. Vaginal misoprostol was effective in 84% (98/122) of patients. The median duration of the induction-to-abortion interval was 16 (5-48)h. The induction-to-abortion interval was correlated with gestational age, while inversely correlated with parity. A correlation was also found between gestational age and pain intensity at 12h from induction. Misoprostol is safe and effective in mid-trimester abortion induction. The induction-to-abortion interval is shorter and abortion less painful with lower gestational age. Higher parity is also associated with shorter induction to abortion interval. Copyright © 2011. Published by Elsevier Ireland Ltd.

Randomized comparison of oral misoprostol and oxytocin for labor induction in term prelabor membrane rupture.

PubMed

Butt, K D; Bennett, K A; Crane, J M; Hutchens, D; Young, D C

1999-12-01

To compare labor induction intervals between oral misoprostol and intravenous oxytocin in women who present at term with premature rupture of membranes. One hundred eight women were randomly assigned to misoprostol 50 microg orally every 4 hours as needed or intravenous oxytocin. The primary outcome measure was time from induction to vaginal delivery. Sample size was calculated using a two-tailed alpha of 0.05 and power of 80%. Baseline demographic data, including maternal age, gestation, parity, Bishop score, birth weight, and group B streptococcal status, were similar. The mean time +/-standard deviation to vaginal birth with oral misoprostol was 720+/-382 minutes compared with 501+/-389 minutes with oxytocin (P = .007). The durations of the first, second, and third stages of labor were similar. There were no differences in maternal secondary outcomes, including cesarean birth (eight and seven, respectively), infection, maternal satisfaction with labor, epidural use, perineal trauma, manual placental removal, or gastrointestinal side effects. Neonatal outcomes including cord pH, Apgar scores, infection, and admission to neonatal intensive care unit were not different. Although labor induction with oral misoprostol was effective, oxytocin resulted in a shorter induction-to-delivery interval. Active labor intervals and other maternal and neonatal outcomes were similar.

Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial.

PubMed

Diop, Ayisha; Daff, Bocar; Sow, Maimouna; Blum, Jennifer; Diagne, Mamadou; Sloan, Nancy L; Winikoff, Beverly

2016-01-01

Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts. We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxiliary midwives located 3-21 km from the closest referral centre were randomly assigned (1:1; via a computer-generated random allocation overseen by Gynuity Health Projects) to either 600 μg oral misoprostol or 10 IU oxytocin in Uniject (intramuscular), stratified by reported previous year clinic volume (deliveries) and geographical location (inland or coastal). Maternity huts that had been included in a previous study of misoprostol for prevention of postpartum haemorrhage were excluded to prevent contamination. Pregnant women in their third trimester were screened for eligibility either during community outreach or at home-based prenatal visits. Only women delivered by the auxiliary midwives in the maternity huts were eligible for the study. Women with known allergies to prostaglandins or pregnancy complications were excluded. The primary outcome was mean change in haemoglobin concentration measured during the third trimester and after delivery. This study was registered with ClinicalTrials.gov, number NCT01713153. 28 maternity hut clusters were randomly assigned-14 to the misoprostol group and 14 to the oxytocin group. Between June 6, 2012, and Sept 21, 2013, 1820 women were recruited. 647 women in the misoprostol group and 402 in the oxytocin group received study drug and had recorded pre-delivery and post-delivery haemoglobin concentrations, and overall 1412 women delivered in the study maternity huts. The mean change in haemoglobin concentrations was 3·5 g/L (SD 16·1) in the misoprostol group and 2·7 g/L (SD 17·8) in the oxytocin group. When adjusted for cluster design, the mean difference in haemoglobin decreases between groups was not significant (0·3 g/L, 95% CI -8·26 to 8·92, p=0·71). Both drugs were well tolerated. Shivering was common in the misoprostol group, and nausea in the oxytocin group. Postpartum haemorrhage was diagnosed in one woman allocated to oxytocin, who was referred and transferred to a higher-level facility for additional care, and fully recovered. No other women were transferred. In terms of effects on haemoglobin concentrations, neither oxytocin nor misoprostol was significantly better than the other, and both drugs were safe and efficacious when delivered by auxiliary midwives. The programmatic limitations of oxytocin, including short shelf life outside the cold chain, mean that misoprostol could be more appropriate for community-level prophylaxis of postpartum haemorrhage. Bill & Melinda Gates Foundation. Copyright © 2016 Diop et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd.. All rights reserved.

Safety and efficacy of misoprostol for induction of labour in a semi-urban hospital setting.

PubMed

Loto, O M; Fadahunsi, A A; Kolade, C O

2004-09-01

Most studies on the use of misoprostol for induction of labour have been carried out in well-endowed hospitals in developed countries with state-of-the-art monitoring equipment. There is need for more studies to be conducted in facilities with limited resources, if more patients are to benefit from the low cost and effectiveness of the drug. Following Ethical Committee approval, 152 women had labour induced in our maternity unit using intravaginal misoprostol. The patients were monitored clinically using the WHO model partograph with digital palpation of uterine contractions and intermittent auscultation of fetal heart with a pinard stethoscope. One hundred and thirty-five (88.8%) of the women had a vaginal delivery, while nine (5.9%) had a caesarean section for various obstetric indications. Eight cases of uterine hyperstimulation were noted but none of uterine rupture. We conclude that misoprostol can be used safely for induction of labour in less endowed hospital settings such as in developing countries, using basic clinical tools for monitoring.

A harm-reduction model of abortion counseling about misoprostol use in Peru with telephone and in-person follow-up: A cohort study.

PubMed

Grossman, Daniel; Baum, Sarah E; Andjelic, Denitza; Tatum, Carrie; Torres, Guadalupe; Fuentes, Liza; Friedman, Jennifer

2018-01-01

In Peru, abortion is legal only to preserve the life and health of the woman. A non-profit clinic system in Peru implemented a harm-reduction model for women with unwanted pregnancy that included pre-abortion care with instructions about misoprostol use and post-abortion care; they started offering telephone follow-up for clients in 2011. This study aimed to evaluate the effectiveness and safety of the harm-reduction model, and to compare outcomes by type of follow-up obtained. Between January 2012 and March 2013, 500 adult women seeking harm-reduction services were recruited into the study. Telephone surveys were conducted approximately four weeks after their initial harm-reduction counseling session with 262 women (response rate 52%); 9 participants were excluded. The survey focused on whether women pursued an abortion, and if so, what their experience was. Demographic and clinical data were also extracted from clinic records. Eighty-six percent of participants took misoprostol; among those taking misoprostol, 89% reported a complete abortion at the time of the survey. Twenty-two percent obtained an aspiration after taking misoprostol and 8% self-reported adverse events including hemorrhage without transfusion, infection, or severe pain. Among women who took misoprostol, 46% reported receiving in-person follow-up (in some cases both telephone and in-person), 34% received telephone only, and 20% did not report receiving any form of follow-up. Those who had in-person follow-up with the counselor were most likely to report a complete abortion (<0.001). Satisfaction with both types of follow-up was very high, with 81%-89% reporting being very satisfied. Liberalization of restrictive abortion laws is associated with improvements in health outcomes, but the process of legal reform is often lengthy. In the interim, giving women information about evidence-based regimens of misoprostol, as well as offering a range of follow-up options to ensure high quality post-abortion care, may reduce the risks associated with unsafe abortion.

A harm-reduction model of abortion counseling about misoprostol use in Peru with telephone and in-person follow-up: A cohort study

PubMed Central

Baum, Sarah E.; Andjelic, Denitza; Tatum, Carrie; Torres, Guadalupe; Fuentes, Liza; Friedman, Jennifer

2018-01-01

Background In Peru, abortion is legal only to preserve the life and health of the woman. A non-profit clinic system in Peru implemented a harm-reduction model for women with unwanted pregnancy that included pre-abortion care with instructions about misoprostol use and post-abortion care; they started offering telephone follow-up for clients in 2011. This study aimed to evaluate the effectiveness and safety of the harm-reduction model, and to compare outcomes by type of follow-up obtained. Methods Between January 2012 and March 2013, 500 adult women seeking harm-reduction services were recruited into the study. Telephone surveys were conducted approximately four weeks after their initial harm-reduction counseling session with 262 women (response rate 52%); 9 participants were excluded. The survey focused on whether women pursued an abortion, and if so, what their experience was. Demographic and clinical data were also extracted from clinic records. Results Eighty-six percent of participants took misoprostol; among those taking misoprostol, 89% reported a complete abortion at the time of the survey. Twenty-two percent obtained an aspiration after taking misoprostol and 8% self-reported adverse events including hemorrhage without transfusion, infection, or severe pain. Among women who took misoprostol, 46% reported receiving in-person follow-up (in some cases both telephone and in-person), 34% received telephone only, and 20% did not report receiving any form of follow-up. Those who had in-person follow-up with the counselor were most likely to report a complete abortion (<0.001). Satisfaction with both types of follow-up was very high, with 81%-89% reporting being very satisfied. Conclusions Liberalization of restrictive abortion laws is associated with improvements in health outcomes, but the process of legal reform is often lengthy. In the interim, giving women information about evidence-based regimens of misoprostol, as well as offering a range of follow-up options to ensure high quality post-abortion care, may reduce the risks associated with unsafe abortion. PMID:29320513

Healing property of the Piper betel phenol, allylpyrocatechol against indomethacin-induced stomach ulceration and mechanism of action

PubMed Central

Bhattacharya, S; Banerjee, D; Bauri, AK; Chattopadhyay, S; Bandyopadhyay, SK

2007-01-01

AIM: To evaluate the protective activity of allylpyrocatechol (APC), the major antioxidant constituent of Piper betel, against the indomethacin-induced stomach ulceration in the rat model and correlates with its antioxidative and mucin protecting properties. METHODS: Male Sprague-Dawley rats were divided into five groups. Normal control rats (group I) were given the vehicle oral dose of gum acacia in distilled water (1 mL per rat); ulcerated control and treated rats (groups II-V) were given a single dose of indomethacin (30 mg/kg body wt.); group II rats were sacrificed 4 h after indomethacin administration; groups III-V rats were given the vehicle (1 mL per rat) or APC (2 mg/kg body wt.) or misoprostol (1.43 μg/kg body wt.) once daily by oral intubation for 7 d starting from 4 h after the indomethacin administration. After 7 d, the stomach tissues were excised for histological examination and biochemical analysis. RESULTS: Treatment with APC (2 mg/kg body wt per day) and misoprostol (1.43 μg/kg body wt per day) for 7 d could effectively heal the stomach ulceration as revealed from the ulcer index and histopathological studies. Compared to the zero day ulcerated group, treatment with APC and misoprostol reduced the ulcer index by 93.4% and 85.4% respectively (P < 0.05). Both APC and misoprostol accelerated ulcer healing observed in natural recovery (P < 0.05), their respective healing capacities not being significantly different. The healing capacities of APC and misoprostol could be attributed to their antioxidant activity as well as the ability to enhance the mucin content of the gastric tissues. Compared to the ulcerated untreated rats, those treated with APC and misoprostol showed near normal MDA levels, while the protein levels were 86% and 78% of the normal value respectively (P < 0.05). Likewise, both APC and misoprostol increased the SOD, catalase, and mucin levels significantly (P < 0.05), the effect of APC being better. CONCLUSION: APC can protect indomethacin-induced gastric ulceration due to its antioxidative and mucin protecting properties. PMID:17659730

Healing property of the Piper betel phenol, allylpyrocatechol against indomethacin-induced stomach ulceration and mechanism of action.

PubMed

Bhattacharya, S; Banerjee, D; Bauri, A-K; Chattopadhyay, S; Bandyopadhyay, S-K

2007-07-21

To evaluate the protective activity of allylpyrocatechol (APC), the major antioxidant constituent of Piper betel, against the indomethacin-induced stomach ulceration in the rat model and correlates with its antioxidative and mucin protecting properties. Male Sprague-Dawley rats were divided into five groups. Normal control rats (group I) were given the vehicle oral dose of gum acacia in distilled water (1 mL per rat); ulcerated control and treated rats (groups II-V) were given a single dose of indomethacin (30 mg/kg body wt.); group II rats were sacrificed 4 h after indomethacin administration; groups III-V rats were given the vehicle (1 mL per rat) or APC (2 mg/kg body wt.) or misoprostol (1.43 mug/kg body wt.) once daily by oral intubation for 7 d starting from 4 h after the indomethacin administration. After 7 d, the stomach tissues were excised for histological examination and biochemical analysis. Treatment with APC (2 mg/kg body wt per day) and misoprostol (1.43 mug/kg body wt per day) for 7 d could effectively heal the stomach ulceration as revealed from the ulcer index and histopathological studies. Compared to the zero day ulcerated group, treatment with APC and misoprostol reduced the ulcer index by 93.4% and 85.4% respectively (P < 0.05). Both APC and misoprostol accelerated ulcer healing observed in natural recovery (P < 0.05), their respective healing capacities not being significantly different. The healing capacities of APC and misoprostol could be attributed to their antioxidant activity as well as the ability to enhance the mucin content of the gastric tissues. Compared to the ulcerated untreated rats, those treated with APC and misoprostol showed near normal MDA levels, while the protein levels were 86% and 78% of the normal value respectively (P < 0.05). Likewise, both APC and misoprostol increased the SOD, catalase, and mucin levels significantly (P < 0.05), the effect of APC being better. APC can protect indomethacin-induced gastric ulceration due to its antioxidative and mucin protecting properties.

Oral misoprostol for preventing postpartum haemorrhage in home births in rural Bangladesh: how effective is it?

PubMed Central

Nasreen, Hashima-E-; Nahar, Shamsun; Al Mamun, Mahfuz; Afsana, Kaosar; Byass, Peter

2011-01-01

Aims Evidence exists about prevention of postpartum haemorrhage (PPH) by oral administration of misoprostol in low-income countries, but effectiveness of prevention by lay community health workers (CHW) is not sufficient. This study aimed to investigate whether a single dose (400 µg) of oral misoprostol could prevent PPH in a community home-birth setting and to assess its acceptability and feasibility among rural Bangladeshi women. Methods This quasi-experimental trial was conducted among 2,017 rural women who had home deliveries between November 2009 and February 2010 in two rural districts of northern Bangladesh. In the intervention district 1,009 women received 400 µg of misoprostol immediately after giving birth by the lay CHWs, and in the control district 1,008 women were followed after giving birth with no specific intervention against PPH. Primary PPH (within 24 hours) was measured by women's self-reported subjective measures of the normality of blood loss using the ‘cultural consensus model.’ Baseline data provided socio-economic, reproductive, obstetric, and bleeding disorder information. Findings The incidence of primary PPH was found to be lower in the intervention group (1.6%) than the control group (6.2%) (p<0.001). Misoprostol provided 81% protection (RR: 0.19; 95% CI: 0.08–0.48) against developing primary PPH. The proportion of retained and manually removed placentae was found to be higher in the control group compared to the intervention group. Women in the control group were more likely to need an emergency referral to a higher level facility and blood transfusion than the intervention group. Unexpectedly few women experienced transient side effects of misoprostol. Eighty-seven percent of the women were willing to use the drug in future pregnancy and would recommend to other pregnant women. Conclusion Community-based distribution of oral misoprostol (400 µg) by CHW appeared to be effective, safe, acceptable, and feasible in reducing the incidence of PPH in rural areas of Bangladesh. This strategy should be scaled up across the country where access to skilled attendance is limited. PMID:21845143

Déclenchement du travail à terme par le misoprostol: expérience d'une maternité tunisienne

PubMed Central

Ouerdiane, Nadia; Tlili, Nihel; Othmani, Kaouther; Daaloul, Walid; Masmoudi, Abdelwaheb; Hamouda, Sonia Ben; Bouguerra, Badreddine

2016-01-01

Evaluer l'efficacité et l'innocuité de l'utilisation du misoprostol par voie vaginale pour le déclenchement du travail à terme. Etude prospective réalisée au service de gynécologie obstétrique B de l'hôpital Charles Nicolle de Tunis sur une durée de 4 mois. La population sélectionnée concernait les patientes à terme devant bénéficier d'une maturation cervicale. Le misoprostol à la dose de 50 µg par voie vaginale toutes les 12 h était utilisé. Les paramètres étudiés étaient les anomalies contractiles, les anomalies du RCF, le mode d'accouchement, le délai d'accouchement et l’état néonatal. 44 patientes ont bénéficié d'une maturation cervicale par misoprostol. Le terme moyen était de 40 SA. Le taux de nullipare était de 23/44 (52%). Le taux d'accouchement par voie basse était de 31/44 (70.4%). 84% des patientes ont reçu une seule dose de misoprostol. Les anomalies du RCF ont été notées dans 14/44 (32%). Le taux de liquides méconiaux était de 12/44 (27%). Un score d'Apgar à 5 mn inférieur à 7 était noté chez 7/44 (16%). Un cas de rupture utérine était survenue chez une primipare et ce après une seule prise de misoprostol. Nos résultats sont décevants en raison de la survenue d'une rupture utérine et d'une morbidité néonatale importante. D'autres études prospectives multicentriques restent utiles pour mieux s'assurer de l'efficacité mais surtout de l'innocuité du misoprostol à dose faible pour le déclenchement du travail à terme. PMID:27583092

Early pregnancy failure management among family physicians.

PubMed

Wallace, Robin; Dehlendorf, Christine; Vittinghoff, Eric; Gold, Katherine J; Dalton, Vanessa K

2013-03-01

Family physicians, as primary care providers for reproductive-aged women, frequently initiate or refer patients for management of early pregnancy failure (EPF). Safe and effective options for EPF treatment include expectant management, medical management with misoprostol, and aspiration in the office or operating room. Current practice does not appear to reflect patient preferences or to utilize the most cost-effective treatments. We compared characteristics and practice patterns among family physicians who do and do not provide multiple options for EPF care. We performed a secondary analysis of a national survey of women's health providers to describe demographic and practice characteristics among family physicians who care for women with EPF. We used multivariate logistic regression to identify correlates of providing more than one option for EPF management. The majority of family physicians provide only one option for EPF; expectant management was most frequently used among our survey respondents. Misoprostol and office-based aspiration were rarely used. Providing more than one option for EPF management was associated with more years in practice, smaller county population, larger proportions of Medicaid patients, intrauterine contraception provision, and prior training in office-based aspiration. Family physicians are capable of providing a comprehensive range of options for EPF management in the outpatient setting but few providers currently do so. To create a more patient-centered and cost-effective model of care for EPF, additional resources should be directed at education, skills training, and system change initiatives to prepare family physicians to offer misoprostol and office-based aspiration to women with EPF.

Women's Experiences with and Preference for Induction of Labor with Oral Misoprostol or Foley Catheter at Term.

PubMed

Ten Eikelder, Mieke L G; van de Meent, Marieke M; Mast, Kelly; Rengerink, Katrien Oude; Jozwiak, Marta; de Graaf, Irene M; Scholtenhuis, Marloes A G Holswilder-Olde; Roumen, Frans J M E; Porath, Martina M; van Loon, Aren J; van den Akker, Eline S; Rijnders, Robbert J P; Feitsma, A Hanneke; Adriaanse, Albert H; Muller, Moira A; de Leeuw, Jan W; Visser, Harry; Woiski, Mallory D; Weerd, Sabina Rombout-de; van Unnik, Gijs A; Pernet, Paula J M; Versendaal, Hans; Mol, Ben W; Bloemenkamp, Kitty W M

2017-01-01

Objective  We assessed experience and preferences among term women undergoing induction of labor with oral misoprostol or Foley catheter. Study Design  In 18 of the 29 participating hospitals in the PROBAAT-II trial, women were asked to complete a questionnaire within 24 hours after delivery. We adapted a validated questionnaire about expectancy and experience of labor and asked women whether they would prefer the same method again in a future pregnancy. Results  The questionnaire was completed by 502 (72%) of 695 eligible women; 273 (54%) had been randomly allocated to oral misoprostol and 229 (46%) to Foley catheter. Experience of the duration of labor, pain during labor, general satisfaction with labor, and feelings of control and fear related to their expectation were comparable between both the groups. In the oral misoprostol group, 6% of the women would prefer the other method if induction is necessary in future pregnancy, versus 12% in the Foley catheter group (risk ratio: 0.70; 95% confidence interval: 0.55-0.90; p =  0.02). Conclusion  Women's experiences of labor after induction with oral misoprostol or Foley catheter are comparable. However, women in the Foley catheter group prefer more often to choose a different method for future inductions. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

The role of prostaglandins E1 and E2, dinoprostone, and misoprostol in cervical ripening and the induction of labor: a mechanistic approach.

PubMed

Bakker, Ronan; Pierce, Stephanie; Myers, Dean

2017-08-01

Prostaglandins play a critical role in cervical ripening by increasing inflammatory mediators in the cervix and inducing cervical remodeling. Prostaglandin E1 (PGE1) and prostaglandin E2 (PGE2) exert different effects on these processes and on myometrial contractility. These mechanistic differences may affect outcomes in women treated with dinoprostone, a formulation identical to endogenous PGE2, compared with misoprostol, a PGE1 analog. The objective of this review is to evaluate existing evidence regarding mechanistic differences between PGE1 and PGE2, and consider the clinical implications of these differences in patients requiring cervical ripening for labor induction. We conducted a critical narrative review of peer-reviewed articles identified using PubMed and other online databases. While both dinoprostone and misoprostol are effective in cervical ripening and labor induction, they differ in their clinical and pharmacological profiles. PGE2 has been shown to stimulate interleukin-8, an inflammatory cytokine that promotes the influx of neutrophils and induces remodeling of the cervical extracellular matrix, and to induce functional progesterone withdrawal. Misoprostol has been shown to elicit a dose-dependent effect on myometrial contractility, which may affect rates of uterine tachysystole in clinical practice. Differences in the mechanism of action between misoprostol and PGE2 may contribute to their variable effects in the cervix and myometrium, and should be considered to optimize outcomes.

Training Traditional Birth Attendants on the Use of Misoprostol and a Blood Measurement Tool to Prevent Postpartum Haemorrhage: Lessons Learnt from Bangladesh

PubMed Central

Passano, Paige; Bohl, Daniel D.; Islam, Arshadul; Prata, Ndola

2014-01-01

A consensus emerged in the late 1990s among leaders in global maternal health that traditional birth attendants (TBAs) should no longer be trained in delivery skills and should instead be trained as promoters of facility-based care. Many TBAs continue to be trained in places where home deliveries are the norm and the potential impacts of this training are important to understand. The primary objective of this study was to gain a more nuanced understanding of the full impact of training TBAs to use misoprostol and a blood measurement tool (mat) for the prevention of postpartum haemorrhage (PPH) at home deliveries through the perspective of those involved in the project. This qualitative study, conducted between July 2009 and July 2010 in Bangladesh, was nested within larger operations research, testing the feasibility and acceptability of scaling up community-based provision of misoprostol and a blood measurement tool for prevention of PPH. A total of 87 in-depth interviews (IDIs) were conducted with TBAs, community health workers (CHWs), managers, and government-employed family welfare visitors (FWVs) at three time points during the study. Computer-assisted thematic data analysis was conducted using ATLAS.ti (version 5.2). Four primary themes emerged during the data analysis, which all highlight changes that occurred following the training. The first theme describes the perceived direct changes linked to the two new interventions. The following three themes describe the indirect changes that interviewees perceived: strengthened linkages between TBAs and the formal healthcare system; strengthened linkages between TBAs and the communities they serve; and improved quality of services/service utilization. The data indicate that training TBAs and CHW supervisors resulted in perceived broader and more nuanced changes than simply improvements in TBAs’ knowledge, attitudes, and practices. Acknowledgeing TBAs’ important role in the community and in home deliveries and integrating them into the formal healthcare system has the potential to result in changes similar to those seen in this study. PMID:24847601

A novel misoprostol delivery system for induction of labor: clinical utility and patient considerations.

PubMed

Stephenson, Megan L; Wing, Deborah A

2015-01-01

Induction of labor is one of the most commonly performed obstetric procedures and will likely become more common as the reproductive population in developed nations changes. As the proportion of women undergoing induction grows, there is a constant search for more efficacious ways to induce labor while maintaining fetal and maternal safety as well as patient satisfaction. With almost half of induced labors requiring cervical ripening, methods for achieving active labor and vaginal delivery are constantly being investigated. Prostaglandins have been shown to be effective induction agents, and specifically vaginal misoprostol, used off-label, have been widely utilized to initiate cervical ripening and active labor. The challenge is to administer this medication accurately while maintaining the ability to discontinue the medication when needed. The misoprostol vaginal insert initiates cervical ripening utilizing a delivery system that controls medication release and can be rapidly removed. This paper reviews the design, development, and clinical utility of the misoprostol vaginal insert for induction of labor as well as patient considerations related to the delivery system.

Misoprostol inhibits gastric mucosal release of endogenous prostaglandin E2 and thromboxane B2 in healthy volunteers.

PubMed Central

Mertz-Nielsen, A; Eskerod, O; Bukhave, K; Rask-Madsen, J

1995-01-01

Prostaglandin analogues of the E-series theoretically offer the ideal antiulcer drugs. Peptic ulcer healing with prostaglandin analogues is, however, no better than would be predicted from their ability to inhibit gastric acid secretion and they are less effective than histamine H2 receptor antagonists in preventing ulcer relapse. It could be that prostaglandin analogues inhibit gastric mucosal synthesis or release of endogenous eicosanoids, thereby abrogating their own effects. This study, therefore, examined how a single therapeutic dose (200 micrograms) of misoprostol, a synthetic analogue of prostaglandin E1, influences gastric mucosal release of endogenous prostaglandin E2 (PGE2), thromboxane B2 (TXB2), and chemotactic leukotriene B4 (LTB4) during basal conditions and in response to gastric luminal acidification (0.1 M HCl; 5 ml/min for 10 minutes). Nine healthy volunteers were studied in a single blind, cross over design. In each subject misoprostol or placebo was instilled in randomised order into the stomach, which was subsequently perfused with isotonic mannitol. Misoprostol significantly decreased basal as well as acid stimulated output of PGE2 and TXB2, without affecting output of LTB4. These data show that misoprostol inhibits gastric mucosal synthesis of prostanoids. Decreased concentrations, or even a changed profile, of native eicosanoids modulating the release of inflammatory mediators from immune cells might explain why prostaglandin analogues have a comparatively poor clinical performance in ulcer healing and prevention. PMID:7737555

Efficacy of misoprostol in the treatment of tinnitus in patients with diabetes and/or hypertension.

PubMed

Akkuzu, Babur; Yilmaz, Ismail; Cakmak, Ozcan; Ozluoglu, Levent N

2004-09-01

To determine the efficacy of the prostaglandin E1 analogue misoprostol in the treatment of tinnitus in diabetic and/or hypertensive patients. Double-blind, randomized, placebo-controlled trial. Tertiary care referral center. The subjects were 42 patients with hypertension and/or diabetes mellitus who had chronic tinnitus and had experienced tinnitus symptoms for a minimum of 6 months. Twenty-eight patients were randomly assigned to Group I (misoprostol treatment), and 14 patients to the Group II (placebo treatment). Misoprostol therapy was started at 200 microg per day, and was increased 200 microg every 7 days until a dose of 800 microg per day was reached. The same numbers of placebo tablets were given to the control group using the same schedule. Both groups were treated for 1 month. The changes in objective and subjective tinnitus findings from baseline to 1 month were assessed, and the group results were compared. The chi(2)-test, student's t-test and paired-samples t-test were used to analyze the study. At the completion of treatment, objective assessment showed that tinnitus loudness decreased in 13 (46%) of the 28 patients in the experimental group, whereas this was observed in only two (14%) of the 14 subjects in the placebo group. Subjective tinnitus scoring revealed improvement rates of 29 and 14% for the misoprostol and placebo groups, respectively. When t-test relating to difference between rates were performed, the difference between improvement rate for tinnitus loudness of the experimental group and control group was found to be statistically significant (P = 0.05), but difference between improvement rate based on subjective tinnitus scoring was insignificant (P = 0.22). Misoprostol is an effective and safe treatment for chronic tinnitus in hypertensive and/or diabetic patients. Our results are encouraging, but further studies of larger series are needed.

Misoprostol administered sublingually at a dose of 12.5 μg versus vaginally at a dose of 25 μg for the induction of full-term labor: a randomized controlled trial protocol.

PubMed

Gattás, Daniele Sofia Moraes Barros; da Silva Junior, José Roberto; Souza, Alex Sandro Rolland; Feitosa, Francisco Edson; de Amorim, Melania Maria Ramos

2018-04-18

Various methods are currently used for the induction of labor. Nevertheless, the most effective method with the fewest side effects remains to be established. Misoprostol, administered vaginally, has been routinely used for this purpose; however, other forms of administration are being proposed, including the use of sublingual tablets. No studies have yet compared the effectiveness and safety of 12.5-μg misoprostol administered sublingually compared to a 25-μg vaginal dose of the drug for the induction of labor. A triple-blind, multicenter, placebo-controlled, randomized clinical trial will be conducted in Brazil at the Instituto de Medicina Integral Prof. Fernando Figueira and at the Assis Chateaubriand Maternity Teaching Hospital of the Federal University of Ceará. A total of 140 patients with full-term pregnancies, a live fetus, a Bishop score ≤ 6 and a recommendation of induction of labor will be randomized to one of two groups. One group will receive 12.5-μg sublingual tablets of misoprostol and placebo vaginal tablets, while the other group will receive placebo sublingual tablets and vaginal tablets containing 25 μg of misoprostol. The principal endpoint is the rate of tachysystole. The secondary endpoints are vaginal delivery within 24 h of induction, uterine hyperstimulation, Cesarean section, severe neonatal morbidity or perinatal death, severe maternal morbidity or maternal death, and maternal preference regarding the route of administration of the drug. Student's t-test, and the chi-square test of association or Fisher's exact test, as appropriate, will be used in the data analysis. Risk ratios and their respective 95% confidence intervals will be calculated. Misoprostol has been identified as a safe, inexpensive, easily administered option for the induction of labor, with satisfactory results. An experimental study has shown that misoprostol administered sublingually at a dose of 25 μg appears to be effective and is associated with greater maternal satisfaction when labor is induced in women with an unfavorable cervix. Nevertheless, the rate of tachysystole remains high; therefore, further studies are required to determine the ideal dose and the ideal interval of time between doses. ClinicalTrial.gov, NCT01406392 .

Results from a study using misoprostol for management of incomplete abortion in Vietnamese hospitals: implications for task shifting.

PubMed

Ngoc, Nguyen Thi Nhu; Shochet, Tara; Blum, Jennifer; Hai, Pham Thanh; Dung, Duong Lan; Nhan, Tran Thanh; Winikoff, Beverly

2013-05-22

Complications following spontaneous or induced abortion are a major cause of maternal morbidity. To manage these complications, post-abortion care (PAC) services should be readily available and easy to access. Standard PAC treatment includes surgical interventions that are highly effective but require surgical providers and medical centers that have the necessary space and equipment. Misoprostol has been shown to be an effective alternative to surgical evacuation and can be offered by lower level clinicians. This study sought to assess whether 400 mcg sublingual misoprostol could effectively evacuate the uterus after incomplete abortion and to confirm its applicability for use at lower level settings. All women presenting with incomplete abortion at one of three hospitals in Vietnam were enrolled. Providers were not asked to record if the abortion was spontaneous or induced. It is likely that all were spontaneous given the legal status and easy access to abortion services in Vietnam. Participants were given 400 mcg sublingual misoprostol and instructed to hold the pills under their tongue for 30 minutes and then swallow any remaining fragments. They were then asked to return one week later to confirm their clinical status. Study clinicians were instructed to confirm a complete expulsion clinically. All women were asked to complete a questionnaire regarding satisfaction with the treatment. Three hundred and two women were enrolled between September 2009 and May 2010. Almost all participants (96.3%) had successful completions using a single dose of 400 mcg misoprostol. The majority of women (87.2%) found the side effects to be tolerable or easily tolerable. Most women (84.3%) were satisfied or very satisfied with the treatment they received; only one was dissatisfied (0.3%). Nine out of ten women would select this method again and recommend it to a friend (91.0% and 90.0%, respectively). This study confirms that 400 mcg sublingual misoprostol effectively evacuates the uterus for most women experiencing incomplete abortion. The high levels of satisfaction and side effect tolerability also attest to the ease of use of this method. From these data and given the international consensus around the effectiveness of misoprostol for incomplete abortion care, it seems timely that use of the drug for this indication be widely expanded both throughout Vietnam and wherever access to abortion care is limited. ClinicalTrials.gov, NCT00670761.

Which method is best for the induction of labour? A systematic review, network meta-analysis and cost-effectiveness analysis.

PubMed

Alfirevic, Zarko; Keeney, Edna; Dowswell, Therese; Welton, Nicky J; Medley, Nancy; Dias, Sofia; Jones, Leanne V; Gyte, Gillian; Caldwell, Deborah M

2016-08-01

More than 150,000 pregnant women in England and Wales have their labour induced each year. Multiple pharmacological, mechanical and complementary methods are available to induce labour. To assess the relative effectiveness, safety and cost-effectiveness of labour induction methods and, data permitting, effects in different clinical subgroups. We carried out a systematic review using Cochrane methods. The Cochrane Pregnancy and Childbirth Group's Trials Register was searched (March 2014). This contains over 22,000 reports of controlled trials (published from 1923 onwards) retrieved from weekly searches of OVID MEDLINE (1966 to current); Cochrane Central Register of Controlled Trials (The Cochrane Library); EMBASE (1982 to current); Cumulative Index to Nursing and Allied Health Literature (1984 to current); ClinicalTrials.gov; the World Health Organization International Clinical Trials Registry Portal; and hand-searching of relevant conference proceedings and journals. We included randomised controlled trials examining interventions to induce labour compared with placebo, no treatment or other interventions in women eligible for third-trimester induction. We included outcomes relating to efficacy, safety and acceptability to women. In addition, for the economic analysis we searched the Database of Abstracts of Reviews of Effects, and Economic Evaluations Databases, NHS Economic Evaluation Database and the Health Technology Assessment database. We carried out a network meta-analysis (NMA) using all of the available evidence, both direct and indirect, to produce estimates of the relative effects of each treatment compared with others in a network. We developed a de novo decision tree model to estimate the cost-effectiveness of various methods. The costs included were the intervention and other hospital costs incurred (price year 2012-13). We reviewed the literature to identify preference-based utilities for the health-related outcomes in the model. We calculated incremental cost-effectiveness ratios, expected costs, utilities and net benefit. We represent uncertainty in the optimal intervention using cost-effectiveness acceptability curves. We identified 1190 studies; 611 were eligible for inclusion. The interventions most likely to achieve vaginal delivery (VD) within 24 hours were intravenous oxytocin with amniotomy [posterior rank 2; 95% credible intervals (CrIs) 1 to 9] and higher-dose (≥ 50 µg) vaginal misoprostol (rank 3; 95% CrI 1 to 6). Compared with placebo, several treatments reduced the odds of caesarean section, but we observed considerable uncertainty in treatment rankings. For uterine hyperstimulation, double-balloon catheter had the highest probability of being among the best three treatments, whereas vaginal misoprostol (≥ 50 µg) was most likely to increase the odds of excessive uterine activity. For other safety outcomes there were insufficient data or there was too much uncertainty to identify which treatments performed 'best'. Few studies collected information on women's views. Owing to incomplete reporting of the VD within 24 hours outcome, the cost-effectiveness analysis could compare only 20 interventions. The analysis suggested that most interventions have similar utility and differ mainly in cost. With a caveat of considerable uncertainty, titrated (low-dose) misoprostol solution and buccal/sublingual misoprostol had the highest likelihood of being cost-effective. There was considerable uncertainty in findings and there were insufficient data for some planned subgroup analyses. Overall, misoprostol and oxytocin with amniotomy (for women with favourable cervix) is more successful than other agents in achieving VD within 24 hours. The ranking according to safety of different methods was less clear. The cost-effectiveness analysis suggested that titrated (low-dose) oral misoprostol solution resulted in the highest utility, whereas buccal/sublingual misoprostol had the lowest cost. There was a high degree of uncertainty as to the most cost-effective intervention. Future trials should be powered to detect a method that is more cost-effective than misoprostol solution and report outcomes included in this NMA. This study is registered as PROSPERO CRD42013005116. The National Institute for Health Research Health Technology Assessment programme.

Randomized trial of oral misoprostol treatment for cervical ripening before tandem application in cervix cancer.

PubMed

Cepni, Kimia; Gul, Sule; Cepni, Ismail; Güralp, Onur; Sal, Veysel; Mayadagli, Alpaslan

2011-11-01

To investigate the efficacy of oral misoprostol administered to facilitate tandem application to the cervix as a part of brachytherapy in patients with cervical cancer. Eighty patients with cervical cancer who had been planned to undergo brachytherapy at Dr. Lütfi Kırdar Kartal Training and Research Hospital were evaluated in a double-blind, prospective, randomized trial. Patients were divided randomly into two groups of 40 patients. The first and second groups received 400 μg of misoprostol orally and placebo, respectively, 3 h before tandem application. The two groups were compared in terms of age, diameter of tumor, parity, age at first intercourse, amount of bleeding and pain at first tandem application, length of endometrial cavity measured by hysterometer, and size of Hegar dilators used for cervical dilatation. Of all cases, 63.6%, 16.3%, 10%, 6.3%, 2.5%, and 1.3% were Stage IIB, IIIB, IIIA, IVA, IIA and IIC, respectively. Mean (±SD) age (range) was 49.3 ± 13.1 (25-83) years and 56.6 ± 13.2 (30-78) years in the study and control groups, respectively (p = 0.015). Age at first intercourse, diameter of tumor, parity, amount of bleeding at first tandem application, and length of endometrial cavity measured by hysterometer were not significantly different between the two groups. Pain score was significantly higher in the control group (p < 0.001). Application was significantly easier in the study group compared with controls (p < 0.001). Average size of initial Hegar dilators used for cervical dilatation was significantly higher in the study group compared with controls (p = 0.017). Administration of misoprostol 400 μg orally for cervical ripening before tandem application facilitates the procedure, increases patient tolerability and comfort, and may decrease complication rates. Copyright © 2011 Elsevier Inc. All rights reserved.

Knowledge of medical abortion among Brazilian medical students.

PubMed

Fernandes, Karayna Gil; Camargo, Rodrigo Pauperio Soares; Duarte, Graciana Alves; Faúndes, Anibal; Sousa, Maria Helena; Maia Filho, Nelson Lourenço; Pacagnella, Rodolfo Carvalho

2012-09-01

To assess the knowledge of Brazilian medical students regarding medical abortion (MA) and the use of misoprostol for MA, and to investigate factors influencing their knowledge. All students from 3 medical schools in São Paulo State were invited to complete a pretested structured questionnaire with precoded response categories. A set of 12 statements on the use and effects of misoprostol for MA assessed their level of knowledge. Of about 1260 students invited to participate in the study, 874 completed the questionnaire, yielding a response rate of 69%. The χ(2) test was used for the bivariate analysis, which was followed by multiple regression analysis. Although all students in their final year of medical school had heard of misoprostol for termination of pregnancy, and 88% reported having heard how to use it, only 8% showed satisfactory knowledge of its use and effects. Academic level was the only factor associated with the indicators of knowledge investigated. The very poor knowledge of misoprostol use for MA demonstrated by the medical students surveyed at 3 medical schools makes the review and updating of the curriculum urgently necessary. Copyright © 2012 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

[Medical induced abortion].

PubMed

Bettahar, K; Pinton, A; Boisramé, T; Cavillon, V; Wylomanski, S; Nisand, I; Hassoun, D

2016-12-01

Updated clinical recommendations for medical induced abortion procedure. A systematic review of French and English literature, reviewing the evidence relating to the provision of medical induced abortion was carried out on PubMed, Cochrane Library and international scientific societies recommendations. The effectiveness of medical abortion is higher than 95% when the protocols are adjusted to gestational age (EL1). Misoprostol alone is less effective than a combination of mifepristone and misoprostol (EL1). Gemeprost is less effective than misoprostol (EL2). The dose of 200mg of mifepristone should be preferred to 600mg (NP1, Rank A). Mifepristone can be taken at home (professional agreement). The optimum interval between mifepristone and misoprostol intake should be 24 to 48 hours (EL1, grade A). Before 7 weeks LMP, the dose of 400μg misoprostol should be given orally (EL1, grade A) eventually repeated after 3hours if no bleeding occurs. For optimal effectiveness between 7 and 14 LMP, the interval between mifepristone and misoprostol should not be shortened to less than 8hours (grade 1). An interval of 24 to 48hours will not affect the effectiveness of the method provided misoprostol dosage is 800μg (EL1). Vaginal, sublingual or buccal routes of administration are more effective and better tolerated than the oral route, which should be abandoned (EL1). An amount of 800μg sublingual or buccal misoprostol route has the same effectiveness than the vaginal route but more gastrointestinal side effects (EL1, grade A). Between 7 and 9 LMP, it does not seem necessary to repeat misoprostol dose whereas it should be repeated beyond 9 SA (grade B). Between 9 and 14 LMP, the dose of 400μg misoprostol given either vaginally, buccally or sublingually should be repeated every 3hours if needed (with a maximum of 5 doses) (EL2, grade B). There is no strong evidence supporting routine antibiotic prophylaxis for medical abortion (professional agreement). Rare contraindications should be respected (known hypersensitivity to misoprostol or mifepristone, inherited porphyria, severe anemia, hemorrhagic disorders or current anticoagulation therapy, suspected or confirmed ectopic pregnancy) as well as precautions of use (severe disease or on-going corticosteroid therapy). With no risk factors or symptoms, a pregnancy of unknown location (PUL) at the endovaginal ultrasound associated with a level of hCG usually chosen at less than 1500IU (or 2500IU with an abdominal probe) is not a contraindication of medical abortion as long as the woman is informed of the risk of undiagnosed ectopic pregnancy and knows how and when to seek emergency attention. An earlier than usual follow-up of the decrease of hCG levels is highly recommended. Breastfeeding, obesity, twin pregnancy and scared uterus are not contraindications for first trimester medical abortion. Side effects (gastro intestinal and thermoregulation disorders) during the procedure are generally of low intensity and short duration. A prophylactic treatment for nausea should be proposed (professional agreement). The pain increases with gestational age of the pregnancy (EL1). Ibuprofen is the first choice of painkiller (EL1). Ibuprofen will be systematically proposed or given on demand according to the practice of each facility (professional agreement). After a medical abortion, a follow-up assessment to confirm completion of the abortion is recommended (EL2, grade B). Clinical history combined with ultrasound and/or hCG blood level are both reliable methods and can be left with the choice of each facility (grade B). A fall of more than 80% of the initial blood level of hCG, fifteen days after the procedure is in favor of the success of the method (grade B). Medical abortion is a safe and efficient abortion method up to 14 weeks LMP. To be effective, the drug regimen should be adapted to gestational age. Women should be informed of advantages and disadvantages of the method according to the gestational age and side effects so she can choose the method that fits her best. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Effectiveness and safety of misoprostol distributed to antenatal women to prevent postpartum haemorrhage after child-births: a stepped-wedge cluster-randomized trial.

PubMed

Ononge, Sam; Campbell, Oona M R; Kaharuza, Frank; Lewis, James J; Fielding, Katherine; Mirembe, Florence

2015-11-26

Oral misoprostol, administered by trained health-workers is effective and safe for preventing postpartum haemorrhage (PPH). There is interest in expanding administration of misoprostol by non-health workers, including task-shifting to pregnant women themselves. However, the use of misoprostol for preventing PPH in home-births remains controversial, due to the limited evidence to support self-administration or leaving it in the hands of non-health workers. This study aimed to determine if antenatally distributing misoprostol to pregnant women to self-administer at home birth reduces PPH. Between February 2013 and March 2014, we conducted a stepped-wedge cluster-randomized trial in six health facilities in Central Uganda. Women at 28+ weeks of gestation attending antenatal care were eligible. Women in the control-arm received the standard-of-care; while the intervention-arm were offered 600 mcg of misoprostol to swallow immediately after birth of baby, when oxytocin was not available. The primary outcome (PPH) was a drop in postpartum maternal haemoglobin (Hb) by ≥ 2 g/dl, lower than the prenatal Hb. Analysis was by intention-to-treat at the cluster level and we used a paired t-tests to assess whether the mean difference between the control and intervention groups was statistically significant. 97% (2466/2545) of eligible women consented to participate; 1430 and 1036 in the control and intervention arms respectively. Two thousand fifty-seven of the participants were successfully followed up and 271 (13.2%) delivered outside a health facility. There was no significant difference between the study group in number of women who received a uterotonic at birth (control 80.4% vs intervention 91.4%, mean difference = -11.0%, 95% confidence interval [CI] -25.7% to 3.6%, p = 0.11). No woman took misoprostol before their baby's birth. Shivering and fever were 14.9% in the control arm compared to 22.2% in the intervention arm (mean difference = -7.2%, 95% CI -11.1% to -3.7%), p = 0.005). There was a slight, but non-significant, reduction in the percentage of women with Hb drop ≥ 2g/dl from 18.5% in the control arm to 11.4% in the intervention arm (mean difference = 7.1%, 95% CI -3.1% to 17.3%, p = 0.14). Similarly, there was no significant difference between the groups in the primary outcome in the women who delivered at home (control 9.6% vs intervention 14.5%, mean difference -4.9; 95% CI -12.7 to 2.9), p = 0.17). This study was unable to detect a significant reduction in PPH following the antenatal distribution of misoprostol. The study was registered with Pan-African Clinical Trials Network ( PACTR201303000459148, on 19/11/2012).

Misoprostol for Prevention of Postpartum Hemorrhage at Home Birth in Afghanistan: Program Expansion Experience.

PubMed

Haver, Jaime; Ansari, Nasratullah; Zainullah, Partamin; Kim, Young-Mi; Tappis, Hannah

2016-01-01

Afghanistan has a maternal mortality ratio of 400 per 100,000 live births. Hemorrhage is the leading cause of maternal death. Two-thirds of births occur at home. A pilot program conducted from 2005 to 2007 demonstrated the effectiveness of using community health workers for advance distribution of misoprostol to pregnant women for self-administration immediately following birth to prevent postpartum hemorrhage. The Ministry of Public Health requested an expansion of the pilot to study implementation on a larger scale before adopting the intervention as national policy. The purpose of this before-and-after study was to determine the effectiveness of advance distribution of misoprostol for self-administration across 20 districts in Afghanistan and identify any adverse events that occurred during expansion. Cross-sectional household surveys were conducted pre- (n = 408) and postintervention (n = 408) to assess the effect of the program on uterotonic use among women who had recently given birth. Maternal death audits and verbal autopsies were conducted to investigate peripartum maternal deaths that occurred during implementation in the 20 districts. Uterotonic use among women in the sample increased from 50.3% preintervention to 74.3% postintervention. Because of a large-scale investment in Afghanistan in training and deployment of community midwives, it was assumed that all women who gave birth in facilities received a uterotonic. A significant difference in uterotonic use at home births was observed among women who lived farthest from a health facility (> 90 minutes self-reported travel time) compared to women who lived closer (88.5% vs 38.9%; P < .0001). All women who accepted misoprostol and gave birth at home used the drug. No maternal deaths were identified among those women who used misoprostol. The results of this study build on the findings of the pilot program and provide evidence on the effectiveness, primarily measured by uterotonic use, of an expansion of advance distribution of misoprostol for self-administration. © 2016 The Authors. The Journal of Midwifery and Women's Health, published by Wiley Periodicals, Inc., on behalf of the American College of Nurse-Midwives.

Analysis of misoprostol and chlorhexidine policy gains in Pakistan: the advocacy experience of Mercy Corps Pakistan.

PubMed

Sarwar, Zahida; Cutherell, Andrea; Noor, Arif; Naureen, Farah; Norman, Jennifer

2015-11-25

While Pakistan has made progress toward achieving Millennium Development Goal 5 for maternal health, it is unlikely to achieve the target; further, it is also not on track for Millennium Development Goal 4 regarding child health. Two low-cost, temperature stable and life-saving drugs, misoprostol and chlorhexidine, can respectively avert maternal and newborn deaths, and are particularly pertinent for poor and marginalized areas which bear the brunt of maternal and newborn deaths in Pakistan. In response, Mercy Corps led focused advocacy efforts to promote changes in policies, protocols, and regulatory environments for misoprostol (2012-2014) and for chlorhexidine (2014). These short-duration advocacy projects facilitated significant policy gains, such as inclusion of misoprostol and chlorhexidine into province-specific essential drug lists, development and endorsement of clinical protocols for the two drugs by provincial health departments, inclusion of misoprostol into pre-service training curriculum for several health cadres, and application for registration of chlorhexidine (at the concentration required for newborn care) by two pharmaceutical companies. These results were achieved by a consultative and evidence-based process which generated feedback from community members, program implementers, and policymakers, and ultimately put the government in the driver's seat to facilitate change. Community Action Dialogue forums were linked with provincial-level Technical Working Groups and Provincial Steering Committees, who passed on endorsed recommendations to the Health Secretary. The key factors which facilitated change were the identification of champions within the provincial health departments, prioritization of relationship building and follow-up, focus on concrete advocacy aims rather than broad objectives, and the use of multi-stakeholder forums to secure an enabling environment for the policy changes to take root. While these advocacy initiatives resulted in significant policy changes in Pakistan's devolved health system, to ensure these policy changes have an impact on health outcomes, Pakistan should focus on the scale-up of appropriate use of chlorhexidine and misoprostol. Further, future policy initiatives in Pakistan should make use of similar multi-stakeholder policy forums, while ensuring a third party to facilitate the process so that civil society and community voices are not lost in the policy development discussion.

Comparative study of titrated oral misoprostol solution and vaginal dinoprostone for labor induction at term pregnancy.

PubMed

Wang, Xiu; Yang, Aijun; Ma, Qingyong; Li, Xuelan; Qin, Li; He, Tongqiang

2016-09-01

To evaluate effectiveness and safety of titrated oral misoprostol solution (OMS) in comparison with vaginal dinoprostone for cervix ripening and labor induction in term pregnant women. A multicenter randomized controlled trial of women with term singleton pregnancy with indications for labor induction; 481 participants were allocated to receive titrated OMS with different doses by hourly administration according to the procedure or insert vaginal dinoprostone for cervix ripening and labor induction to compare maternal outcomes including indication of labor induction, mode of outcome of delivery, maternal morbidity, and neonatal outcomes between two groups for evaluating the efficacy and safety of titrated oral misoprostol induction. Proportion of delivery within 12 h of titrated oral misoprostol is significantly less than vaginal dinoprostone (p = 0.03), but no difference of total vaginal delivery rate (p = 0.93); the mean time of first treatment to vaginal delivery was longer in OMS group (21.3 ± 14.5 h) compared with the vaginal dinoprostone group (15.7 ± 9.6 h). Although the proportion of cesarean section between the two groups showed no statistically significant difference, OMS group showed significantly lower frequency of uterine hyperstimulation, hypertonus, partus precipitatus and non-reassuring fetal heart rate than dinoprostone group. Neonatal outcomes were similar evaluating from Apgar score and NICU admission. Our study also showed that labor induction of women with cervix Bishop score ≤3 needed increased dosage of misoprostol solution. Titrated OMS is as effective as vaginal dinoprostone in labor induction for term pregnant women, with safer effect for its lower rate of adverse effect for women.

Development and validation of LC methods for the separation of misoprostol related substances and diastereoisomers.

PubMed

Kahsay, Getu; Song, Huiying; Eerdekens, Fran; Tie, Yaxin; Hendriks, Danny; Van Schepdael, Ann; Cabooter, Deirdre; Adams, Erwin

2015-01-01

Misoprostol is a synthetic prostaglandin E1 analogue which is mainly used for prevention and treatment of gastric ulcers, but also for abortion due to its labour inducing effect. Misoprostol exists as a mixture of diastereoisomers (1:1) and has several related impurities owing to its instability at higher temperatures and moisture. A simple and robust reversed phase liquid chromatographic (RPLC) method is described for the separation of the related substances and a normal phase (NP) LC method for the separation of misoprostol diastereoisomers. The RPLC method was performed using an Ascentis Express C18 (150 mm × 4.6 mm, 5 μm) column kept at 35 °C. The mobile phase was a gradient mixture of mobile phase A (ACN-H2O-MeOH, 28:69:3 v/v/v) and mobile phase B (ACN-H2O-MeOH, 47:50:3 v/v/v) eluted at a flow rate of 1.5 mL/min. UV detection was performed at 200 nm. The NPLC method was undertaken by using an XBridge bare silica (150 mm × 2.1 mm, 3.5 μm) column at 35 °C. The mobile phase contained 1-propanol-heptane-TFA (4:96:0.1%, v/v/v), pumped at a flow rate of 0.5 mL/min. UV detection was performed at 205 nm. This LC method can properly separate the two diastereoisomers (Rs > 2) within an analysis time of less than 20 min. Both methods were validated according to the ICH guidelines. Furthermore, these new LC methods have been successfully applied for purity control and diastereoisomers ratio determination of misoprostol bulk drug, tablets and dispersion. Copyright © 2015 Elsevier B.V. All rights reserved.

Medical management of early pregnancy failure (EPF): a retrospective analysis of a combined protocol of mifepristone and misoprostol used in clinical practice.

PubMed

Colleselli, Valeria; Schreiber, Courtney A; D'Costa, Elisabeth; Mangesius, Stephanie; Wildt, Ludwig; Seeber, Beata E

2014-06-01

To evaluate the efficacy of a combined protocol of mifepristone and misoprostol in the management of early pregnancy failure (EPF) and the average time to expulsion of tissue and rate of side effects. Retrospective chart review of all consecutive women treated with primary medical management for EPF at our institution from 2006 to 2012. 168 patients were included in the present study. The overall success rate, defined as the absence of the need for surgical intervention, was 61 % and did not differ by calendar year. There was no difference in success rate grouped by diagnosis [intrauterine embryonic/fetal demise (IUED/IUFD) vs. anembryonic gestation; p = 0.30] or gestational age (<9 or ≥9 weeks; p = 0.48). The success rate varied significantly according to the required dose of misoprostol, ≤800 or >800 μg (68 vs. 50 %, p = 0.029). Of the possible predictive factors of success, only the dose of misoprostol required was a significant independent negative predictor. Mean and median time to tissue expulsion after the first dose of misoprostol were 8.4 and 5.5 h, respectively. The incidence of side effects was low with no blood transfusions required. The success rate in this study is markedly below published data. This can possibly be attributed to retrospective study design, allowing for physician subjectivity and patients' wishes in the absence of strict study requirements. The protocol was well tolerated with a paucity of side effects. We make suggestions for enhancing success rates in the clinical setting by optimizing medication protocols, establishing precise treatment guidelines and training physicians in the accurate interpretation of treatment outcomes.

Medical abortion with mifepristone and home administration of misoprostol up to 63 days' gestation.

PubMed

Løkeland, Mette; Iversen, Ole Erik; Engeland, Anders; Økland, Ingrid; Bjørge, Line

2014-07-01

To evaluate the acceptability and efficacy of medical abortion at home up to 63 days' gestation without limits on travel distance to a registered institution. Observational prospective study. Haukeland University Hospital between May 2006 and May 2009. A total of 1018 women requesting abortion before 63 days' gestation who chose medical termination with mifepristone and home administration of misoprostol. The women took 200 mg mifepristone under nurse supervision and self-administered 800 μg misoprostol vaginally 36-48 h later at home. All were contacted by phone for follow-up and assessment of bleeding, pain and acceptability. Evacuation rate, pain, bleeding, acceptability, influence of distance on treatment. Median gestational age was 50 (range 35-63) days and 70 (7.1%) of the women lived more than 60 min travel from the clinic. The rate of completed abortion was 93.6% and surgical evacuation was performed in 50 (4.9%) cases. Two women requested treatment on the day of misoprostol use. Moderate to strong pain was experienced by 68.4%, and 74.7% reported moderate to heavy bleeding. Parous women experienced less pain than nulliparous women (odds ratio 0.27; 95% confidence interval 0.19-0.34). In all, 95.1% of the women were satisfied with staying at home. Travel distance did not influence treatment outcome variables. In our experience, home administration of misoprostol is an effective and acceptable method for abortion up to 63 days of gestation and women should be eligible for this treatment option regardless of their travel distance from hospital. © 2014 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons on behalf of Nordic Federation of Societies of Obstetrics and Gynecology.

[Cost comparative analysis of drug therapy for non-steroidal anti-inflammatory drug (NSAID)-induced gastric ulcer in Japan].

PubMed

Hashiguchi, Masayuki; Yamauchi, Nobuaki; Uchikura, Takeshi; Mochizuki, Mayumi

2008-04-01

Drug selection for the treatment of non-steroidal anti-inflammatory drug (NSAID)-induced gastric ulcer was analyzed pharmacoeconomically. Two patterns consisting of continuation of an NSAID plus administration of the prostaglandin (PG) preparation misoprostol (PG model) for 8 weeks and continuation of an NSAID plus administration of the proton-pump inhibitors omeprazole and lansoprazole (PPI model) for 8 weeks were examined. Decision analysis models were created on the basis of reports of clinical studies and epidemiologic studies relating to the drugs and gastric ulcer, and cost-comparative analyses were conducted based on the number of persons who had ulcer healing as health outcomes. Costs were estimated with respect to health expenditures from the third-party payer (public) perspective. In the case of continuation of an NSAID plus administration of the proton-pump inhibitor omeprazole for 8 weeks, the health outcomes improved and costs were reduced in comparison with continuation of an NSAID plus administration of misoprostol, thus making the administration of omeprazole the dominant choice. With continuation of an NSAID plus administration of lansoprazole for 8 weeks, the cost-savings of lansoprazole were inferior to those of misoprostol. The generic omeprazole product was the most cost-saving among the four drugs (misoprostol, original omeprazole product, generic omeprazole product, and lansoprazole) examined.

Update on second-trimester surgical abortion.

PubMed

Shaw, Kate A; Lerma, Klaira

2016-12-01

To review the recent literature on surgical second-trimester abortion, with specific attention to cervical preparation techniques. Confirming previous studies, a recent retrospective observational cohort study, including 54 911 abortions, estimated the total abortion-related complication rate to be 0.41% for second-trimester or later procedures. Cervical preparation is known to reduce risks associated with second-trimester dilation and evacuation (D&E). When considering adjuncts to osmotic dilators for cervical preparation prior to D&E after 16 weeks, both misoprostol and mifepristone are effective alone and in combination or as adjuncts to osmotic dilators. Misoprostol consistently has been shown to cause more pain and cramping than placebo, but is an effective adjunct to osmotic dilators after 16 weeks. Although mifepristone has fewer side-effects, at its current price, it may not be as cost-effective as misoprostol. Second-trimester abortion is safe. The use of mifepristone and misoprostol for second-trimester abortion has improved safety and efficacy of medical and surgical methods when used alone or in combination and as adjuncts to osmotic dilators. An important aspect of D&E, cervical preparation, is not a one-size-fits-all practice; the approach and methods are contingent on patient, provider and setting and should consider all the evidence-based options.

Mifepristone-misoprostol for menstrual regulation in public sector facilities in Bangladesh.

PubMed

Alam, Anadil; Lotarevich, Tatyana; Das, Tapash R; Reichenbach, Laura; Bracken, Hillary

2018-02-01

To examine the use of mifepristone and misoprostol for menstrual regulation among Bangladeshi women attending public sector facilities. In a prospective study, women (aged ≥18 years) with up to 9 weeks of amenorrhea were enrolled at 24 government health facilities in Bangladesh from November 2012 to June 2015. Paramedics or female welfare visitors provided most menstrual regulation care. Participants took 200 mg mifepristone followed by 800 μg buccal misoprostol after 24 hours, and were asked to return to the clinic 10-14 days later for clinical assessment and an exit interview. The primary outcome was successful evacuation of the uterus without need for surgical intervention. Women who completed follow-up were included in analyses for the primary outcome. Among 1744 enrolled participants, 1738 completed follow-up. Most (1674, 96.3%) had a successful uterine evacuation without the need for surgical intervention. A successful outcome was significantly more common in primary (724/744, 97.3%) and secondary facilities (861/895, 96.2%) than in the specialty hospital (89/99, 89.9%; P<0.001 and P=0.004, respectively). Menstrual regulation with mifepristone and misoprostol can be provided effectively in public sector facilities in Bangladesh. CLINICALTRIALS.GOV: NCT01798017. © 2017 International Federation of Gynecology and Obstetrics.

If we can do it for misoprostol, why not for mifepristone? The case for taking mifepristone out of the office in medical abortion.

PubMed

Gold, Marji; Chong, Erica

2015-09-01

Given the highly political nature of abortion in the United States, the provision of medical abortion with mifepristone (Mifeprex®) and misoprostol has always occurred under a unique set of circumstances. The Food and Drug Administration-approved regimen requires clinicians to administer the mifepristone in the office and also requires women to return to the office for the misoprostol. In the US, where off-label drug use is an accepted practice when supportive evidence exists, most clinicians give women the misoprostol at the initial visit for her to take at home, eliminating an unnecessary visit to the office. This commentary suggests that, based on current studies, there is also enough evidence to offer women the option to self-administer mifepristone out of the office and that this is just another feature of off-label use. Six studies, enrolling over 1800 women, found that the option of taking mifepristone out of the office was popular and acceptable among women and providers. Given that it is safe, highly acceptable and not burdensome on providers, outside-office-use of mifepristone should be offered to all women as part of routine medical abortion services. Copyright © 2015 Elsevier Inc. All rights reserved.

First-trimester medical abortion service in Hong Kong.

PubMed

Lo, Sue S T; Ho, P C

2015-10-01

Research on medical abortion has been conducted in Hong Kong since the 1990s. It was not until 2011 that the first-trimester medical abortion service was launched. Mifepristone was registered in Hong Kong in April 2014 and all institutions that are listed in the Gazette as a provider for legal abortion can purchase mifepristone from the local provider. This article aimed to share our 3-year experience of this service with the local medical community. Our current protocol is safe and effective, and advocates 200-mg mifepristone and 400-µg sublingual misoprostol 24 to 48 hours later, followed by a second dose of 400-µg sublingual misoprostol 4 hours later if the patient does not respond. The complete abortion rate is 97.0% and ongoing pregnancy rate is 0.4%. Some minor side-effects have been reported and include diarrhoea, fever, abdominal pain, and allergy. There have been no serious adverse events such as heavy bleeding requiring transfusion, anaphylactic reaction, septicaemia, or death.

Surgical versus medical methods for second trimester induced abortion.

PubMed

Lohr, P A; Hayes, J L; Gemzell-Danielsson, K

2008-01-23

Determining the optimal method of performing second-trimester abortions is important, since they account for a disproportionate amount of abortion-related morbidity and mortality. To compare surgical and medical methods of inducing abortion in the second trimester of pregnancy with regard to efficacy, side effects, adverse events, and acceptability. We identified trials using Pub Med, EMBASE, POPLINE, and the Cochrane Central Register of Controlled Trials (CENTRAL). We also searched the reference lists of identified studies, relevant review articles, book chapters, and conference proceedings for additional, previously unidentified studies. We contacted experts in the field for information on other published or unpublished research. Randomised trials comparing any surgical to any medical method of inducing abortion at >/= 13 weeks' gestation were included. We assessed the validity of each study using the methods suggested in the Cochrane Handbook. Investigators were contacted as needed to provide additional information regarding trial conduct or outcomes. Two reviewers abstracted the data. Odds ratios and 95% confidence intervals were calculated for dichotomous variables using RevMan 4.2. The trials did not have uniform interventions, therefore, we were unable to combine them into a meta-analysis. Two studies met criteria for this review. One compared dilation and evacuation (D&E) to intra-amniotic instillation of prostaglandin F(2) (alpha). The second study compared D&E to induction with mifepristone and misoprostol. Compared with prostaglandin instillation, the combined incidence of minor complications was lower with D&E (OR 0.17, 95% CI 0.04-0.65) as was the total number of minor and major complications (OR 0.12, 95% CI 0.03-0.46). The number of women experiencing adverse events was also lower with D&E than with mifepristone and misoprostol (OR 0.06, 95% CI 0.01-0.76). Although women treated with mifepristone and misoprostol reported significantly more pain than those undergoing D&E, efficacy and acceptability were the same in both groups. In both trials, fewer subjects randomised to D&E required overnight hospitalisation. Dilation and evacuation is superior to instillation of prostaglandin F(2) (alpha). The current evidence also appears to favour D&E over mifepristone and misoprostol, however larger randomised trials are needed.

Provider knowledge, attitudes and treatment preferences for early pregnancy failure

PubMed Central

Dalton, Vanessa K.; Harris, Lisa H.; Gold, Katherine J.; Kane-Low, Lisa; Schulkin, Jay; Guire, Ken; Fendrick, A. Mark

2010-01-01

Objective To describe health care provider knowledge, attitudes and treatment preferences for early pregnancy failure (EPF). Study Design We surveyed 976 obstetrician/gynecologists, midwives and family medicine practitioners on their knowledge and attitudes toward treatment options for EPF, and barriers to adopting misoprostol and office uterine evacuations. We used descriptive statistics to compare practices by provider specialty and logistic regression to identify associations between provider factors and treatment practices. Results Seventy percent of providers have not used misoprostol and 91% have not used an office uterine evacuation to treat EPF in the past 6 months. Beliefs about safety and patient preferences, and prior induced abortion training were significantly associated with use of both of these treatments. Conclusions Increasing education and training on the use of misoprostol and office uterine evacuation, and clarifying patient treatment preferences may increase the willingness of providers to adopt new practices for EPF treatment. PMID:20227674

First trimester medication abortion practice in the United States and Canada.

PubMed

Jones, Heidi E; O'Connell White, Katharine; Norman, Wendy V; Guilbert, Edith; Lichtenberg, E Steve; Paul, Maureen

2017-01-01

We conducted a cross-sectional survey of abortion facilities from professional networks in the United States (US, n = 703) and Canada (n = 94) to estimate the prevalence of medication abortion practices in these settings and to look at regional differences. Administrators responded to questions on gestational limits, while up to five clinicians per facility reported on 2012 medication abortion practice. At the time of fielding, mifepristone was not approved in Canada. 383 (54.5%) US and 78 (83.0%) Canadian facilities participated. In the US, 95.3% offered first trimester medication abortion compared to 25.6% in Canada. While 100% of providers were physicians in Canada, just under half (49.4%) were advanced practice clinicians in the US, which was more common in Eastern and Western states. All Canadian providers used misoprostol; 85.3% with methotrexate. 91.4% of US providers used 200 mg of mifepristone and 800 mcg of misoprostol, with 96.7% reporting home misoprostol administration. More than three-quarters of providers in both countries required an in-person follow-up visit, generally with ultrasound. 87.7% of US providers routinely prescribed antibiotics compared to 26.2% in Canada. Nonsteroidal anti-inflammatory drugs were the most commonly reported analgesic, with regional variation in opioid narcotic prescription. In conclusion, medication abortion practice follows evidence-based guidelines in the US and Canada. Efforts to update practice based on the latest evidence for reducing in-person visits and increasing provision by advanced practice clinicians could strengthen these services and reduce barriers to access. Research is needed on optimal antibiotic and analgesic use.

Sublingual misoprostol to decrease blood loss after caesarean delivery: a randomised controlled trial.

PubMed

Ugwu, I A; Enabor, O O; Adeyemi, A B; Lawal, O O; Oladokun, A; Olayemi, O

2014-07-01

The aim of the study was to compare the efficacy of sublingual misoprostol in addition to intravenous oxytocin, with oxytocin alone, in reducing blood loss during and following caesarean section. A total of 120 women undergoing caesarean delivery at the University College Hospital, Ibadan, were randomised into two equal groups. In Group A, 20 IU of intravenous oxytocin was given after umbilical cord clamping, while in Group B, the women received 400 μg misoprostol sublingually and 20 IU oxytocin intravenously. The outcome measures were blood loss, additional uterotonics, change in packed cell volume and side-effect profile. Associations between variables were determined by the χ(2) and Student's t-test. Relative risks were calculated for side-effects; the level of significance was p < 0.05. Intraoperative and postoperative blood loss were significantly lower in Group B (451.3 ml vs 551.2 ml, p = 0.007; 22.7 vs 42.2 ml, p < 0.001, respectively). In Group B, women were 7.4 (p < 0.001) and 9.0 (p = 0.008) times more likely to experience shivering and fever, respectively. The need for additional uterotonics was greater in the oxytocin group (66.7% vs 27.6%, p < 0.001). The addition of sublingual misoprostol to intravenous oxytocin reduces postpartum blood loss and the need for additional uterotonics. There is however, an increased risk of shivering and fever with this combination.

Clostridium sordellii toxic shock syndrome after medical abortion with mifepristone and intravaginal misoprostol--United States and Canada, 2001-2005.

PubMed

2005-07-29

On July 19, 2005, the Food and Drug Administration (FDA) issued a public health advisory regarding the deaths of four women in the United States after medical abortions with Mifeprex (mifepristone, formerly RU-486; Danco Laboratories, New York, New York) and intravaginal misoprostol. Two of these deaths occurred in 2003, one in 2004, and one in 2005. Two of these U.S. cases had clinical illness consistent with toxic shock and had evidence of endometrial infection with Clostridium sordellii, a gram-positive, toxin-forming anaerobic bacteria. In addition, a fatal case of C. sordellii toxic shock syndrome after medical abortion with mifepristone and misoprostol was reported in 2001, in Canada. All three cases of C. sordellii infection were notable for lack of fever, and all had refractory hypotension, multiple effusions, hemoconcentration, and a profound leukocytosis. C. sordellii previously has been described as a cause of pregnancy-associated toxic shock syndrome.

“Who Wants to Go Repeatedly to the Hospital?” Perceptions and Experiences of Simplified Medical Abortion in Rajasthan, India

PubMed Central

Iyengar, Kirti; Klingberg Allvin, Marie; Iyengar, Sharad D.; Danielsson, Kristina Gemzell; Essén, Birgitta

2016-01-01

The aim of this study is to explore women’s experiences and perceptions of home use of misoprostol and of the self-assessment of the outcome of early medical abortion in a low-resource setting in India. In-depth interviews were conducted with 20 women seeking early medical abortion, who administered misoprostol at home and assessed their own outcome of abortion using a low-sensitivity pregnancy test. With home use of misoprostol, women were able to avoid inconvenience of travel, child care, and housework, and maintain confidentiality. The use of a low-sensitivity pregnancy test alleviated women’s anxieties about retained products. Majority said they would prefer medical abortion involving a single visit in future. This study provides nuanced understanding of how women manage a simplified medical abortion in the context of low literacy and limited communication facilities. Service delivery guidelines should be revised to allow women to have medical abortion with fewer visits. PMID:28462355

"Who Wants to Go Repeatedly to the Hospital?" Perceptions and Experiences of Simplified Medical Abortion in Rajasthan, India.

PubMed

Iyengar, Kirti; Klingberg Allvin, Marie; Iyengar, Sharad D; Danielsson, Kristina Gemzell; Essén, Birgitta

2016-01-01

The aim of this study is to explore women's experiences and perceptions of home use of misoprostol and of the self-assessment of the outcome of early medical abortion in a low-resource setting in India. In-depth interviews were conducted with 20 women seeking early medical abortion, who administered misoprostol at home and assessed their own outcome of abortion using a low-sensitivity pregnancy test. With home use of misoprostol, women were able to avoid inconvenience of travel, child care, and housework, and maintain confidentiality. The use of a low-sensitivity pregnancy test alleviated women's anxieties about retained products. Majority said they would prefer medical abortion involving a single visit in future. This study provides nuanced understanding of how women manage a simplified medical abortion in the context of low literacy and limited communication facilities. Service delivery guidelines should be revised to allow women to have medical abortion with fewer visits.

Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial

PubMed Central

Levine, Lisa D.; Downes, Katheryne L.; Elovitz, Michal A.; Parry, Samuel; Sammel, Mary D.; Srinivas, Sindhu K

2016-01-01

Objective To evaluate the effectiveness of four commonly used induction methods. Methods This randomized trial compared four induction methods: Misoprostol alone, Foley alone, Misoprostol–cervical Foley concurrently, and Foley–oxytocin concurrently,. Women undergoing labor induction with full term (≥37 weeks), singleton, vertex presenting gestations, with no contraindication to vaginal delivery, intact membranes, Bishop score ≤6, and cervical dilation ≤2cm were included. Women were enrolled only once during the study period. Our primary outcome was time to delivery. Neither patients nor providers were blinded to assigned treatment group since examinations are required for placement of all methods; however, research personnel were blinded during data abstraction. A sample size of 123 per group (N=492) was planned to compare the four groups pairwise (P≤.008), with a 4-hour reduction in delivery time considered clinically meaningful. Results From May 2013 through June 2015, 997 women were screened and 491 were randomized and analyzed. Demographic and clinical characteristics were similar among the four treatment groups. When comparing all induction method groups, combination methods achieved a faster median time to delivery than single-agent methods, (misoprostol–Foley: 13.1 hours, Foley–oxytocin: 14.5 hours, misoprostol: 17.6 hours, Foley: 17.7 hours, p<0.001). When censored for cesarean and adjusting for parity, women who received misoprostol–Foley delivered almost twice as likely to deliver before women who received misoprostol alone (hazard ratio (HR, 95% CI) 1.92 [1.42–2.59]) or Foley alone (HR, 95%CI: 1.87 [1.39–2.52]), whereas Foley–oxytocin was not statistically different from single-agent methods. Conclusion After censoring for cesarean and adjusting for parity, misoprostol–cervical Foley resulted in twice the chance of delivering before either single-agent method. PMID:27824758

Assessment of pain during medical abortion with home use of misoprostol.

PubMed

Cavet, Sandra; Fiala, Christian; Scemama, Agathe; Partouche, Henri

2017-06-01

Although medical abortion with home use of misoprostol has been shown to be safe and acceptable, there are few data about the experience of pain during the procedure. The aims of this study were to assess the intensity of pain associated with home use of misoprostol for medical abortion and to identify variables associated with severe pain. This was an observational study using an anonymous web-based questionnaire in patients having a medical abortion at home in France between 1 December 2013 and 30 April 2014. The questionnaire was completed by 232 women and the results of 193 were retained for analysis. The average pain score was 5.6 on a 10 point scale. A pain score ≥6 was rated as severe and was reported by 105 patients (54%). Nulliparity (odds ratio [OR] 4.10; 95% confidence interval [CI] 2.04, 8.22; p < .0001), lack of choice regarding the method of abortion (OR 2.32; 95% CI 1.13, 4.78; p = .0218) and lack of information about the level of pain associated with the procedure (OR 3.27; 95% CI 1.09, 9.74; p = .0334) were significantly correlated with severe pain. Analgesic prescriptions were very heterogeneous. Pain remains the main side effect of medical abortion. More studies are needed on pain assessment and the effectiveness of analgesic treatments in women using misoprostol at home for medical abortion, in order to improve their care and improve evidence-based guidelines.

A randomized trial of vaginal misoprostol for cervical priming before hysteroscopy in postmenopausal women

PubMed Central

Kant, Anita; Divyakumar; Priyambada, Usha

2011-01-01

Objective: To perform hysteroscopy the cervix needs to be dilated and in nullipara and postmenopausal women this is sometimes difficult. Well-known, entry-related complications during hysteroscopy include cervical tear, creation of false tract, bleeding, uterine perforation, scarring, and subsequent anatomical stenosis. Materials and Methods: This study was done to investigate the priming effect of vaginal misoprostol on cervical dilatation in postmenopausal women, before hysteroscopy, to prevent such complications. Two hundred micrograms of misoprostol was inserted into the vagina at least 12 hours before the procedure and the control group did not receive any cervical priming agent. Pre-procedural dilatation, additional dilatation required, and time taken for dilatation was noted in each case. Observations: The study showed a significant difference between the study group (7.7 ± 1.7 mm) and the control group (4.5 ± 1.8 mm) in terms of pre-procedural cervical width and the number of women requiring a dditional dilatation (7 / 25 versus 22 / 25), and hence, the time required for dilatation (4.7 ± 8 seconds versus 20.6 ± 9.3 seconds). Conclusion: The pre-procedural cervical width was significantly more in the study group as compared to that in the control group. We found significant differences between the study and control groups with respect to the number of women who required cervical dilatation. To conclude, this study helps derive a conclusion that vaginal misoprostol as a cervical priming agent in postmenopausal women appears to be safe, effective, and inexpensive, with mild side effects. PMID:21897735

Economic evaluation of gastric ulcer prophylaxis in patients with arthritis receiving non-steroidal anti-inflammatory drugs.

PubMed Central

Knill-Jones, R.; Drummond, M.; Kohli, H.; Davies, L.

1990-01-01

This study assesses the economic benefits of misoprostol in the prophylaxis of gastric ulcers larger than 0.3 cm in patients with osteoarthritis receiving non-steroidal anti-inflammatory drugs. Independent epidemiological data were obtained for patients in Scotland and the West Midlands. Co-diagnosis of arthritis with gastric ulcer recorded in the routine data was substantially less (4% Scotland, 10% West Midlands) than the 21% found at case review. These data were combined with cost and patient management data in a decision analysis model to explore whether prophylactic use of misoprostol altered substantially the average cost of managing gastric ulcer. Using conservative assumptions and a daily dose of 400 micrograms, cost savings per patient to the National Health Service of 5-8 pounds over a 3-month period are expected in the groups of patients studied, while at the 800 micrograms dose there would be a net cost of 23-25 pounds. Sensitivity analysis showed that under many assumptions misoprostol is expected to be cost saving or cost neutral. PMID:2120690

Comparing the World Health Organization-versus China-recommended protocol for first-trimester medical abortion: a retrospective analysis.

PubMed

Ngo, Thoai D; Park, Min Hae; Xiao, Yuanhong

2012-01-01

To compare the effectiveness, in terms of complete abortion, of the World Health Organization (WHO)- and the China-recommended protocol for first-trimester medical abortion. A retrospective analysis of clinical data from women presenting for first trimester medical abortion between January 2009 and August 2010 at reproductive health clinics in Qingdao, Xi'an, Nanjing, Nanning, and Zhengzhou was conducted. One clinic in Qingdao administered the WHO-recommended protocol (200 mg mifepristone orally followed by 0.8 mg misoprostol buccally 36-48 hours later). Four clinics in the other locations provided the China-recommended procedure (Day 1: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 2: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 3: 0.6 mg oral misoprostol). Data on reproductive and demographic characteristics were extracted from clinic records, and complete termination was determined on day 14 (post-mifepristone administration). A total of 337 women underwent early medical abortion (167 WHO- and 170 China-recommended procedures). Complete abortion was significantly higher among women who had the WHO protocol than those who received the China protocol (91.0% vs 77.7%, respectively; P < 0.001). Women using the China-recommended protocol were three times more likely to require an additional dose of misoprostol than women using the WHO protocol (21.8% vs 7.8%, respectively; P < 0.001), and had significantly more bleeding on the day of misoprostol administration (12.5 mL vs 18.5 mL; P < 0.001). This clinical audit provides preliminary evidence suggesting the WHO-recommended protocol may be more effective than the China-recommended protocol for early medical abortion. A larger scale study is necessary to compare the methods' effectiveness and acceptability.

Pre-emptive effect of ibuprofen versus placebo on pain relief and success rates of medical abortion: a double-blind, randomized, controlled study.

PubMed

Avraham, Sarit; Gat, Itai; Duvdevani, Nir-Ram; Haas, Jigal; Frenkel, Yair; Seidman, Daniel S

2012-03-01

To determine the efficacy of pre-emptive administration of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen vs. a placebo on pain relief during medical abortion and to evaluate whether NSAIDs interfere with the action of misoprostol. Prospective, double-blind, randomized, controlled study. University-affiliated tertiary hospital. Sixty-one women who underwent first-trimester termination of pregnancy. Patients received 600 mg mifepristone orally, followed by 400 μg oral misoprostol 2 days later. They were randomized to receive pre-emptively two tablets of 400 mg ibuprofen orally or a placebo, when taking the misoprostol. The patients completed a questionnaire about side effects and pain score and returned for an ultrasound follow-up examination 10-14 days after the medical abortion. Significant pain, assessed by the need for additional analgesia, and failure rates, defined by a need for surgical intervention. Pre-emptive ibuprofen treatment was found to be more effective than a placebo in pain prevention, as determined by a significantly lower need for additional analgesia: 11 of 29 (38%) vs. 25 of 32 (78%), respectively. Treatment failure rate was not statistically different between the ibuprofen and placebo groups: 4 of 28 (14.2%) vs. 3 of 31 (9.7%), respectively. History of menstrual pain was predictive for the need of additional analgesia. Pre-emptive use of ibuprofen had a statistically significant beneficial effect on the need for pain relief during a mifepristone and misoprostol regimen for medical abortion. Ibuprofen did not adversely affect the outcome of medical abortion. NCT00997074. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Randomized controlled trial comparing 200μg and 400μg sublingual misoprostol for prevention of primary postpartum hemorrhage.

PubMed

Ugwu, Innocent A; Oluwasola, Timothy A; Enabor, Obehi O; Anayochukwu-Ugwu, Ngozi N; Adeyemi, Abolaji B; Olayemi, Oladapo O

2016-05-01

To compare efficacy and adverse effects of 200μg and 400μg misoprostol for prevention of postpartum hemorrhage (PPH). In a randomized control trial, women with term singleton pregnancies in active labor attending University College Hospital, Ibadan, Nigeria, were enrolled between July 2011 and February 2012. Participants were randomly assigned using random numbers (block size four) to receive 200μg or 400μg sublingual misoprostol after delivery of the anterior shoulder, alongside intravenous oxytocin. Investigators were masked to group assignment, but participants were not. The primary outcomes were blood loss up to 1h after delivery, PPH (blood loss ≥500mL), and adverse effects. Overall, 62 patients were assigned to each group. No significant differences between the 200-μg and 400-μg groups were recorded in mean peripartum blood loss (307±145mL vs 296±151mL; P=0.679) and PPH occurrence (5 [8.1%] vs 6 [9.7%] women; P=0.752). Noticeable adverse effects were reported by 16 (25.8%) women in the 200-μg group and 42 (67.7%) in the 400-μg group (P<0.001). Risk of shivering was significantly lower with 200μg than 400μg (relative risk 0.33, 95% confidence interval 0.19-0.58). Blood loss and PPH occurrence did not differ by misoprostol dose, but a 200-μg dose was associated with a reduction in adverse effects. Pan Africa Clinical Trials Registry: PACTR201505001107182. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Early pregnancy failure: factors affecting successful medical treatment.

PubMed

Odeh, Marwan; Tendler, Rene; Kais, Mohamad; Maximovsky, Olga; Ophir, Ella; Bornstein, Jacob

2010-06-01

The results of medical treatment for early pregnancy failure are conflicting. To determine whether gestational sac volume measurement as well as other variables can predict the success rate of medical treatment for early pregnancy failure. The study group comprised 81 women diagnosed with missed abortion or anembryonic pregnancy who consented to medical treatment. Demographic data were collected and beta-human chorionic gonadotropin level was documented. Crown-rump length and the sac volume were measured using transvaginal ultrasound. TVU was performed 12-24 hours after intravaginal administration of 800 micro g misoprostol. If the thickness of the uterine cavity was less than 30 mm, the women were discharged. If the sac was still intact or the thickness of the uterine cavity exceeded 30 mm, they were offered an additional dosage of intravaginal misoprostol or surgical uterine evacuation. Medical treatment successfully terminated 32 pregnancies (39.5%), 30 after one dose of misoprostol and 2 after two doses (group A); 49 underwent surgical evacuation (group B), 47 following one dose of misoprostol and 2 following two doses. There were no significant differences between the groups in age and gestational week. Gestational sac volume did not differ between groups A and B (10.03 and 11.98 ml respectively, P = 0.283). Parity (0.87 and 1.43, P = 0.015), previous pregnancies (2.38 and 2.88, P = 0.037), and betahCG concentration (6961 and 28,748 mlU, P = 0.013) differed significantly between the groups. Gestational sac volume is not a predictor of successful medical treatment for early pregnancy failure. Previous pregnancies and deliveries and higher betahCG concentration negatively affect the success rate of medical treatment.

Evidence of anti-oxidant role of sucralfate in gastric mucosal protection.

PubMed

Laudanno, O M; Bedini, O A; Cesolari, J A; San Miguel, P

1990-02-01

Six percent hydrogen peroxide (H2O2) was used as a generator of the *OH free radical, and as an aggressor of gastric mucosa, in 100 Wistar rats. The mucosal cytoprotector effect of sucralfate, misoprostol, enprostil, cimetidine, ranitidine, famotidine and 10% aluminum sulphate yielded almost complete macroscopic and histological protection to the gastric mucosa. Misoprostol or enprostil gave partial protection whereas the H2 blockers aggravated the gastric necrotic lesions produced by the H2O2. We conclude that sucralfate is a true anti-oxidant that protects the gastric mucosa through its aluminum and sulphydril components, the increment of gastric mucins and endogenous PGs.

Prostaglandin E1 and Its Analog Misoprostol Inhibit Human CML Stem Cell Self-Renewal via EP4 Receptor Activation and Repression of AP-1.

PubMed

Li, Fengyin; He, Bing; Ma, Xiaoke; Yu, Shuyang; Bhave, Rupali R; Lentz, Steven R; Tan, Kai; Guzman, Monica L; Zhao, Chen; Xue, Hai-Hui

2017-09-07

Effective treatment of chronic myelogenous leukemia (CML) largely depends on the eradication of CML leukemic stem cells (LSCs). We recently showed that CML LSCs depend on Tcf1 and Lef1 factors for self-renewal. Using a connectivity map, we identified prostaglandin E1 (PGE1) as a small molecule that partly elicited the gene expression changes in LSCs caused by Tcf1/Lef1 deficiency. Although it has little impact on normal hematopoiesis, we found that PGE1 treatment impaired the persistence and activity of LSCs in a pre-clinical murine CML model and a xenograft model of transplanted CML patient CD34 + stem/progenitor cells. Mechanistically, PGE1 acted on the EP4 receptor and repressed Fosb and Fos AP-1 factors in a β-catenin-independent manner. Misoprostol, an FDA-approved EP4 agonist, conferred similar protection against CML. These findings suggest that activation of this PGE1-EP4 pathway specifically targets CML LSCs and that the combination of PGE1/misoprostol with conventional tyrosine-kinase inhibitors could provide effective therapy for CML. Copyright © 2017 Elsevier Inc. All rights reserved.

Pain during medical abortion, the impact of the regimen: a neglected issue? A review.

PubMed

Fiala, Christian; Cameron, Sharon; Bombas, Teresa; Parachini, Mirella; Saya, Laurence; Gemzell-Danielsson, Kristina

2014-12-01

To evaluate pain and other early adverse events associated with different regimens of medical abortion up to nine weeks of amenorrhoea. The literature was searched for comparative studies of medical abortion using mifepristone followed by the prostaglandin analogue misoprostol. Publications, which included pain assessment were further analysed. Of the 1459 publications on medical abortion identified, only 23 comparative, prospective trials corresponded to the inclusion criteria. Patients in these studies received different dosages of mifepristone in combination with different dosages of misoprostol administered via diverse routes or at various intervals. Information on pain level was reported in 12/23 papers (52%), information regarding systematic administration of analgesics in 12/23 articles (52%) and information concerning analgesia used was available for only 10/23 studies (43%). Neither pain nor its treatment are systematically reported in clinical trials of medical abortion; this shortcoming reflects a neglect of the individual pain perception. When data are mentioned, they are too inconsistent to allow for any comparison between different treatment protocols. Standardised evaluation of pain is needed and the correlation between the dosage of misoprostol and the intensity of pain must be assessed in future studies.

Synthetic prostaglandin E1 misoprostol as a treatment for tinnitus.

PubMed

Briner, W; House, J; O'Leary, M

1993-06-01

A pilot study to determine if the synthetic prostaglandin E1 misoprostol is effective in treating severe tinnitus, to test the hypothesis that tinnitus production is related to prostaglandin metabolism. Blinded, placebo controlled, hemicrossover. House Ear Clinic, Los Angeles, Calif. A volunteer and convenience sample of 24 subjects complaining of severe tinnitus was recruited from mailings, telephone calls, and the clinic population. The patients were not preselected except to be in otherwise good health. Subjects were started on a regimen of placebo or 200 micrograms/d of misoprostol. The dosage was increased every 5 days by 200 micrograms until a total of 800 micrograms/d was achieved. After 1 month of drug administration, the placebo group was crossed over to the active drug phase. Outcome was measured in terms of subjective reports of tinnitus severity, sleep patterns, and ability to concentrate. Eight (33%) of the 24 patients reported improvement during the active drug phase. There were no placebo responders. Responders reported improvement in tinnitus severity, sleep, and concentration. Findings support the contention that prostaglandins may be useful in the treatment of tinnitus. Further studies with larger samples are needed before widespread use of this intervention can be recommended.

Ibuprofen and paracetamol for pain relief during medical abortion: a double-blind randomized controlled study.

PubMed

Livshits, Anna; Machtinger, Ronit; David, Liat Ben; Spira, Maya; Moshe-Zahav, Aliza; Seidman, Daniel S

2009-05-01

To determine the efficacy of a nonsteroidal anti-inflammatory drug vs. paracetamol in pain relief during medical abortion and to evaluate whether nonsteroidal anti-inflammatory drugs interfere with the action of misoprostol. A prospective double-blind controlled study. University-affiliated tertiary hospital. One hundred twenty women who underwent first-trimester termination of pregnancy. Patients received 600 mg mifepristone orally, followed by 400 microg of oral misoprostol 2 days later. They were randomized to receive ibuprofen or paracetamol when pain relief was necessary. Patients completed a questionnaire about side effects and pain score and returned for an ultrasound follow-up examination 10-14 days after medical abortion. Success rates, as defined by no surgical intervention, and pain scores were assessed. Ibuprofen was found to be statistically significantly more effective for pain relief after medical abortion compared with paracetamol. There was no difference in the failure rate of medical abortion, and the frequency of surgical intervention was slightly higher in the group that received paracetamol (16.3% vs. 8.5%). Ibuprofen was found to be more effective than paracetamol for pain reduction during medical abortion. A history of surgical or medical abortion was predictive for high pain scores. Despite its anti-prostaglandin effects, ibuprofen use did not interfere with the action of misoprostol.

Comparing the World Health Organization-versus China-recommended protocol for first-trimester medical abortion: a retrospective analysis

PubMed Central

Ngo, Thoai D; Park, Min Hae; Xiao, Yuanhong

2012-01-01

Objective To compare the effectiveness, in terms of complete abortion, of the World Health Organization (WHO)- and the China-recommended protocol for first-trimester medical abortion. Methods A retrospective analysis of clinical data from women presenting for first trimester medical abortion between January 2009 and August 2010 at reproductive health clinics in Qingdao, Xi’an, Nanjing, Nanning, and Zhengzhou was conducted. One clinic in Qingdao administered the WHO-recommended protocol (200 mg mifepristone orally followed by 0.8 mg misoprostol buccally 36–48 hours later). Four clinics in the other locations provided the China-recommended procedure (Day 1: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 2: 50 mg of mifepristone in the morning, 25 mg in the afternoon; Day 3: 0.6 mg oral misoprostol). Data on reproductive and demographic characteristics were extracted from clinic records, and complete termination was determined on day 14 (post-mifepristone administration). Results A total of 337 women underwent early medical abortion (167 WHO- and 170 China-recommended procedures). Complete abortion was significantly higher among women who had the WHO protocol than those who received the China protocol (91.0% vs 77.7%, respectively; P < 0.001). Women using the China-recommended protocol were three times more likely to require an additional dose of misoprostol than women using the WHO protocol (21.8% vs 7.8%, respectively; P < 0.001), and had significantly more bleeding on the day of misoprostol administration (12.5 mL vs 18.5 mL; P < 0.001). Conclusion This clinical audit provides preliminary evidence suggesting the WHO-recommended protocol may be more effective than the China-recommended protocol for early medical abortion. A larger scale study is necessary to compare the methods’ effectiveness and acceptability. PMID:22505831

[Prevention of NSAID gastropathy: the difference between a coxibs and the addition of a PPI].

PubMed

Lems, Willem F; Kuipers, Ernst J

2010-01-01

Several strategies are available for the prevention of NSAID gastropathy: the addition of misoprostol or proton pump inhibitors (PPIs) to conventional NSAIDs, or selective use of cyclo-oxygenase 2 inhibitors, the 'coxibs'. The recently published CONDOR study was a randomized trial comparing celecoxib with omeprazole in patients at high risk for NSAID gastropathy. A statistically significant reduction in the primary endpoint was found: hazard ratio: 4.3 (95% CI: 2.6-6.7; p < 0.0001). However, the reduction was largely based on a higher incidence of anaemia in the diclofenac plus omeprazole group. The study has strengths and weaknesses. The most important conclusion is that the nature of the gastro-protective effects of celecoxib and diclofenac/misoprostol are different.

Misoprostol in the treatment of tinnitus: a double-blind study.

PubMed

Yilmaz, Ismail; Akkuzu, Babür; Cakmak, Ozcan; Ozlüoglu, Levent N

2004-05-01

To test the efficacy of misoprostol as a treatment for tinnitus. A prospective, placebo-controlled, double-blind study. Başkent University Otolaryngology Clinic. Forty adult patients who had had tinnitus for a minimum of 6 months and were free of systemic or otolaryngologic disease. Twenty-eight patients were randomly assigned to the experimental group (group I) and 12 to the control group (group II). The respective groups received active drug and placebo in increasing doses for 4 months. The effect of medications on tinnitus were evaluated by determining improvement rates in tinnitus loudness and subjective tinnitus scoring. In the experimental group, 18 of 28 patients showed improvement in tinnitus loudness, representing an improvement rate of 64%. The improvement rate based on subjective tinnitus scoring was 36% (10 of 28 patients). In the control group, the improvement rate for tinnitus loudness was 33% (n = 4), and the rate for subjective tinnitus scoring was 17% (n = 2). The difference between improvement rate for tinnitus loudness of the experimental group and control group was found to be statistically significant (P = 0.039), but difference between improvement rate based on subjective tinnitus scoring was insignificant (P = 0.119). When results in the experimental group were analyzed according to etiological factors, the improvement rate was highest in the sudden-onset subgroup (77%). Misoprostol provided therapeutic relief for some patients with tinnitus we studied, but further investigation of larger groups is needed.

Misoprostol

MedlinePlus

... who take certain arthritis or pain medicines, including aspirin, that can cause ulcers. It protects the stomach ... and nonprescription medications you are taking, especially antacids, aspirin, arthritis medications, and vitamins.tell your doctor if ...

Medical abortion options may advance in 1998.

PubMed

1997-12-01

The US debut of mifepristone (RU-486) was delayed in 1997 by legal and manufacturer problems. However, the Population Council is searching worldwide for companies to produce mifepristone for the US market. In the meantime, women in a number of US cities can obtain mifepristone through clinical trials coordinated by the New York City-based Abortion Rights Mobilization. The trials are evaluating the effectiveness of a 200 mg dosage of the drug and will continue until there is a commercial product. New developments in medical abortion will be announced in 1998. Currently, 29 Planned Parenthood Federation of America (PPFA) affiliates are recruiting women for its study of methotrexate and misoprostol. By midsummer 1998, the organization expects to have data from what is the largest multicenter trial to date of a methotrexate and misoprostol medical abortion regimen.

Feasibility and effectiveness of unintended pregnancy prevention with low-dose mifepristone combined with misoprostol before expected menstruation.

PubMed

Li, Cui-Lan; Chen, Dun-Jin; Deng, Yi-Fan; Song, Li-Ping; Mo, Xue-Tang; Liu, Kai-Jie

2015-12-01

What is the efficacy of maintaining or restoring non-pregnant status with low-dose mifepristone combined with misoprostol administered before expected menstruation? Low-dose mifepristone and misoprostol administered at the time of expected menstruation was effective and safe in maintaining or restoring non-pregnant status, with no obvious menstrual disturbance. Menstrual regulation involves the medical or mechanical stimulation of uterine sloughing in women with up to 2-3 weeks of menstrual delay. Low-dose mifepristone plus misoprostol is efficacious for termination of ultra-early pregnancy (≤ 35 days of amenorrhoea) with no obvious menstrual disturbance. A total of 678 women fulfilled all criteria and were recruited. Seventeen women dropped out after deciding to remain pregnant and 11 others were lost to follow-up. Thus, data from 650 women who completed the procedure were included in analyses. Participants were enrolled at any time during their menstrual cycle and administered medication 1 day before expected menstruation. The end of the study was defined on a per-patient basis as the date of completion of the post-treatment menstrual cycle. The primary outcome was the efficacy of abortion induction (for pregnant women) or menstrual regulation (for non-pregnant women). Women with regular menstrual cycles (25-35 days) were voluntarily recruited for this study between February 2012 and December 2014. Serum β-hCG was measured before mifepristone intake. Mifepristone (50 mg) was administered orally 1 day before expected menstruation and 200 µg misoprostol was administered orally on the day of expected menstruation. Efficacy, disturbance in bleeding patterns in the treatment and post-treatment cycles, satisfaction with the treatment, and subsequent contraception preference were analysed. Retrospective analysis of serum β-hCG levels at admission indicated that 23.3% (158/678) of the women were pregnant. The success rate for pregnancy termination was 98.6% (136/138). Two women (1.5%, 2/138) had ongoing pregnancy that was subsequently terminated surgically. The overall bleeding induction rate within 7 days was 98.3% (639/650), with 100% (138/138) in pregnant participants and 97.9% (501/512) in non-pregnant participants. Most pregnant and non-pregnant participants experienced no significant menstrual disturbance during the treatment [96.3% (131/136) versus 97.6% (489/501)] or post-treatment [97.8% (133/136) versus 98.4% (493/501)] menstrual cycle. The general rate of satisfaction with the treatment was 96.7% (618/639). Generally, 36.0% (230/639) of participants preferred to use the regimen as a routine contraception method versus the 64.0% (409/639) who preferred to use it as a remedy for pregnancy prevention after unprotected sex (P < 0.001). Study participants were recruited from a single region; further studies should include participants from multiple centres in different cities and nations. Given the uncertain efficacy of regimen reuse, the assessment of efficacy was based solely on the first treatment administration. Studies with larger samples and long-term follow-up may provide more data on whether repeated use of this regimen hampers its efficacy. Menstrual regulation with low-dose mifepristone and misoprostol at expected menstruation can be efficacious and highly acceptable to maintain or restore non-pregnant status, which may have potential for routine contraception. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A prospective survey of cases of complications of induced abortion presenting to Goroka Hospital, Papua New Guinea, 2011.

PubMed

Asa, Isaac; de Costa, Caroline; Mola, Glen

2012-10-01

Induced abortion on demand or for socio-economic indications is illegal in Papua New Guinea under the 1974 Criminal Code. Nevertheless, the procedure is known to be widely practised. This prospective study examines the demographic and medical features of women presenting with complications of induced abortion to Goroka Hospital in a 6-month period. It was noted that abortion was most commonly induced using the synthetic prostaglandin analogue misoprostol. Although illegal induced abortion cannot be condoned, it appears that misoprostol, much safer in this context than mechanical or traditional herbal methods, is now being widely used for the purpose of induced abortion in Papua New Guinea, as it is in other developing countries. © 2012 The Authors ANZJOG © 2012 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Effect of synthetic prostaglandin E1 analog on gastric emptying of meals in man.

PubMed

Moore, J G; Alazraki, N; Clay, G D

1986-01-01

Forty-five subjects with healed duodenal ulcer were administered either a placebo or a low-dose or high-dose regimen of misoprostol, a synthetic PGE1 analog, in a double-blind, random, parallel-group design to assess the effect of this prostaglandin compound on the gastric emptying of liquid-solid meals. A dual-radionuclide technique to measure liquid- and solid-phase gastric emptying rates of physiological meals by external gamma camera imaging was used. All subjects had a pretreatment control (baseline) evaluation, followed one week later by a treatment-influenced emptying study. The results demonstrated that misoprostol did not significantly alter gastric emptying of either liquids or solids; however, these results cannot be extrapolated to other prostaglandin compounds because of the diverse and sometimes paradoxical effects of different prostaglandins on gastric motility.

Physical symptoms and emotional responses among women undergoing induced abortion protocols during the second trimester.

PubMed

Freeman, Martine D; Porat, Nurit; Rojansky, Nathan; Elami-Suzin, Matan; Winograd, Orit; Ben-Meir, Assaf

2016-11-01

To compare the physical and emotional effects of two medical protocols for induced abortion during the second trimester. The present study was part of a prospective randomized controlled trial comparing mifepristone followed by oxytocin or misoprostol that was conducted at the Hadassah Hebrew University Medical Center, Jerusalem, Israel, from January 10, 2009, to February 22, 2012. Inclusion criteria were pregnancy (14-24weeks), epidural analgesia, and medical induction of abortion (either elective or following missed abortion). A structured questionnaire was used to assess the participants' physical symptoms and emotional responses. The primary outcome for the present analysis was the degree of physical symptoms reported. Overall, 68 women in the oxytocin group and 67 in the misoprostol group received epidural analgesia and completed the questionnaire. As assessed using a five-point Likert scale, women in the misoprostol group were more likely than those in the oxytocin group to experience diarrhea (1.34±0.84 vs 1.10±0.55; P=0.05) and shivers (3.03±1.75 vs 1.75±1.21; P<0.001). No other between-group differences were detected for the physical or emotional variables evaluated. Differences in physical symptoms experienced by the two treatment groups did not influence the participants' subsequent emotional response. ClinicalTrials.gov: NCT00784797. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Determinants of abortion among women admitted to hospitals in Fortaleza, North Eastern Brazil.

PubMed

Misago, C; Fonseca, W; Correia, L; Fernandes, L M; Campbell, O

1998-10-01

Maternal mortality from complications of unsafe abortion constitutes a serious problem in several developing countries. There is, however, a paucity of well-designed and implemented studies in this area, especially in Latin America. The aim of this paper is to present the findings on the determinants and medical characteristics of abortions among women admitted to hospitals. A descriptive cross-sectional hospital-based study was carried out between October 1992 and September 1993 in Fortaleza, Brazil. A Cox's proportional hazard model was used to estimate prevalence rate ratios after adjustment for confounding. Among 2074 (48%) women who admitted to terminating the pregnancy, 66% reported using misoprostol to induce abortion. Women with an induced abortion as compared with those with an unlikely induced abortion are younger, more often not married, have fewer children alive and experienced one or more previous induced abortions. We have not found any important differences with regard to complication or duration of stay in hospital. This finding, at odds with most previous studies, could reflect the special situation in Brazil where misoprostol is used for illegally-induced abortion. The use of misoprostol by this population may have contributed to the reduction of severe complications related to induced abortion which were most prevalent with more invasive methods. Recommendations are made as to the need for confirmatory studies as well as on information regarding cultural perceptions and concepts of abortion, and reasons why poor women fail to adopt available family planning methods.

Novel mechanisms and signaling pathways of esophageal ulcer healing: the role of prostaglandin EP2 receptors, cAMP, and pCREB

PubMed Central

Ahluwalia, Amrita; Baatar, Dolgor; Jones, Michael K.

2014-01-01

Clinical studies indicate that prostaglandins of E class (PGEs) may promote healing of tissue injury e.g., gastroduodenal and dermal ulcers. However, the precise roles of PGEs, their E-prostanoid (EP) receptors, signaling pathways including cAMP and cAMP response element-binding protein (CREB), and their relation to VEGF and angiogenesis in the tissue injury healing process remain unknown, forming the rationale for this study. Using an esophageal ulcer model in rats, we demonstrated that esophageal mucosa expresses predominantly EP2 receptors and that esophageal ulceration triggers an increase in expression of the EP2 receptor, activation of CREB (the downstream target of the cAMP signaling), and enhanced VEGF gene expression. Treatment of rats with misoprostol, a PGE1 analog capable of activating EP receptors, enhanced phosphorylation of CREB, stimulated VEGF expression and angiogenesis, and accelerated esophageal ulcer healing. In cultured human esophageal epithelial (HET-1A) cells, misoprostol increased intracellular cAMP levels (by 163-fold), induced phosphorylation of CREB, and stimulated VEGF expression. A cAMP analog (Sp-cAMP) mimicked, whereas an inhibitor of cAMP-dependent protein kinase A (Rp-cAMP) blocked, these effects of misoprostol. These results indicate that the EP2/cAMP/protein kinase A pathway mediates the stimulatory effect of PGEs on angiogenesis essential for tissue injury healing via the induction of CREB activity and VEGF expression. PMID:25059824

Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis.

PubMed

Gallos, Ioannis D; Williams, Helen M; Price, Malcolm J; Merriel, Abi; Gee, Harold; Lissauer, David; Moorthy, Vidhya; Tobias, Aurelio; Deeks, Jonathan J; Widmer, Mariana; Tunçalp, Özge; Gülmezoglu, Ahmet Metin; Hofmeyr, G Justus; Coomarasamy, Arri

2018-04-25

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. Prophylactic uterotonic drugs can prevent PPH, and are routinely recommended. There are several uterotonic drugs for preventing PPH but it is still debatable which drug is best. To identify the most effective uterotonic drug(s) to prevent PPH, and generate a ranking according to their effectiveness and side-effect profile. We searched Cochrane Pregnancy and Childbirth's Trials Register (1 June 2015), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) for unpublished trial reports (30 June 2015) and reference lists of retrieved studies. All randomised controlled comparisons or cluster trials of effectiveness or side-effects of uterotonic drugs for preventing PPH.Quasi-randomised trials and cross-over trials are not eligible for inclusion in this review. At least three review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We estimated the relative effects and rankings for preventing PPH ≥ 500 mL and PPH ≥ 1000 mL as primary outcomes. We performed pairwise meta-analyses and network meta-analysis to determine the relative effects and rankings of all available drugs. We stratified our primary outcomes according to mode of birth, prior risk of PPH, healthcare setting, dosage, regimen and route of drug administration, to detect subgroup effects.The absolute risks in the oxytocin are based on meta-analyses of proportions from the studies included in this review and the risks in the intervention groups were based on the assumed risk in the oxytocin group and the relative effects of the interventions. This network meta-analysis included 140 randomised trials with data from 88,947 women. There are two large ongoing studies. The trials were mostly carried out in hospital settings and recruited women who were predominantly more than 37 weeks of gestation having a vaginal birth. The majority of trials were assessed to have uncertain risk of bias due to poor reporting of study design. This primarily impacted on our confidence in comparisons involving carbetocin trials more than other uterotonics.The three most effective drugs for prevention of PPH ≥ 500 mL were ergometrine plus oxytocin combination, carbetocin, and misoprostol plus oxytocin combination. These three options were more effective at preventing PPH ≥ 500 mL compared with oxytocin, the drug currently recommended by the WHO (ergometrine plus oxytocin risk ratio (RR) 0.69 (95% confidence interval (CI) 0.57 to 0.83), moderate-quality evidence; carbetocin RR 0.72 (95% CI 0.52 to 1.00), very low-quality evidence; misoprostol plus oxytocin RR 0.73 (95% CI 0.60 to 0.90), moderate-quality evidence). Based on these results, about 10.5% women given oxytocin would experience a PPH of ≥ 500 mL compared with 7.2% given ergometrine plus oxytocin combination, 7.6% given carbetocin, and 7.7% given misoprostol plus oxytocin. Oxytocin was ranked fourth with close to 0% cumulative probability of being ranked in the top three for PPH ≥ 500 mL.The outcomes and rankings for the outcome of PPH ≥ 1000 mL were similar to those of PPH ≥ 500 mL. with the evidence for ergometrine plus oxytocin combination being more effective than oxytocin (RR 0.77 (95% CI 0.61 to 0.95), high-quality evidence) being more certain than that for carbetocin (RR 0.70 (95% CI 0.38 to 1.28), low-quality evidence), or misoprostol plus oxytocin combination (RR 0.90 (95% CI 0.72 to 1.14), moderate-quality evidence)There were no meaningful differences between all drugs for maternal deaths or severe morbidity as these outcomes were so rare in the included randomised trials.Two combination regimens had the poorest rankings for side-effects. Specifically, the ergometrine plus oxytocin combination had the higher risk for vomiting (RR 3.10 (95% CI 2.11 to 4.56), high-quality evidence; 1.9% versus 0.6%) and hypertension [RR 1.77 (95% CI 0.55 to 5.66), low-quality evidence; 1.2% versus 0.7%), while the misoprostol plus oxytocin combination had the higher risk for fever (RR 3.18 (95% CI 2.22 to 4.55), moderate-quality evidence; 11.4% versus 3.6%) when compared with oxytocin. Carbetocin had similar risk for side-effects compared with oxytocin although the quality evidence was very low for vomiting and for fever, and was low for hypertension. Ergometrine plus oxytocin combination, carbetocin, and misoprostol plus oxytocin combination were more effective for preventing PPH ≥ 500 mL than the current standard oxytocin. Ergometrine plus oxytocin combination was more effective for preventing PPH ≥ 1000 mL than oxytocin. Misoprostol plus oxytocin combination evidence is less consistent and may relate to different routes and doses of misoprostol used in the studies. Carbetocin had the most favourable side-effect profile amongst the top three options; however, most carbetocin trials were small and at high risk of bias.Amongst the 11 ongoing studies listed in this review there are two key studies that will inform a future update of this review. The first is a WHO-led multi-centre study comparing the effectiveness of a room temperature stable carbetocin versus oxytocin (administered intramuscularly) for preventing PPH in women having a vaginal birth. The trial includes around 30,000 women from 10 countries. The other is a UK-based trial recruiting more than 6000 women to a three-arm trial comparing carbetocin, oxytocin and ergometrine plus oxytocin combination. Both trials are expected to report in 2018.Consultation with our consumer group demonstrated the need for more research into PPH outcomes identified as priorities for women and their families, such as women's views regarding the drugs used, clinical signs of excessive blood loss, neonatal unit admissions and breastfeeding at discharge. To date, trials have rarely investigated these outcomes. Consumers also considered the side-effects of uterotonic drugs to be important but these were often not reported. A forthcoming set of core outcomes relating to PPH will identify outcomes to prioritise in trial reporting and will inform futures updates of this review. We urge all trialists to consider measuring these outcomes for each drug in all future randomised trials. Lastly, future evidence synthesis research could compare the effects of different dosages and routes of administration for the most effective drugs.

[Experience of treatment of patients with gastropathy induced by non-steroid anti-inflammatory drugs].

PubMed

Vakhrushev, Ia M; Loshchakova, O Iu

2007-01-01

A complex study of 147 patients who were taking non-steroid anti-inflammatory drugs (NSAIDs) revealed gastric lesions in 120 patients (81.6%). H2 blocker (ranitidine) was used for treating 40 patients with NSAID-induced gastropathy, proton pump inhibitor (omeprazole) was used for 40 patients, and Gastrozepin combined with Misoprostol--for 40 patients. Pain syndrome and dyspepsia were eliminated in most of the patients as a result of the treatment. Using Gastrozepin and Misoprostol produced an active effect on the trophic processes in the gastric mucous coat and caused erosion and ulcer healing. As compared to ranitidine and omeprazole, Gastrozepin used in combination with Cytotec produces a lower effect on the reduction of the acid-producing stomach function, yet it has a considerably greater effect on the normalization of the gastric mucus structure and restoration of metabolism of the gastric mucous coat collagen.

Missed appendicitis after self-induced abortion.

PubMed

Punguyire, Damien; Iserson, Victor Kenneth

2011-01-01

Female lower abdominal pain poses diagnostic difficulties for clinicians, especially when little more than the history and physical examination are available. A girl presented with constant lower abdominal pain after taking misoprostol for pregnancy termination. She was eventually referred to a rural District Hospital, where a laparotomy demonstrated acute appendicitis. After treating herself for a self-diagnosed pregnancy with illegally provided misoprostol, this patient presented with persistent lower abdominal pain. The differential diagnosis included ectopic pregnancy and all other causes of female abdominal pain. Yet diagnosing two diseases in the same anatomical area at the same time contradicts diagnostic parsimony. System problems in resource-poor areas can limit access to healthcare services and encourage dispensing potentially dangerous medications without clinicians' authorization. It is dangerous to rely on patients' self-diagnoses while neglecting other diagnoses. More than one diagnosis may be needed to explain temporally and anatomically related symptoms.

Achieving community-based postpartum follow up in eastern Uganda: the field experience from the MamaMiso Study on antenatal distribution of misoprostol.

PubMed

Ditai, James; Frye, Laura J; Durocher, Jill; Byrne, Meagan E; Ononge, Sam; Winikoff, Beverly; Weeks, Andrew D

2017-10-26

Advance provision of misoprostol to women during antenatal care aims to achieve broader access to uterotonics for the prevention of postpartum hemorrhage. Studies of this community-based approach usually involve antenatal education as well as timely postpartum follow-up visits to confirm maternal and neonatal outcomes. The MamaMiso study in Mbale, Uganda sought to assess the feasibility of conducting follow-up visits in the postpartum period following advance provision of misoprostol for postpartum hemorrhage prevention. MamaMiso recruited women during antenatal care visits. Participants were asked to contact the research team within 48 h of giving birth so that postpartum follow-up visits could be carried out at their homes. Women's baseline and delivery characteristics were collected and analyzed with respect to follow-up time ('on time' ≤ 7 days, 'late' > 7 days, and 'lost to follow up'). Every woman who was followed up late due to a failure to report the delivery was asked for the underlying reasons for the delay. When attempts at following up participants were unsuccessful, a file note was generated explaining the details of the failure. We abstracted data and identified themes from these notes. Of 748 recruited women, 700 (94%) were successfully followed up during the study period, 465 (62%) within the first week postpartum. The median time to follow up was 4 days and was similar for women who delivered at home or in facilities and for women who had attended or unattended births. Women recruited at the urban hospital site (as opposed to rural health clinics) were more likely to be lost to follow up or followed up late. Of the women followed up late, 202 provided a reason. File notes explaining failed attempts at follow up were generated for 164 participants. Several themes emerged from qualitative analysis of these notes including phone difficulties, inaccurate baseline information, misperceptions, postpartum travel, and the condition of the mother and neonate. Keeping women connected to the health system in the postpartum period is feasible, though reaching them within the first week of their delivery is challenging. Understanding characteristics of women who are harder to reach can help tailor follow-up efforts and elucidate possible biases in postpartum study data. Trial Registration Number ISRCTN70408620 December 28, 2011.

[Between the stigma and the law: legal abortion in Mexico City].

PubMed

Lamas, Marta

2014-01-01

The present contribution is part of a research developed with qualitative social research methods. It offers part of the results attained in a study performed at a clinic belonging to Mexico City´s Government, and explores the effects on staff of the implementation of Legal Pregnancy Termination (ILE, for its initials in Spanish). The results highlights that, besides diminishing health risks in the women who abort, the use of misoprostol prompted assertive attitudes in many women, that reduced the negative effects produced by the stigma of abortion. It also acknowledges the persistence of stigma in the opinions of the health personnel. The empowering of the self-image of women who become subject to this procedure is due to the full exercise of their legal right.

Implementing medical abortion with mifepristone and misoprostol in Norway 1998–2013

PubMed Central

Løkeland, Mette; Bjørge, Tone; Iversen, Ole-Erik; Akerkar, Rupali; Bjørge, Line

2017-01-01

Abstract Background: Medical abortion with mifepristone and misoprostol was introduced in Norway in 1998, and since then there has been an almost complete change from predominantly surgical to medical abortions. We aimed to describe the medical abortion implementation process, and to compare characteristics of women obtaining medical and surgical abortion. Methods: Information from all departments of obstetrics and gynaecology in Norway on the time of implementation of medical abortion and abortion procedures in use up to 12 weeks of gestation was assessed by surveys in 2008 and 2012. We also analysed data from the National Abortion Registry comprising 223 692 women requesting abortion up to 12 weeks of gestation during 1998–2013. Results: In 2012, all hospitals offered medical abortion, 84.4% offered medical abortion at 9–12 weeks of gestation and 92.1% offered home administration of misoprostol. The use of medical abortion increased from 5.9% of all abortions in 1998 to 82.1% in 2013. Compared with women having a surgical abortion, women obtaining medical abortion had higher odds for undergoing an abortion at 4–6 weeks (adjusted OR 2.33; 95% confidence interval 2.28-2.38). Waiting time between registered request for an abortion until termination was reduced from 11.3 days in 1998 to 7.3 days in 2013. Conclusions: Norwegian women have gained access to more treatment modalities and simplified protocols for medical abortion. At the same time they obtained abortions at an earlier gestational age and the waiting time has been reduced. PMID:28031316

Obstetric outcomes of pre-induction of labor with a 200 μg misoprostol vaginal insert.

PubMed

Jagielska, Iwona; Kazdepka-Ziemińska, Anita; Tyloch, Małgorzata; Sopońska-Brzoszczyk, Paulina; Nowak, Karina; Dziedzic, Dawid; Dzikowska, Ewa; Grabiec, Marek

2017-01-01

Labor induction is indicated in 20% to 40% of pregnancies. Over half of pregnancies qualified for the induction of labor require stimulation of the cervix to ripen. The drug used increasingly more often in pre-induction is the PGE-1 pros-taglandin analog - misoprostol 200 μg. The study includes a total of 100 patients qualified for labor pre-induction with Misodel® (miso-prostol 200 μg vaginal insert). The study group comprises two subgroups: primigravidas and multiparas. Assessments included: indications for labor pre-induction, time from Misodel application to delivery, caesarean section rate and indica-tions, duration of first and second stage of labor, rate of vaginal deliveries, need for oxytocin or fenoterol administration side effects and newborn condition. The most common indication for labor induction was gestational diabetes and pregnancy past term. The average time to vaginal delivery was 14 h 45 min, time to the onset of active phase of labor - 11 h 45 min, time to membranes' rupture - 15 h, time to vaginal delivery - 14 h 18 min. The times of multiparas were significantly shorter. The rate of vaginal deliveries within 12 hours amounted to 42.42%, while within 24 hours it reached 83.33%. The overall caesarean section rate was 33%. The most common indication for caesarean section was the risk of intrauterine hypoxia. Tachysystole and hyperstimulation was observed in 4% of cases, while abnormalities in the cardiotocographic tracing in 43%. Misodel is an effective method for labor pre-induction, without affecting the caesarean section rate and has no adverse effect on the newborn condition.

Use of gastroprotection in patients discharged from hospital on nonsteroidal anti-inflammatory drugs.

PubMed

Coté, Gregory A; Norvell, John P; Rice, John P; Bulsiewicz, William J; Howden, Colin W

2008-01-01

Gastrointestinal (GI) hemorrhage is responsible for 200-400,000 hospitalizations in the United States annually. Nonsteroidal anti-inflammatory drugs (NSAIDs) are responsible for > or =30% of admissions due to GI hemorrhage. Misoprostol reduces the number of NSAID-related upper GI events while proton pump inhibitors (PPIs) reduce the incidence of endoscopic ulcers. To measure the utilization of GI prophylaxis in patients discharged from hospital on ulcerogenic medicines. We performed a medical record review of all 480 patients discharged from the medical service over a 3-month period on aspirin or nonaspirin NSAIDs. Use of gastroprotection was recorded, particularly among those patients not previously prescribed a PPI or misoprostol. Patients with a different indication for PPI therapy were excluded. In all, 480 patients were identified, and 142 were excluded. Of the 338 remaining patients, 154 (46%) were prescribed GI prophylaxis. In particular, 240 patients had not been receiving a PPI or misoprostol at the time of admission (gastroprotection naive). Of these, 23.3% received a new prescription for GI prophylaxis at discharge. Use of gastroprotection increased among patients older than 60 years compared with those 60 years and younger (P = 0.008), but there was no difference among patients with higher baseline comorbidity or those receiving multiple agents of interest. Although hospitalization offers an opportunity to recognize patients at high risk of developing upper GI complications from NSAIDs, utilization of appropriate gastroprotection seemed suboptimal. Educational efforts directed at physicians may help them recognize risk factors for GI hemorrhage and current indications for prophylaxis.

The effect of parity and gravidity on the outcome of medical termination of pregnancy.

PubMed

Odeh, Marwan; Tendler, Rene; Sosnovsky, Vladimir; Kais, Mohamad; Ophir, Ella; Bornstein, Jacob

2010-10-01

Previous pregnancies may influence the success of medical termination of pregnancy. To determine the effect of parity and gravidity on the successful termination of pregnancy using mifepristone and misoprostol. The medical files of all patients attending a department of obstetrics and gynecology during the years 2006 and 2007 for the purpose of medical termination of pregnancy at < or = 49 days of gestation were analyze retrospectively. The medical history, previous pregnancies and deliveries were recorded. Mifepristone was administered orally followed by 400 mg of misoprostol 48 hours later. A second dose of misoprostol was offered 2 weeks later if uterine content thickness was more than 15 mm. Then, after 24 hours, if uterine content thickness was more than 15 mm the uterus was evacuated by dilation and curettage. Of 403 women, 349 (86.6%) aborted following the basic regime; 207 (51.4%) (group A) were primiparous while 196 (48.6%) (group B) had at least one prior pregnancy. Uterine curettage was performed in 17 patients (8.2%) in group A and in 37 (18.9%) in group B (P = 0.002). When patients with a history of a previous abortion were excluded from group B, 32 of 143 (22.4%) required curettage (P < 0.001). When patients without a history of previous cesarean section were excluded, 10 of 52 (19.2%) underwent curettage (P = 0.038). Previous pregnancies negatively affect the success of medical termination of pregnancy, especially in women with a previous term pregnancy. This information is important when counseling women about the method of pregnancy termination.

Efficacy and safety of misoprostol, dinoprostone and Cook's balloon for labour induction in women with foetal growth restriction at term.

PubMed

Duro-Gómez, Jorge; Garrido-Oyarzún, María Fernanda; Rodríguez-Marín, Ana Belén; de la Torre González, Antonio Jesús; Arjona-Berral, José Eduardo; Castelo-Branco, Camil

2017-10-01

To compare effectiveness and safety of dinoprostone, misoprostol and Cook's balloon as labour-inducing agents in women with intrauterine growth restriction (IUGR) at term. Retrospective cohort chart review of women diagnosed with foetal growth restriction at term in Reina Sofia Hospital, Cordoba, Spain from January 2014 to December 2015. Registration of baseline characteristics and method of induction was made. The main outcome was time from induction to delivery. Obstetric and perinatal outcomes were also collected. A total of 99 women were diagnosed with IUGR in the mentioned period. Of them, 21 women were induced with dinoprostone [dinoprostone group (DG)], 20 with misoprostol (MG) and in 58 with Cook's balloon (CG). Groups were homogeneous regarding pre-induction Bishop score and parity. The CG required more time (24.36 vs. 19.23 h; p = 0.02) and more oxytocin dose for conduction of labour from induction to delivery (6.75 vs. 1.24 mUI; p < 0.01) than DG. Moreover, the CG also needed more oxytocin than MG, 6.75 vs. 2.37 mUI (p < 0.001). Caesarean rate was 5, 14.9 and 17.3% in MG, DG and CG, respectively. No differences were observed in rates of uterine tachysystole, non-reassuring foetal status and neonatal adverse events. Prostaglandins were more effective than Cook's balloon to induce labour and achieve vaginal birth in this sample of women with IUGR at term, with a similar safety profile.

Two prophylactic medication approaches in addition to a pain control regimen for early medical abortion < 63 days' gestation with mifepristone and misoprostol: study protocol for a randomized, controlled trial.

PubMed

Dragoman, Monica V; Grossman, Daniel; Kapp, Nathalie; Huong, Nguyen My; Habib, Ndema; Dung, Duong Lan; Tamang, Anand

2016-10-12

Pain is often cited as one of the worst features of medical abortion. Further, inadequate pain management may motivate some women to seek unnecessary clinical care. There is a need to identify effective methods for pain control in this setting. We propose a randomized, placebo-controlled trial. 576 participants (288 nulliparous; 288 parous) from study sites in Nepal, South Africa and Vietnam will be randomly allocated to one of three treatments: (1) ibuprofen 400 mg PO and metoclopramide 10 mg PO; (2) tramadol 50 mg PO and a placebo; or (3) two placebo pills, to be taken immediately before misoprostol and repeated once four hours later. All women will be provided with supplementary analgesia for use as needed during the medical abortion. We hypothesize that women receiving prophylactic analgesia will report lower maximal pain scores in the first 8 h following misoprostol administration compared to women receiving placebos for medical abortion through 63 days' gestation. Our primary objective is to determine whether prophylactic administration of ibuprofen and metoclopramide or tramadol provides superior pain relief compared to analgesia administration after pain begins, measured during the first eight hours after misoprostol administration. Secondary objectives include identifying covariates associated with higher reported pain scores; determining any impact of the study medicines on medical abortion success; and, qualitatively exploring women's physical experiences of medical abortion, especially related to pain, and how can they be improved. Data sources include medical records, participant symptom diaries and interview data obtained on the day of enrollment, during the medical abortion, and at follow-up. Participants will be contacted via telephone on day 3 and return for follow-up will occur approximately 14 days after mifepristone, concluding study participation. A subset of 42 women will also be invited to undergo in-depth qualitative interviews following study completion. Although pain is one of the most common side effects encountered with medical abortion, little is known about optimal pain management for this process. This multi-arm trial design offers an efficient approach to evaluating two prophylactic pain management regimens compared to use of pain medication as needed. ACTRN12613000017729 (Prospectively registered 8/1/2013).

Unexpected heaping in reported gestational age for women undergoing medical abortion.

PubMed

Sivin, Irving; Trussell, James; Lichtenberg, E Steve; Fjerstad, Mary; Cleland, Kelly; Cullins, Vanessa

2009-09-01

In August 2006, the Planned Parenthood Federation of America (Planned Parenthood) conducted an extensive audit of first-trimester medical abortions with oral mifepristone plus buccal misoprostol through 56 days of gestation so that patients could be given accurate information about the success rate of the new regimen. We sought to evaluate the effectiveness of this buccal misoprostol regimen and to examine correlates of its success during routine service delivery. Audits in 10 large urban service points were conducted in 2006 to estimate the success rates of the buccal regimen. Success was defined as medical abortion without vacuum aspiration. We discovered unexpected heaping of reported gestational age (GA) on days divisible by 7. Such heaping, which has not been reported in the literature, would make it more difficult to detect a modest trend in declining effectiveness with increasing GA, if there were one. High coefficients of variation of sac size and crown-rump length characterize the early gestational weeks. We suspect, but are unable to prove, that the source of the heaping found in our investigation is a tendency for operators of ultrasound machines at some sites to simplify reporting by rounding a portion of the results to a date corresponding to the nearest complete gestational week. We believe that immediate supervisory awareness and feedback may reduce the extent of the problem. However, the problem may persist in multiple-site studies given the underlying variability of ultrasound measurements with differently calibrated machines and different rules for recording data, some of which may permit acceptance of an estimate based on the stated date of the last menses, if it differs by no more than 2 or 3 days from the ultrasound result.

Systematic review of the cost effectiveness of prophylactic treatments in the prevention of gastropathy in patients with rheumatoid arthritis or osteoarthritis taking non-steroidal anti-inflammatory drugs

PubMed Central

van Dieten, H. E M; Bos, I.; van Tulder, M. W; Lems, W.; Dijkmans, B.; Boers, M.

2000-01-01

A systematic review on the cost effectiveness of prophylactic treatments of non-steroidal anti-inflammatory drug (NSAID) induced gastropathy in patients with osteoarthritis or rheumatoid arthritis was conducted. Two reviewers conducted the literature search and the review. Both full and partial economic evaluations published in English, Dutch, or German were included. The criteria list published in the textbook of Drummond was used to determine the quality of the economic evaluations. The methodological quality of three randomised controlled trials (RCTs) in which the economic evaluations obtained probability estimates of NSAID induced gastropathy and adverse events was assessed by a list of internal validity criteria. The conclusions were based on a rating system consisting of four levels of evidence.
  Ten economic evaluations were included; three were based on RCTs. All evaluations studied misoprostol as prophylactic treatment: in one evaluation misoprostol was studied as a fixed component in a combination with diclofenac (Arthrotec). All economic evaluations comprised analytical studies containing a decision tree. The three trials were of high methodological quality. Nine economic evaluations were considered high quality and one economic evaluation was considered of low methodological quality. There is strong evidence (level "A") that the use of misoprostol for the prevention of NSAID induced gastropathy is cost effective, and limited evidence (level "C") that the use of Arthrotec is cost effective. Although the levels of evidence used in this review are arbitrary, it is believed that a qualitative analysis is useful: quantitative analyses in this field are hampered by the heterogeneity of economic evaluations. Existing criteria to evaluate the methodological quality of economic evaluations may need refinement for use in systematic reviews.

 PMID:11005773

Systematic review of the cost effectiveness of prophylactic treatments in the prevention of gastropathy in patients with rheumatoid arthritis or osteoarthritis taking non-steroidal anti-inflammatory drugs.

PubMed

van Dieten, H E; Korthals-de Bos, I B; van Tulder, M W; Lems, W F; Dijkmans, B A; Boers, M

2000-10-01

A systematic review on the cost effectiveness of prophylactic treatments of non-steroidal anti-inflammatory drug (NSAID) induced gastropathy in patients with osteoarthritis or rheumatoid arthritis was conducted. Two reviewers conducted the literature search and the review. Both full and partial economic evaluations published in English, Dutch, or German were included. The criteria list published in the textbook of Drummond was used to determine the quality of the economic evaluations. The methodological quality of three randomised controlled trials (RCTs) in which the economic evaluations obtained probability estimates of NSAID induced gastropathy and adverse events was assessed by a list of internal validity criteria. The conclusions were based on a rating system consisting of four levels of evidence. Ten economic evaluations were included; three were based on RCTs. All evaluations studied misoprostol as prophylactic treatment: in one evaluation misoprostol was studied as a fixed component in a combination with diclofenac (Arthrotec). All economic evaluations comprised analytical studies containing a decision tree. The three trials were of high methodological quality. Nine economic evaluations were considered high quality and one economic evaluation was considered of low methodological quality. There is strong evidence (level "A") that the use of misoprostol for the prevention of NSAID induced gastropathy is cost effective, and limited evidence (level "C") that the use of Arthrotec is cost effective. Although the levels of evidence used in this review are arbitrary, it is believed that a qualitative analysis is useful: quantitative analyses in this field are hampered by the heterogeneity of economic evaluations. Existing criteria to evaluate the methodological quality of economic evaluations may need refinement for use in systematic reviews.

Effect of track structure and radioprotectors on the induction of oncogenic transformation in murine fibroblasts by heavy ions

NASA Technical Reports Server (NTRS)

Miller, R. C.; Martin, S. G.; Hanson, W. R.; Marino, S. A.; Hall, E. J.; Wachholz, B. W. (Principal Investigator)

1998-01-01

The oncogenic potential of high-energy 56Fe particles (1 GeV/nucleon) accelerated with the Alternating Gradient Synchrotron at the Brookhaven National Laboratory was examined utilizing the mouse C3H 10T1/2 cell model. The dose-averaged LET for high-energy 56Fe is estimated to be 143 keV/micrometer with the exposure conditions used in this study. For 56Fe ions, the maximum relative biological effectiveness (RBEmax) values for cell survival and oncogenic transformation were 7.71 and 16.5 respectively. Compared to 150 keV/micrometer 4He nuclei, high-energy 56Fe nuclei were significantly less effective in cell killing and oncogenic induction. The prostaglandin E1 analog misoprostol, an effective oncoprotector of C3H 10T1/2 cells exposed to X rays, was evaluated for its potential as a radioprotector of oncogenic transformation with high-energy 56Fe. Exposure of cells to misoprostol did not alter 56Fe cytotoxicity or the rate of 56Fe-induced oncogenic transformation.

Effectiveness and safety of early medication abortion provided in pharmacies by auxiliary nurse-midwives: A non-inferiority study in Nepal.

PubMed

Rocca, Corinne H; Puri, Mahesh; Shrestha, Prabhakar; Blum, Maya; Maharjan, Dev; Grossman, Daniel; Regmi, Kiran; Darney, Philip D; Harper, Cynthia C

2018-01-01

Expanding access to medication abortion through pharmacies is a promising avenue to reach women with safe and convenient care, yet no pharmacy provision interventions have been evaluated. This observational non-inferiority study investigated the effectiveness and safety of mifepristone-misoprostol medication abortion provided at pharmacies, compared to government-certified public health facilities, by trained auxiliary nurse-midwives in Nepal. Auxiliary nurse-midwives were trained to provide medication abortion through twelve pharmacies and public facilities as part of a demonstration project in two districts. Eligible women were ≤63 days pregnant, aged 16-45, and had no medical contraindications. Between 2014-2015, participants (n = 605) obtained 200 mg mifepristone orally and 800 μg misoprostol sublingually or intravaginally 24 hours later, and followed-up 14-21 days later. The primary outcome was complete abortion without manual vacuum aspiration; the secondary outcome was complication requiring treatment. We assessed risk differences by facility type with multivariable logistic mixed-effects regression. Over 99% of enrolled women completed follow-up (n = 600). Complete abortions occurred in 588 (98·0%) cases, with ten incomplete abortions and two continuing pregnancies. 293/297 (98·7%) pharmacy participants and 295/303 (97·4%) public facility participants had complete abortions, with an adjusted risk difference falling within the pre-specified 5 percentage-point non-inferiority margin (1·5% [-0·8%, 3·8%]). No serious adverse events occurred. Five (1.7%) pharmacy and two (0.7%) public facility participants experienced a complication warranting treatment (aRD, 0.8% [-1.0%-2.7%]). Early mifepristone-misoprostol abortion was as effective and safe when provided by trained auxiliary nurse-midwives at pharmacies as at government-certified health facilities. Findings support policy expanding provision through registered pharmacies by trained auxiliary nurse-midwives to improve access to safe care.

Effectiveness and safety of early medication abortion provided in pharmacies by auxiliary nurse-midwives: A non-inferiority study in Nepal

PubMed Central

Puri, Mahesh; Shrestha, Prabhakar; Blum, Maya; Maharjan, Dev; Grossman, Daniel; Regmi, Kiran; Darney, Philip D.; Harper, Cynthia C.

2018-01-01

Background Expanding access to medication abortion through pharmacies is a promising avenue to reach women with safe and convenient care, yet no pharmacy provision interventions have been evaluated. This observational non-inferiority study investigated the effectiveness and safety of mifepristone-misoprostol medication abortion provided at pharmacies, compared to government-certified public health facilities, by trained auxiliary nurse-midwives in Nepal. Methods Auxiliary nurse-midwives were trained to provide medication abortion through twelve pharmacies and public facilities as part of a demonstration project in two districts. Eligible women were ≤63 days pregnant, aged 16–45, and had no medical contraindications. Between 2014–2015, participants (n = 605) obtained 200 mg mifepristone orally and 800 μg misoprostol sublingually or intravaginally 24 hours later, and followed-up 14–21 days later. The primary outcome was complete abortion without manual vacuum aspiration; the secondary outcome was complication requiring treatment. We assessed risk differences by facility type with multivariable logistic mixed-effects regression. Results Over 99% of enrolled women completed follow-up (n = 600). Complete abortions occurred in 588 (98·0%) cases, with ten incomplete abortions and two continuing pregnancies. 293/297 (98·7%) pharmacy participants and 295/303 (97·4%) public facility participants had complete abortions, with an adjusted risk difference falling within the pre-specified 5 percentage-point non-inferiority margin (1·5% [-0·8%, 3·8%]). No serious adverse events occurred. Five (1.7%) pharmacy and two (0.7%) public facility participants experienced a complication warranting treatment (aRD, 0.8% [-1.0%-2.7%]). Conclusions Early mifepristone-misoprostol abortion was as effective and safe when provided by trained auxiliary nurse-midwives at pharmacies as at government-certified health facilities. Findings support policy expanding provision through registered pharmacies by trained auxiliary nurse-midwives to improve access to safe care. PMID:29351313

[Determinants of induced abortion among poor women admitted to hospitals in a locality of northeastern Brazil].

PubMed

Fonseca, W; Misago, C; Correia, L L; Parente, J A; Oliveira, F C

1996-02-01

In Brazil, abortion is legally allowed only when it is necessary to save a woman's life or when pregnancy has occurred following rape. Despite this law, induced abortion is widely carried out. This study presents the findings as to the determinants of 2,084 abortions admitted to two major obstetric hospitals in Fortaleza, Brazil, between October 1992 and September 1993. Most of these women (2,074) have admitted an attempt to terminate pregnancy and 10 women were classified as induced abortion cases based on the findings of signs of intervention such as cervical laceration, perforation or foreign bodies in the vagina or uterus. The study findings indicate that self-administration of medicines plays an important role in terminating pregnancy. Among the 2,074 women who admitted to terminating the pregnancy 66% reported using misoprostol to induce abortion. Misoprostol, a prostaglandin E1 analogue indicated for ulcer treatment, has been widely used as an abortifacient by women in Brazil. Misoprostol has some uterine effects but it is not effective in inducing abortion. Among women who were hospitalized for complications resulting from abortion about 59.7% were 20 to 29 years old and 22.6% were aged less than 20. The majority of the women (91.6%) were Catholic and only 4.3% were illiterate. About 62% of the abortion cases lived alone or did not have a stable partner. Most of the women (59.2%) reported less than 2 live births and 11.8% had experienced a previous abortion; 61.1% of the women were not using a contraceptive method at the time of conception. The main reasons for this were "fear of side effects", "did not expect to have sexual intercourse" and "did not expect to get pregnant". The authors suggest that the situation of a high rate of self-inflicted abortion may be changed by the application of an appropriate contraceptive and reproductive health programme.

Medication Abortion within a Student Health Care Clinic: A Review of the First 46 Consecutive Cases

ERIC Educational Resources Information Center

Godfrey, Emily M.; Bordoloi, Anita; Moorthie, Mydhili; Pela, Emily

2012-01-01

Objective: Medication abortion with mifepristone and misoprostol has been available in the United States since 2000. The authors reviewed the first 46 medication abortion cases conducted at a university-based student health care clinic to determine the safety and feasibility of medication abortion in this type of clinical setting. Participants:…

Induced abortion among Brazilian female sex workers: a qualitative study.

PubMed

Madeiro, Alberto Pereira; Diniz, Debora

2015-02-01

Prostitutes are vulnerable to unplanned pregnancies and abortions. In Brazil, abortion is a crime and there is no data about unsafe abortions for this population. The study describes how prostitutes perform illegal abortions and the health consequences thereof. Semi-structured interviews with 39 prostitutes from three cities in Brazil with previous induced abortion experience were conducted. Sixty-six abortions, with between one and eight occurrences per woman, were recorded. The majority of the cases resulted from sexual activity with clients. The inconsistent use of condoms with regular clients and the consumption of alcohol during work were indicated as the main causes of unplanned pregnancies. The main method to perform abortion was the intravaginal and oral use of misoprostol, acquired in pharmacies or on the black market. Invasive measures were less frequently reported, however with more serious health complications. The fear of complaint to the police meant that most women do not inform the health team regarding induced abortion. The majority of prostitutes aborted with the use of illegally-acquired misoprostol, ending abortion in a public hospital with infection and hemorrhagic complications. The data indicate the need for a public policy focusing on the reproductive health of prostitutes.

Medical abortion practices among private providers in Vietnam

PubMed Central

Park, Min Hae; Nguyen, Thang Huu; Dang, Anh Thi Ngoc; Ngo, Thoai Dinh

2013-01-01

Objective To describe medical abortion (MA) practices among private providers in Vietnam. Methods The study subjects were women (n = 258) undergoing early MA through 12 private providers in Hanoi during February–June 2012. The women were interviewed on the day of their procedure and were followed up by telephone 14 days after mifepristone administration. Results Of the 258 women in the study, 97% used a regimen of mifepristone plus misoprostol; 80% were instructed to administer misoprostol at home. MA resulted in a complete termination in 90.8% of cases. All women were provided with information on potential complications and were instructed to return for a follow-up visit. We successfully followed up 77.5% (n = 200) of participants by telephone, while nearly two-thirds of women returned to the clinic for a follow-up visit. At follow-up, 39.5% of women reported having used a Help line service, while 7% had sought help from a health provider. A high unmet need for postabortion family planning was identified. Conclusion Follow-up of women, postabortion care, and the provision of family planning have been identified as important areas to address for strengthening MA services in the private sector in Vietnam. PMID:24082795

Cervical dilation before first-trimester surgical abortion (<14 weeks' gestation).

PubMed

Allen, Rebecca H; Goldberg, Alisa B

2016-04-01

First-trimester surgical abortion is a common, safe procedure with a major complication rate of less than 1%. Cervical dilation before suction abortion is usually accomplished using tapered mechanical dilators. Risk factors for major complications in the first trimester include increasing gestational age and provider inexperience. Cervical priming before first-trimester surgical abortion has been studied using osmotic dilators and pharmacologic agents, most commonly misoprostol. Extensive data demonstrate that a variety of agents are safe and effective at causing preoperative cervical softening and dilation; however, given the small absolute risk of complications, the benefit of routine use of misoprostol or osmotic dilators in first-trimester surgical abortion is unclear. Although cervical priming results in reduced abortion time and improved provider ease, it requires a delay of at least 1 to 3 h and may confer side effects. The Society of Family Planning does not recommend routine cervical priming for first-trimester suction abortion but recommends limiting consideration of cervical priming for women at increased risk of complications from cervical dilation, including those late in the first trimester, adolescents and women in whom cervical dilation is expected to be challenging. Copyright © 2016 Elsevier Inc. All rights reserved.

Latin American women’s experiences with medical abortion in settings where abortion is legally restricted

PubMed Central

2012-01-01

Abortion is legally restricted in most of Latin America where 95% of the 4.4 million abortions performed annually are unsafe. Medical abortion (MA) refers to the use of a drug or a combination of drugs to terminate pregnancy. Mifepristone followed by misoprostol is the most effective and recommended regime. In settings where mifepristone is not available, misoprostol alone is used. Medical abortion has radically changed abortion practices worldwide, and particularly in legally restricted contexts. In Latin America women have been using misoprostol for self-induced home abortions for over two decades. This article summarizes the findings of a literature review on women’s experiences with medical abortion in Latin American countries where voluntary abortion is illegal. Women’s personal experiences with medical abortion are diverse and vary according to context, age, reproductive history, social and educational level, knowledge about medical abortion, and the physical, emotional, and social circumstances linked to the pregnancy. But most importantly, experiences are determined by whether or not women have the chance to access: 1) a medically supervised abortion in a clandestine clinic or 2) complete and accurate information on medical abortion. Other key factors are access to economic resources and emotional support. Women value the safety and effectiveness of MA as well as the privacy that it allows and the possibility of having their partner, a friend or a person of their choice nearby during the process. Women perceive MA as less painful, easier, safer, more practical, less expensive, more natural and less traumatic than other abortion methods. The fact that it is self-induced and that it avoids surgery are also pointed out as advantages. Main disadvantages identified by women are that MA is painful and takes time to complete. Other negatively evaluated aspects have to do with side effects, prolonged bleeding, the possibility that it might not be effective, and the fact that some women eventually need to seek medical care at a hospital where they might be sanctioned for having an abortion and even reported to the police. PMID:23259660

Postabortion Care: 20 Years of Strong Evidence on Emergency Treatment, Family Planning, and Other Programming Components

PubMed Central

Huber, Douglas; Curtis, Carolyn; Irani, Laili; Pappa, Sara; Arrington, Lauren

2016-01-01

ABSTRACT Worldwide 75 million women need postabortion care (PAC) services each year following safe or unsafe induced abortions and miscarriages. We reviewed more than 550 studies on PAC published between 1994 and 2013 in the peer-reviewed and gray literature, covering emergency treatment, postabortion family planning, organization of services, and related topics that impact practices and health outcomes, particularly in the Global South. In this article, we present findings from studies with strong evidence that have major implications for programs and practice. For example, vacuum aspiration reduced morbidity, costs, and time in comparison to sharp curettage. Misoprostol 400 mcg sublingually or 600 mcg orally achieved 89% to 99% complete evacuation rates within 2 weeks in multiple studies and was comparable in effectiveness, safety, and acceptability to manual vacuum aspiration. Misoprostol was safely introduced in several PAC programs through mid-level providers, extending services to secondary hospitals and primary health centers. In multiple studies, postabortion family planning uptake before discharge increased by 30–70 percentage points within 1–3 years of strengthening postabortion family planning services; in some cases, increases up to 60 percentage points in 4 months were achieved. Immediate postabortion contraceptive acceptance increased on average from 32% before the interventions to 69% post-intervention. Several studies found that women receiving immediate postabortion intrauterine devices and implants had fewer unintended pregnancies and repeat abortions than those who were offered delayed insertions. Postabortion family planning is endorsed by the professional organizations of obstetricians/gynecologists, midwives, and nurses as a standard of practice; major donors agree, and governments should be encouraged to provide universal access to postabortion family planning. Important program recommendations include offering all postabortion women family planning counseling and services before leaving the facility, especially because fertility returns rapidly (within 2 to 3 weeks); postabortion family planning services can be quickly replicated to multiple sites with high acceptance rates. Voluntary family planning uptake by method should always be monitored to document program and provider performance. In addition, vacuum aspiration and misoprostol should replace sharp curettage to treat incomplete abortion for women who meet eligibility criteria. PMID:27571343

Modulation of leukocyte adhesion in rat mesenteric venules by aspirin and salicylate.

PubMed

Asako, H; Kubes, P; Wallace, J; Wolf, R E; Granger, D N

1992-07-01

Erythrocyte velocity, vessel diameter, leukocyte rolling velocity, and number of adherent and emigrated leukocytes were measured in postcapillary venules both before and during superfusion of rat mesentery with either aspirin or sodium salicylate. In some experiments, animals were treated with either a leukotriene (LT)-synthesis inhibitor (L-663,536), an LTD4 antagonist (MK-571), an LTB4 antagonist (SC-41930), misoprostol, or prostaglandin (PG) I2, then the aspirin protocol was repeated. Superfusion of aspirin but not sodium salicylate resulted in increased leukocyte adherence and a reduced leukocyte rolling velocity but did not affect leukocyte emigration. Aspirin-induced leukocyte adhesion was effectively prevented by the LT-synthesis inhibitor and LTB4 antagonist but not by the LTD4 antagonist. Misoprostol and PGI2 also prevented the aspirin-induced adhesion responses. Superfusion of the mesentery with either platelet-activating factor (PAF) or LTB4 enhanced leukocyte adherence and emigration while reducing leukocyte rolling velocity. Sodium salicylate prevented all of the adhesion responses elicited by LTB4. Although salicylate did not affect the PAF-induced leukocyte adherence and rolling responses, it completely prevented the increased leukocyte emigration. These results indicate that aspirin promotes, whereas sodium salicylate inhibits, leukocyte-endothelial cell adhesive interactions at therapeutically relevant concentrations.

Abortion in Chile: the practice under a restrictive regime.

PubMed

Casas, Lidia; Vivaldi, Lieta

2014-11-01

This article examines, from a human rights perspective, the experience of women, and the practices of health care providers regarding abortion in Chile. Most abortions, as high as 100,000 a year, are obtained surreptitiously and clandestinely, and income and connections play a key role. The illegality of abortion correlates strongly with vulnerability, feelings of guilt and loneliness, fear of prosecution, physical and psychological harm, and social ostracism. Moreover, the absolute legal ban on abortion has a chilling effect on health care providers and endangers women's lives and health. Although misoprostol use has significantly helped to prevent greater harm and enhance women's agency, a ban on sales created a black market. Against this backdrop, feminists have taken action in aid of women. For instance, a feminist collective opened a telephone hotline, Linea Aborto Libre (Free Abortion Line), which has been crucial in informing women of the correct and safe use of misoprostol. Chile is at a crossroads. For the first time in 24 years, abortion law reform seems plausible, at least when the woman's life or health is at risk and in cases of rape and fetal anomalies incompatible with life. The political scenario is unfolding as we write. Congressional approval does not mean automatic enactment of a new law; a constitutional challenge is highly likely and will have to be overcome. Copyright © 2014 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

Pain during medical abortion: a multicenter study in France.

PubMed

Saurel-Cubizolles, Marie-Josèphe; Opatowski, Marion; David, Philippe; Bardy, Françoise; Dunbavand, Annabel

2015-11-01

To compare the level of pain reported by women by dose of mifepristone, 200 or 600mg, and describe the main factors related to the pain level in the 5 days after a medical abortion. Observational study in 11 medical centers in France between October 2013 and September 2014. The protocols were 200 or 600mg orally mifepristone on day 1 of the medical abortion and 400, 600 or 800μg orally misoprostol on day 3. Women returned a questionnaire that they completed during 5 days following the abortion; pain was recorded on a visual analog scale (0-10) daily. 453 women were included; the mean age was 29 years (range 18-49 years). Pain was greater with 200 than 600mg mifepristone: 33% of women reported a pain level of ≥8 on day 3 with 200mg as compared with 16% with 600mg. This difference remained after controlling for age, gestational age, gravidity, usual painful menstruation and misoprostol dose. Percentages of symptoms as vomiting or diarrhea were also lower with 600mg mifépristone than 200mg. The mean pain severity experienced by women undergoing medical abortion is high; it is higher with a regimen of 200mg mifepristone. The findings emphasize the need to improve analgesic strategies and invite to opt for a protocol of 600mg instead of 200mg mifepristone. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Simplified medical abortion screening: a demonstration project.

PubMed

Raymond, Elizabeth G; Tan, Yi-Ling; Comendant, Rodica; Sagaidac, Irina; Hodorogea, Stelian; Grant, Melissa; Sanhueza, Patricio; Van Pratt, Emigdio; Gillespie, Ginger; Boraas, Christy; Weaver, Mark A; Platais, Ingrida; Bousieguez, Manuel; Winikoff, Beverly

2018-04-01

The objectives were to evaluate the safety and acceptability of outpatient medical abortion in selected women without a pretreatment ultrasound or pelvic examination. We conducted a prospective case-series study to estimate the incidence of serious adverse events (death, life-threatening event, hospitalization, transfusion or any other medical problem that we judged to be significant), surgical completion of the abortion and satisfaction in women provided with medical abortion without a pretreatment ultrasound or pelvic examination. We enrolled 406 women requesting medical abortion in Moldova, Mexico and the United States. To be eligible, a woman must have been certain that her last menstrual period started within the prior 56days, have had regular menses before the pregnancy, not have used hormonal contraceptives in the prior 2months (in the United States and Mexico) or 3months (in Moldova), have no risk factors for or symptoms of ectopic pregnancy, and not have had an ultrasound or pelvic exam in this pregnancy. One site also excluded women with uterine enlargement on abdominal palpation. Each participant received mifepristone (200mg orally) and misoprostol (400 mcg sublingually in Moldova; 800 mcg buccally at all other sites) and was followed until complete abortion, defined as requiring no further treatment. Of the 365 (90%) participants who provided sufficient follow-up information for analysis, 347 (95%) had complete abortion without additional treatment, 5 (1%) had surgical aspiration, and 10 (3%) had extra misoprostol. Three participants (1%) had serious adverse events; these included two hospital admissions for heavy bleeding managed with aspiration and one diagnosis of persistent gestational sac 19days after enrollment. Most (317, 90%) participants were pleased with omitting the pretreatment ultrasound and pelvic exam. In this study, medical abortion without screening ultrasound or pelvic exam resulted in no serious adverse events that were likely to have been prevented by those tests and was highly acceptable. Screening for medical abortion without exam or ultrasound shows promise as a means for increasing access to this service. More research is needed to develop screening criteria that are more inclusive and simpler for clinical use. Copyright © 2017. Published by Elsevier Inc.

What causes autism? Exploring the environmental contribution.

PubMed

Landrigan, Philip J

2010-04-01

Autism is a biologically based disorder of brain development. Genetic factors--mutations, deletions, and copy number variants--are clearly implicated in causation of autism. However, they account for only a small fraction of cases, and do not easily explain key clinical and epidemiological features. This suggests that early environmental exposures also contribute. This review explores this hypothesis. Indirect evidence for an environmental contribution to autism comes from studies demonstrating the sensitivity of the developing brain to external exposures such as lead, ethyl alcohol and methyl mercury. But the most powerful proof-of-concept evidence derives from studies specifically linking autism to exposures in early pregnancy - thalidomide, misoprostol, and valproic acid; maternal rubella infection; and the organophosphate insecticide, chlorpyrifos. There is no credible evidence that vaccines cause autism. Expanded research is needed into environmental causation of autism. Children today are surrounded by thousands of synthetic chemicals. Two hundred of them are neurotoxic in adult humans, and 1000 more in laboratory models. Yet fewer than 20% of high-volume chemicals have been tested for neurodevelopmental toxicity. I propose a targeted discovery strategy focused on suspect chemicals, which combines expanded toxicological screening, neurobiological research and prospective epidemiological studies.

Radioprotection of intestinal stem cells and whole body radiation lethality from photons and neutrons by prostaglandins along or in combination with WR-2721. Technical report 24 Feb 86-30 Sep 89

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hanson, W.R.

1990-12-01

Prostaglandins (PGs) have been shown to protect the gastrointestinal and hematopoietic cell renewal systems from some degree of radiation damage. The mechanism(s) to account for these observations are unknown. Based on preliminary evidence that PGs varied in the degree to which they afforded protection of intestinal stem cells, we studied protection by several PGs and their analogues. The most protective PGs found to date were 16,16 dm PGE2, misoprostol, a PGE1 analogues, and iloprost, a PGI2 analogue. The relative degrees of protection were 400%, 700% and 800% above control values at a dose of 13.5 137 Cs gamma radiation. Thesemore » three PGs were used for subsequent studies. Iloprost is a stable PG at room temperature and was found to be protective given orally. In addition to radioprotection of the intestinal stem cells, these Pgs increased the LD50/6, LD50/30 and animal longevity through both the gastrointestinal and hematopoietic syndromes. Misoprostol protected the gut from JANUS neutrons and increased animal longevity following neutron irradiation. Although the mechanism for PG-induced radioprotection is unknown, it appears to be different compared to the widely studied amino thiol, WR-2721. Evidence to support this contention came from data showing that all these analogues were additive to the protective effect of Wr-2721.« less

Electrohysterographic characterization of the uterine myoelectrical response to labor induction drugs.

PubMed

Benalcazar-Parra, Carlos; Ye-Lin, Yiyao; Garcia-Casado, Javier; Monfort-Orti, Rogelio; Alberola-Rubio, Jose; Perales, Alfredo; Prats-Boluda, Gema

2018-06-01

Labor induction is a common practice to promote uterine contractions and labor onset. Uterine electrohysterogram (EHG) has proved its suitability for characterizing the uterus electrophysiological condition in women with spontaneous labor. The aim of this study was to characterize and compare uterine myoelectrical activity during the first 4 h in response to labor induction drugs, Misoprostol (G1) and Dinoprostone (G2), by analyzing the differences between women who achieved active phase of labor and those who did not (successful and failed inductions). A set of temporal, spectral and complexity parameters were computed from the EHG-bursts. As for successful inductions, statistical significant and sustained increases with respect to basal period were obtained for EHG amplitude, mean frequency, uterine activity index (UAI) and Teager, after 60' for the G1 group; duration, amplitude, number of contractions and UAI for the G2 group, after 120'. Moreover, Teager showed statistical significant and sustained differences between successful and failed inductions (1.43 ± 1.45 µV 2. Hz 2. 10 5  vs. 0.40 ± 0.26 µV 2. Hz 2. 10 5 after 240') for the G1 group, but not in the G2 group, probably due to the slower pharmacokinetics of this drug. These results revealed that EHG could be useful for successful induction prediction in the early stages of induction, especially when using Misoprostol. Copyright © 2018 Elsevier Ltd. All rights reserved.

A review of evidence for safe abortion care.

PubMed

Kapp, Nathalie; Whyte, Patti; Tang, Jennifer; Jackson, Emily; Brahmi, Dalia

2013-09-01

The provision of safe abortion services to women who need them has the potential to drastically reduce or eliminate maternal deaths due to unsafe abortion. The World Health Organization recently updated its evidence-based guidance for safe and effective clinical practices using data from systematic reviews of the literature. Systematic reviews pertaining to the evidence for safe abortion services, from pre-abortion care, medical and surgical methods of abortion and post-abortion care were evaluated for relevant outcomes, primarily those relating to safety, effectiveness and women's preference. Sixteen systematic reviews were identified and evaluated. The available evidence does not support the use of pre-abortion ultrasound to increase safety. Routine use of cervical preparation with osmotic dilators, mifepristone or misoprostol after 14 weeks gestation reduces complications; at early gestational ages, surgical abortions have very few complications. Prophylactic antibiotics result in lower rates of post-surgical abortion infection. Pain medication such as non-steroidal anti-inflammatories should be offered to women undergoing abortion procedures; acetaminophen, however, is not effective in reducing pain. Women who are eligible should be offered a choice between surgical (vacuum aspiration or dilation and evacuation) and medical methods (mifepristone and misoprostol) of abortion when possible. Modern methods of contraception can be safely initiated immediately following abortion procedures. Evidence-based guidelines assist health care providers and policymakers to utilize the best data available to provide safe abortion care and prevent the millions of deaths and disabilities that result from unsafe abortion. Copyright © 2013 Elsevier Inc. All rights reserved.

[Modern approach to the prevention and treatment of NSAID-gastropathy].

PubMed

Drozdov, V N; Kim, V A; Lazebnik, L B

2011-01-01

The article presents the results of the first Russian open randomized comparative multicenter study on the effectiveness of Famotidine in the prevention of NSAID-gastropathy--Barrier. In addition, were showen the results of studies of the drugs effect used for prevention of NSAID gastropathy (Famotidine, Lansoprazole, Misoprostol) for the synthesis of prostaglandins in the gastric mucosa in patients with osteoarthritis. Was shown the impact of alternative anti-inflammatory drug on the basis of an extract of ginger as joint pain, and the mucous upper gastrointestinal tract in patients with osteoarthritis.

Beyond usual care: the economic consequences of expanding treatment options in early pregnancy loss.

PubMed

Dalton, Vanessa K; Liang, Angela; Hutton, David W; Zochowski, Melissa K; Fendrick, A Mark

2015-02-01

The objective of this study was to estimate the economic consequences of expanding options for early pregnancy loss (EPL) treatment beyond expectant management and operating room surgical evacuation (usual care). We constructed a decision model using a hypothetical cohort of women undergoing EPL management within a 30 day horizon. Treatment options under the usual care arm include expectant management and surgical uterine evacuation in an operating room (OR). Treatment options under the expanded care arm included all evidence-based safe and effective treatment options for EPL: expectant management, misoprostol treatment, surgical uterine evacuation in an office setting, and surgical uterine evacuation in an OR. Probabilities of entering various treatment pathways were based on previously published observational studies. The cost per case was US $241.29 lower for women undergoing treatment in the expanded care model as compared with the usual care model (US $1033.29 per case vs US $1274.58 per case, expanded care and usual care, respectively). The model was the most sensitive to the failure rate of the expectant management arm, the cost of the OR surgical procedure, the proportion of women undergoing an OR surgical procedure under usual care, and the additional cost per patient associated with implementing and using the expanded care model. This study demonstrates that expanding women's treatment options for EPL beyond what is typically available can result in lower direct medical expenditures. Copyright © 2015 Elsevier Inc. All rights reserved.

Induced abortion: an overview for internists.

PubMed

Grimes, David A; Creinin, Mitchell D

2004-04-20

Internists care for many women who have had abortions and many who will seek abortions in the future. Each year, about 2% of all women of reproductive age have an abortion. Women having abortions tend to be young, white, unmarried, and early in pregnancy. Most abortions are done by suction curettage under local anesthesia in a freestanding clinic. However, medical abortion is growing in popularity as a nonsurgical alternative. The regimen approved by the U.S. Food and Drug Administration specifies mifepristone, 600 mg orally, followed 2 days later by misoprostol, 400 microg orally (within 49 days from last menses). Recent studies have recommended alternative approaches, such as mifepristone, 200 mg orally, followed in 1 to 3 days by misoprostol, 800 microg vaginally (up to 63 days). Medical abortion can be provided by a broader variety of physicians than can surgical abortion. The overall case-fatality rate for abortion is less than 1 death per 100,000 procedures. Infection, hemorrhage, acute hematometra, and retained tissue are among the more common complications. Referral back to the original abortion provider for management is advisable. Overall, induced abortion does not lead to late sequelae, either medical or psychiatric. Of importance, no link exists between induced abortion and later breast cancer. For physicians who are asked to help with a referral, the National Abortion Federation and Planned Parenthood Federation of America have helpful Web sites and networks of high-quality clinics. The cost of abortion (currently about 372 dollars at 10 weeks) has decreased in recent decades. Provision of ongoing contraception and encouragement of emergency contraception can reduce unintended pregnancies and the need for abortion.

[Induced abortion: Guidelines for clinical practice - Text of the Guidelines (short text)].

PubMed

Vayssière, C; Gaudineau, A; Attali, L; Bettahar, K; Eyraud, S; Faucher, P; Fournet, P; Hassoun, D; Hatchuel, M; Jamin, C; Letombe, B; Linet, T; Msika Razon, M; Ohanessian, A; Segain, H; Vigoureux, S; Winer, N; Wylomanski, S; Agostini, A

2016-12-01

Develop recommendations for the practice of induced abortion. The Pubmed database, the Cochrane Library and the recommendations from the French and foreign Gyn-Obs societies or colleges have been consulted. The number of induced abortions (IA) has been stable for several decades. There are a lot of factors explaining the choice of abortion when there is an unplanned pregnancy (UPP). Early initiation and choice of contraception in connection to the woman's life are associated with lower NSP. Reversible contraceptives of long duration of action should be positioned fist in line for the teenager because of its efficiency (grade C). Ultrasound before induced abortion must be encouraged but should not be obligatory before performing IA (Professional consensus). As soon as the sonographic apparition of the embryo, the estimated date of pregnancy is done by measuring the crown-rump length (CRL) or by measuring the biparietal diameter (BIP) from 11 weeks on (grade B). Reliability of these parameters being±5 days, IA could be done if measurements are respectively less than 90mm for CRL and less than 30mm for BIP (Professional consensus). A medical IA performed with a dose of 200mg mifepristone combined with misoprostol is effective at any gestational age (EL1). Before 7 weeks, mifepristone followed between 24 and 48hours by taking misoprostol orally, buccally sublingually or eventually vaginally at a dose of 400 ug possibly renewed after 3hours (EL1, grade A). Beyond 7 weeks, misoprostol given vaginally, sublingually or buccally are better tolerated with fewer side effects than oral route (EL1). It is recommended to always use a cervical preparation during an instrumental abortion (Professional consensus). Misoprostol is a first-line agent for cervical preparation at a dose of 400 mcg (grade A). Aspiration evacuation is preferable to curettage (grade B). A perforated uterus during an instrumental suction should not be considered as a scarred uterus (Professional consensus). IA is not associated with increased subsequent risk of infertility or ectopic pregnancy (EL2). The pre-abortion medical consultations does not affect, most of the time, the decision to request an IA. Indeed, a majority of women is quite sure of her choice during these consultations. Acceptability of the method of IA and satisfaction appears to be larger when they are able to choose the abortion method (grade B). There is no relationship between an increase in psychiatric disorders and IA (EL2). Women with psychiatric histories are at increased risk of mental disorders after the occurrence of an UPP (EL2). In case of instrumental abortion, oral estrogen-progestogen contraceptives and the patch should be started from the day of the abortion, the vaginal ring inserted within 5 days of IA (grade B). In case of medical abortion, the vaginal ring should be inserted within a week of taking mifepristone, oral estrogen-progestogen contraceptives and the patch should be initiated on the same day or the day after taking prostaglandins (grade C). In case of instrumental abortion, the contraceptive implant may be inserted on the day of the abortion (grade B). In case of medical abortion, the implant can be inserted on the day of mifepristone (grade C). The copper Intrauterine Device (IUD) and levonorgestrel should be inserted preferably on the day of instrumental abortion (grade A). In case of medical abortion, an IUD can be inserted within 10 days following mifepristone after ensuring by ultrasound of the absence of intrauterine pregnancy (grade C). The implementation of these guidelines may promote a better and more homogenous care for women requesting IA in our country. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Fetal exposure to teratogens: evidence of genes involved in autism.

PubMed

Dufour-Rainfray, Diane; Vourc'h, Patrick; Tourlet, Sébastien; Guilloteau, Denis; Chalon, Sylvie; Andres, Christian R

2011-04-01

Environmental challenges during the prenatal period can result in behavioral abnormalities and cognitive deficits that appear later in life such as autism. Prenatal exposure to valproic acid, ethanol, thalidomide and misoprostol has been shown to be associated with an increased incidence of autism. In addition, rodents exposed in utero to some of these drugs show autism-like abnormalities, including brain changes and lifelong behavior dysfunction. Our aim is to summarize current understanding of the relationship between in utero exposure to these drugs and autism in humans and in autism-like animal model phenotypes. It also highlights the importance of these models to understanding the neurobiology of autism, particularly in the identification of susceptibility genes. These drugs are able to modulate the expression of many genes involved in processes such as proliferation, apoptosis, neuronal differentiation and migration, synaptogenesis and synaptic activity. It seems essential to focus research on genes expressed during early neurodevelopment which may be the target of mutations or affected by drugs such as those included in this review. Copyright © 2011. Published by Elsevier Ltd.

[Surgical methods of abortion].

PubMed

Linet, T

2016-12-01

A state of the art of surgical method of abortion focusing on safety and practical aspects. A systematic review of French-speaking or English-speaking evidence-based literature about surgical methods of abortion was performed using Pubmed, Cochrane and international recommendations. Surgical abortion is efficient and safe regardless of gestational age, even before 7 weeks gestation (EL2). A systematic prophylactic antibiotics should be preferred to a targeted antibiotic prophylaxis (grade A). In women under 25 years, doxycycline is preferred (grade C) due to the high prevalence of Chlamydia trachomatis. Systematic cervical preparation is recommended for reducing the incidence of complications from vacuum aspiration (grade A). Misoprostol is a first-line agent (grade A). When misoprostol is used before a vacuum aspiration, a dose of 400 mcg is recommended. The choice of vaginal route or sublingual administration should be left to the woman: (i) the vaginal route 3 hours before the procedure has a good efficiency/safety ratio (grade A); (ii) the sublingual administration 1 to 3 hours before the procedure has a higher efficiency (EL1). The patient should be warned of more common gastrointestinal side effects. The addition of mifepristone 200mg 24 to 48hours before the procedure is interesting for pregnancies between 12 and 14 weeks gestations (EL2). The systematic use of nonsteroidal anti-inflammatory drugs is recommended for limiting the operative and postoperative pain (grade B). Routine vaginal application of an antiseptic prior to the procedure cannot be recommended (grade B). The type of anesthesia (general or local) should be left up to the woman after explanation of the benefit-risk ratio (grade B). Paracervical local anesthesia (PLA) is recommended before performing a vacuum aspiration under local anesthesia (grade A). The electric or manual vacuum methods are very effective, safe and acceptable to women (grade A). Before 9 weeks gestation, the manual vacuum aspiration could have a subjective interest (grade B). The electric vacuum aspiration is recommended after 9 weeks gestation (best practice agreement). For a pregnancy of unknown location, the success of the procedure can reasonably be determined if hCG drops more than 50 % on day 5 and 80 % on day 7 (NP3). After a surgical abortion, paracetamol or addition of paracetamol and codeine is not recommended (grade B). Copyright © 2016. Published by Elsevier Masson SAS.

Uterine rupture disguised by urinary retention following a second trimester induced abortion: a case report.

PubMed

Jiang, Qiaoying; Yang, Liwei; Ashley, Charles; Medlin, Erin E; Kushner, David M; Zheng, Yanmei

2015-01-22

Uterine rupture classically presents with severe abdominal pain, loss of fetal station, vaginal bleeding, and shock. We present a case of uterine rupture presenting as significant urinary retention that occurred following a second trimester abortion induced with mifepristone and misoprostol. Uterine rupture was discovered unexpectedly on diagnostic laparoscopy. The uterine rupture was contained by dense adhesions between the omentum and bladder with the previous uterine cesarean hysterotomy scar. This case highlights the difficulties in diagnosis of abnormal placentation and an unusual presentation of uterine rupture. This case was managed successfully laparoscopically.

Haloperidol-stomach lesions attenuation by pentadecapeptide BPC 157, omeprazole, bromocriptine, but not atropine, lansoprazole, pantoprazole, ranitidine, cimetidine and misoprostol in mice.

PubMed

Bilic, I; Zoricic, I; Anic, T; Separovic, J; Stancic-Rokotov, D; Mikus, D; Buljat, G; Ivankovic, D; Aralica, G; Prkacin, I; Perovic, D; Mise, S; Rotkvic, I; Petek, M; Rucman, R; Seiwerth, S; Sikiric, P

2001-03-09

The focus was on haloperidol (central dopamine antagonist)-stomach lesion, a longly described suitable counterpart of dopamine blocker cysteamine-duodenal lesion. In this, the contribution of blockade of central/peripheral dopamine receptors and prostaglandins synthesis, along with influence of antiulcer agents was evaluated in mice. Male NMRI Hannnover mice were sacrificed 24 h after haloperidol (25 mg/kg b.w. i.p., given alone or with saline (haloperidol+saline) (i) or in combination (ii,iii)). Supporting central dopamine predominance for haloperidol stomach lesion induction, co-administration of peripheral dopamine receptor antagonist domperidone (5 mg/kg i.p.) (haloperidol+ domperidone) (ii), or prostaglandin synthesis inhibitor indomethacin (10 mg/kg s.c.) (haloperidol+ indomethacin) (iii) did not aggravate this lesion. (i) In haloperidol+saline challenged mice the lesions were inhibited by co-administration (/kg i.p.) of a gastric pentadecapeptide BPC 157, GlyGluProProProGlyLysProAlaAspAspAlaGlyLeuVal, M.W. 1419 (10 microg, 10 ng, 10 pg, but not 1 pg, 100 fg, 10 fg), bromocriptine (10 mg), omeprazole (10 mg, 100 mg, but not 1 mg). Atropine (10, 100, 200 mg), pirenzepine (10, 100, 200 mg), misoprostol (10, 100, 200 microg), pantoprazole (1, 10, 100 mg), lansoprazole (0.1, 1, 10 mg), cimetidine (10, 100, 200 mg) and ranitidine (10, 100, 200 mg) were not effective. (ii) Dopamine peripheral blockade influence: in haloperidol+domperidone mice, previously effective bromocriptine, pentadecapeptide BPC 157 (10 microg) or omeprazole (10 mg) did not attenuate stomach lesions. (iii) Prostaglandins synthesis blockade effect: in haloperidol+indomethacin mice, previously effective agents, bromocriptine or omeprazole were not active, while BPC 157 effect was only lessened.

Mucosal protective agents prevent exacerbation of NSAID-induced small intestinal lesions caused by antisecretory drugs in rats.

PubMed

Satoh, Hiroshi; Amagase, Kikuko; Takeuchi, Koji

2014-02-01

Antisecretory drugs such as histamine H₂-receptor antagonists and proton pump inhibitors are commonly used for the treatment of upper gastrointestinal mucosal lesions induced by nonsteroidal anti-inflammatory drugs (NSAIDs). However, it has recently been reported that these drugs exacerbate NSAID-induced small intestinal lesions in rats. Unfortunately, there are few effective agents for the treatment of this complication. We examined the effects of mucosal protective agents (MPAs) (misoprostol, irsogladine, and rebamipide) and mucin of porcine stomach on diclofenac-induced intestinal lesions and the exacerbation of the lesions by ranitidine or omeprazole. The effects of the drugs on intestinal motility and mucus distribution/content were also examined. Male Wistar rats (180-220 g) were used. Each drug was administered orally under fed conditions. Diclofenac (1-10 mg/kg) produced multiple lesions in the small intestine dose-dependently. Both ranitidine (30 mg/kg) and omeprazole (100 mg/kg) significantly increased the intestinal lesions induced by low doses (3 and 6 mg/kg) of diclofenac. Misoprostol (0.03-0.3 mg/kg), irsogladine (3-30 mg/kg), and rebamipide (30-300 mg/kg), as well as mucin (30-300 mg/kg) inhibited the formation of intestinal lesions caused by a high dose (10 mg/kg) of diclofenac alone and prevented the exacerbation of diclofenac-induced lesions by antisecretory drugs. Diclofenac (10 mg/kg) markedly increased the intestinal motility and decreased the mucosal mucus, and the decrease of mucus was significantly inhibited by the MPAs. These results indicate the usefulness of the MPAs for the treatment of intestinal lesions induced by NSAIDs alone or by coadministration with antisecretory drugs, and suggest that mucus plays an important role in the protection of intestinal mucosa by the MPAs.

Mifepristone (RU 486) in the United States. What does the future hold?

PubMed

Rosenfield, A

1993-05-27

RU-486 or mifepristone developed by Roussel-UCLAF was approved in France in September 1988. Mifepristone coupled with a prostaglandin and administered within 49 days of the last menstrual period produces a complete abortion in about 95% of cases. A new regimen involves supplementing mifepristone with an oral prostaglandin, misoprostol. Mifepristone has been also reported to be effective as a postcoital agent, and it is being evaluated in the treatment of meningioma, recurrent breast cancer, Cushing's syndrome, and glaucoma. Despite these potentially important medical uses, the drug is not available in the US, although its popularity is demonstrated by the large number of women in France who have chosen it over 1st trimester surgical curettage. Many American women prefer a medical abortifacient to be taken privately because of harassment of patients outside abortion facilities; 83% of US countries do not have an abortion facility; a diminishing number of physicians are willing to provide abortion because of the violent protests by antiabortion groups (e.g., the recent murder of Dr. David Gunn); and few residency programs in obstetrics and gynecology routinely offer training in abortion procedures. The manufacturer has restricted the distribution of mifepristone, thus it is available only in France, the UK, and Sweden. The Clinton administration has a pro-choice position, hence Roussel had agreed to grant a license to the Population Council and to provide the Food and Drug Administration with toxicologic and chemical data on mifepristone. Approval will likely take place within 2-3 years. The drug should be used by obstetrician-gynecologists and perhaps by family practitioners and nurse-midwives. Physicians should provide counseling about the side effects and potential complications of abortion. Misoprostol is marketed in the US under the trade name Cytotec, thus its review for use with mifepristone should be simple.

Eliminating the high abortion related complications and deaths in Cameroon: the restrictive legal atmosphere on abortions is no acceptable excuse.

PubMed

Bain, Luchuo Engelbert; Kongnyuy, Eugene Justine

2018-05-24

The abortion law in Cameroon is highly restrictive. The law permits induced abortions only when the woman's life is at risk, to preserve her physical and mental health, and on grounds of rape or incest. Unsafe abortions remain rampant with however rare reported cases of persecution, even when these abortions are proven to have been carried out illegally. Available public health interventions are cheap and feasible (Misoprostol and Manual Vacuum Aspiration in post abortion care, modern contraception, post-abortion counseling), and must be implemented to reduce unacceptably high maternal mortality rates in the country which still stand at as high as 596/100.000. Changes in the legal status of abortions might take a long time to come by. Albeit, advocacy efforts must be reinforced to render the law more liberal to permit women to seek safe abortion services. The frequency of abortions, generally clandestine, in this restrictive legal atmosphere has adverse economic, health and social justice implications. We argue that a non-optimal or restrictive legal atmosphere is not an acceptable excuse to justify these high maternal deaths resulting from unsafe abortions, especially in Cameroon where unsafe abortions remain rampant. Implementing currently available, cheap and effective evidence based practice guidelines are possible in the country. Expansion and use of Manual Vacuum Aspiration kits in health care facilities, post-abortion misoprostol and carefully considering the content of post abortion counseling packages deserve keen attention. More large scale qualitative and quantitative studies nationwide to identify and act on context specific barriers to contraception use and abortion related stigma are urgently needed.

Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review

PubMed Central

Park, Min Hae; Shakur, Haleema; Free, Caroline

2011-01-01

Abstract Objective To compare medical abortion practised at home and in clinics in terms of effectiveness, safety and acceptability. Methods A systematic search for randomized controlled trials and prospective cohort studies comparing home-based and clinic-based medical abortion was conducted. The Cochrane Central Register of Controlled Trials, EMBASE, MEDLINE and Popline were searched. Failure to abort completely, side-effects and acceptability were the main outcomes of interest. Odds ratios and their 95% confidence intervals (CIs) were calculated. Estimates were pooled using a random-effects model. Findings Nine studies met the inclusion criteria (n = 4522 participants). All were prospective cohort studies that used mifepristone and misoprostol to induce abortion. Complete abortion was achieved by 86–97% of the women who underwent home-based abortion (n = 3478) and by 80–99% of those who underwent clinic-based abortion (n = 1044). Pooled analyses from all studies revealed no difference in complete abortion rates between groups (odds ratio = 0.8; 95% CI: 0.5–1.5). Serious complications from abortion were rare. Pain and vomiting lasted 0.3 days longer among women who took misoprostol at home rather than in clinic. Women who chose home-based medical abortion were more likely to be satisfied, to choose the method again and to recommend it to a friend than women who opted for medical abortion in a clinic. Conclusion Home-based abortion is safe under the conditions in place in the included studies. Prospective cohort studies have shown no differences in effectiveness or acceptability between home-based and clinic-based medical abortion across countries. PMID:21556304

Medical abortion and manual vacuum aspiration for legal abortion protect women's health and reduce costs to the health system: findings from Colombia.

PubMed

Rodriguez, Maria Isabel; Mendoza, Willis Simancas; Guerra-Palacio, Camilo; Guzman, Nelson Alvis; Tolosa, Jorge E

2015-02-01

The majority of abortions in Colombia continue to take place outside the formal health system under a range of conditions, with the majority of women obtaining misoprostol from a thriving black market for the drug and self-administering the medication. We conducted a cost analysis to compare the costs to the health system of three approaches to the provision of abortion care in Colombia: post-abortion care for complications of unsafe abortions, and for legal abortions in a health facility, misoprostol-only medical abortion and vacuum aspiration abortion. Hospital billing records from three institutions, two large maternity hospitals and one specialist reproductive health clinic, were analysed for procedure and complication rates, and costs by diagnosis. The majority of visits (94%) were to the two hospitals for post-abortion care; the other 6% were for legal abortions. Only one minor complication was found among the women having legal abortions, a complication rate of less than 1%. Among the women presenting for post-abortion care, 5% had complications during their treatment, mainly from infection or haemorrhage. Legal abortions were associated not only with far fewer complications for women, but also lower costs for the health system than for post-abortion care. We calculated based on our findings that for every 1,000 women receiving post-abortion care instead of a legal abortion within the health system, 16 women experienced avoidable complications, and the health system spent US $48,000 managing them. Increasing women's access to safe abortion care would not only reduce complications for women, but would also be a cost-saving strategy for the health system. Copyright © 2015 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

Prophylactic compared with therapeutic ibuprofen analgesia in first-trimester medical abortion: a randomized controlled trial.

PubMed

Raymond, Elizabeth G; Weaver, Mark A; Louie, Karmen S; Dean, Gillian; Porsch, Lauren; Lichtenberg, E Steve; Ali, Rose; Arnesen, Michelle

2013-09-01

To compare the effectiveness of two oral analgesic regimens in first-trimester medical abortion. We randomly assigned 250 participants undergoing first-trimester abortion with mifepristone and misoprostol at three clinics to two ibuprofen regimens: therapeutic (800 mg every 4-6 hours as needed for pain) or prophylactic (800 mg starting 1 hour before the misoprostol dose, then every 4-6 hours for 48 hours regardless of pain, then as needed). We asked each participant to record her maximum pain on a scale of 0-10 daily thereafter. Of participants assigned to the prophylactic and therapeutic regimens, 111 of 123 (90%) and 117 of 127 (92%), respectively, provided follow-up data. More than 80% of the participants in each group complied with their assigned treatment. Participants in the prophylactic group used substantially more ibuprofen than those in the therapeutic group (median of nine and four tablets, respectively). The mean maximum pain score was 7.1 in the prophylactic group and 7.3 in the therapeutic group (standard deviations 2.5 and 2.2, respectively); the difference was not statistically significant (P=.87, adjusted for site). Duration of pain, verbal pain ratings reported at follow-up, and use of other analgesics did not differ significantly by group (all P>.05). No significant benefit of the prophylactic regimen was apparent in any population subgroup. Abortion failure and ibuprofen side effects in the two groups were similar. We found no evidence that prophylactic administration of ibuprofen reduces pain severity or duration in first-trimester medical abortion. The average pain severity experienced by participants using both regimens was high. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01457521. I.

Cost-effectiveness of strategies for primary prevention of nonsteroidal anti-inflammatory drug-induced peptic ulcer disease.

PubMed

Ko, C W; Deyo, R A

2000-06-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of peptic ulcer disease by 5- to 7-fold in the first 3 months of treatment. This study examined the relative cost-effectiveness of different strategies for the primary prevention of NSAID-induced ulcers in patients that are starting NSAID treatment. A decision analysis model was developed to compare the cost-effectiveness of 6 prophylactic strategies relative to no prophylaxis for patients 65 years of age starting a 3-month course of NSAIDs: (1) testing for Helicobacter pylori infection and treating those with positive tests; (2) empiric treatment of all patients for Helicobacter pylori; (3) conventional-dose histamine2 receptor antagonists; (4) high-dose histamine2 receptor antagonists; (5) misoprostol; and (6) omeprazole. Costs were estimated from 1997 Medicare reimbursement schedules and the Drug Topics Red Book. Empiric treatment of Helicobacter pylori with bismuth, metronidazole, and tetracycline was cost-saving in the baseline analysis. Selective treatment of Helicobacter pylori, misoprostol, omeprazole, and conventional-dose or high-dose histamine2 receptor antagonists cost $23,800, $46,100, $34,400, and $15,600 or $21,500 per year of life saved, respectively, relative to prophylaxis. The results were sensitive to the probability of an ulcer, the probability and mortality of ulcer complications, and the cost of, efficacy of, and compliance with prophylaxis. The cost-effectiveness estimates did not change substantially when costs associated with antibiotic resistance of Helicobacter pylori were incorporated. Several strategies for primary prevention of NSAID-induced ulcers in patients starting NSAIDs were estimated to have acceptable cost-effectiveness relative to prophylaxis. Empirically treating all patients for Helicobacter pylori with bismuth, metronidazole, and tetracycline was projected to be cost-saving in older patients.

Anti-Helicobacter pylori and antiulcerogenic activity of Aframomum pruinosum seeds on indomethacin-induced gastric ulcer in rats.

PubMed

Kouitcheu Mabeku, Laure Brigitte; Nanfack Nana, Blandine; Eyoum Bille, Bertrand; Tchuenteu Tchuenguem, Roland; Nguepi, Eveline

2017-12-01

Peptic ulcer is one of the most common diseases affecting mankind. Although there are many products used for its treatment, most of these products produce severe adverse reactions requiring the search for novel compounds. Some Afromomum species are used traditionally to cure acute gastritis. To evaluate the antiulcer activity of the methanol extract of Aframomum pruinosum Gagnepain (Zingiberaceae) seeds against two major etiologic agents of peptic ulcer disease; Helicobacter pylori and non-steroidal anti-inflammatory drugs. The anti-Helicobacter activity of A. pruinosum was evaluated using the broth microdilution method. After oral administration of indomethacin (5 mg/kg) for 5 consecutive days, gastric ulcerated animals were divided into control group and five other groups: three groups that recieved respectively 125, 250 and 500 mg/kg of plant extract, the fourth group received Maalox (50 mg/kg) and the fifth group, Misoprostol (100 μg/kg), respectively, for 5 days. Ulcer areas, gastric mucus content and nitric oxide gastric levels of animals were assessed 24 h after this treatment. A. pruinosum extract shows a moderate anti-Helicobacter activity with an MIC value of 128 μg/mL. A. pruinosum extract, like Misoprostol and Maalox, markedly reduces the % of ulcerated area from 8.15 ± 0.33 to 1.71 ± 0.44% (500 mg/kg). It also increased significantly mucus and NO gastric production with respective values of 4.44 ± 1.35 and 965.81 ± 106.74 μmol/g (500 mg/kg). These findings suggest that A. pruinosum methanol extract possesses antiulcer properties as ascertained by the comparative decreases in ulcer areas, increase of mucus and NO gastric production.

[Digestive and extra-digestive complications of nonsteroidal anti-inflammatory drugs. Preventive and curative strategies].

PubMed

Sternon, J; Adler, M

1997-04-01

The authors review the digestive ulceration risk factors and the criteria for selecting a non steroidal antiinflammatory (NSAI), included the most recent drugs, such as selective anti-cyclo-oxygenases 2. They actualize the preventive strategies and insist on the values of misoprostol and of slow acting anti-rheumatic drugs. In the case of digestive ulcerations, they plead for the immediate stop of the NSAI and its replacement if necessary by corticosteroids, for the prescription of a proton pump inhibitor (PPI) or mesalazine according to the localisation of the lesion, finally for the eradication within 8 days of Helicobacter pylori.

Evidence of global demand for medication abortion information An analysis of www.medicationabortion.com

PubMed Central

Foster, Angel M.; Wynn, L. L.; Trussell, James

2013-01-01

Introduction The worldwide expansion of the Internet offers an important modality of disseminating medically accurate information about medication abortion. We chronicle the story of www.medicationabortion.com, an English-, Spanish-, Arabic-, and French-language website dedicated to three early abortion regimens. Methods We evaluated the website use patterns from 2005 through 2009. We also conducted a content and thematic analysis of 1,910 emails submitted during this period. Results The website experienced steady growth in use. In 2009, it received 35,000 visits each month from more than 20,000 unique visitors and was accessed by users in 208 countries and territories. More than half of all users accessed the website from a country in which abortion is legally restricted. Users from more than 40 countries sent emails with individual questions. Women often wrote in extraordinary detail about the circumstances of their pregnancies and attempts to obtain an abortion. These emails also reflect considerable demand for information about the use of misoprostol for self-induction. Conclusion The use patterns of www.medicationabortion.com indicate that there is significant demand for online information about abortion, and the findings suggest future priorities for research, collaboration, and educational outreach. PMID:24360644

Comparison of Outcomes before and after Ohio's Law Mandating Use of the FDA-Approved Protocol for Medication Abortion: A Retrospective Cohort Study.

PubMed

Upadhyay, Ushma D; Johns, Nicole E; Combellick, Sarah L; Kohn, Julia E; Keder, Lisa M; Roberts, Sarah C M

2016-08-01

In February 2011, an Ohio law took effect mandating use of the United States Food and Drug Administration (FDA)-approved protocol for mifepristone, which is used with misoprostol for medication abortion. Other state legislatures have passed or enacted similar laws requiring use of the FDA-approved protocol for medication abortion. The objective of this study is to examine the association of this legal change with medication abortion outcomes and utilization. We used a retrospective cohort design, comparing outcomes of medication abortion patients in the prelaw period to those in the postlaw period. Sociodemographic and clinical chart data were abstracted from all medication abortion patients from 1 y prior to the law's implementation (January 2010-January 2011) to 3 y post implementation (February 2011-October 2014) at four abortion-providing health care facilities in Ohio. Outcome data were analyzed for all women undergoing abortion at ≤49 d gestation during the study period. The main outcomes were as follows: need for additional intervention following medication abortion (such as aspiration, repeat misoprostol, and blood transfusion), frequency of continuing pregnancy, reports of side effects, and the proportion of abortions that were medication abortions (versus other abortion procedures). Among the 2,783 medication abortions ≤49 d gestation, 4.9% (95% CI: 3.7%-6.2%) in the prelaw and 14.3% (95% CI: 12.6%-16.0%) in the postlaw period required one or more additional interventions. Women obtaining a medication abortion in the postlaw period had three times the odds of requiring an additional intervention as women in the prelaw period (adjusted odds ratio [AOR] = 3.11, 95% CI: 2.27-4.27). In a mixed effects multivariable model that uses facility-months as the unit of analysis to account for lack of independence by site, we found that the law change was associated with a 9.4% (95% CI: 4.0%-18.4%) absolute increase in the rate of requiring an additional intervention. The most common subsequent intervention in both periods was an additional misoprostol dose and was most commonly administered to treat incomplete abortion. The percentage of women requiring two or more follow-up visits increased from 4.2% (95% CI: 3.0%-5.3%) in the prelaw period to 6.2% (95% CI: 5.5%-8.0%) in the postlaw period (p = 0.003). Continuing pregnancy was rare (0.3%). Overall, 12.6% of women reported at least one side effect during their medication abortion: 8.4% (95% CI: 6.8%-10.0%) in the prelaw period and 15.6% (95% CI: 13.8%-17.3%) in the postlaw period (p < 0.001). Medication abortions fell from 22% (95% CI: 20.8%-22.3%) of all abortions the year before the law went into effect (2010) to 5% (95% CI: 4.8%-5.6%) 3 y after (2014) (p < 0.001). The average patient charge increased from US$426 in 2010 to US$551 in 2014, representing a 16% increase after adjusting for inflation in medical prices. The primary limitation to the study is that it was a pre/post-observational study with no control group that was not exposed to the law. Ohio law required use of a medication abortion protocol that is associated with a greater need for additional intervention, more visits, more side effects, and higher costs for women relative to the evidence-based protocol. There is no evidence that the change in law led to improved abortion outcomes. Indeed, our findings suggest the opposite. In March 2016, the FDA-protocol was updated, so Ohio providers may now legally provide current evidence-based protocols. However, this law is still in place and bans physicians from using mifepristone based on any new developments in clinical research as best practices continue to be updated.

Non-Steroidal Anti-Inflammatory Drug Use and the Risk of Acute Myocardial Infarction in the General German Population: A Nested Case-Control Study.

PubMed

Thöne, Kathrin; Kollhorst, Bianca; Schink, Tania

2017-09-01

Use of non-steroidal anti-inflammatory drugs (NSAIDs) has been associated with an increased relative risk of acute myocardial infarction (AMI), but the label warnings refer particularly to patients with cardiovascular risk factors. The magnitude of relative AMI risk for patients with and without cardiovascular risk factors varies between studies depending on the drugs and doses studied. The aim of our study was to estimate population-based relative AMI risks for individual and widely used NSAIDs, for a cumulative amount of NSAID use, and for patients with and without a prior history of cardiovascular risk factors. Based on data from the German Pharmacoepidemiological Research Database (GePaRD) of about 17 million insurance members from four statutory health insurance providers, for the years 2004-2009, a nested case-control study was conducted within a cohort of 3,476,931 new NSAID users classified into current, recent, or past users. Up to 100 controls were matched to each case by age, sex, and length of follow-up using risk set sampling. Multivariable conditional logistic regression was applied to estimate odds ratios (ORs) and 95% confidence intervals (CIs). Duration of NSAID use was calculated by the cumulative amount of dispensed defined daily doses (DDDs), and stratified analyses were conducted for potential effect modifiers. Overall, 17,236 AMI cases were matched to 1,714,006 controls. Elevated relative AMI risks were seen for current users of fixed combinations of diclofenac with misoprostol (OR 1.76, 95% CI 1.26-2.45), indometacin (1.69, 1.22-2.35), ibuprofen (1.54, 1.43-1.65), etoricoxib (1.52, 1.24-1.87), and diclofenac (1.43, 1.34-1.52) compared with past use. A low cumulative NSAID amount was associated with a higher relative AMI risk for ibuprofen, diclofenac, and indometacin. The relative risk associated with current use of diclofenac, fixed combinations of diclofenac with misoprostol, etoricoxib, and ibuprofen was highest in the younger age group (<60 years) and similar for patients with or without major cardiovascular risk factors. Relative AMI risk estimates differed among the 15 investigated individual NSAIDs. Diclofenac and ibuprofen, the most frequently used NSAIDs, were associated with a 40-50% increased relative risk of AMI, even for low cumulative NSAID amounts. The relative AMI risk in patients with and without cardiovascular risk factors was similarly elevated.

Challenges in managing postpartum hemorrhage in resource-poor countries.

PubMed

Karoshi, Mahantesh; Keith, Louis

2009-06-01

Managing postpartum hemorrhage depends in part on having a prepared mind, a complement of trained coworkers, and full access to modern therapies. The last 2 components are rare in resource-poor areas and their absence may be accentuated by climatic instability and lack of basic transportation. Greater use of the active management of third stage of labor and administration of misoprostol by nontrained birth attendants will provide beneficial reductions in hemorrhage rates in resource-poor areas. Additional improvements depend on increasing public awareness, facilitating existing nongovernmental organizations in their community-related, upgrading training of traditional birth attendants, and providing cell phone communication to workers in remote areas, in addition to providing better access to blood.

Are national policies and programs for prevention and management of postpartum hemorrhage and preeclampsia adequate? A key informant survey in 37 countries.

PubMed

Smith, Jeffrey Michael; Currie, Sheena; Cannon, Tirza; Armbruster, Deborah; Perri, Julia

2014-08-01

Although maternal mortality has declined substantially in recent years, efforts to address postpartum hemorrhage (PPH) and preeclampsia/eclampsia (PE/E) must be systematically scaled up in order for further reduction to take place. In 2012, a key informant survey was conducted to identify both national and global gaps in PPH and PE/E program priorities and to highlight focus areas for future national and global programming. Between January and March 2012, national program teams in 37 countries completed a 44-item survey, consisting mostly of dichotomous yes/no responses and addressing 6 core programmatic areas: policy, training, medication distribution and logistics, national reporting of key indicators, programming, and challenges to and opportunities for scale up. An in-country focal person led the process to gather the necessary information from key local stakeholders. Some countries also provided national essential medicines lists and service delivery guidelines for comparison and further analysis. Most surveyed countries have many elements in place to address PPH and PE/E, but notable gaps remain in both policy and practice. Oxytocin and magnesium sulfate were reported to be regularly available in facilities in 89% and 76% of countries, respectively. Only 27% of countries, however, noted regular availability of misoprostol in health facilities. Midwife scope of practice regarding PPH and PE/E is inconsistent with global norms in a number of countries: 22% of countries do not allow midwives to administer magnesium sulfate and 30% do not allow them to perform manual removal of the placenta. Most countries surveyed have many of the essential policies and program elements to prevent/manage PPH and PE/E, but absence of commodities (especially misoprostol), limitations in scope of practice for midwives, and gaps in inclusion of maternal health indicators in the national data systems have impeded efforts to scale up programs nationally.

The potential of task shifting selected maternal interventions to auxiliary midwives in Myanmar: a mixed-method study.

PubMed

Than, Kyu Kyu; Tin, Khaing Nwe; La, Thazin; Thant, Kyaw Soe; Myint, Theingi; Beeson, James G; Luchters, Stanley; Morgan, Alison

2018-01-03

An estimated 282 women die for every 100,000 live births in Myanmar, most due to preventable causes. Auxiliary Midwives (AMWs) in Myanmar are responsible for providing a package of care during pregnancy and childbirth to women in rural hard to reach areas where skilled birth attendants (Midwives) are not accessible. This study aims to examine the role of AMWs in Myanmar and to assess the current practices of three proposed essential maternal interventions (oral supplement distribution to pregnant women; administration of misoprostol to prevent postpartum haemorrhage; management of puerperal sepsis with oral antibiotics) in order to facilitate a formal integration of these tasks to AMWs in Myanmar. A mixed methods study was conducted in Magwe Region, Myanmar involving a survey of 262 AMWs, complemented by 15 focus group discussions with midwives (MWs), AMWs, mothers and community members, and 10 key informant interviews with health care providers at different levels within the health care system. According to current government policy, AMWs are responsible for identifying pregnant women, screening for danger signs and facilitating early referral, provision of counselling on nutrition and birth preparedness for women in hard-to-reach areas. AMWs also assist at normal deliveries and help MWs provide immunization services. In practice, they also provide oral supplements to pregnant women (84%), provide antibiotics to mothers during the puerperium (43%), and provide misoprostol to prevent postpartum haemorrhage (41%). The current practices of AMWs demonstrate the potential for task shifting on selected essential maternal interventions. However, to integrate these interventions into formal practice they must be complemented with appropriate training, clear guidelines on drug use, systematic recording and reporting, supportive monitoring and supervision and a clear political commitment towards task shifting. With the current national government's commitment towards one AMW in one village, this study highlights the potential for shifting specific maternal lifesaving tasks to AMWs.

[Off-label drug use of the misoprostol in gynecology & obstetrics: From a medico-economics benefit to a potential legal risk].

PubMed

Decamps-Mini, D; Pelofi, J; Treisser, A

2015-06-01

The scandal of the Mediator® case led the legislature to take measures in order to regulate off-label drugs prescriptions. Indeed the law issued in December 29th, 2011 on strengthening the safety of drugs and all derivative health products came to pave the way for an "over-cautious" practice of medicine in line with the precautionary principle erected as a constitutional principle. The supervision of off-label prescribing has had a direct impact on the exercise of the medical profession and has resurrected the issues related to the freedom of prescription, the obligation to provide information to patients and in general their whole responsibility. It is important to mention that the prescribing act is part of the freedom and the strict prerogative of those skilled in the art: the physician in this case. The off-label prescription is commonly accepted in certain specialties, such as anesthesia and intensive care, oncology or pediatrics where it is even subject of a memorandum of use because of concerns regarding the availability of forms adapted to children. However, the physician must ensure that no appropriate therapeutic alternative is available and inform the patient, fundamental principle of the right to respect for the will of the person. Off-label use of the prostaglandin-E1 analogue misoprostol in obstetrics and gynecology is a good example. In fact, this drug obtained a marketing authorization for the treatment or prevention of peptic ulcers and other stomach disorders, is commonly used off-label when inducing labour or intrauterine device insertion. These are the issues that need to be clarify and carefully assessed in order to help physicians to understand the impact of the law and the state of the jurisprudence on the exercise of their profession. Copyright © 2015. Published by Elsevier SAS.

Reduction in resource use with the misoprostol vaginal insert vs the dinoprostone vaginal insert for labour induction: a model-based analysis from a United Kingdom healthcare perspective.

PubMed

Draycott, T; van der Nelson, H; Montouchet, C; Ruff, L; Andersson, F

2016-02-10

In view of the increasing pressure on the UK's maternity units, new methods of labour induction are required to alleviate the burden on the National Health Service, while maintaining the quality of care for women during delivery. A model was developed to evaluate the resource use associated with misoprostol vaginal inserts (MVIs) and dinoprostone vaginal inserts (DVIs) for the induction of labour at term. The one-year Markov model estimated clinical outcomes in a hypothetical cohort of 1397 pregnant women (parous and nulliparous) induced with either MVI or DVI at Southmead Hospital, Bristol, UK. Efficacy and safety data were based on published and unpublished results from a phase III, double-blind, multicentre, randomised controlled trial. Resource use was modelled using data from labour induction during antenatal admission to patient discharge from Southmead Hospital. The model's sensitivity to key parameters was explored in deterministic multi-way and scenario-based analyses. Over one year, the model results indicated MVI use could lead to a reduction of 10,201 h (28.9%) in the time to vaginal delivery, and an increase of 121% and 52% in the proportion of women achieving vaginal delivery at 12 and 24 h, respectively, compared with DVI use. Inducing women with the MVI could lead to a 25.2% reduction in the number of midwife shifts spent managing labour induction and 451 fewer hospital bed days. These resource utilisation reductions may equate to a potential 27.4% increase in birthing capacity at Southmead Hospital, when using the MVI instead of the DVI. Resource use, in addition to clinical considerations, should be considered when making decisions about labour induction methods. Our model analysis suggests the MVI is an effective method for labour induction, and could lead to a considerable reduction in resource use compared with the DVI, thereby alleviating the increasing burden of labour induction in UK hospitals.

[Japanese epidemiologic investigation for non-steroidal anti-inflammatory drugs-induced ulcers].

PubMed

Miyake, Kazumasa; Sakamoto, Choitsu

2011-06-01

This review summaried epidemiologic investigation for non-steroidal anti-inflammatory drugs (NSAIDs)-induced ulcers to focus on the Japanese evidence. In Japan, national health insurance does not cover procedures that prevent or lower the risk for NSAIDs-induced ulcer. In NSAIDs treatment to patients with risk factors, it is desirable to administer antiulcer agents. However, in Japan, there are no large-scale studies on the efficacy of co-medication such as proton pump inhibitors, prostaglandin analogs (misoprostol) or histamine-H2 receptor antagonists or on the effectiveness of H. pylori eradication or selective COX-2 antagonists. In the future, large-scale clinical studies should be conducted to accumulate high quality evidence including cost-effectiveness and overall safety including cardiovascular events, because Japanese differ from Westerners in several genetical or acquired factors.

Nonsteroidal, antiinflammatory drug-induced gastrointestinal injuries and related adverse reactions: epidemiology, pathogenesis and management.

PubMed

Al Mofleh, Ibrahim A; Al Rashed, Rashed S

2007-01-01

A large proportion of the population all over the world consumes acetylsalicylic acid (ASA: aspirin) or other nonsteroidal, antiinflammatory drugs (NSAIDs). This is associated with a considerable morbidity and mortality. Elderly patients, patients with prior history of peptic ulcer disease (PUD) or its complications, those who require high doses of NSAIDs and those undergoing concomitant therapy with corticosteroids or anticoagulants, are at particularly high risk of developing gastroduodenal injuries and related adverse reactions. Gastroduodenal mucosal injuries induced by NSAIDs vary from subtle microscopic to gross macroscopic changes including ulcers. These injuries are induced by both topical and systemic actions of NSAIDs. Inhibition of gastroduodenal cyclooxygenase (COX) enzyme by NSAIDs is considered to be a major pathogenetic factor. Reactive oxygen species (ROS) appear also to play a significant role in the pathogenesis of mucosal injury. Withdrawal of NSAIDs is preferably the first therapeutic option; however, it is not feasible in the majority of patients. Therefore, several drugs including antisecretory drugs (ASDs-proton pump inhibitors and Histamine-2 receptor antagonists) and misoprostol, a prostaglandin analog are used for the prevention and treatment of NSAID-induced gastroduodenal injuries. Among ASDs, proton pump inhibitors (PPIs) are the most commonly used drugs. The antiulcerogenic effect of PPIs is similar to that of misoprostol and superior to standard doses of histamine-2 receptor antagonists (H2-RAs). The adverse effects of m, isoprostol such as diarrhea, abdominal pain, nausea, flatulence, headache, dyspepsia, vomiting, constipation, abortifacient and teratogenicity limit its general use. Aside from their antisecretory action, PPIs also possess an antioxidative effect. PPI maintenance is recommended in chronic NSAID treatment in those with an increased risk of complications and is more effective than Helicobacter pylori eradication. Low PPI dosage maintenance is as effective as a standard dosage regimen. The effect of H. pylori eradication remains controversial. It is advocated in naïve NSAID users, in chronic users with recent ulcer or ulcer complications and in those with an increased risk of ulcer and ulcer complications. In addition, some herbs have shown inhibition of gastric mucosal damage experimentally induced by necrotizing agents through their antisecretory and antioxidant properties.

The effect of 7 days of letrozole pretreatment combined with misoprostol on the expression of progesterone receptor and apoptotic factors of placental and decidual tissues from first-trimester abortion: a randomized controlled trial.

PubMed

Yung, Sofie Shuk Fei; Lee, Vivian Chi Yan; Chiu, Philip Chi Ngong; Li, Hang Wun Raymond; Ng, Ernest Hung Yu; Yeung, William Shu Biu; Ho, Pak Chung

2016-04-01

To evaluate if letrozole-induced suppression of estradiol reduces progesterone receptor expression and apoptosis in the first-trimester placenta. We performed a double-blinded, randomized, placebo-controlled trial. We randomized 20 women requesting first-trimester abortion with gestation up to 63 days to receive either letrozole 10 mg daily or placebo pretreatment for 7 days before administrating 400 mcg of vaginal misoprostol followed by suction abortion. We collected the placental and decidual tissues on which we performed immunohistochemical staining for progesterone receptor and apoptotic markers (active caspase 3, caspase 3, Bcl2, CD95, fas ligand) and determined H-scores of each based on the intensities of staining. We performed terminal deoxynucleotidyl transferase-mediated dUTP-digoxigenin nick end labeling (TUNEL) assay for apoptosis in the samples of four women to confirm the findings from apoptotic markers. We excluded one woman in the letrozole group from the analysis because she had passage of abortus after taking letrozole, leaving 19 women (9 in the letrozole group, 10 in the placebo group) for analysis. There was no significant difference in the H-scorings of progesterone receptor and apoptotic markers, as well as proportion of apoptotic cells on TUNEL assay between the two groups. The H-scores for the progesterone receptor were 8.17 ± 2.67 (mean ± SD) in the letrozole group and 9.01 ± 2.82 in the placebo group (p=0.36). We did not detect a difference in the expression of progesterone receptor and apoptotic markers in placental and decidual tissues after letrozole pretreatment for 7 days in first-trimester abortion. We did not confirm the hypothesis that letrozole reduces progesterone receptor expression and induces apoptosis in the first-trimester placenta. Further studies are required to allow better understanding of the mechanism by which estrogen suppression following the use of letrozole can lead to improved abortion rate in the first trimester. Copyright © 2016 Elsevier Inc. All rights reserved.

Modified hysteroscopic myomectomy of large submucous fibroids.

PubMed

Darwish, Atef

2003-01-01

To compare the efficacy, feasibility, operative time and possible complications of a modified technique of hysteroscopic removal of large submucus myomata versus traditional morcellation technique, and to assess the efficacy of preoperative sonohysterography (SHG). A prospective comparative study. Gynecologic Endoscopy Unit, Assiut University Hospital, Assiut, Egypt. One hundred forty-two women of childbearing age with a clinical and transvaginal sonographic diagnosis of large solitary submucous myomata (>3 cm in diameter) with or without an intramural element. The patients were divided into two groups. In group A (65 patients), a modified resectoscopic technique was used where the base of the myoma was excised followed by ring forceps extraction after misoprostol priming. In group B (77 patients), the myoma was cut using traditional resectoscopic morcellation. For each patient, operating time, intra- and postoperative complications and feasibility of the procedure were recorded. The accuracy of preoperative SHG in localizing submucous myoma and detecting intramural extension was assessed by diagnostic hysteroscopy. Transvaginal SHG showed good agreement with hysteroscopy in localizing submucous myomata and detecting intramural extension (k = 0.83). The operating time was significantly shorter in group A (15.6 +/- 3.02 min) than in group B (28.9 +/- 4.3 min). The procedure was completed in 60 (92%) and 51 patients (66%), whereas a second session was required in 2 (3%) and 20 patients (25.9%) in both groups respectively. Glycine volume was highly significantly less in group A (2.3 +/- 0.86 vs. 6.3+/- 1.7 liters, p = 0.001). Intraoperative complications were encountered in 9 (13.8%) and 22 patients (28.5%) in both groups respectively (p = 0.03). Cervical laceration was diagnosed in 3 cases (4.6%) in group A. Postoperative visual disturbances were diagnosed in 4 cases (5%) in group B. Hysteroscopic resection of large submucous myomata with minimal intramural encroachment is feasible using a modified technique. It shows a minimal complication rate and fluid deficit and a shorter operative time than the standard morcellation technique. If the excised myoma is extracted as one mass, this carries a minimal risk of cervical lacerations and possible cervical incompetence in a subsequent pregnancy. Transvaginal SHG is a reliable diagnostic aid to assess submucous myomata. Copyright 2003 S. Karger AG, Basel

Perceptions and Practices of Illegal Abortion among Urban Young Adults in the Philippines: A Qualitative Study

PubMed Central

Gipson, Jessica D.; Hirz, Alanna E.; Avila, Josephine L.

2015-01-01

This study draws on in-depth interviews and focus group discussions with young adults in a metropolitan area of the Philippines to examine perceptions and practices of illegal abortion. Study participants indicated that unintended pregnancies are common and may be resolved through eventual acceptance or through self-induced injury or ingestion of substances to terminate the pregnancy. Despite the illegality of abortion and the restricted status of misoprostol, substantial knowledge and use of the drug exists. Discussions mirrored broader controversies associated with abortion in this setting. Abortion was generally thought to invoke gaba (bad karma), yet some noted its acceptability under certain circumstances. This study elucidates the complexities of pregnancy decisionmaking in this restrictive environment and the need for comprehensive and confidential reproductive health services for Filipino young adults. PMID:22292245

Perceptions and practices of illegal abortion among urban young adults in the Philippines: a qualitative study.

PubMed

Gipson, Jessica D; Hirz, Alanna E; Avila, Josephine L

2011-12-01

This study draws on in-depth interviews and focus group discussions with young adults in a metropolitan area of the Philippines to examine perceptions and practices of illegal abortion. Study participants indicated that unintended pregnancies are common and may be resolved through eventual acceptance or through self-induced injury or ingestion of substances to terminate the pregnancy. Despite the illegality of abortion and the restricted status of misoprostol, substantial knowledge and use of the drug exists. Discussions mirrored broader controversies associated with abortion in this setting. Abortion was generally thought to invoke gaba (bad karma), yet some noted its acceptability under certain circumstances. This study elucidates the complexities of pregnancy decisionmaking in this restrictive environment and the need for comprehensive and confidential reproductive health services for Filipino young adults.

Introducing early medical abortion in Australia: there is a need to update abortion laws.

PubMed

de Costa, Caroline M; Russell, Darren B; de Costa, Naomi R; Carrette, Michael; McNamee, Heather M

2007-12-01

Recent changes to Federal Therapeutic Goods Administration legislation have seen the limited introduction of the drug mifepristone to Australia for the purpose of early medical abortion. At the same time it has become evident that both methotrexate and misoprostol, licenced and available for other indications, are being used safely and appropriately for early abortion by Australian medical practitioners. Early medical abortion is widely practiced overseas where its safety and effectiveness are well supported by current evidence. However, abortion law in many states is still contained within the Criminal Codes and does not reflect current evidence-based abortion practice. In other states and territories restrictions on where abortions may be performed pose potential barriers to the introduction of mifepristone for medical abortion. There is an urgent need for abortion law to be clarified and made uniform across the country so that the best possible services can be provided to Australian women.

Successful treatment of recalcitrant necrotizing eosinophilic folliculitis using indomethacin and cephalexin.

PubMed

Fallah, Haady; Dunlop, Kate; Kossard, Steven

2006-11-01

A 56-year-old man presented with a 4-month history of a painful and pruritic eruption consisting of crusted plaques and blisters on his face, scalp and chest. The patient suffered from headaches and malaise but was afebrile. Two skin biopsies revealed an epidermis which was eroded and covered by locules of serum and neutrophils. In the underlying dermis, there was a marked mixed inflammatory reaction including lymphocytes, neutrophils and numerous eosinophils. There was exocytosis of eosinophils into several follicles with areas of follicular mucinosis. A diagnosis of necrotizing eosinophilic folliculitis was made based upon the clinical and histopathological findings. The diagnosis was supported by the rapid response to a combination of indomethacin and cephalexin. The patient has taken continuous indomethacin (with rabeprazole and misoprostol cover) and cephalexin for 2 years. If treatment is withdrawn he experiences a flare of his disease within 2 weeks. This case highlights the potentially chronic nature of this disease.

Contribution of the Central American and Caribbean obstetrics and gynecology societies to the prevention of unsafe abortion in the region.

PubMed

de Gil, Marina Padilla

2014-07-01

Unsafe abortion is a very important public health issue in the Central America and Caribbean region, where the use of modern contraceptive methods remains low and the restrictive legal framework reduces access to safe abortion. The International Federation of Gynecology and Obstetrics (FIGO) Initiative for the Prevention of Unsafe Abortion and its Consequences is contributing toward resolving this problem by strengthening collaboration between medical societies, representatives of each country's Ministry of Health, and local and international agencies. In the 8 countries that decided to join this initiative in 2008, progress has been achieved in improving access to modern contraceptive methods, increasing the use of manual vacuum aspiration and misoprostol, and updating guidelines on postabortion care. Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Unsafe abortion: the silent scourge.

PubMed

Grimes, David A

2003-01-01

An estimated 19 million unsafe abortions occur worldwide each year, resulting in the deaths of about 70,000 women. Legalization of abortion is a necessary but insufficient step toward improving women's health. Without skilled providers, adequate facilities and easy access, the promise of safe, legal abortion will remain unfulfilled, as in India and Zambia. Both suction curettage and pharmacological abortion are safe methods in early pregnancy; sharp curettage is inferior and should be abandoned. For later abortions, either dilation and evacuation or labour induction are appropriate. Hysterotomy should not be used. Timely and appropriate management of complications can reduce morbidity and prevent mortality. Treatment delays are dangerous, regardless of their origin. Misoprostol may reduce the risks of unsafe abortion by providing a safer alternative to traditional clandestine abortion methods. While the debate over abortion will continue, the public health record is settled: safe, legal, accessible abortion improves health.

Abortion in Latin America: changes in practice, growing conflict, and recent policy developments.

PubMed

Kulczycki, Andrzej

2011-09-01

Latin America is undergoing profound social, economic, political, demographic, and epidemiologic change. Reproductive health indicators have generally improved over the past two decades, but most pregnancies are still unintended and more than 4 million are terminated annually. Clandestine abortions necessitated by restrictive legal and social structures cause more than 1,000 deaths and 500,000 hospitalizations per year, primarily among poor and marginalized women. Abortions are becoming safer and less frequent, however, as a consequence of increased modern contraceptive use, misoprostol adoption, emergency contraception availability, and postabortion care provision, notwithstanding many impediments to these changes. Advocacy and conflict over abortion have grown. The contested policy shifts include Mexico City's 2007 legalization of first-trimester abortion. Drawing on numerous sources of evidence, this article provides a regional analysis of the rapidly changing practice and context of abortion in Latin America, and examines emerging issues, legal and policy developments, and contrasting country situations.

Paracervical block as pain treatment during second-trimester medical termination of pregnancy: an RCT with bupivacaine versus sodium chloride.

PubMed

Andersson, I-M; Benson, L; Christensson, K; Gemzell-Danielsson, K

2016-01-01

Can paracervical block (PCB) administered before the onset of pain decrease women's pain experience during second-trimester medical termination of pregnancy (MToP)? There were no clinically significant differences between groups receiving PCB with bupivacaine or saline with regard to the highest and lowest pain intensity, morphine consumption or induction-to abortion interval. The most common side effect of misoprostol is pain; nevertheless, there are sparse studies in pain and pain treatment during MToP, especially in second-trimester abortion. Pain reported in second-trimester medical abortion is often intense, and peaks when the fetal expulsion occurs. A double-blinded RCT was carried out from May 2012 until April 2015. A power calculation was based on a previous pilot study showing that the proportion of women with severe pain [visual analogue scale (VAS) ≥7] was 63%. A clinically significant reduction was considered to yield 35% with severe pain, and with a power of 80% and significance level of 5% (two-sided) 112 women were needed. Accounting for a 20% drop-out rate, a total of 140 women were needed. The primary outcome, pain intensity measured as any VAS ≥7, was analysed using a generalized estimating equations model. The level of significance was set to P < 0.05 two-sided. A computer generated randomization list with block size of 10 was used. The treatment allocation was placed in a sealed, opaque, envelope and picked consecutively. A total of 589 women attending a gynaecological clinic had a second-trimester abortion during the study period and 276 were invited to participate. A total of 113 women undergoing abortion from 13 weeks of gestation and above were recruited, of which 55 were randomly allocated to receive a PCB with bupivacaine and 58 a PCB with sodium chloride 1 h after the first dose of misoprostol. The full analysis set (FAS) population was defined as all randomized women that had at least one value for any of the outcomes (n = 102). The per-protocol (PP) population was defined as a subset of the FAS excluding patients with major protocol deviations or without a value for the primary outcome (n = 99). Pain was measured by VAS at misoprostol initiation (baseline) and repeated every 30 min until fetal expulsion. The primary outcome was the highest VAS pain intensity at any time point. The highest pain intensity, did not show any differences at a cut-off of VAS ≥7 [risk ratio (RR): 1.1; 95% confidence interval (CI): 0.9-1.5; P = 0.0.292]. In the PP analyses, there were 75% women in the bupivacaine group and 64% in the sodium chloride group with VAS ≥7 (RR: 1.2; 95% CI: 0.9-1.5; P = 0.235). Most women did not experience pain at the misoprostol start, 19 women scored a VAS of >0, ranging from 1 to 4 with a mean of 1.8 and median of 2 (P = 1.000). Immediately prior to PCB, 61 women scored a VAS of >0, from 1 to 10 with a mean of 2.0 and median of 1 (P = 0.771). There was a 48% loss of VAS scores at the time of expulsion and the remaining scores did not differ between groups (RR: 1.5; 95% CI: 0.9-2.5). A subgroup analysis of primipara did not show any difference in highest pain intensity VAS ≥7 (RR: 1.2; 95% CI: 0.9-1.6; P = 0.283). No statistically significant differences were observed between groups with regard to the highest and lowest (P = 553 and 0.182) pain intensity and morphine consumption (P = 0.772). Side effects were reported by 28 women (14 women in each group), with no differences between groups. Most common was nausea and vomiting in connection to morphine injection. Nearly 60% of the invited women did not want to participate in the study (fear of needles and fear of receiving the placebo) therefore women who tolerate pain may have been overrepresented in the study population. Data collection was stopped, in error, when 113 participants had been recruited. The loss to follow-up was, however, only 11 women (10%), which was lower than expected but intrinsically the study did not fully reach the intended number of women, which may have influenced the results. In addition, the obstetrical and gynaecological background of participating women differs. The participants were informed that they had a 50% chance of receiving a PCB with active substance, which could theoretically have affected their expectations and pain experience (placebo effect). The frequent attention at VAS scoring and the overall care provided may also have affected the participants in a positive way, and helped women to feel supported and more relaxed during the abortion. The highest pain intensity was severe (VAS: 7-10) among 65-75% of the participants, as reported for first-trimester medical abortion; however, the maximal pain scores remain high despite the PCB. There is, therefore, a clear need for more optimal pain treatment but only limited data exist on pain treatment during MToP over all gestational lengths. As PCB was well tolerated, did not cause any serious side effects and had no negative impact on the abortion process and efficacy, another approach may be worth exploring, namely PCB given on demand at the onset of painful contractions. The study was supported by grants from the Swedish Research Council (grant no: 2012-2844), ALF (Karolinska Institutet - Stockholm County Council, Agreement on Medical Research and Training) funding, the Karolinska Institutet, Stockholm South General Hospital, and Swedish Nurses in the Area of Pain - SSOS together with GlaxoSmithKline. None of the authors have any conflicts of interest. The trial was registered with ClinicalTrials.gov (identifier: NCT01617564) and The EudraCT (number: 2010-020780-21) and was approved by The Regional Ethical Review Board at Karolinska Institutet (dnr: 2007/1277-31/2 and 2010/410-31/1). Clinical trial registration was done in May 2012 before initiation of patient recruitment. 29 May 2012. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Contraception and induced abortion in the West Indies: a review.

PubMed

Boersma, A A; de Bruijn, J G M

2011-10-01

Most islands in the West Indies do not have liberal laws on abortion, nor laws on pregnancy prevention programmes (contraception). We present results of a literature review about the attitude of healthcare providers and women toward (emergency) contraception and induced abortion, prevalence, methods and juridical aspects of induced abortion and prevention policies. Articles were obtained from PubMed, EMBASE, MEDLINE, PsychlNFO and Soclndex (1999 to 2010) using as keywords contraception, induced abortion, termination of pregnancy, medical abortion and West Indies. Thirty-seven articles met the inclusion criteria: 18 on contraception, 17 on induced abortion and two on both subjects. Main results indicated that healthcare providers' knowledge of emergency contraception was low. Studies showed a poor knowledge of contraception, but counselling increased its effective use. Exact numbers about prevalence of abortion were not found. The total annual number of abortions in the West Indies is estimated at 300 000; one in four pregnancies ends in an abortion. The use of misoprostol diminished the complications of unsafe abortions. Legislation of abortion varies widely in the different islands in the West Indies: Cuba, Puerto Rico, Martinique, Guadeloupe and St Martin have legal abortions. Barbados was the first English-speaking island with liberal legislation on abortion. All other islands have restrictive laws. Despite high estimated numbers of abortion, research on prevalence of abortion is missing. Studies showed a poor knowledge of contraception and low use among adolescents. Most West Indian islands have restrictive laws on abortion.

[Is it already time to legalize the usage of Cytotec (Misoprostol) in the obstetrics' practice?].

PubMed

Bozhinova, S

2007-01-01

Cytotec (Misoprostol) is a prostaglandin E1 9(PgE1) analogue. Despite that it is not officially registered for obstetric and gynaecological targets, Cytotec (C) is widely used in this sphere. The author aims to study the effect and results from C application used for delivery (birth) induction, as well as means for cervical maturation. In order to reach this aim, beside the group of 45 pregnant women to who we applied C, we also reviewed the existing literature, which reported proves for C efficacy, pharma-kynetics and the safe aspects of its application (usage) in pregnancy. C was used with 45 pregnant women, divided in two groups: I group--27 pregnant women with oral application and II group--18 pregnant women with vaginal application. C was given per os in dosage 50 microg at 4 hours, the maximum dosage being 200 microg. When applied in the vagina, the dosage was twice 50 microg, every 6 hours. Four hours after the second dosage, if the effective delivery activity was not sufficient, we continued with sub-lingual application in dosage 50 microg every 4 hours till the regular delivery activity was reached. The vaginal delivery (childbirth) till the 24th hour of C application is considered as a successful induction. The delivery (childbirth) continuation, though with insignificant difference, is less under vaginal application. Uterine contractions begin (start) 30-35 minutes earlier under C application. Sectio Caesarea has smaller frequency under C application, in comparison with the general population frequency for the same period (year 2006 and the first half of 2007). The C induction is successful in 40 (88.89%), and with 7 (25.93%) the per oral application was prolonged via oxytocine infusion, and with half of the patients the vaginal application was continued via sun-lingual one. The author reaches the conclusion, that Cytotec is an effective and safe means for delivery (childbirth) induction, and that when dosage and application manner are set-up, the individual characterics of the patients should be taken into account. Mother-fetal results are the best under single dosage of 50 microg, applied in per oral, vaginal or sub-lingual way. Due to the wide application of Cytotec medicine, it is already high time to legalize it and to standardize the protocols from its application.

Barriers and facilitators in the provision of post-abortion care at district level in central Uganda – a qualitative study focusing on task sharing between physicians and midwives

PubMed Central

2014-01-01

Background Abortion is restricted in Uganda, and poor access to contraceptive methods result in unwanted pregnancies. This leaves women no other choice than unsafe abortion, thus placing a great burden on the Ugandan health system and making unsafe abortion one of the major contributors to maternal mortality and morbidity in Uganda. The existing sexual and reproductive health policy in Uganda supports the sharing of tasks in post-abortion care. This task sharing is taking place as a pragmatic response to the increased workload. This study aims to explore physicians’ and midwives’ perception of post-abortion care with regard to professional competences, methods, contraceptive counselling and task shifting/sharing in post-abortion care. Methods In-depth interviews (n = 27) with health care providers of post-abortion care were conducted in seven health facilities in the Central Region of Uganda. The data were organized using thematic analysis with an inductive approach. Results Post-abortion care was perceived as necessary, albeit controversial and sometimes difficult to provide. Together with poor conditions post-abortion care provoked frustration especially among midwives. Task sharing was generally taking place and midwives were identified as the main providers, although they would rarely have the proper training in post-abortion care. Additionally, midwives were sometimes forced to provide services outside their defined task area, due to the absence of doctors. Different uterine evacuation skills were recognized although few providers knew of misoprostol as a method for post-abortion care. An overall need for further training in post-abortion care was identified. Conclusions Task sharing is taking place, but providers lack the relevant skills for the provision of quality care. For post-abortion care to improve, task sharing needs to be scaled up and in-service training for both doctors and midwives needs to be provided. Post-abortion care should further be included in the educational curricula of nurses and midwives. Scaled-up task sharing in post-abortion care, along with misoprostol use for uterine evacuation would provide a systematic approach to improving the quality of care and accessibility of services, with the aim of reducing abortion-related mortality and morbidity in Uganda. PMID:24447321

Assessment of an aqueous seed extract of Parkia clappertoniana on reproductive performance and toxicity in rodents.

PubMed

Boye, Alex; Boampong, Victor Addai; Takyi, Nutifafa; Martey, Orleans

2016-06-05

The seeds of Parkia clappertoniana Keay (Family: Fabaceae) are extensively used in food in the form of a local condiment called 'Dawadawa' in Ghana and consumed by all class of people including sensitive groups such as pregnant women and children. Also, crudely pounded preparations of P. clappertoniana seeds are used as labor inducing agent in farm animals by local farmers across northern Ghana where nomadism is the livelihood of most indigenes. Ecologically, P. clappertoniana is extensively distributed across the savannah ecological zone of many African countries where just like Ghana it enjoys ethnobotanical usage. Although, many studies have investigated some aspects of the pharmacological activity of P. clappertoniana, none of these studies focused on the reproductive system, particularly its effects on reproductive performance and toxicity. To contribute, this study assessed the effect of aqueous seed extract of P. clappertoniana (PCE) on reproductive performance and toxicity in Sprague-Dawley rats and ICR mice. After preparation of PCE, it was then tested on rodents at different gestational and developmental windows (1-7, 8-14, and 15-term gestational days) to assess the following: mating behavior, implantation rate, maternal and developmental toxicities. Generally, animals were randomly grouped into five and treated as follows: normal saline group (5ml/kg po), cytotec (misoprostol) group (200mg/kg po), folic acid group (5mg/kg po), and PCE groups (100, 200, and 500mg/kg po), however, these groupings were varied to suit the specific requirements of some parameters. For acute toxicity, animals were orally administered PCE (3 and 5g/kg for mice and rats respectively). PCE-treated rats showed improved mating behavior compared to control rats. PCE improved implantation rate compared to misoprostol-treated rats. On the average, PCE-treated rats delivered termed live pubs at 21 days compared to that of folic acid-treated rats at 23 days. Also, PCE-treated rats showed no observable maternal and developmental toxicities compared to folic acid and control rats. PCE (3-5g/kg po) was orally tolerated in rodents. Oral administration of Parkia clappertoniana seed extract improves reproductive performance in rodents with no observable maternal and developmental toxicity. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Acute Effects of Prostaglandin E1 and E2 on Vascular Reactivity and Blood Flow in situ in the Chick Chorioallantoic Membrane

PubMed Central

Fay, K.; Dunn, B.E.; Gruenloh, S.K.; Narayanan, J.; Jacobs, E.R.; Medhora, M.

2013-01-01

1. The chick chorioallantoic membrane (CAM) subserves gas exchange in the developing embryo and shell-less culture affords a unique opportunity for direct observations over time of individual blood vessels to pharmacologic interventions. We tested a number of lipids including prostaglandins PGE1&2 for vascular effects and signaling in the CAM. Application of PGE1&2 induced a decrease in the diameter of large blood vessels and a concentration-dependent, localized, reversible loss of blood flow through small vessels. The loss of flow was also mimicked by misoprostol, an agonist for 3 of 4 known PGE receptors, EP2-4, and by U46619, a thromboxane mimetic. Selective receptor antagonists for EP3 and thromboxane each partially blocked the response. This is a first report of the effects of prostaglandins on vasoreactivity in the CAM. Our model allows the unique ability to examine simultaneous responses of large and small vessels in real time and in vivo. PMID:22858445

Contribution of obstetrics and gynecology societies in West and Central African countries to the prevention of unsafe abortion.

PubMed

Leke, Robert J I

2014-07-01

Unsafe abortion is a major public health issue in low-resource countries. In the countries of West and Central Africa, abortion-related maternal mortality rates are extremely high, the prevalence of modern contraceptive use is very low, and the unmet need for family planning is also high. The International Federation of Gynecology and Obstetrics (FIGO) Initiative for the Prevention of Unsafe Abortion and its Consequences has contributed substantially toward increasing awareness of the problem of abortion, bringing abortion-related issues to the attention of the professional societies, individual gynecologists and obstetricians, Ministries of Health, healthcare providers, and to the community in general. The promotion of quality postabortion care including the use of manual vacuum aspiration, misoprostol, and postabortion contraception has greatly improved access to services; however, there is still a long way to go. Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Cost-effectiveness analysis of unsafe abortion and alternative first-trimester pregnancy termination strategies in Nigeria and Ghana.

PubMed

Hu, Delphine; Grossman, Daniel; Levin, Carol; Blanchard, Kelly; Adanu, Richard; Goldie, Sue J

2010-06-01

To explore the policy implications of increasing access to safe abortion in Nigeria and Ghana, we developed a computer-based decision analytic model which simulates induced abortion and its potential complications in a cohort of women, and comparatively assessed the cost-effectiveness of unsafe abortion and three first-trimester abortion modalities: hospital-based dilatation and curettage, hospital- and clinic-based manual vacuum aspiration (MVA), and medical abortion using misoprostol (MA). Assuming all modalities are equally available, clinic-based MVA is the most cost-effective option in Nigeria. If clinic-based MVA is not available, MA is the next best strategy. Conversely, in Ghana, MA is the most cost-effective strategy, followed by clinic-based MVA if MA is not available. From a real world policy perspective, increasing access to safe abortion in favor over unsafe abortion is the single most important factor in saving lives and societal costs, and is more influential than the actual choice of safe abortion modality.

Second trimester abortions in India.

PubMed

Dalvie, Suchitra S

2008-05-01

This article gives an overview of what is known about second trimester abortions in India, including the reasons why women seek abortions in the second trimester, the influence of abortion law and policy, surgical and medical methods used, both safe and unsafe, availability of services, requirements for second trimester service delivery, and barriers women experience in accessing second trimester services. Based on personal experiences and personal communications from other doctors since 1993, when I began working as an abortion provider, the practical realities of second trimester abortion and case histories of women seeking second trimester abortion are also described. Recommendations include expanding the cadre of service providers to non-allopathic clinicians and trained nurses, introducing second trimester medical abortion into the public health system, replacing ethacridine lactate with mifepristone-misoprostol, values clarification among providers to challenge stigma and poor treatment of women seeking second trimester abortion, and raising awareness that abortion is legal in the second trimester and is mostly not requested for reasons of sex selection.

The Brazilian experience with Cytotec.

PubMed

Barbosa, R M; Arilha, M

1993-01-01

Cytotec, the commercial name for misoprostol, which is a synthetic analogue of prostaglandin E1, was approved for use in Brazil in 1986 to treat gastric and duodenal ulcers. The drug can and has also been used to induce abortion, which has created controversy in a country in which induced abortion is illegal. A study of the drug was undertaken in 1992 that included analyses of the drug's sales profile, of information published by the media, and of its use from women's and gynecologists' points of view, the latter examined using qualitative methodologies. The analysis of Cytotec's sales volume showed quick growth from its introduction until the first half of 1991, when its use was restricted by the Ministry of Health. For women, Cytotec's main advantages have been that it is relatively inexpensive, convenient to use, and can be used in private. Data obtained from gynecologists show that Cytotec's addition to the obstetric therapeutic arsenal was welcome and also confirmed the drug's influence in reducing the complications of illegal abortions shown in other studies.

Patterns of Second-Line Uterotonic Use in a Large Sample of Hospitalizations for Childbirth in the United States: 2007 - 2011

PubMed Central

Bateman, Brian T.; Tsen, Lawrence C.; Liu, Jun; Butwick, Alexander J.; Huybrechts, Krista F.

2015-01-01

Introduction The incidence of postpartum hemorrhage due to uterine atony has increased significantly in the United States during the past decade. For patients with refractory uterine atony after oxytocin administration, second-line uterotonics including methylergonovine maleate, carboprost, and misoprostol are recommended. In this study we describe hospital-level patterns of second-line uterotonic use in a large, nationwide sample of admissions for childbirth in the United States. Methods The Premier Research Database was used to define a cohort of 2,180,916 patients hospitalized for delivery at 1 of 367 hospitals from 2007 to 2011. Mixed-effects logistic regression models were used to estimate the hospital-specific frequency of second-line uterotonic use adjusting for measured patient-level and hospital-level characteristics that might be risk factors for uterine atony. Results The median hospital-level frequency of second-line uterotonic use was 7.1% (interquartile range 5.2% to 10.8%). In the fully adjusted model, the mean (SE) predicted probability of second-line uterotonic use was 7.02% (0.26%), with 95% of the hospitals having a predicted (SE) probability between 1.69% (0.12%) and 24.96% (1.28%). Conclusions We observed wide interhospital variation in the use of second-line uterotonics that was not explained by patient-level or hospital-level characteristics. Studies aimed at defining the optimal pharmacologic strategies for the management of uterine atony are needed, particularly in light of the increasing incidence of atonic postpartum hemorrhage in the United States and other developed countries. PMID:25166464

Gastroprotective strategies in chronic NSAID users: a cost-effectiveness analysis comparing single-tablet formulations with individual components.

PubMed

de Groot, N L; Spiegel, B M R; van Haalen, H G M; de Wit, N J; Siersema, P D; van Oijen, M G H

2013-01-01

To evaluate the cost-effectiveness of competing gastroprotective strategies, including single-tablet formulations, in the prevention of gastrointestinal (GI) complications in patients with chronic arthritis taking nonsteroidal anti-inflammatory drugs (NSAIDs). We performed a cost-utility analysis to compare eight gastroprotective strategies including NSAIDs, cyclooxygenase-2 inhibitors, proton pump inhibitors (PPIs), histamine-2 receptor antagonists, misoprostol, and single-tablet formulations. We derived estimates for outcomes and costs from medical literature. The primary outcome was incremental cost per quality-adjusted life-year gained. We performed sensitivity analyses to assess the effect of GI complications, compliance rates, and drug costs. For average-risk patients, NSAID + PPI cotherapy was most cost-effective. The NSAID/PPI single-tablet formulation became cost-effective only when its price decreased from €0.78 to €0.56 per tablet, or when PPI compliance fell below 51% in the NSAID + PPI strategy. All other strategies were more costly and less effective. The model was highly sensitive to the GI complication risk, costs of PPI and NSAID/PPI single-tablet formulation, and compliance to PPI. In patients with a threefold higher risk of GI complications, both NSAID + PPI cotherapy and single-tablet formulation were cost-effective. NSAID + PPI cotherapy is the most cost-effective strategy in all patients with chronic arthritis irrespective of their risk for GI complications. For patients with increased GI risk, the NSAID/PPI single-tablet formulation is also cost-effective. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Randomised preference trial of medical versus surgical termination of pregnancy less than 14 weeks' gestation (TOPS).

PubMed

Robson, S C; Kelly, T; Howel, D; Deverill, M; Hewison, J; Lie, M L S; Stamp, E; Armstrong, N; May, C R

2009-11-01

To determine the acceptability, efficacy and costs of medical termination of pregnancy (MTOP) compared with surgical termination of pregnancy (STOP) at less than 14 weeks' gestation, and to understand women's decision-making processes and experiences when accessing the termination service. A partially randomised preference trial and economic evaluation with follow-up at 2 weeks and 3 months. The Royal Victoria Infirmary, Newcastle upon Tyne, UK. Women accepted for termination of pregnancy (TOP) under the relevant Acts of Parliament with pregnancies < 14 weeks' gestation on the day of abortion. A further group of women attending contraception and sexual health clinics participated in a discrete choice experiment (DCE). STOP: all women > or = 6 weeks' and < 14 weeks' gestation were primed with misoprostol 400 micrograms 2 hours before the procedure. STOP was performed under general anaesthesia using vacuum aspiration. MTOP: all women < 14 weeks' gestation were given mifepristone 200 milligrams orally, returning 36-48 hours later for misoprostol. Main outcome measure was acceptability of TOP method. Secondary outcome measures included strength of preference by willingness to pay (WTP); distress, using the Impact of Event Scale (IES); anxiety and depression; satisfaction with care; experience of care; frequency and extent of symptoms including self-assessment of pain; clinical effectiveness; and complications. A DCE was used to identify attributes that shape women's preferences for abortion services. The trial recruited 1877 women, 349 in the randomised arms and 1528 in the preference arms. Of those in the preference arms, 54% chose MTOP. At 2 weeks after the procedure more women having STOP would choose the same method again in the future. Acceptability of MTOP declined with increasing gestational age. The difference in acceptability between STOP and MTOP persisted at 3 months. At 2 weeks after TOP, women in the preference arms were prepared to pay more to have their preferred option. There was no difference in anxiety or depression scores in women having MTOP or STOP. However, women randomised to MTOP had higher scores on subscales of the IES at both 2 weeks and 3 months. There was no difference in IES scores between MTOP and STOP in the preference arm. Women were more likely to be satisfied overall and with technical and interpersonal aspects of care if they had STOP rather than MTOP. Experience of care scores were lower after MTOP in both randomised and preference arms. During admission women undergoing MTOP had more symptoms and reported higher mean pain scores, and after discharge reported more nausea and diarrhoea. There were no differences in time taken to return to work between groups; around 90% had returned to work and normal activity by 2 weeks. Rates of unplanned or emergency admissions were higher after MTOP than after STOP. Overall complication rates were also higher after MTOP, although this only achieved statistical significance in the preference arm. Overall, STOP cost more than MTOP due to higher inpatient standard costs. Even though complication rates were higher with MTOP, it was still more cost-effective. DCE identified three attributes with an almost equal impact on women's preferences: provision of counselling, number of days delay to the procedure, and possibility of an overnight stay. MTOP was associated with more negative experiences of care and lower acceptability. Acceptability of MTOP declined with increasing gestational age. MTOP was less costly but also less effective than STOP. The majority of women choosing MTOP were satisfied with their care and found the procedure acceptable. RECOMMENDATIONS FOR FURTHER RESEARCH: An audit of provision of MTOP and STOP in England and Wales is urgently required. Further studies exploring the barriers to offering women the choice of method of TOP are needed, together with research on the acceptability and effectiveness of (1) MTOP and manual VA in pregnancies below 9 weeks' gestation and (2) MTOP and dilatation and evacuation after 14 weeks' gestation. Current Controlled Trials ISRCTN07823656.

Omeprazole. A review of its use in Helicobacter pylori infection, gastro-oesophageal reflux disease and peptic ulcers induced by nonsteroidal anti-inflammatory drugs.

PubMed

Langtry, H D; Wilde, M I

1998-09-01

Omeprazole is a well studied proton pump inhibitor that reduces gastric acid secretion. This review examines its use in Helicobacter pylori infection, gastro-oesophageal reflux disease (GORD) with or without oesophagitis and gastrointestinal damage caused by nonsteroidal anti-inflammatory drugs (NSAIDs). Optimal omeprazole regimens for anti-H. pylori therapy are those that administer the drug at a dosage of 40 mg/day (in 1 or 2 divided doses) for 7, 10 or 14 days in combination with 2 antibacterial agents. As a component of 3-drug regimens in direct comparative studies, omeprazole was at least as effective as lansoprazole, pantoprazole, bismuth compounds and ranitidine. However, a meta-analysis suggests that triple therapies with omeprazole are more effective than comparable regimens containing ranitidine, lansoprazole or bismuth. Omeprazole also appears to be successful in triple therapy regimens used in children with H. pylori infection. In patients with acute GORD with oesophagitis, omeprazole is at least as effective as lansoprazole or pantoprazole in promoting healing, and superior to ranitidine, cimetidine or cisapride in oesophagitis healing and symptom relief. Omeprazole was similar to lansoprazole and superior to ranitidine in preventing oesophagitis relapse in patients with all grades of oesophagitis, but may be superior to lansoprazole or pantoprazole in patients with more severe disease. More patients with symptomatic GORD without oesophagitis experienced symptom relief after short term treatment with omeprazole than with ranitidine, cisapride or placebo, and symptoms were more readily prevented by omeprazole than by cimetidine or placebo. Omeprazole was effective in healing and relieving symptoms of reflux oesophagitis in children with oesophagitis refractory to histamine H2 receptor antagonists. Omeprazole is superior to placebo in preventing NSAID-induced gastrointestinal damage in patients who must continue to take NSAIDs. It is also similar to misoprostol and superior to ranitidine in its ability to heal NSAID-induced peptic ulcers and erosions, and superior to misoprostol, ranitidine or placebo in its ability to prevent relapse. In long and short term studies, omeprazole was well tolerated, with diarrhoea, headache, dizziness, flatulence, abdominal pain and constipation being the most commonly reported adverse events. Usual omeprazole dosages, alone or combined with other agents, are 10 to 40 mg/day for adults and 10 to 20 mg/day for children. Omeprazole is a well studied and well tolerated agent effective in adults or children as a component in regimens aimed at eradicating H. pylori infections or as monotherapy in the treatment and prophylaxis of GORD with or without oesophagitis or NSAID-induced gastrointestinal damage.

Intrinsic Hormone-Like Molecules and External Root Resorption During Orthodontic Tooth Movement. A Systematic Review and Meta-Analysis in Preclinical in-Vivo Research

PubMed Central

Spoerri, Andreas; Koletsi, Despina; Eliades, Theodore

2018-01-01

Background: External root resorption constitutes an adverse effect of orthodontic treatment. The aim of the present meta-analysis was to identify the effect of induced intrinsic/ hormone-like molecules such as prostaglandins, interleukins and others on external root resorption after orthodontic tooth movement in experimental animals Methods: An electronic database search of the literature was performed (Medline via PubMed, EMBASE, LILACS, and Open Gray). Search terms included root resorption, tooth movement and animal type. Risk of bias assessment was made using the SYRCLE guidelines for animal studies and reporting quality was assessed through ARRIVE. Random effects meta-analysis was performed for the outcome root resorption after orthodontic tooth movement. Results: Of the 124 articles initially retrieved, 13 were eligible for inclusion in the systematic review, while only 2 were included in the quantitative synthesis. Five studies investigated the effect of Prostaglandin E2, four studies the effect of Thyroxine, two the effect of Calcium ions (Ca++), while the rest investigated Misoprostol, Interleukin-12 and Interleukin-4. Risk of Bias in all studies was judged to be high overall, while reporting quality was suboptimal. According to the quantitative synthesis, there was no difference in root resorption after orthodontic tooth movement when Prostaglandin E2 coupled with Ca++ was administered in comparison to no substance administration (SMD: 0.48 mm2; 95% CI: −0.22, 1.19; p = 0.18). Conclusions: Overall, there was no evidence to suggest a variation in root resorption when Prostaglandin E2 and Ca++ were administered, while there is an overriding need for further high quality experimental studies to inform available evidence on the effect of intrinsic substances on external root resorption. PMID:29643818

Intrinsic Hormone-Like Molecules and External Root Resorption During Orthodontic Tooth Movement. A Systematic Review and Meta-Analysis in Preclinical in-Vivo Research.

PubMed

Spoerri, Andreas; Koletsi, Despina; Eliades, Theodore

2018-01-01

Background: External root resorption constitutes an adverse effect of orthodontic treatment. The aim of the present meta-analysis was to identify the effect of induced intrinsic/ hormone-like molecules such as prostaglandins, interleukins and others on external root resorption after orthodontic tooth movement in experimental animals Methods: An electronic database search of the literature was performed (Medline via PubMed, EMBASE, LILACS, and Open Gray). Search terms included root resorption, tooth movement and animal type. Risk of bias assessment was made using the SYRCLE guidelines for animal studies and reporting quality was assessed through ARRIVE. Random effects meta-analysis was performed for the outcome root resorption after orthodontic tooth movement. Results: Of the 124 articles initially retrieved, 13 were eligible for inclusion in the systematic review, while only 2 were included in the quantitative synthesis. Five studies investigated the effect of Prostaglandin E2, four studies the effect of Thyroxine, two the effect of Calcium ions (Ca++), while the rest investigated Misoprostol, Interleukin-12 and Interleukin-4. Risk of Bias in all studies was judged to be high overall, while reporting quality was suboptimal. According to the quantitative synthesis, there was no difference in root resorption after orthodontic tooth movement when Prostaglandin E2 coupled with Ca++ was administered in comparison to no substance administration (SMD: 0.48 mm 2 ; 95% CI: -0.22, 1.19; p = 0.18). Conclusions: Overall, there was no evidence to suggest a variation in root resorption when Prostaglandin E2 and Ca++ were administered, while there is an overriding need for further high quality experimental studies to inform available evidence on the effect of intrinsic substances on external root resorption.

Surgical abortion in second trimester: initial experiences in Nepal.

PubMed

Shrivastava, V; Bajracharya, L; Thapa, S

2010-01-01

In spite of legalising abortion and making safe abortion available at affordable price at accessible distance to almost everyone, unsafe abortion especially second trimester abortion is still a big health problem in Nepal. The objective of the study is to fi nd the demographic profile, reasons for seeking abortion and to see the effectiveness of Misoprostol in preparing the cervix. A prospective study was done in the two second trimester abortion trainings conducted in Maternity hospital, Kathmandu. Total 57 clients had second trimester abortion performed. Information was collected from structured questionnaire and then data was analysed. Commonest reason for seeking abortion was, multiparity (61.4%). Common reasons for second trimester abortion were, completed family size with unwanted pregnancy (61.4%), unwanted pregnancy in married (10.52%) unwanted pregnancy in unmarried (5.26%). Second trimester abortion is one of the most common procedures performed in reproductive-aged women and when performed by a skilled provider in the appropriate setting, it is one of the safest surgeries, if it is well supported by change in policy of the country and acceptability of the people.

Global warming and reproductive health.

PubMed

Potts, Malcolm; Henderson, Courtney E

2012-10-01

The largest absolute numbers of maternal deaths occur among the 40-50 million women who deliver annually without a skilled birth attendant. Most of these deaths occur in countries with a total fertility rate of greater than 4. The combination of global warming and rapid population growth in the Sahel and parts of the Middle East poses a serious threat to reproductive health and to food security. Poverty, lack of resources, and rapid population growth make it unlikely that most women in these countries will have access to skilled birth attendants or emergency obstetric care in the foreseeable future. Three strategies can be implemented to improve women's health and reproductive rights in high-fertility, low-resource settings: (1) make family planning accessible and remove non-evidenced-based barriers to contraception; (2) scale up community distribution of misoprostol for prevention of postpartum hemorrhage and, where it is legal, for medical abortion; and (3) eliminate child marriage and invest in girls and young women, thereby reducing early childbearing. Copyright © 2012 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Mid-trimester induced abortion: a review.

PubMed

Lalitkumar, S; Bygdeman, M; Gemzell-Danielsson, K

2007-01-01

Mid-trimester abortion constitutes 10-15% of all induced abortion. The aim of this article is to provide a review of the current literature of mid-trimester methods of abortion with respect to efficacy, side effects and acceptability. There have been continuing efforts to improve the abortion technology in terms of effectiveness, technical ease of performance, acceptability and reduction of side effects and complications. During the last decade, medical methods for mid-trimester induced abortion have shown a considerable development and have become safe and more accessible. The combination of mifepristone and misoprostol is now an established and highly effective method for termination of pregnancy (TOP). Advantages and disadvantages of medical versus surgical methods are discussed. Randomized studies are lacking, and more studies on pain treatment and the safety of any method used in patients with a previous uterine scar are debated, and data are scarce. Pain management in abortion requires special attention. This review highlights the need for randomized studies to set guidelines for mid-trimester abortion methods in terms of safety and acceptability as well as for better analgesic regimens.

Assessment of structural heterogeneity and viscosity in the cervix using shear wave elasticity imaging: initial results from a Rhesus macaque model

PubMed Central

Rosado-Mendez, Ivan M.; Palmeri, Mark L.; Drehfal, Lindsey C.; Guerrero, Quinton W.; Simmons, Heather; Feltovich, Helen; Hall, Timothy J.

2016-01-01

Shear Wave Elasticity Imaging (SWEI) shows promise for evaluating the pregnant cervix. Changes in shear wave group velocity have been attributed exclusively to changes in stiffness. This assumes homogeneity within the region of interest and purely elastic tissue behavior. However, the cervix is structurally/microstructurally heterogeneous and viscoelastic. We therefore developed strategies to investigate these complex tissue properties. SWEI was performed ex vivo on 14 unripened and 13 misoprostol-ripened cervix specimens from Rhesus macaques. After application of tests of significant and uniform shear wave displacement, as well as reliability of estimates, group velocity decreased significantly from the distal (vaginal) to proximal (uterine) end of unripened, but not ripened, specimens. Viscosity was quantified by the slope of the phase velocity vs. frequency. Dispersion was observed in both groups (median 5.5 m/s/kHz, interquartile range: 1.5–12.0 m/s/kHz), also decreasing towards the proximal cervix. This work suggests that comprehensive assessment of complex tissues such as cervix requires consideration of structural heterogeneity and viscosity. PMID:28189282

[Prescribed and reported drug use during pregnancy].

PubMed

Osorio-de-Castro, Claudia Garcia Serpa; Pepe, Vera Lucia Edais; Luiza, Vera Lucia; Cosendey, Marly Aparecida Elias; Freitas, Aline Matias de; Miranda, Frederico Fonseca; Bermudez, Jorge Antonio Zepeda; Leal, Maria do Carmo

2004-01-01

Few studies describe drug utilization in pregnancy focusing on prescribing practices. This study is part of a larger survey on perinatal care in the City of Rio de Janeiro, Brazil. The type of hospital (public, contracted out by the Unified National Health System, or private) determined the stratification of 10,072 hospitalized post-partum women, who were asked about medication used during pregnancy. Hospital records supplied information on drugs prescribed during labor. Drugs were classified according to the Anatomical Therapeutic Chemical (ATC) system. Another system was used for specific cases of referred use. A mean of 2.08 drugs was prescribed during labor, and a mean of 2.3 was reported during pregnancy. Anesthetics, antibiotics, oxytocin, and analgesics were the most frequently prescribed during labor, with significant differences between strata. Ferrous sulfate, vitamins, scopolamine, and acetaminophen were the main drugs reported during pregnancy. Women who had attempted abortion referred use of various kinds of tea (49.7%) and misoprostol (9.2%). The drug utilization pattern was consistent with the literature. This study offers knowledge on prescribing patterns during labor and self-reported use during pregnancy in both the public and private sectors.

The effect of letrozole with misoprostol for medical termination of pregnancy on the expression of steroid receptors in the placenta.

PubMed

Lee, Vivian Chi-Yan; Gao, Jing; Lee, Kai-Fai; Ng, Ernest Hung-Yu; Yeung, William Shu-Biu; Ho, Pak-Chung

2013-11-01

What is the effect of letrozole on the expression of steroid receptors in the placentae in cases of termination of pregnancies? The expression of estrogen receptor-α (ERα) and progesterone receptor (PR) transcripts, as well as ERα protein, in placentae was suppressed by letrozole pretreatment in second trimester termination of pregnancy. There have been no data in the literature on the effect of letrozole in termination of human pregnancies. This study is part of a clinical randomized trial in which 50 subjects were recruited and 44 placentae were collected. Women (n = 50) requesting second trimester abortion between 12 and 20 gestational weeks were randomized to receive either letrozole or placebo pretreatment for 3 days before administration of vaginal misoprostol. Placentae were collected from both groups of women after the abortion. Total RNA from the frozen placenta samples was extracted and subjected to real-time RT-PCR analysis of ERα and estrogen receptor-β (ERβ), PR and glucocorticoid receptor (GR) transcripts. Immunohistochemical studies of ERα, ERβ, PR and GR expression, as well as Ki67 and PCNA staining for proliferation, were performed. TUNEL assays were performed to determine the extent of apoptosis. Real-time RT-PCR demonstrated that the median ERα {3.900 [95% confidence interval (CI): -0.643-8.443] in the letrozole group versus 4.714 (95% CI: 1.776-7.652) in the control group; P = 0.005} and the median PR [0.701 (95% CI: 0.333-1.069) in the letrozole group versus 1.774 (95% CI: 1.07-2.478) in the control group; P = 0.003] were significantly lower in the letrozole group compared with the control group. Furthermore, ERα protein levels, in both syncytiotrophoblasts and cytotrophoblasts but not in villous stromal cells, were significantly reduced [H-score of 113 (95% CI: 103-119) in the letrozole group versus 217 (95% CI: 214-290) in the control group, in syncytiotrophoblasts; 100 (95% CI: 98-105) in the letrozole group versus 210 (95% CI: 200-286) in the control group, in cytotrophoblasts; P = 0.004], while the expression levels of ERβ, PR, GR, PCNA, Ki67 and TUNEL were not significantly different between the two groups. Only the placentae from the second trimester termination of pregnancy were collected in this study. Information from first trimester terminations is still lacking. The results shed some light on the mechanism of action of letrozole pretreatment in termination of pregnancies. This study was funded by the GRF/RGC and CRCG grants of the University of Hong Kong. HKClinicalTrials.com with trial number HKCTR-695.

Medical termination of pregnancy in general practice in Australia: a descriptive-interpretive qualitative study.

PubMed

Dawson, Angela J; Nicolls, Rachel; Bateson, Deborah; Doab, Anna; Estoesta, Jane; Brassil, Ann; Sullivan, Elizabeth A

2017-03-14

Australian Government approval in 2012 for the use of mifepristone and misoprostol for medical termination of pregnancy (MTOP) allows general practitioners (GPs) to provide early gestation abortion in primary care settings. However, uptake of the MTOP provision by GPs appears to be low and the reasons for this have been unclear. This study investigated the provision of and referral for MTOP by GPs. We undertook descriptive-interpretive qualitative research and selected participants for diversity using a matrix. Twenty-eight semi-structured interviews and one focus group (N = 4), were conducted with 32 GPs (8 MTOP providers, 24 non MTOP providers) in New South Wales, Australia. Interviews were recorded and transcribed verbatim. A framework to examine access to abortion services was used to develop the interview questions and emergent themes identified thematically. Three main themes emerged: scope of practice; MTOP demand, care and referral; and workforce needs. Many GPs saw abortion as beyond the scope of their practice (i.e. a service others provide in specialist private clinics). Some GPs had religious or moral objections; others regarded MTOP provision as complicated and difficult. While some GPs expressed interest in MTOP provision they were concerned about stigma and the impact it may have on perceptions of their practice and the views of colleagues. Despite a reported variance in demand most MTOP providers were busy but felt isolated. Difficulties in referral to a local public hospital in the case of complications or the provision of surgical abortion were noted. Exploring the factors which affect access to MTOP in general practice settings provides insights to assist the future planning and delivery of reproductive health services. This research identifies the need for support to increase the number of MTOP GP providers and for GPs who are currently providing MTOP. Alongside these actions provision in the public sector is required. In addition, formalised referral pathways to the public sector are required to ensure timely care in the case of complications or the provision of surgical options. Leadership and coordination across the health sector is needed to facilitate integrated abortion care particularly for rural and low income women.

Methods for assessing pre-induction cervical ripening

PubMed Central

Ezebialu, Ifeanyichukwu U; Eke, Ahizechukwu C; Eleje, George U; Nwachukwu, Chukwuemeka E

2015-01-01

Background Induction of labour is the artificial initiation of labour in a pregnant woman after the age of fetal viability but without any objective evidence of active phase labour and with intact fetal membranes. The need for induction of labour may arise due to a problem in the mother, her fetus or both, and the procedure may be carried out at or before term. Obstetricians have long known that for this to be successful, it is important that the uterine cervix (the neck of the womb) has favourable characteristics in terms of readiness to go into the labour state. Objectives To compare Bishop score with any other method for assessing pre-induction cervical ripening in women admitted for induction of labour. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015) and reference lists of retrieved studies to identify randomised controlled trials (RCTs). Selection criteria All RCTs comparing Bishop score with any other methods of pre-induction cervical assessment in women admitted for induction of labour. Cluster-RCTs were eligible for inclusion but none were identified. Quasi-RCTs and studies using a cross-over design were not eligible for inclusion. Studies published in abstract form were eligible for inclusion if they provided sufficient information. Comparisons could include the following. Bishop score versus transvaginal ultrasound (TVUS). Bishop score versus Insulin-like growth factor binding protein-1 (IGFBP-1). Bishop score versus vaginal fetal fibronectin (fFN). However, we only identified data for a comparison of Bishop score versus TVUS. Data collection and analysis Two review authors independently assessed the trials for inclusion, extracted the data and assessed trial quality. Data were checked for accuracy. Main results We included two trials that recruited a total of 234 women. The overall risk of bias was low for the two studies. Both studies compared Bishop score withTVUS. The two included studies did not show any clear difference between the Bishop score and TVUS groups for the following main outcomes: vaginal birth (RR 1.07, 95% CI 0.92 to 1.25, moderate quality evidence), caesarean delivery (RR 0.81, 95% CI 0.49 to 1.34, moderate quality evidence), neonatal admission into neonatal intensive care unit (RR 1.67, 95% CI 0.41 to 6.71, moderate quality evidence). Both studies only provided median data in relation to induction-delivery interval and reported no clear difference between the Bishop and TVUS groups. Perinatal mortality was not reported in the included studies. For the review's secondary outcomes, the need for misoprostol for cervical ripening was more frequent in the TVUS group compared to the Bishop score group (RR 0.52, 95% CI 0.41 to 0.66, two studies, 234 women, moderate quality evidence). In contrast, there were no clear differences between the Bishop scope and TVUS groups in terms of meconium staining of the amniotic fluid, fetal heart rate abnormality in labour, and Apgar score less than seven. Only one trial reported median data on the induction-delivery interval and induction to active phase interval, the trialist reported no difference between the Bishop group and the TVUS group for this outcome. Neither of the included studies reported on uterine rupture. Authors' conclusions Moderate quality evidence from two small RCTs involving 234 women that compared two different methods for assessing pre-induction cervical ripening (Bishop score and TVUS) did not demonstrate superiority of one method over the other in terms of the main outcomes assessed in this review. We did not identify any data relating to perinatal mortality. Whilst use of TVUS was associated with an increased need for misoprostol for cervical ripening, both methods could be complementary. The choice of a particular method of assessing pre-induction cervical ripening may differ depending on the environment and need where one is practicing since some methods (i.e. TVUS) may not be readily available and affordable in resource-poor settings where the sequelae of labour and its management is prevalent. The evidence in this review is based on two studies that enrolled a small number of women and there is insufficient evidence to support the use of TVUS over the standard digital vaginal assessment in pre-induction cervical ripening. Further adequately powered RCTs involving TVUS and the Bishop score and including other methods of pre-induction cervical ripening assessment are warranted. Such studies need to address uterine rupture, perinatal mortality, optimal cut-off value of the cervical length and Bishop score to classify women as having favourable or unfavourable cervices and cost should be included as an outcome. PLAIN LANGUAGE SUMMARY Methods for assessing pre-induction cervical ripening, the ability of the cervix to open in response to spontaneous uterine contractions In this review, researchers from The Cochrane Collaboration examined a comparison between the Bishop score and any other method for checking pre-induction cervical ripening in women admitted for induction of labour. The Bishop score is the traditional method of determining the readiness of the cervix to open (dilate) before labour induction. It also assesses the position, softening and shortening of the cervix, and the location of the presenting part of the baby. After searching for relevant trials up to 31 March 2015, we included two randomised controlled trials that recruited 234 pregnant women. What are the methods for pre-induction softening of the neck of womb and why is it important to soften the neck of womb before induction of labour? Induction of labour is the non-natural process of starting labour in a pregnant woman after the age the baby is more likely to survive following delivery, when there is no clear evidence of serious onset of labour and the membranes covering the baby are unruptured. Induction of labour may be needed because of a problem in the mother, or her baby or both, and is carried out at or before the ninth (last) month of pregnancy. Obstetricians (specialist caring for pregnant women) have long known that for this to be successful, it is important that the uterine cervix (the neck of the womb) has the favourable characteristics that make it ready to go into the labour. The delivery method and total duration of labour are affected by many factors and cervical readiness (ripeness) is just one of these. What the research says Moderate quality evidence was available from the two included studies which compared the Bishop score with transvaginal ultrasound (TVUS) (ultrasound done through the vagina). The studies were considered to be at a low risk of bias. The need for misoprostol (a drug) for softening the cervix (cervical ripening) was more common in the TVUS arm. No clear difference was seen between the two methods in terms of vaginal birth, caesarean delivery, admission of the newborn into the neonatal intensive care unit, meconium staining of the amniotic fluid, abnormal heart beat of the baby within the womb whilst the mother was in labour and Apgar score less than seven (difficulty of the baby establishing life and other life movements on its own immediately after childbirth). None of the included studies reported on tears of the womb or death of the baby just before, during or immediately after childbirth. We did not find any studies that compared Bishop score with any other methods such as the presence of vaginal fetal fibronectin or insulin-like growth factor binding protein-1. Authors conclusions Although the overall quality of evidence is moderate, there is no difference in outcomes between the two methods (Bishop score and TVUS) apart from the increased need of misoprostol in the TVUS group. Both methods could be useful to each other, or complementary as the Bishop score does not need any special equipment and uses digital examination which is required to induce labour (to insert a cervical ripening agent, rupture the membranes or separate them from the cervix) but TVUS can give additional information that may affect the course and management of the labour. The choice of a particular method may differ depending on the environment and need since TVUS requires training and may not be readily available and affordable in resource-poor countries. Future research The two included studies involved a small number of women and further studies are needed. Such studies should include outcomes such as rupture of the womb, perinatal mortality, most appropriate cut-off value for the cervical length and Bishop score to classify women as having ripe or unripe cervices, and cost. PMID:26068943

Co-Operative Advances in Behavioral Health and Performance Research and Operations

NASA Technical Reports Server (NTRS)

VanderArk, Stephen T.; Leveton, Lauren B.

2011-01-01

In organizations that engage in both operations and applied research, with operational needs guiding research questions and research informing improved operations, the ideal goal is a synergy of ideas and information. In reality, this ideal synergy is often lacking. Real-time operational needs driving day-to-day decisions, lack of communication, lag time in getting research advances plugged into operations can cause both areas to suffer from this gap between operations and research. At Johnson Space Center, the Behavior Health and Performance group (BHP) strives to bridge this gap by following a Human Research Program framework: Expectations of future operational needs identify the knowledge gaps; the gaps in turn guide research leading to a product that is transitioned into operations. Thus, the direction those of us in research take is in direct response to current and future needs of operations. Likewise, those of us in operations actively seek knowledge that is supported by evidence-based research. We make an ongoing effort to communicate across the research and operations gap by working closely with each other and making a conscious effort to keep each other informed. The objective of the proposed panel discussion is to demonstrate through the following presentations the results of a successful collaboration between research and operations and to provide ASMA members with more practical knowledge and strategies for building these bridges to serve our field of practice well. The panel will consist of six presenters from BHP operations, internal BHP research, and external research instigated by BHP who together represent the entire BHP Research Transition to Operations Framework

Piroxicam and doxycycline treatment for an oral squamous cell carcinoma in an inshore bottlenose dolphin (Tursiops aduncus).

PubMed

March, D T; Blyde, D J; Bossart, G D; Begg, A P; Taylor, D P; McClure, V

2016-06-01

The virus family Papillomaviridae has been documented in a wide range of animal species and can cause benign and malignant proliferative lesions. The presence of concurrent lingual papillomas and squamous cell carcinomas (SCC) in cetaceans has also been documented in both wild and captive populations, suggesting malignant transformation of benign papilloma to SCC may occur in this species. In 2008, a 38-year-old captive male inshore bottlenose dolphin (Tursiops aduncus) was diagnosed with papillomatous lesions on the intermandibular frenulum rostral to the tongue and an infiltrative SCC of the soft palate following biopsy and histological analysis. A treatment regimen of piroxicam and doxycycline was initiated with misoprostol as a gastroprotectant. The treatment resulted in a marked reduction in tumour size and reversible hepatotoxicosis. Subsequent biopsies revealed the presence of SCC in the oral cavity; however, the disease remains stable at the time of writing. To the best of our knowledge, this case is the first report of piroxicam and doxycycline used to treat SCC in a bottlenose dolphin. The treatment was successful in reducing the clinical presentation of the disease. © 2016 Australian Veterinary Association.

Progestin-based contraceptive on the same day as medical abortion.

PubMed

Park, Jeanna; Robinson, Nuriya; Wessels, Ursula; Turner, James; Geller, Stacie

2016-05-01

To determine the success rate of medical abortion when a progestin-based contraceptive-either an etonogestrel implant or depot medroxyprogesterone acetate (DMPA) injection-is given on the same day as mifepristone for medical abortion. In a retrospective chart review, data were assessed for women aged 15-49years who underwent medical abortion (≤63days of pregnancy) at two hospitals in KwaZulu Natal, South Africa, between August 2013 and July 2014. The women were given oral mifepristone (200mg) and buccal misoprostol (800μg), and received an etonogestrel implant or DMPA injection on the same day as mifepristone. The primary outcome was the success rate of medical abortion. Comparative data were obtained through a PubMed search. A total of 89 women were included. Complete termination was achieved in 87 (98%, 95% confidence interval 95%-100%) women. This success rate is similar to that reported in a previous systematic review of the rate of medical abortion success without progestin contraceptive administration (94.8%). Administration of a progestin-based contraceptive such as an etonogestrel implant or DMPA injection on the same day as mifepristone for medical abortion did not alter the success rates. Published by Elsevier Ireland Ltd.

Practical approaches to minimizing gastrointestinal and cardiovascular safety concerns with COX-2 inhibitors and NSAIDs

PubMed Central

2005-01-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are highly effective in treating the pain and inflammation associated with osteoarthritis and rheumatoid arthritis, but it is well recognized that these agents are associated with substantial gastrointestinal toxicity. Treatment guidelines suggest that patients with one or more risk factors for NSAID associated ulcers should be prescribed preventive treatment. However, well over 80% of such patients may not receive an appropriate therapeutic intervention. Multiple strategies are available to reduce the risk for NSAID associated gastrointestinal complications. First, risk may be reduced by using non-NSAID analgesics. Second, use of the minimum effective dose of the NSAID may reduce risk. Third, co-therapy with a proton pump inhibitor or misoprostol may be desirable in at-risk patients. Use of cyclo-oxygenase-2 inhibitors may also reduce the risk for gastrointestinal events, although this benefit is eliminated in patients who receive aspirin, and cyclo-oxygenase-2 inhibitors may increase cardiovascular adverse events. The optimal management of NSAID related gastrointestinal complications must be based on the individual patient's risk factors for gastrointestinal and cardiovascular disease, as well as on the efficacy and tolerability of both the NSAID and accompanying gastroprotective agent. PMID:16168078

Medication abortion: Potential for improved patient access through pharmacies.

PubMed

Raifman, Sarah; Orlando, Megan; Rafie, Sally; Grossman, Daniel

2018-05-08

To discuss the potential for improving access to early abortion care through pharmacies in the United States. Despite the growing use of medications to induce termination of early pregnancy, pharmacist involvement in abortion care is currently limited. The Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex® (mifepristone 200 mg), the principal drug used in early medication abortion, prohibits the dispensing of the drug by prescription at pharmacies. This commentary reviews the pharmacology of medication abortion with the use of mifepristone and misoprostol, as well as aspects of service delivery and data on safety, efficacy, and acceptability. Given its safety record, mifepristone no longer fits the profile of a drug that requires an REMS. The recent implementation of pharmacy dispensing of mifepristone in community pharmacies in Australia and some provinces of Canada has improved access to medication abortion by increasing the number of medication abortion providers, particularly in rural areas. Provision of mifepristone in pharmacies, which involves dispensing and patient counseling, would likely improve access to early abortion in the United States without increasing risks to women. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Saving maternal lives in resource-poor settings: facing reality.

PubMed

Prata, Ndola; Sreenivas, Amita; Vahidnia, Farnaz; Potts, Malcolm

2009-02-01

Evaluate safe-motherhood interventions suitable for resource-poor settings that can be implemented with current resources. Literature review to identify interventions that require minimal treatment/infrastructure and are not dependent on skilled providers. Simulations were run to assess the potential number of maternal lives that could be saved through intervention implementation according to potential program impact. Regional and country level estimates are provided as examples of settings that would most benefit from proposed interventions. Three interventions were identified: (i) improve access to contraception; (ii) increase efforts to reduce deaths from unsafe abortion; and (iii) increase access to misoprostol to control postpartum hemorrhage (including for home births). The combined effect of postpartum hemorrhage and unsafe abortion prevention would result in the greatest gains in maternal deaths averted. Bold new initiatives are needed to achieve the Millennium Development Goal of reducing maternal mortality by three-quarters. Ninety-nine percent of maternal deaths occur in developing countries and the majority of these women deliver alone, or with a traditional birth attendant. It is time for maternal health program planners to reprioritize interventions in the face of human and financial resource constraints. The three proposed interventions address the largest part of the maternal health burden.

Pharmacy workers’ knowledge and provision of medication for termination of pregnancy in Kenya

PubMed Central

Reiss, Kate; Footman, Katharine; Akora, Vitalis; Liambila, Wilson; Ngo, Thoai D

2016-01-01

Objective To assess pharmacy workers’ knowledge and provision of abortion information and methods in Kenya. Methods In 2013 we interviewed 235 pharmacy workers in Nairobi, Mombasa and Kisumu about the medical abortion services they provide. We also used mystery clients, who made 401 visits to pharmacies to collect first-hand information on abortion practices. Results The majority (87.5%) of pharmacy workers had heard of misoprostol but only 39.2% had heard of mifepristone. We found that pharmacy workers had limited knowledge of correct medical abortion regimens, side effects and complications and the legal status of abortion drugs. 49.8% of pharmacy workers reported providing abortion information to clients and 4.3% reported providing abortion methods. 75.2% of pharmacies referred mystery clients to another provider, though 64.2% of pharmacies advised mystery clients to continue with their pregnancy. Pharmacy workers reported that they were experiencing demand for abortion services from clients. Conclusions Pharmacy workers are important providers of information and referrals for women seeking abortion, however their medical abortion knowledge is limited. Training pharmacy workers on medical abortion may improve the quality of information provided and access to safe abortion. PMID:26869694

Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term.

PubMed

Kelly, Anthony J; Malik, Sidra; Smith, Lee; Kavanagh, Josephine; Thomas, Jane

2009-10-07

Prostaglandins have been used for induction of labour since the 1960s. Initial work focused on prostaglandin F2a as prostaglandin E2 was considered unsuitable for a number of reasons. With the development of alternative routes of administration, comparisons were made between various formulations of vaginal prostaglandins. To determine the effects of vaginal prostaglandins E2 and F2a for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment or other vaginal prostaglandins (except misoprostol). We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (May 2009) and bibliographies of relevant papers. Clinical trials comparing vaginal prostaglandins used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods. We assessed studies and extracted data independently. Sixty-three (10,441 women) have been included.Vaginal prostaglandin E2 compared with placebo or no treatment reduced the likelihood of vaginal delivery not being achieved within 24 hours (18.1% versus 98.9%, risk ratio (RR) 0.19, 95% confidence interval (CI) 0.14 to 0.25, two trials, 384 women). The risk of the cervix remaining unfavourable or unchanged was reduced (21.6% versus 40.3%, RR 0.46, 95% CI 0.35 to 0.62, five trials, 467 women); and the risk of oxytocin augmentation reduced (35.1% versus 43.8%, RR 0.83, 95% CI 0.73 to 0.94, 12 trials, 1321 women) when PGE2 was compared to placebo. There was no evidence of a difference between caesarean section rates, although the risk of uterine hyperstimulation with fetal heart rate changes was increased (4.4% versus 0.49%, RR 4.14, 95% CI 1.93 to 8.90, 14 trials, 1259 women).PGE2 tablet, gel and pessary appear to be as efficacious as each other and the use of sustained release PGE2 inserts appear to be associated with a reduction in instrumental vaginal delivery rates (9.9 % versus 19.5%, RR 0.51, 95% CI 0.35 to 0.76, NNT 10 (6.7 to 24.0), five trials, 661 women) when compared to vaginal PGE2 gel or tablet. PGE2 increases successful vaginal delivery rates in 24 hours and cervical favourability with no increase in operative delivery rates. Sustained release vaginal PGE2 is superior to vaginal PGE2 gel with respect to some outcomes studied.Further research is needed to assess the best vehicle for delivering vaginal prostaglandins and this should, where possible, include some examination of the cost-analysis.

Doing more for less: identifying opportunities to expand public sector access to safe abortion in South Africa through budget impact analysis.

PubMed

Lince-Deroche, Naomi; Harries, Jane; Constant, Deborah; Morroni, Chelsea; Pleaner, Melanie; Fetters, Tamara; Grossman, Daniel; Blanchard, Kelly; Sinanovic, Edina

2018-02-01

To estimate the costs of public-sector abortion provision in South Africa and to explore the potential for expanding access at reduced cost by changing the mix of technologies used. We conducted a budget impact analysis using public sector abortion statistics and published cost data. We estimated the total costs to the public health service over 10 years, starting in South Africa's financial year 2016/17, given four scenarios: (1) holding service provision constant, (2) expanding public sector provision, (3) changing the abortion technologies used (i.e. the method mix), and (4) expansion plus changing the method mix. The public sector performed an estimated 20% of the expected total number of abortions in 2016/17; 26% and 54% of all abortions were performed illegally or in the private sector respectively. Costs were lowest in scenarios where method mix shifting occurred. Holding the proportion of abortions performed in the public-sector constant, shifting to more cost-effective service provision (more first-trimester services with more medication abortion and using the combined regimen for medical induction in the second trimester) could result in savings of $28.1 million in the public health service over the 10-year period. Expanding public sector provision through elimination of unsafe abortions would require an additional $192.5 million. South Africa can provide more safe abortions for less money in the public sector through shifting the methods provided. More research is needed to understand whether the cost of expanding access could be offset by savings from averting costs of managing unsafe abortions. South Africa can provide more safe abortions for less money in the public sector through shifting to more first-trimester methods, including more medication abortion, and shifting to a combined mifepristone plus misoprostol regimen for second trimester medical induction. Expanding access in addition to method mix changes would require additional funds. Copyright © 2017 Elsevier Inc. All rights reserved.

Is operational research delivering the goods? The journey to success in low-income countries.

PubMed

Zachariah, Rony; Ford, Nathan; Maher, Dermot; Bissell, Karen; Van den Bergh, Rafael; van den Boogaard, Wilma; Reid, Tony; Castro, Kenneth G; Draguez, Bertrand; von Schreeb, Johan; Chakaya, Jeremiah; Atun, Rifat; Lienhardt, Christian; Enarson, Don A; Harries, Anthony D

2012-05-01

Operational research in low-income countries has a key role in filling the gap between what we know from research and what we do with that knowledge-the so-called know-do gap, or implementation gap. Planned research that does not tangibly affect policies and practices is ineffective and wasteful, especially in settings where resources are scarce and disease burden is high. Clear parameters are urgently needed to measure and judge the success of operational research. We define operational research and its relation with policy and practice, identify why operational research might fail to affect policy and practice, and offer possible solutions to address these shortcomings. We also propose measures of success for operational research. Adoption and use of these measures could help to ensure that operational research better changes policy and practice and improves health-care delivery and disease programmes. Copyright © 2012 Elsevier Ltd. All rights reserved.

Research and Exploration for Operational Research Education in Industry and Engineering Subject

ERIC Educational Resources Information Center

Wu, Yu-hua; Wang, Feng-ming; Du, Gang

2007-01-01

On the basic of exploring the relationship of industry engineering and operational research technique, the thesis analyzes the location and utility of the operational research education in the whole industry engineering subject education. It brings forward the system design about operational research and relative class among industry engineering…

Medical versus surgical abortion methods for pregnancy in China: a cost-minimization analysis.

PubMed

Xia, Wei; She, Shouzhang; Lam, Tai Hing

2011-01-01

Both medical and surgical abortions are popular in developing countries. However, the monetary costs of these two methods have not been compared. 430 women seeking abortions were recruited in 2008. Either a medical or surgical method was used for the abortion. We adopted the perspective of a third-party payer. Cost-minimization analysis was used based on all charges for the overall procedures in an out-patient clinic in Guangzhou, China. 219 subjects (51%) chose a medical method (mifepristone and misoprostol), whereas 211 subjects (49%) chose a surgical method. The efficacy in the surgical group was significantly higher than in the medical group (100 vs. 90%, p < 0.001). Surgical abortion incurred much more costs than medical abortion on average after initial treatment. When the subsequent costs were accumulated within the 2-week follow-up, the mean total cost in the medical group increased significantly due to failure of abortion and persistent bleeding. Patients undergoing medical abortion eventually incurred equivalent expenses compared to patients undergoing surgical abortion (p = 0.42). There was no difference in the mean final costs between the two abortion methods. Complications of persistent bleeding and failure to abort (requiring surgical intervention) in the medical treatment group increased the final mean total cost substantially. Copyright © 2011 S. Karger AG, Basel.

Unsafe abortion requiring hospital admission in the Eastern Highlands of Papua New Guinea--a descriptive study of women's and health care workers' experiences.

PubMed

Vallely, Lisa M; Homiehombo, Primrose; Kelly-Hanku, Angela; Whittaker, Andrea

2015-03-21

In Papua New Guinea induced abortion is restricted under the Criminal Code Law. Unsafe abortions are known to be widely practiced and sepsis due to unsafe abortion is a leading cause of maternal mortality. We undertook a six month, prospective, mixed methods study at the Eastern Highlands Provincial Hospital. Semi structured and in depth interviews were undertaken with women presenting following induced abortion. This paper describes the reasons why women resorted to unsafe abortion, the techniques used, decision to seek post abortion care and women's reflections post abortion. 28 women were admitted to hospital following an induced abortion. Reasons for inducing an abortion included: wanting to continue with studies, relationship problems and socio-cultural factors. Misoprostol was the most frequently used method to end the pregnancy. Physical and mechanical means, traditional herbs and spiritual beliefs were also reported. Women sought care post abortion due to excessive vaginal bleeding, and severe abdominal pain with some afraid they would die if they did not seek help. In the absence of contraceptive information and services to avoid, postpone or space pregnancies, women in this setting are resorting to unsafe means to end an unwanted pregnancy, putting their lives at risk. Women need access to safe, effective means of abortion.

Setting priorities for safe motherhood interventions in resource-scarce settings.

PubMed

Prata, Ndola; Sreenivas, Amita; Greig, Fiona; Walsh, Julia; Potts, Malcolm

2010-01-01

Guide policy-makers in prioritizing safe motherhood interventions. Three models (LOW, MED, HIGH) were constructed based on 34 sub-Saharan African countries to assess the relative cost-effectiveness of available safe motherhood interventions. Cost and effectiveness data were compiled and inserted into the WHO Mother Baby Package Costing Spreadsheet. For each model we assessed the percentage in maternal mortality reduction after implementing all interventions, and optimal combinations of interventions given restricted budgets of US$ 0.50, US$ 1.00, US$ 1.50 per capital maternal health expenditures respectively for LOW, MED, and HIGH models. The most cost-effective interventions were family planning and safe abortion (fpsa), antenatal care including misoprostol distribution for postpartum hemorrhage prevention at home deliveries (anc-miso), followed by sepsis treatment (sepsis) and facility-based postpartum hemorrhage management (pph). The combination of interventions that avert the greatest number of maternal deaths should be prioritized and expanded to cover the greatest number of women at risk. Those which save the most number of lives in each model are 'fpsa, anc-miso' and 'fpsa, sepsis, safe delivery' for LOW; 'fpsa, anc-miso' and 'fpsa, sepsis, safe delivery' for MED; and 'fpsa, anc-miso, sepsis, eclampsia treatment, safe delivery' for HIGH settings. Safe motherhood interventions save a significant number of newborn lives.

[Adverse effects of non-steroidal anti-inflammatory drugs. A prevalence study in Austria].

PubMed

Kolarz, Gernot; Mayrhofer, Franz; Neumann, Kurt; Singer, Franz

2003-01-31

Gastrointestinal side effects are the limiting factor in the prescription of non-steroidal antirheumatic drugs (NSAID). However, there are no recent data from Austria. The aim of this prevalence study was therefore to assess the gastrointestinal risk from NSAID in Austria. A total of 1347 patients were observed in an outpatient setting between March 2000 and February 2001. Side effects from NSAID were documented by questionnaire at two time points with a mean interval of 31 days. Documented data were analysed descriptively using an explorative strategy. The prevalence of side effects was compared to data from literature. Side effects were reported by 18.1% of the patients, severe gastro-intestinal complications (ulcer, bleeding, perforation) were diagnosed in 0.7%. Prescription of effective GI-protection (proton pump inhibitors, misoprostole, famotidin in high dose) was seen in only one third of the patients at risk. The prevalence of severe gastrointestinal side effects by NSAIDs assessed in our study was clearly lower than the prevalence reported in the Anglo-American literature. This may be due to a different prescription behaviour: about 75% of the patients took Diclofenac, lbuprofen or Meloxicam, drugs which have a very low potential of gastrointestinal complications. However, more information for general practitioners is needed yet to sufficiently protect patients at gastrointestinal risk from NSAID.

Pharmacy workers' knowledge and provision of medication for termination of pregnancy in Kenya.

PubMed

Reiss, Kate; Footman, Katharine; Akora, Vitalis; Liambila, Wilson; Ngo, Thoai D

2016-07-01

To assess pharmacy workers' knowledge and provision of abortion information and methods in Kenya. In 2013 we interviewed 235 pharmacy workers in Nairobi, Mombasa and Kisumu about the medical abortion services they provide. We also used mystery clients, who made 401 visits to pharmacies to collect first-hand information on abortion practices. The majority (87.5%) of pharmacy workers had heard of misoprostol but only 39.2% had heard of mifepristone. We found that pharmacy workers had limited knowledge of correct medical abortion regimens, side effects and complications and the legal status of abortion drugs. 49.8% of pharmacy workers reported providing abortion information to clients and 4.3% reported providing abortion methods. 75.2% of pharmacies referred mystery clients to another provider, though 64.2% of pharmacies advised mystery clients to continue with their pregnancy. Pharmacy workers reported that they were experiencing demand for abortion services from clients. Pharmacy workers are important providers of information and referrals for women seeking abortion, however their medical abortion knowledge is limited. Training pharmacy workers on medical abortion may improve the quality of information provided and access to safe abortion. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The path to impact of operational research on tuberculosis control policies and practices in Indonesia

PubMed Central

Probandari, Ari; Widjanarko, Bagoes; Mahendradhata, Yodi; Sanjoto, Hary; Cerisha, Ancila; Nungky, Saverina; Riono, Pandu; Simon, Sumanto; Farid, Muhammad Noor; Giriputra, Sardikin; Putra, Artawan Eka; Burhan, Erlina; Wahyuni, Chatarina U.; Mustikawati, Dyah; Widianingrum, Christina; Tiemersma, Edine W.; Alisjahbana, Bachti

2016-01-01

Background Operational research is currently one of the pillars of the global strategy to control tuberculosis. Indonesia initiated capacity building for operational research on tuberculosis over the last decade. Although publication of the research in peer-reviewed journals is an important indicator for measuring the success of this endeavor, the influence of operational research on policy and practices is considered even more important. However, little is known about the process by which operational research influences tuberculosis control policy and practices. Objective We aimed to investigate the influence of operational research on tuberculosis control policy and practice in Indonesia between 2004 and 2014. Design Using a qualitative study design, we conducted in-depth interviews of 50 researchers and 30 policy makers/program managers and performed document reviews. Transcripts of these interviews were evaluated while applying content analysis. Results Operational research contributed to tuberculosis control policy and practice improvements, including development of new policies, introduction of new practices, and reinforcement of current program policies and practices. However, most of these developments had limited sustainability. The path from the dissemination of research results and recommendations to policy and practice changes was long and complex. The skills, interests, and political power of researchers and policy makers, as well as health system response, could influence the process. Conclusions Operational research contributed to improving tuberculosis control policy and practices. A systematic approach to improve the sustainability of the impact of operational research should be explored. PMID:26928217

The path to impact of operational research on tuberculosis control policies and practices in Indonesia.

PubMed

Probandari, Ari; Widjanarko, Bagoes; Mahendradhata, Yodi; Sanjoto, Hary; Cerisha, Ancila; Nungky, Saverina; Riono, Pandu; Simon, Sumanto; Farid, Muhammad Noor; Giriputra, Sardikin; Putra, Artawan Eka; Burhan, Erlina; Wahyuni, Chatarina U; Mustikawati, Dyah; Widianingrum, Christina; Tiemersma, Edine W; Alisjahbana, Bachti

2016-01-01

Operational research is currently one of the pillars of the global strategy to control tuberculosis. Indonesia initiated capacity building for operational research on tuberculosis over the last decade. Although publication of the research in peer-reviewed journals is an important indicator for measuring the success of this endeavor, the influence of operational research on policy and practices is considered even more important. However, little is known about the process by which operational research influences tuberculosis control policy and practices. We aimed to investigate the influence of operational research on tuberculosis control policy and practice in Indonesia between 2004 and 2014. Using a qualitative study design, we conducted in-depth interviews of 50 researchers and 30 policy makers/program managers and performed document reviews. Transcripts of these interviews were evaluated while applying content analysis. Operational research contributed to tuberculosis control policy and practice improvements, including development of new policies, introduction of new practices, and reinforcement of current program policies and practices. However, most of these developments had limited sustainability. The path from the dissemination of research results and recommendations to policy and practice changes was long and complex. The skills, interests, and political power of researchers and policy makers, as well as health system response, could influence the process. Operational research contributed to improving tuberculosis control policy and practices. A systematic approach to improve the sustainability of the impact of operational research should be explored.

Behavioral Health and Performance at NASA JSC: Recent Successes and Future Plan for BHP Research and Operations

NASA Technical Reports Server (NTRS)

Leveton, L. B.; VanderArk, S. T.

2014-01-01

The Behavioral Health and Performance discipline at NASA Johnson Space Center is organized into two distinct Divisions (Biomedical Research and Environmental Science Division and Space and Clinical Operations Division) but is integrated and interrelated in its day-to-day work. Ongoing operations supporting NASA's spaceflight goals benefit from the research portfolios that address risks to mission success. Similarly, these research portfolios are informed by operations to ensure investigations stay relevant given the dynamic environment of spaceflight. There are many success stories that can be presented where initial work begun as a BHP Research project, and funded through the Human Research Program, was fully implemented in operations or addressed an operational need. Examples include improving effectiveness of the debriefings used within Mission Control by the Mission Operations Directorate and countermeasures for fatigue management. There is also ongoing collaboration with research and operations for developing selection methods for future generation astronauts, and to enhance and inform the current family support function. The objective of this panel is to provide examples of recent success stories, describe areas where close collaboration is benefitting ongoing research and operations, and summarize how this will come together as NASA plans for the one year ISS mission - a unique opportunity for both BHP operations and research to learn more about preparing and supporting crewmembers for extended missions in space. The proposed panel will be comprised of six presentations, each describing a unique aspect of research or operations and the benefits to current and future spaceflight.

The development of scientific identification theory to conduct operation research in education management

NASA Astrophysics Data System (ADS)

Hardhienata, S.

2017-01-01

Operations research is a general method used in the study and optimization of a system through modeling of the system. In the field of education, especially in education management, operations research has not been widely used. This paper gives an exposition of ideas about how operations research can be used to conduct research and optimization in the field of education management by developing SITOREM (Scientific Identification Theory for Operation Research in Education Management). To clarify the intent of the idea, an example of applying SITOREM to enhance the professional commitment of lecturers associated with achieving the vision of university will be described.

Applied Operations Research: Operator's Assistant

NASA Technical Reports Server (NTRS)

Cole, Stuart K.

2015-01-01

NASA operates high value critical equipment (HVCE) that requires trouble shooting, periodic maintenance and continued monitoring by Operations staff. The complexity HVCE and information required to maintain and trouble shoot HVCE to assure continued mission success as paper is voluminous. Training on new HVCE is commensurate with the need for equipment maintenance. LaRC Research Directorate has undertaken a proactive research to support Operations staff by initiation of the development and prototyping an electronic computer based portable maintenance aid (Operator's Assistant). This research established a goal with multiple objectives and a working prototype was developed. The research identified affordable solutions; constraints; demonstrated use of commercial off the shelf software; use of the US Coast Guard maintenance solution; NASA Procedure Representation Language; and the identification of computer system strategies; where these demonstrations and capabilities support the Operator, and maintenance. The results revealed validation against measures of effectiveness and overall proved a substantial training and capability sustainment tool. The research indicated that the OA could be deployed operationally at the LaRC Compressor Station with an expectation of satisfactorily results and to obtain additional lessons learned prior to deployment at other LaRC Research Directorate Facilities. The research revealed projected cost and time savings.

Meeting global health challenges through operational research and management science

PubMed Central

2011-01-01

Abstract This paper considers how operational research and management science can improve the design of health systems and the delivery of health care, particularly in low-resource settings. It identifies some gaps in the way operational research is typically used in global health and proposes steps to bridge them. It then outlines some analytical tools of operational research and management science and illustrates how their use can inform some typical design and delivery challenges in global health. The paper concludes by considering factors that will increase and improve the contribution of operational research and management science to global health. PMID:21897489

Meeting global health challenges through operational research and management science.

PubMed

Royston, Geoff

2011-09-01

This paper considers how operational research and management science can improve the design of health systems and the delivery of health care, particularly in low-resource settings. It identifies some gaps in the way operational research is typically used in global health and proposes steps to bridge them. It then outlines some analytical tools of operational research and management science and illustrates how their use can inform some typical design and delivery challenges in global health. The paper concludes by considering factors that will increase and improve the contribution of operational research and management science to global health.

The operations manual: a mechanism for improving the research process.

PubMed

Bowman, Ann; Wyman, Jean F; Peters, Jennifer

2002-01-01

The development and use of an operations manual has the potential to improve the capacity of nurse scientists to address the complex, multifaceted issues associated with conducting research in today's healthcare environment. An operations manual facilitates communication, standardizes training and evaluation, and enhances the development and standard implementation of clear policies, processes, and protocols. A 10-year review of methodology articles in relevant nursing journals revealed no attention to this topic. This article will discuss how an operations manual can improve the conduct of research methods and outcomes for both small-scale and large-scale research studies. It also describes the purpose and components of a prototype operations manual for use in quantitative research. The operations manual increases reliability and reproducibility of the research while improving the management of study processes. It can prevent costly and untimely delays or errors in the conduct of research.

NASA Research to Support the Airlines

NASA Technical Reports Server (NTRS)

Mogford, Richard

2017-01-01

This is a PowerPoint document that reviews NASA aeronautics research that supports airline operations. It provides short descriptions of several lines of work including the Airline Operations Workshop, Airline Operations Research Laboratory Forum, Flight Awareness Collaboration Tool, dispatcher human factors study, turbulence research, ramp area accidents research, and Traffic Aware Strategic Aircrew Requests.

Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term.

PubMed

Kelly, A J; Kavanagh, J; Thomas, J

2003-01-01

Prostaglandins have been used for induction of labour since the 1960s. Initial work focused on prostaglandin F2a as prostaglandin E2 was considered unsuitable for a number of reasons. With the development of alternative routes of administration, comparisons were made between various formulations of vaginal prostaglandins. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. To determine the effects of vaginal prostaglandins E2 and F2a for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment or other vaginal prostaglandins (except misoprostol). The Cochrane Pregnancy and Childbirth Group trials register (May 2003) and bibliographies of relevant papers. Clinical trials comparing vaginal prostaglandins used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods. A strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. In total, 101 studies were considered: 43 excluded and 57 (10,039 women) included. One study is awaiting assessment. Vaginal prostaglandin E2 compared with placebo or no treatment reduced the likelihood of vaginal delivery not being achieved within 24 hours (18% versus 99%, relative risk (RR) 0.19, 95% confidence interval (CI) 0.14 to 0.25, 2 trials, 384 women), there was no evidence of a difference between caesarean section rates although the risk of uterine hyperstimulation with fetal heart rate changes was increased (4.6% versus 0.51%, RR 4.14, 95% CI 1.93 to 8.90, 13 trials, 1203 women). Comparison of vaginal prostaglandin F2a with placebo showed similar caesarean section rates but the cervical score was more likely to be improved (15% versus 60%, RR 0.25, 95% CI 0.13 to 0.49, 5 trials, 467 women), and the risk of oxytocin augmentation reduced (53.9% versus 89.1%, RR 0.60, 95% CI 0.43 to 0.84, 11 trials, 1265 women) with the use of vaginal PGF2a. There were insufficient data to make meaningful conclusions for the comparison of vaginal PGE2 and PGF2a.PGE2 tablet, gel and pessary appear to be as efficacious as each other. Lower dose regimens, as defined in the review, appear as efficacious as higher dose regimens. The primary aim of this review was to examine the efficacy of vaginal prostaglandin E2 and F2a. This is reflected by an increase in successful vaginal delivery rates in 24 hours, no increase in operative delivery rates and significant improvements in cervical favourability within 24 to 48 hours. Further research is needed to quantify the cost-analysis of induction of labour with vaginal prostaglandins, with special attention to different methods of administration.

Improving the prevention, diagnosis and treatment of TB among people living with HIV: the role of operational research

PubMed Central

2011-01-01

Operational research is necessary to improve the access to and delivery of tuberculosis prevention, diagnosis and treatment interventions for people living with HIV. We conducted an extensive review of the literature and reports from recent expert consultations and research-related meetings organized by the World Health Organization and the Stop TB Partnership to identify a TB/HIV operational research agenda. We present critical operational research questions in a series of key areas: optimizing TB prevention by enhancing the uptake of isoniazid preventive therapy and the implementation of infection control measures; assessing the effectiveness of existing diagnostic tools and scaling up new technologies; improving service delivery models; and reducing risk factors for mortality among TB patients living with HIV. We discuss the potential impact that addressing the operational research questions may have on improving programmes’ performance, assessing new strategies or interventions for TB control, or informing global or national policy formulation. Financial resources to implement these operational research questions should be mobilized from existing and new funding mechanisms. National TB and HIV/AIDS programmes should develop their operational research agendas based on these questions, and conduct the research that they consider crucial for improving TB and HIV control in their settings in collaboration with research stakeholders. PMID:21967874

Blast Injury: Translating Research Into Operational Medicine (Preprint)

DTIC Science & Technology

2008-05-20

i Blast Injury: Translating Research into Operational Medicine Report Documentation Page Form ApprovedOMB No. 0704-0188 Public reporting burden for...SUBTITLE Blast Injury: Translating Research Into Operational Medicine 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S...Z39-18 iii Blast Injury: Translating Research into Operational Medicine Preprint BI-QP-JHS-CH10 Borden Institute This chapter was originally

The Nitty Gritty: How We Make Analogs Work

NASA Technical Reports Server (NTRS)

Self, A. L.; Huppman, S. R.; Spence, L. A.

2017-01-01

NASA's Human Research Program (HRP) is becoming increasingly reliant on Isolated, Confined and Controlled (ICC) analogs to accomplish many of its research objectives. Compared to other research platforms, ICC analogs present a unique set of operational challenges that must be addressed in order to ensure a high fidelity research environment. In particular, the Human Exploration Research Analog (HERA) habitat, which is classified as an ICC environment, has been developed over the past three years to accommodate the operational needs of research investigations from each of the HRP Elements. During the development period, various types of requirements have contributed to the current operational model, which strives to achieve the highest possible level of mission fidelity with limited resources. This presentation will focus on the operational aspects of the HERA habitat, with emphasis on how we develop the analog research environment to meet researchers' needs. Specific discussion topics include mission scenario development, operational tasks, mission timeline integration, stressor implementation, console support, and improvements based on lessons learned. The information is intended to help investigators better understand the details behind HERA operations and the benefits to their research goals.

Navigating the "Research-to-Operations" Bridge of Death: Collaborative Transition of Remotely-Sensed Snow Data from Research into Operational Water Resources Forecasting

NASA Astrophysics Data System (ADS)

Miller, W. P.; Bender, S.; Painter, T. H.; Bernard, B.

2016-12-01

Water and resource management agencies can benefit from hydrologic forecasts during both flood and drought conditions. Improved predictions of seasonal snowmelt-driven runoff volume and timing can assist operational water managers with decision support and efficient resource management within the spring runoff season. Using operational models and forecasting systems, NOAA's Colorado Basin River Forecast Center (CBRFC) produces hydrologic forecasts for stakeholders and water management groups in the western United States. Collaborative incorporation of research-oriented remote sensing data into CBRFC operational models and systems is one route by which CBRFC forecasts can be improved, ultimately for the benefit of water managers. Successful navigation of research-oriented remote sensing products across the "research-to-operations"/R2O gap (also known as the "valley of death") to operational destinations requires dedicated personnel on both the research and operations sides, working in a highly collaborative environment. Since 2012, the operational CBRFC has collaborated with the research-oriented Jet Propulsion Laboratory (JPL) under funding from NASA to transition remotely-sensed snow data into CBRFC's operational models and forecasting systems. Two specific datasets from JPL, the MODIS Dust Radiative Forcing in Snow (MODDRFS) and the MODIS Snow Covered-Area and Grain size (MODSCAG) products, are used in CBRFC operations as of 2016. Over the past several years, JPL and CBRFC have worked together to analyze patterns in JPL's remote sensing snow datasets from the operational perspective of the CBRFC and to develop techniques to bridge the R2O gap. Retrospective and real-time analyses have yielded valuable insight into the remotely-sensed snow datasets themselves, CBRFC's operational systems, and the collaborative R2O process. Examples of research-oriented JPL snow data, as used in CBRFC operations, are described. A timeline of the collaboration, challenges encountered during the journey across the R2O gap, or "valley of death", and solutions to those challenges are also illustrated.

Hanford Laboratories Operation monthly activities report, August 1959

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1959-09-15

This is the monthly report for the Hanford Laboratories Operation, August, 1959. Reactor fuels, chemistry, dosimetry, separation processes, reactor technology financial activities, visits, biology operation, physics and instrumentation research, employee relations, and operations research and synthesis operation are discussed.

Hanford Laboratories Operation monthly activities report, September 1961

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1961-10-16

This is the monthly report for the Hanford Laboratories Operation September 1961. Reactor fuels, chemistry, dosimetry, separation processes, reactor technology, financial activities, biology operation, physics and instrumentation research, operations research and synthesis, programming, and radiation protection operation are discussed.

78 FR 63569 - Proposed Collection; Comment Request for Cognitive and Psychological Research Coordinated by...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... Cognitive and Psychological Research Coordinated by Statistics of Income on Behalf of All IRS Operations... Cognitive and Psychological Research Coordinated by Statistics of Income on Behalf of All IRS Operations...: Cognitive and Psychological Research Coordinated by Statistics of Income on Behalf of All IRS Operations...

75 FR 56657 - Proposed Collection; Comment Request for Cognitive and Psychological Research Coordinated by...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-16

... Cognitive and Psychological Research Coordinated by Statistics of Income on Behalf of All IRS Operations... Cognitive and Psychological Research Coordinated by Statistics of Income on Behalf of All IRS Operations...: Cognitive and Psychological Research Coordinated by Statistics of Income on Behalf of All IRS Operations...

Forecast-Informed Reservoir Operations: Lessons Learned from a Multi-Agency Collaborative Research and Operations Effort to improve Flood Risk Management, Water Supply and Environmental Benefits

NASA Astrophysics Data System (ADS)

Talbot, C. A.; Ralph, M.; Jasperse, J.; Forbis, J.

2017-12-01

Lessons learned from the multi-agency Forecast-Informed Reservoir Operations (FIRO) effort demonstrate how research and observations can inform operations and policy decisions at Federal, State and Local water management agencies with the collaborative engagement and support of researchers, engineers, operators and stakeholders. The FIRO steering committee consists of scientists, engineers and operators from research and operational elements of the National Oceanographic and Atmospheric Administration and the US Army Corps of Engineers, researchers from the US Geological Survey and the US Bureau of Reclamation, the state climatologist from the California Department of Water Resources, the chief engineer from the Sonoma County Water Agency, and the director of the Scripps Institution of Oceanography's Center for Western Weather and Water Extremes at the University of California-San Diego. The FIRO framework also provides a means of testing and demonstrating the benefits of next-generation water cycle observations, understanding and models in water resources operations.

Performance tasks for operator-skills research.

DOT National Transportation Integrated Search

1966-06-01

The selection, development, and operation of several tasks for use in skilled-operator-performance research are described. The tasks are intended, collectively, to sample a broad spectrum of abilities required by complex operator systems; individuall...

Untersuchung des Funktionsumfangs und der fachlichen Grundlagen des LAMBDA Tools (Examination of the functional scope and the technical basics of the LAMBDA- Tools)

DTIC Science & Technology

2017-01-01

Copyrighted. (1 and 20) ABSTRACT (Maximum 200 words) The founding years of Operations Research (OR) are the years just before and during the Second World... Research ............................................................................................. 1 1.2 Teilgebiete des Operations Research ...2 1.3 Madelle des Operations Research

Using full-mission simulation for human factors research in air transport operations

NASA Technical Reports Server (NTRS)

Orlady, Harry W.; Hennessy, Robert W.; Obermayer, Richard; Vreuls, Donald; Murphy, Miles R.

1988-01-01

This study examined state-of-the-art mission oriented simulation and its use in human factors research. Guidelines were developed for doing full-mission human factors research on crew member behavior during simulated air transport operations. The existing literature was reviewed. However, interviews with experienced investigators provided the most useful information. The fundamental scientific and practical issues of behavioral research in a simulation environment are discussed. Guidelines are presented for planning, scenario development, and the execution of behavioral research using full-mission simulation in the context of air transport flight operations . Research is recommended to enhance the validity and productivity of full-mission research by: (1) validating the need for high-fidelity simulation of all major elements in the operational environment, (2) improving methods for conducting full-mission research, and (3) examining part-task research on specific problems through the use of vehicles which contain higher levels of abstraction (and lower fidelity) of the operational environment.

Chemical Processing Department monthly report, September 1956

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1956-10-18

The September, 1956 monthly report for the Chemical Processing Department of Hanford Atomic Products Operation includes information regarding research and engineering efforts with respect to the Purex and Redox process technology. Also discussed is the production operation, finished products operation, power and general maintenance, financial operation, engineering and research operations, and employee operations. (MB)

Chemical Processing Department monthly report, November 1957

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1957-12-23

The November, 1957 monthly report for the Chemical Processing Department of the Hanford Atomic Products Operation includes information regarding research and engineering efforts with respect to the Purex and Redox process technology. Also discussed is the production operation, finished product operation, power and general maintenance, financial operation, engineering and research operations, and employee operation. (MB)

40 CFR 52.272 - Research operations exemptions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 3 2011-07-01 2011-07-01 false Research operations exemptions. 52.272 Section 52.272 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.272 Research operations...

40 CFR 52.272 - Research operations exemptions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 3 2014-07-01 2014-07-01 false Research operations exemptions. 52.272 Section 52.272 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.272 Research operations...

40 CFR 52.272 - Research operations exemptions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 3 2012-07-01 2012-07-01 false Research operations exemptions. 52.272 Section 52.272 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.272 Research operations...

Operational Research during the Ebola Emergency.

PubMed

Fitzpatrick, Gabriel; Decroo, Tom; Draguez, Bertrand; Crestani, Rosa; Ronsse, Axelle; Van den Bergh, Rafael; Van Herp, Michel

2017-07-01

Operational research aims to identify interventions, strategies, or tools that can enhance the quality, effectiveness, or coverage of programs where the research is taking place. Médecins Sans Frontières admitted ≈5,200 patients with confirmed Ebola virus disease during the Ebola outbreak in West Africa and from the beginning nested operational research within its emergency response. This research covered critical areas, such as understanding how the virus spreads, clinical trials, community perceptions, challenges within Ebola treatment centers, and negative effects on non-Ebola healthcare. Importantly, operational research questions were decided to a large extent by returning volunteers who had first-hand knowledge of the immediate issues facing teams in the field. Such a method is appropriate for an emergency medical organization. Many challenges were also identified while carrying out operational research across 3 different countries, including the basic need for collecting data in standardized format to enable comparison of findings among treatment centers.

NATO Code of Best Practice for C2 Assessment (revised)

DTIC Science & Technology

2002-10-01

Based Research, Inc . for the United States Office of Naval Research. These collaboration metrics focus on individual and team cognitive/awareness, team...Troops, Time, and Civil considerations OOTW – Operations Other Than War PESTLE – Political, Economic, Social, Technological, Legal, and Environmental...Operational Analysis OOTW Operations Other Than War OR Operations Research P PESTLE Political, Economic, Social, Technological, Legal, and Environmental

Quality of life and acceptability of medical versus surgical management of early pregnancy failure*

PubMed Central

Harwood, B; Nansel, T

2008-01-01

Objective This study compares quality of life (QOL) and acceptability of medical versus surgical treatment of early pregnancy failure (EPF). Design A randomised clinical trial of treatment for EPF compared misoprostol vaginally versus vacuum aspiration (VA). Setting A multisite trial at four US Urban University Hospitals. Population A total of 652 women with an EPF were randomised to treatment. Methods Participants completed a daily symptom diary and a questionnaire 2 weeks after treatment. Main outcome measures The questionnaire assessment included subscales of the Short Form-36 Health Survey Revised for QOL and measures of wellbeing, recovery difficulties, and treatment acceptability. Results The two groups did not differ in mean scores for QOL except bodily pain; medical treatment was associated with higher levels of bodily pain than VA (P < 0.001). Success of treatment was not related to QOL, but acceptability of the procedure was decreased for medical therapy if unsuccessful (P = 0.003). Type of treatment was not associated with differences in recovery, and the two groups reported similar acceptability except for cramping (P = 0.02), bleeding (P < 0.001), and symptom duration (P = 0.03). Conclusions Despite reporting greater pain and lower acceptability of treatment-related symptoms, QOL and treatment acceptability were similar for medical and surgical treatment of EPF. Acceptability, but not QOL, was influenced by success or failure of medical management. PMID:18271887

Teratogens: a public health issue – a Brazilian overview

PubMed Central

Mazzu-Nascimento, Thiago; Melo, Débora Gusmão; Morbioli, Giorgio Gianini; Carrilho, Emanuel; Vianna, Fernanda Sales Luiz; da Silva, André Anjos; Schuler-Faccini, Lavinia

2017-01-01

Abstract Congenital anomalies are already the second cause of infant mortality in Brazil, as in many other middle-income countries in Latin America. Birth defects are a result of both genetic and environmental factors, but a multifactorial etiology has been more frequently observed. Here, we address the environmental causes of birth defects – or teratogens – as a public health issue and present their mechanisms of action, categories and their respective maternal-fetal deleterious effects. We also present a survey from 2008 to 2013 of Brazilian cases involving congenital anomalies (annual average of 20,205), fetal deaths (annual average of 1,530), infant hospitalizations (annual average of 82,452), number of deaths of hospitalized infants (annual average of 2,175), and the average cost of hospitalizations (annual cost of $7,758). Moreover, we report on Brazilian cases of teratogenesis due to the recent Zika virus infection, and to the use of misoprostol, thalidomide, alcohol and illicit drugs. Special attention has been given to the Zika virus infection, now proven to be responsible for the microcephaly outbreak in Brazil, with 8,039 cases under investigation (from October 2015 to June 2016). From those cases, 1,616 were confirmed and 324 deaths occurred due to microcephaly complications or alterations on the central nervous system. Congenital anomalies impact life quality and raise costs in specialized care, justifying the classification of teratogens as a public health issue. PMID:28534929

Knowledge and provision practices regarding medical abortion among public providers in Hanoi, Khanh Hoa, and Ho Chi Minh City, Vietnam.

PubMed

Ngo, Thoai D; Free, Caroline; Le, Hoan T; Edwards, Phil; Pham, Kiet H T; Nguyen, Yen B T; Nguyen, Thang H

2014-03-01

To assess public service providers' knowledge of medical abortion (MA) and practices, and perspectives on expanding the use of MA to primary and secondary health facilities in Vietnam. A cross-sectional study was conducted via an interviewer-administered questionnaire among abortion providers (n=905) from public health facilities between August 2011 and January 2012. Overall, 31.1% of providers performed both surgical and medical abortions; 68.9% offered only surgical abortion. Providers were knowledgeable about the regimen/dosage of mifepristone plus misoprostol regimen; however, knowledge scores were low for gestational age limits for MA, adverse effects of the combined drug regimen, and safety and effectiveness of MA compared with surgical abortion. Knowledge scores were significantly lower among providers in rural areas than among those in urban settings. A large proportion of providers (82.9%) thought that MA should be expanded to primary and secondary health facilities. Perceived barriers to MA expansion included lack of knowledge and training, qualified staff, adequate drug supplies, equipment, or facilities, guidelines and protocols on MA, and patient awareness. Provision of MA in Vietnam was found to be disproportionate to surgical abortion provision and to vary by region. Knowledge of MA was moderate, but poorer among providers in rural settings. Copyright © 2013 International Federation of Gynecology and Obstetrics. All rights reserved.

PHARMACOLOGICAL TREATMENTS FOR TINNITUS: NEW AND OLD

PubMed Central

Salvi, R.; Lobarinas, E.; Sun, W.

2011-01-01

Subjective tinnitus, the phantom ringing or buzzing sensation that occurs in the absence of sound, affects 12–14% of adults; in some cases the tinnitus is so severe or disabling that patients seek medical treatment. However, although the economic and emotional impact of tinnitus is large, there are currently no FDA-approved drugs to treat this condition. Clinical trials are now underway to evaluate the efficacy of N-methyl-d-aspartate (NMDA) and dopamine D2 antagonists, selective serotonin reuptake inhibitors (SSRIs), γ-aminobutyric acid (GABA) agonists and zinc dietary supplements. Previous off-label clinical studies, while not definitive, suggest that patients with severe depression may experience improvement in their tinnitus after treatment with antidepressants such as nortriptyline or sertraline. A small subpopulation of patients with what has been described as “typewriter tinnitus” have been shown to gain significant relief from the anticonvulsant carbamazepine. Preliminary studies with misoprostol, a synthetic prostaglandin E1 analogue, and sulpiride, a dopamine D2 antagonist, have shown promise. Animal behavioral studies suggest that GABA transaminase inhibitors and potassium channel modulators can suppress tinnitus. Additionally, improvements in tinnitus have also been noted in patients taking melatonin for significant sleep disturbances. Like other complex neurological disorders, one drug is unlikely to resolve tinnitus in all patients; therapies targeting specific subgroups are likely to yield the greatest success. PMID:21765586

Costs of postabortion care in public sector health facilities in Malawi: a cross-sectional survey.

PubMed

Benson, Janie; Gebreselassie, Hailemichael; Mañibo, Maribel Amor; Raisanen, Keris; Johnston, Heidi Bart; Mhango, Chisale; Levandowski, Brooke A

2015-12-17

Health systems could obtain substantial cost savings by providing safe abortion care rather than providing expensive treatment for complications of unsafely performed abortions. This study estimates current health system costs of treating unsafe abortion complications and compares these findings with newly-projected costs for providing safe abortion in Malawi. We conducted in-depth surveys of medications, supplies, and time spent by clinical personnel dedicated to postabortion care (PAC) for three treatment categories (simple, severe non-surgical, and severe surgical complications) and three uterine evacuation (UE) procedure types (manual vacuum aspiration (MVA), dilation and curettage (D&C) and misoprostol-alone) at 15 purposively-selected public health facilities. Per-case treatment costs were calculated and applied to national, annual PAC caseload data. The median cost per D&C case ($63) was 29% higher than MVA treatment ($49). Costs to treat severe non-surgical complications ($63) were almost five times higher than those of a simple PAC case ($13). Severe surgical complications were especially costly to treat at $128. PAC treatment in public facilities cost an estimated $314,000 annually. Transition to safe, legal abortion would yield an estimated cost reduction of 20%-30%. The method of UE and severity of complications have a large impact on overall costs. With a liberalized abortion law and implementation of induced abortion services with WHO-recommended UE methods, current PAC costs to the health system could markedly decrease.

Significant Adverse Events and Outcomes After Medical Abortion

PubMed Central

Cleland, Kelly; Creinin, Mitchell D.; Nucatola, Deborah; Nshom, Montsine; Trussell, James

2013-01-01

Objective To analyze rates of significant adverse events and outcomes in women having a medical abortion at Planned Parenthood health centers in 2009 and 2010, and to identify changes in the rates of adverse events and outcomes between the 2 years. Methods In this database review we analyzed data from Planned Parenthood affiliates that provided medical abortion in 2009 and 2010, almost exclusively using an evidence-based buccal misoprostol regimen. We evaluated the incidence of six clinically significant adverse events (hospital admission, blood transfusion, emergency room treatment, intravenous antibiotics administration, infection, and death) and two significant outcomes (ongoing pregnancy and ectopic pregnancy diagnosed after medical abortion treatment was initiated). We calculated an overall rate as well as rates for each event and identified changes between the 2 years. Results Amongst 233,805 medical abortions provided in 2009 and 2010, significant adverse events or outcomes were reported in 1,530 cases (0.65%). There was no statistically significant difference in overall rates between years. The most common significant outcome was ongoing intrauterine pregnancy (0.50%); significant adverse events occurred in 0.16% of cases. One patient death occurred due to an undiagnosed ectopic pregnancy. Only rates for emergency room treatment and blood transfusion differed by year, and were slightly higher in 2010. Conclusion Review of this large dataset reinforces the safety of the evidence-based medical abortion regimen. PMID:23262942

Medical abortions performed by specialists in private practice.

PubMed

Pay, Aase Serine Devold; Aabø, Runa Sigrid; Økland, Inger; Janbu, Torunn; Iversen, Ole-Erik; Løkeland, Mette

2018-05-29

I Norge utføres abort kun i offentlige sykehus. I 2010 besluttet Helse- og omsorgsdepartementet å iverksette et toårig prøveprosjekt som ga avtalespesialister i fødselshjelp og kvinnesykdommer adgang til å tilby medikamentell abort før utgangen av 9. svangerskapsuke. Prøveprosjektet ble igangsatt 1.3.2015 og varte til 31.3.2017. I denne artikkelen presenterer vi de første erfaringene, herunder hvordan behandlingstilbudet ble mottatt av kvinnene. Gravide med en svangerskapsvarighet < 63 dager ultrasonografisk vurdert, som oppsøkte avtalespesialist for medikamentell abort, ble fortløpende inkludert i prosjektet (n = 476). Kvinnene inntok 200 mg mifepriston peroralt på legekontoret, 36-48 timer senere satte de selv 800 µg misoprostol vaginalt hjemme. Informasjon ble innhentet ved spørreskjema på den første konsultasjonen, under aborten og ved etterkontrollen 2-4 uker etter aborten. Under aborten rapporterte 66 % (296/450) moderat eller sterk smerte og 79 % (358/451) moderat eller sterk blødning. De fleste opplevde det som trygt å være hjemme. 96 % (390/406) ville valgt medikamentell abort hos avtalespesialist ved en eventuell senere abort, og 97 % (392/405) ville anbefalt behandlingstilbudet til andre i samme situasjon. Kvinnene i studien opplevde abortbehandling hos avtalespesialist som trygt. Tilbudet gir større valgfrihet til gravide som ønsker abort, og pasientene er tilfredse.

Implications of the Value of Hydrologic Information to Reservoir Operations--Learning from the Past

ERIC Educational Resources Information Center

Hejazi, Mohamad Issa

2009-01-01

Closing the gap between theoretical reservoir operation and the real-world implementation remains a challenge in contemporary reservoir operations. Past research has focused on optimization algorithms and establishing optimal policies for reservoir operations. In this research, we attempt to understand operators' release decisions by investigating…

From the Research Laboratory to the Operating Company: How Information Travels.

ERIC Educational Resources Information Center

Coppin, Ann S.; Palmer, Linda L.

1980-01-01

Reviews transmission processes of Chevron Oil Field Research Company (COFRC) research results from laboratories to end-user operating companies worldwide. Information dissemination methods described included informal communication, intercompany meetings, visits by COFRC personnel to operating company offices, distribution of written reports,…

Operations

ERIC Educational Resources Information Center

Wilkins, Jesse L. M.; Norton, Anderson; Boyce, Steven J.

2013-01-01

Previous research has documented schemes and operations that undergird students' understanding of fractions. This prior research was based, in large part, on small-group teaching experiments. However, written assessments are needed in order for teachers and researchers to assess students' ways of operating on a whole-class scale. In this study,…

Early serum human chorionic gonadotropin (hCG) trends after medication abortion.

PubMed

Pocius, Katherine D; Maurer, Rie; Fortin, Jennifer; Goldberg, Alisa B; Bartz, Deborah

2015-06-01

Despite increased reliance on human chorionic gonadotropin (hCG) for early pregnancy monitoring, there is limited information about hCG trends soon after medication abortion. The purpose of this study was to determine if there is a predictable decline in serum hCG values shortly after medication abortion. This is a retrospective study of women with early intrauterine pregnancies who underwent medication abortion with mifepristone and misoprostol and had a serum hCG level on Day 1 (day of mifepristone) and a repeat value on Day 2 to 6. The percent hCG decline was calculated from baseline to repeat measure, with repeat values from the same patient accounted for through repeated measure analysis of variance. Eighty-eight women with a mean gestational age of 5.5 weeks and median baseline hCG of 5220 IU met study criteria over a 3-year period. The mean decline (±SD) in hCG from the Day 1 baseline value was 56.9%±29.5% on Day 3, 73.5%±38.6% on Day 4, 86.1%±8.8% on Day 5, and 92.9%±3.4% on Day 6. Eighty-two women (93% of the cohort) had a complete abortion without further intervention. The least square means hCG decline among these women was 57.6% [95% confidence interval (CI): 50.3-64.9%] on Day 3, 78.9% (95% CI: 75.0-82.8%) on Day 4 and 86.2% (95% CI: 81.3-91.1%) on Day 5. There is a rapid decline in serum hCG within the first few days after early medication abortion. Further research is needed to delineate how soon after medication abortion this decline may be specific enough to confirm abortion completion. This study provides the largest cohort of patients followed with serial hCG values in the first few days after medication abortion. Our findings demonstrate the trend in hCG decline in this population, which may be predictable by Day 5. Copyright © 2015 Elsevier Inc. All rights reserved.

Career Profile: Flight Operations Engineer (Airborne Science) Matthew Berry

NASA Image and Video Library

2014-11-05

Operations engineers at NASA's Armstrong Flight Research Center help to advance science, technology, aeronautics, and space exploration by managing operational aspects of a flight research project. They serve as the governing authority on airworthiness related to the modification, operation, or maintenance of specialized research or support aircraft so those aircraft can be flown safely without jeopardizing the pilots, persons on the ground or the flight test project. With extensive aircraft modifications often required to support new research and technology development efforts, operations engineers are key leaders from technical concept to flight to ensure flight safety and mission success. Other responsibilities of an operations engineer include configuration management, performing systems design and integration, system safety analysis, coordinating flight readiness activities, and providing real-time flight support. This video highlights the responsibilities and daily activities of NASA Armstrong operations engineer Matthew Berry during the preparation and execution of flight tests in support of aeronautics research. http://www.nasa.gov/centers/armstrong/home/ http://www.nasa.gov/

Career Profile: Flight Operations Engineer (Aeronautics) Brian Griffin

NASA Image and Video Library

2014-10-17

Operations engineers at NASA's Armstrong Flight Research Center help to advance science, technology, aeronautics, and space exploration by managing operational aspects of a flight research project. They serve as the governing authority on airworthiness related to the modification, operation, or maintenance of specialized research or support aircraft so those aircraft can be flown safely without jeopardizing the pilots, persons on the ground or the flight test project. With extensive aircraft modifications often required to support new research and technology development efforts, operations engineers are key leaders from technical concept to flight to ensure flight safety and mission success. Other responsibilities of an operations engineer include configuration management, performing systems design and integration, system safety analysis, coordinating flight readiness activities, and providing real-time flight support. This video highlights the responsibilities and daily activities of NASA Armstrong operations engineer Brian Griffin during the preparation and execution of flight tests in support of aeronautics research. http://www.nasa.gov/centers/armstrong/home/ http://www.nasa.gov/

SRI’s Tipster 2 Project

DTIC Science & Technology

1996-05-01

Marketing Research USA, a unit of Dun & Bradstreet Corp. He succeeds John H. Costello, who re- signed in March. 1. The N arne Recognizer recognizes the...Information Servicesco operation, will become president and chief operating officer of Nielsen Marketing Research USAco, a unit of Dun...European Information Services operation)NG, [will become)vG [president)NG [and)canj [chief operating officer)NG [of)p [Nielsen Marketing Research USA)NG

Researcher Role in Aviation Operations

DTIC Science & Technology

2016-05-31

Operations and Reports (0704-0188), 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202- 4302. Respondents should be aware that notwithstanding...14-D-6501-0009 Researcher Role in Aviation Operations 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER...the symposium. The overarching goal of the two sessions was to foster a dialogue between operational personnel and researchers towards a safer and more

Measuring Post-Partum Haemorrhage in Low-Resource Settings: The Diagnostic Validity of Weighed Blood Loss versus Quantitative Changes in Hemoglobin

PubMed Central

Atukunda, Esther Cathyln; Mugyenyi, Godfrey Rwambuka; Obua, Celestino; Atuhumuza, Elly Bronney; Musinguzi, Nicholas; Tornes, Yarine Fajardo; Agaba, Amon Ganaafa; Siedner, Mark Jacob

2016-01-01

Background Accurate estimation of blood loss is central to prompt diagnosis and management of post-partum hemorrhage (PPH), which remains a leading cause of maternal mortality in low-resource countries. In such settings, blood loss is often estimated visually and subjectively by attending health workers, due to inconsistent availability of laboratory infrastructure. We evaluated the diagnostic accuracy of weighed blood loss (WBL) versus changes in peri-partum hemoglobin to detect PPH. Methods Data from this analysis were collected as part of a randomized controlled trial comparing oxytocin with misoprostol for PPH (NCT01866241). Blood samples for complete blood count were drawn on admission and again prior to hospital discharge or before blood transfusion. During delivery, women were placed on drapes and had pre-weighed sanitary towels placed around their perineum. Blood was then drained into a calibrated container and the sanitary towels were added to estimate WBL, where each gram of blood was estimated as a milliliter. Sensitivity, specificity, negative and positive predictive values (PPVs) were calculated at various blood volume loss and time combinations, and we fit receiver-operator curves using blood loss at 1, 2, and 24 hours compared to a reference standard of haemoglobin decrease of >10%. Results A total of 1,140 women were enrolled in the study, of whom 258 (22.6%) developed PPH, defined as a haemoglobin drop >10%, and 262 (23.0%) had WBL ≥500mL. WBL generally had a poor sensitivity for detection of PPH (<75% for most volume-time combinations). In contrast, the specificity of WBL was high with blood loss ≥ 500mL at 1h and ≥750mL at any time points excluding PPH in over 97% of women. As such, WBL has a high PPV (>85%) in high prevalence settings when WBL exceeds 750mL. Conclusion WBL has poor sensitivity but high specificity compared to laboratory-based methods of PPH diagnosis. These characteristics correspond to a high PPV in areas with high PPH prevalence. Although WBL is not useful for excluding PPH, this low-cost, simple and reproducible method is promising as a reasonable method to identify significant PPH in such settings where quantifiable red cell indices are unavailable. PMID:27050823

Research to Operations: The Critical Transition

NASA Technical Reports Server (NTRS)

Fogarty, Jennifer A.

2009-01-01

Space Life Sciences Directorate (SLSD) specializes in transitioning technology and knowledge to medical operations. This activity encompasses funding a spectrum of research and technology efforts, such as understanding fundamental biological mechanisms altered by microgravity and executing technology watches for state of the art diagnostic imaging equipment. This broad spectrum approach to fulfilling the need to protect crewmember health and performance during long and short duration missions to the International Space Station, moon and Mars is made possible by having a line of site between research and operations. Currently, SLSD's line of site is articulated in a transition to medical practice (TMP) process. This process is designed to shepherd information and knowledge gained through fundamental and mechanistic research toward the development of an operational solution such as a pre-flight selection criteria; an in-flight countermeasure, monitoring capability or treatment; or a post-flight reconditioning program. The TMP process is also designed to assist with the customization of mature hardware or technology for NASA specific use. The benefits of this process are that the concept of operational usability is interjected early in the research, design, or acquisition phase, and stakeholders are involved early to identify requirements and also periodically asked to assess requirements compliance of research or technology development project. Currently a device known as the actiwatch is being assessed for the final transition to operational use. Specific examples of research to operations transition success help to illustrate the process and bolster communication between the research and medical operations communities.

Ethics and Accountability: Participatory Research in a Worker Co-Operative.

ERIC Educational Resources Information Center

Mellor, Mary

1988-01-01

The author describes a participatory research project that took place in a garment workers' co-operative. The project's purpose was to record the history and working relationships of the co-operative in an attempt to help similar ventures. Problems of participatory research are considered. (CH)

Surface Operations Systems Improve Airport Efficiency

NASA Technical Reports Server (NTRS)

2009-01-01

With Small Business Innovation Research (SBIR) contracts from Ames Research Center, Mosaic ATM of Leesburg, Virginia created software to analyze surface operations at airports. Surface surveillance systems, which report locations every second for thousands of air and ground vehicles, generate massive amounts of data, making gathering and analyzing this information difficult. Mosaic?s Surface Operations Data Analysis and Adaptation (SODAA) tool is an off-line support tool that can analyze how well the airport surface operation is working and can help redesign procedures to improve operations. SODAA helps researchers pinpoint trends and correlations in vast amounts of recorded airport operations data.

Supporting Operational Data Assimilation Capabilities to the Research Community

NASA Astrophysics Data System (ADS)

Shao, H.; Hu, M.; Stark, D. R.; Zhou, C.; Beck, J.; Ge, G.

2017-12-01

The Developmental Testbed Center (DTC), in partnership with the National Centers for Environmental Prediction (NCEP) and other operational and research institutions, provides operational data assimilation capabilities to the research community and helps transition research advances to operations. The primary data assimilation system supported currently by the DTC is the Gridpoint Statistical Interpolation (GSI) system and the National Oceanic and Atmospheric Administration (NOAA) Ensemble Kalman Filter (EnKF) system. GSI is a variational based system being used for daily operations at NOAA, NCEP, the National Aeronautics and Space Administration, and other operational agencies. Recently, GSI has evolved into a four-dimensional EnVar system. Since 2009, the DTC has been releasing the GSI code to the research community annually and providing user support. In addition to GSI, the DTC, in 2015, began supporting the ensemble based EnKF data assimilation system. EnKF shares the observation operator with GSI and therefore, just as GSI, can assimilate both conventional and non-conventional data (e.g., satellite radiance). Currently, EnKF is being implemented as part of the GSI based hybrid EnVar system for NCEP Global Forecast System operations. This paper will summarize the current code management and support framework for these two systems. Following that is a description of available community services and facilities. Also presented is the pathway for researchers to contribute their development to the daily operations of these data assimilation systems.

Applications of Operations Research Techniques in Tufts University Libraries.

ERIC Educational Resources Information Center

Rouse, William B., Ed.

This collection of papers is based on projects done in conjunction with a senior level/graduate course, "Applications of Operations Research Techniques in Systems Engineering." These seven papers describe research studies which utilized user surveys and/or statistical methods to analyze various library operations. The papers are…

Career Profile: Flight Operations Engineer (Airborne Science) Robert Rivera

NASA Image and Video Library

2015-05-14

Operations engineers at NASA's Armstrong Flight Research Center help to advance science, technology, aeronautics, and space exploration by managing operational aspects of a flight research project. They serve as the governing authority on airworthiness related to the modification, operation, or maintenance of specialized research or support aircraft so those aircraft can be flown safely without jeopardizing the pilots, persons on the ground or the flight test project. With extensive aircraft modifications often required to support new research and technology development efforts, operations engineers are key leaders from technical concept to flight to ensure flight safety and mission success. Other responsibilities of an operations engineer include configuration management, performing systems design and integration, system safety analysis, coordinating flight readiness activities, and providing real-time flight support. This video highlights the responsibilities and daily activities of NASA Armstrong operations engineer Robert Rivera during the preparation and execution of the Global Hawk airborne missions under NASA's Science Mission Directorate.

Using Pair Wise Rankings in the Assessment of Adaptive Aiding

DTIC Science & Technology

2017-02-22

Aviation Psychology (ISAP) 9 – 11 May 2017 14. ABSTRACT In remotely piloted aircraft (RPA) operations, operator cognitive workload is an important concern...Force Research Laboratory Wright-Patterson AFB, Ohio In remotely piloted aircraft (RPA) operations, operator cognitive workload is an important...model in future research. Operator cognitive workload is an important concern in remotely piloted aircraft (RPA) operations. RPA use is

ICAO RPAS Symposium: NASA RPAS Operational and Research Activities

NASA Technical Reports Server (NTRS)

Johnson, Chuck

2017-01-01

NASA RPAS Operational and Research Activities presentation discusses the UAS flight operations. UAS vehicles are discussed along with the missions they supported. This is a high level overview of UAS operations at NASA being presented to the RPAS (Remotely Piloted Aircraft Systems) Symposium.

Consensus Statement on Advancing Research in Emergency Department Operations and Its Impact on Patient Care

PubMed Central

Ward, Michael J.; Chang, Anna Marie; Pines, Jesse M.; Jouriles, Nick; Yealy, Donald M.

2016-01-01

The Consensus Conference on “Advancing Research in Emergency Department (ED) Operations and Its Impact on Patient Care,” hosted by The ED Operations Study Group (EDOSG), convened to craft a framework for future investigations in this important but underserved area. The EDOSG is a research consortium dedicated to promoting evidence based clinical practice in Emergency Medicine. The consensus process format was a modified version of the NIH Model for Consensus Conference Development. Recommendations provide an action plan for how to improve ED operations study design, create a facilitating research environment, identify data measures of value for process and outcomes research, and disseminate new knowledge in this area. Specifically, we called for eight key initiatives: 1) the development of universal measures for ED patient care processes; 2) attention to patient outcomes, in addition to process efficiency and best practice compliance; 3) the promotion of multi-site clinical operations studies to create more generalizable knowledge; 4) encouraging the use of mixed methods to understand the social community and human behavior factors that influence ED operations; 5) the creation of robust ED operations research registries to drive stronger evidence based research, 6) prioritizing key clinical questions with the input of patients, clinicians, medical leadership, emergency medicine organizations, payers, and other government stakeholders; 7) more consistently defining the functional components of the ED care system including observation units, fast tracks, waiting rooms, laboratories and radiology sub-units; and 8) maximizing multidisciplinary knowledge dissemination via emergency medicine, public health, general medicine, operations research and nontraditional publications. PMID:26014365

Consensus statement on advancing research in emergency department operations and its impact on patient care.

PubMed

Yiadom, Maame Yaa A B; Ward, Michael J; Chang, Anna Marie; Pines, Jesse M; Jouriles, Nick; Yealy, Donald M

2015-06-01

The consensus conference on "Advancing Research in Emergency Department (ED) Operations and Its Impact on Patient Care," hosted by The ED Operations Study Group (EDOSG), convened to craft a framework for future investigations in this important but understudied area. The EDOSG is a research consortium dedicated to promoting evidence-based clinical practice in emergency medicine. The consensus process format was a modified version of the NIH Model for Consensus Conference Development. Recommendations provide an action plan for how to improve ED operations study design, create a facilitating research environment, identify data measures of value for process and outcomes research, and disseminate new knowledge in this area. Specifically, we call for eight key initiatives: 1) the development of universal measures for ED patient care processes; 2) attention to patient outcomes, in addition to process efficiency and best practice compliance; 3) the promotion of multisite clinical operations studies to create more generalizable knowledge; 4) encouraging the use of mixed methods to understand the social community and human behavior factors that influence ED operations; 5) the creation of robust ED operations research registries to drive stronger evidence-based research; 6) prioritizing key clinical questions with the input of patients, clinicians, medical leadership, emergency medicine organizations, payers, and other government stakeholders; 7) more consistently defining the functional components of the ED care system, including observation units, fast tracks, waiting rooms, laboratories, and radiology subunits; and 8) maximizing multidisciplinary knowledge dissemination via emergency medicine, public health, general medicine, operations research, and nontraditional publications. © 2015 by the Society for Academic Emergency Medicine.

IBM Applications and Techniques of Operations Research. A Selected Bibliography.

ERIC Educational Resources Information Center

International Business Machines Corp., White Plains, NY. Data Processing Div.

This bibliography on the tools and applications of operations research, management science, industrial engineering, and systems engineering lists many entries which appeared between 1961 and 1966 in 186 periodicals and trade journals. Twenty-six texts in operations research are also listed along with an indication as to which of 37 techniques or…

Towards Autonomous Airport Surface Operations: NextGen Flight Deck Implications

NASA Technical Reports Server (NTRS)

Foyle, David C.; Hooey, Becky Lee; Bakowski, Deborah Lee

2017-01-01

Surface Trajectory-based Operations (STBO) is a potential concept candidate for flight deck autonomous operations. Existing research will be reviewed and possible architectures and research issues will be presented.

Transport systems research vehicle color display system operations manual

NASA Technical Reports Server (NTRS)

Easley, Wesley C.; Johnson, Larry E.

1989-01-01

A recent upgrade of the Transport Systems Research Vehicle operated by the Advanced Transport Operating Systems Program Office at the NASA Langley Research Center has resulted in an all-glass panel in the research flight deck. Eight ARINC-D size CRT color displays make up the panel. A major goal of the display upgrade effort was ease of operation and maintenance of the hardware while maintaining versatility needed for flight research. Software is the key to this required versatility and will be the area demanding the most detailed technical design expertise. This document is is intended to serve as a single source of quick reference information needed for routine operation and system level maintenance. Detailed maintenance and modification of the display system will require specific design documentation and must be accomplished by individuals with specialized knowledge and experience.

The Automation-by-Expertise-by-Training Interaction.

PubMed

Strauch, Barry

2017-03-01

I introduce the automation-by-expertise-by-training interaction in automated systems and discuss its influence on operator performance. Transportation accidents that, across a 30-year interval demonstrated identical automation-related operator errors, suggest a need to reexamine traditional views of automation. I review accident investigation reports, regulator studies, and literature on human computer interaction, expertise, and training and discuss how failing to attend to the interaction of automation, expertise level, and training has enabled operators to commit identical automation-related errors. Automated systems continue to provide capabilities exceeding operators' need for effective system operation and provide interfaces that can hinder, rather than enhance, operator automation-related situation awareness. Because of limitations in time and resources, training programs do not provide operators the expertise needed to effectively operate these automated systems, requiring them to obtain the expertise ad hoc during system operations. As a result, many do not acquire necessary automation-related system expertise. Integrating automation with expected operator expertise levels, and within training programs that provide operators the necessary automation expertise, can reduce opportunities for automation-related operator errors. Research to address the automation-by-expertise-by-training interaction is needed. However, such research must meet challenges inherent to examining realistic sociotechnical system automation features with representative samples of operators, perhaps by using observational and ethnographic research. Research in this domain should improve the integration of design and training and, it is hoped, enhance operator performance.

Reduced Crew Operations Research at NASA Ames Research Center

NASA Technical Reports Server (NTRS)

Brandt, Summer L.; Lachter, Joel

2017-01-01

In 2012, NASA began exploring the feasibility of single pilot reduced crew operations (SPORCO) in the context of scheduled passenger air carrier operations (i.e., Parts 121 and 135). This research was spurred by two trends in aviation research: the trend toward reducing costs and a shortage of pilots. A series of simulations were conducted to develop tools and a concept of operations to support RCO. This slide deck is a summary of the NASA Ames RCO research prepared for an R T team at Airbus. Airbus is considering moving forward with reducing crew during the cruise phase of flight with long-haul flights and is interested in the work we have completed.

27 CFR 19.34 - Experimental or research operations by scientific institutions and colleges of learning.

Code of Federal Regulations, 2013 CFR

2013-04-01

... operations by scientific institutions and colleges of learning. 19.34 Section 19.34 Alcohol, Tobacco Products... SPIRITS PLANTS Administrative and Miscellaneous Provisions Alternate Methods Or Procedures and Experimental Operations § 19.34 Experimental or research operations by scientific institutions and colleges of...

27 CFR 19.34 - Experimental or research operations by scientific institutions and colleges of learning.

Code of Federal Regulations, 2014 CFR

2014-04-01

... operations by scientific institutions and colleges of learning. 19.34 Section 19.34 Alcohol, Tobacco Products... SPIRITS PLANTS Administrative and Miscellaneous Provisions Alternate Methods Or Procedures and Experimental Operations § 19.34 Experimental or research operations by scientific institutions and colleges of...

27 CFR 19.34 - Experimental or research operations by scientific institutions and colleges of learning.

Code of Federal Regulations, 2012 CFR

2012-04-01

... operations by scientific institutions and colleges of learning. 19.34 Section 19.34 Alcohol, Tobacco Products... SPIRITS PLANTS Administrative and Miscellaneous Provisions Alternate Methods Or Procedures and Experimental Operations § 19.34 Experimental or research operations by scientific institutions and colleges of...

40 CFR 60.4390 - What are my reporting requirements if I operate an emergency combustion turbine or a research and...

Code of Federal Regulations, 2011 CFR

2011-07-01

... operate an emergency combustion turbine or a research and development turbine? 60.4390 Section 60.4390... PERFORMANCE FOR NEW STATIONARY SOURCES Standards of Performance for Stationary Combustion Turbines Reporting § 60.4390 What are my reporting requirements if I operate an emergency combustion turbine or a research...

40 CFR 60.4390 - What are my reporting requirements if I operate an emergency combustion turbine or a research and...

Code of Federal Regulations, 2010 CFR

2010-07-01

... operate an emergency combustion turbine or a research and development turbine? 60.4390 Section 60.4390... PERFORMANCE FOR NEW STATIONARY SOURCES Standards of Performance for Stationary Combustion Turbines Reporting § 60.4390 What are my reporting requirements if I operate an emergency combustion turbine or a research...

40 CFR 60.4390 - What are my reporting requirements if I operate an emergency combustion turbine or a research and...

Code of Federal Regulations, 2012 CFR

2012-07-01

... operate an emergency combustion turbine or a research and development turbine? 60.4390 Section 60.4390... PERFORMANCE FOR NEW STATIONARY SOURCES Standards of Performance for Stationary Combustion Turbines Reporting § 60.4390 What are my reporting requirements if I operate an emergency combustion turbine or a research...

40 CFR 60.4390 - What are my reporting requirements if I operate an emergency combustion turbine or a research and...

Code of Federal Regulations, 2014 CFR

2014-07-01

... operate an emergency combustion turbine or a research and development turbine? 60.4390 Section 60.4390... PERFORMANCE FOR NEW STATIONARY SOURCES Standards of Performance for Stationary Combustion Turbines Reporting § 60.4390 What are my reporting requirements if I operate an emergency combustion turbine or a research...

40 CFR 60.4390 - What are my reporting requirements if I operate an emergency combustion turbine or a research and...

Code of Federal Regulations, 2013 CFR

2013-07-01

... operate an emergency combustion turbine or a research and development turbine? 60.4390 Section 60.4390... PERFORMANCE FOR NEW STATIONARY SOURCES Standards of Performance for Stationary Combustion Turbines Reporting § 60.4390 What are my reporting requirements if I operate an emergency combustion turbine or a research...

NATO Guide for Judgement-Based Operational Analysis in Defence Decision Making (Guide OTAN pour l’analyse operationnelle basee sur le jugement dans la prise de decision de defense). Analyst-Oriented Volume: Code of Best Practice for Soft Operational Analysis

DTIC Science & Technology

2012-06-01

Military Operational Research , with special theme ‘The use of ‘soft’ methods in OR’. OR52 (7 – 9 September 2010, Royal Holloway University of London...on human judgement. Judgement-based OA applies the methods of ‘Soft Operational Research ’ developed in academia. It has appeared, however, that the...similarity between judgemental methods in operational research practice and a number of other modes of professional analytical practice. The closest

Intelligent command and control systems for satellite ground operations

NASA Technical Reports Server (NTRS)

Mitchell, Christine M.

1994-01-01

The Georgia Tech portion of the Intelligent Control Center project includes several complementary activities. Two major activities entail thesis level research; the other activities are either support activities or preliminary explorations (e.g., task analyses) to support the research. The first research activity is the development of principles for the design of active interfaces to support monitoring during real-time supports. It is well known that as the operator's task becomes less active, i.e., more monitoring and less active control, there is concern that the operator will be less involved and less able to rapidly identify anomalous or failure situations. The research project to design active monitoring interfaces is an attempt to remediate this undesirable side-effect of increasingly automated control systems that still depend ultimately on operator supervision. The second research activity is the exploration of the use of case-based reasoning as a way to accumulate operator experience and make it available in computational form.

Reporting guidelines for implementation and operational research.

PubMed

Hales, Simon; Lesher-Trevino, Ana; Ford, Nathan; Maher, Dermot; Ramsay, Andrew; Tran, Nhan

2016-01-01

In public health, implementation research is done to improve access to interventions that have been shown to work but have not reached many of the people who could benefit from them. Researchers identify practical problems facing public health programmes and aim to find solutions that improve health outcomes. In operational research, routinely-collected programme data are used to uncover ways of delivering more effective, efficient and equitable health care. As implementation research can address many types of questions, many research designs may be appropriate. Existing reporting guidelines partially cover the methods used in implementation and operational research, so we ran a consultation through the World Health Organization (WHO), the Alliance for Health Policy & Systems Research (AHPSR) and the Special Programme for Research and Training in Tropical Diseases (TDR) and developed guidelines to facilitate the funding, conduct, review and publishing of such studies. Our intention is to provide a practical reference for funders, researchers, policymakers, implementers, reviewers and editors working with implementation and operational research. This is an evolving field, so we plan to monitor the use of these guidelines and develop future versions as required.

Learning on the Move, OSS Detachment 101 Special Operations in Burma

DTIC Science & Technology

2015-06-12

directives while others advocated for coastal operations closer to Rangoon in Southern Burma to achieve greater psychological effects against the...of the Environment PR Personnel Recovery PSYOP Psychological Operations R&A OSS Research and Analysis Branch R&D OSS Research and Development...actions would serve as shaping effects for larger conventional operations. Modern US Army Special Operations doctrine further supports this

Benefits and challenges of health information systems for operations research: an illustrative example to improve surgical scheduling.

PubMed

Chow, Vincent S; Huang, Wenhai; Puterman, Martin L

2009-01-01

Operations research (OR) is playing an increasing role in the support of many health care initiatives. However one of the main challenges facing OR practitioners is the availability and the integrity of operations data. Hospital information systems (HIS) are often designed with a clinical or accounting focus and may lack the data necessary for operational studies. In this paper, we illustrate the data processing methods and data challenges faced by our team during a study of surgical scheduling practices at the Vancouver Island Health Authority. We also provide some general recommendations to improve HIS from an operations perspective. In general, more integration between operations researchers and HIS specialists are required to support ongoing operational improvements in the health care sector.

Cognitive Systems Modeling and Analysis of Command and Control Systems

NASA Technical Reports Server (NTRS)

Norlander, Arne

2012-01-01

Military operations, counter-terrorism operations and emergency response often oblige operators and commanders to operate within distributed organizations and systems for safe and effective mission accomplishment. Tactical commanders and operators frequently encounter violent threats and critical demands on cognitive capacity and reaction time. In the future they will make decisions in situations where operational and system characteristics are highly dynamic and non-linear, i.e. minor events, decisions or actions may have serious and irreversible consequences for the entire mission. Commanders and other decision makers must manage true real time properties at all levels; individual operators, stand-alone technical systems, higher-order integrated human-machine systems and joint operations forces alike. Coping with these conditions in performance assessment, system development and operational testing is a challenge for both practitioners and researchers. This paper reports on research from which the results led to a breakthrough: An integrated approach to information-centered systems analysis to support future command and control systems research development. This approach integrates several areas of research into a coherent framework, Action Control Theory (ACT). It comprises measurement techniques and methodological advances that facilitate a more accurate and deeper understanding of the operational environment, its agents, actors and effectors, generating new and updated models. This in turn generates theoretical advances. Some good examples of successful approaches are found in the research areas of cognitive systems engineering, systems theory, and psychophysiology, and in the fields of dynamic, distributed decision making and naturalistic decision making.

There Is an Alternative: A Report on an Action Research Project to Develop a Framework for Co-Operative Higher Education

ERIC Educational Resources Information Center

Neary, Mike; Winn, Joss

2017-01-01

This report provides an interim account of a participatory action research project undertaken during 2015-16. The research brought together scholars, students and expert members of the co-operative movement to design a theoretically informed and practically grounded framework for co-operative higher education that activists, educators and the…

Ten Years of Spatial Disorientation in U.S. Army Rotary-Wing Operations (Reprint)

DTIC Science & Technology

2012-10-01

and reinforces the importance and relevance of SD awareness, research, education , and training in RW operations. Aviation, Space, and Environmental...and relevance of SD awareness, research, education , and training in RW operations. Keywords: spatial disorientation , aircraft accidents...generally included the areas of awareness, research, education and training, and technological initiatives. A thorough treatment of this subject is

Utilising Enterprise Risk Management Strategies to Develop a Governance and Operations Framework for a New Research Complex: A Case Study

ERIC Educational Resources Information Center

Clyde-Smith, Jodi

2014-01-01

Enterprise risk management strategies were used to develop a regulatory and operational framework for a new multi-partner Research Institute that will house up to 900 staff from four different institutions in Queensland, Australia. The Institute will operate in a business environment while functioning as a research resource for the higher…

Efficient, quality-assured data capture in operational research through innovative use of open-access technology

PubMed Central

Naik, B.; Guddemane, D. K.; Bhat, P.; Wilson, N.; Sreenivas, A. N.; Lauritsen, J. M.; Rieder, H. L.

2013-01-01

Ensuring quality of data during electronic data capture has been one of the most neglected components of operational research. Multicentre studies are also challenged with issues about logistics of travel, training, supervision, monitoring and troubleshooting support. Allocating resources to these issues can pose a significant bottleneck for operational research in resource-limited settings. In this article, we describe an innovative and efficient way of coordinating data capture in multicentre operational research using a combination of three open access technologies—EpiData for data capture, Dropbox for sharing files and TeamViewer for providing remote support. PMID:26392997

Railroad operations research and training.

DOT National Transportation Integrated Search

2014-07-01

This research is necessary to address training and research needs for railroads. Very few institutions provide instruction in railroad engineering, operations or management. With increasing government regulation there is a need for Class I railroads,...

Aberration-Corrected STEM Imaging Through Off-Site Remote Operation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jarvis, Karalee; Allard Jr, Lawrence Frederick; Jerome, Timothy Y

2010-01-01

Recent advances in aberration-corrected electron microscopy have allowed researchers to image materials at sub- ngstr m resolution. Many of these modern instruments are designed to be operated from separate 'control' rooms, removing the effect of the operator on the instrument s physical environment. This capability also allows operation from suitable workstations, over internet connections, from literally anywhere in the world [1]. Researchers at the University of Texas at Austin (UTA) have collaborated with Oak Ridge National Laboratory (ORNL) and JEOL Ltd. to routinely conduct research sessions in which high-resolution images and X-ray microanalytical data are acquired during after-hours research sessions,more » utilizing the JEOL 2200FS aberration-corrected STEM/TEM at ORNL from their lab in Austin. Details of the remote operation are presented here.« less

Science Based Human Reliability Analysis: Using Digital Nuclear Power Plant Simulators for Human Reliability Research

NASA Astrophysics Data System (ADS)

Shirley, Rachel Elizabeth

Nuclear power plant (NPP) simulators are proliferating in academic research institutions and national laboratories in response to the availability of affordable, digital simulator platforms. Accompanying the new research facilities is a renewed interest in using data collected in NPP simulators for Human Reliability Analysis (HRA) research. An experiment conducted in The Ohio State University (OSU) NPP Simulator Facility develops data collection methods and analytical tools to improve use of simulator data in HRA. In the pilot experiment, student operators respond to design basis accidents in the OSU NPP Simulator Facility. Thirty-three undergraduate and graduate engineering students participated in the research. Following each accident scenario, student operators completed a survey about perceived simulator biases and watched a video of the scenario. During the video, they periodically recorded their perceived strength of significant Performance Shaping Factors (PSFs) such as Stress. This dissertation reviews three aspects of simulator-based research using the data collected in the OSU NPP Simulator Facility: First, a qualitative comparison of student operator performance to computer simulations of expected operator performance generated by the Information Decision Action Crew (IDAC) HRA method. Areas of comparison include procedure steps, timing of operator actions, and PSFs. Second, development of a quantitative model of the simulator bias introduced by the simulator environment. Two types of bias are defined: Environmental Bias and Motivational Bias. This research examines Motivational Bias--that is, the effect of the simulator environment on an operator's motivations, goals, and priorities. A bias causal map is introduced to model motivational bias interactions in the OSU experiment. Data collected in the OSU NPP Simulator Facility are analyzed using Structural Equation Modeling (SEM). Data include crew characteristics, operator surveys, and time to recognize and diagnose the accident in the scenario. These models estimate how the effects of the scenario conditions are mediated by simulator bias, and demonstrate how to quantify the strength of the simulator bias. Third, development of a quantitative model of subjective PSFs based on objective data (plant parameters, alarms, etc.) and PSF values reported by student operators. The objective PSF model is based on the PSF network in the IDAC HRA method. The final model is a mixed effects Bayesian hierarchical linear regression model. The subjective PSF model includes three factors: The Environmental PSF, the simulator Bias, and the Context. The Environmental Bias is mediated by an operator sensitivity coefficient that captures the variation in operator reactions to plant conditions. The data collected in the pilot experiments are not expected to reflect professional NPP operator performance, because the students are still novice operators. However, the models used in this research and the methods developed to analyze them demonstrate how to consider simulator bias in experiment design and how to use simulator data to enhance the technical basis of a complex HRA method. The contributions of the research include a framework for discussing simulator bias, a quantitative method for estimating simulator bias, a method for obtaining operator-reported PSF values, and a quantitative method for incorporating the variability in operator perception into PSF models. The research demonstrates applications of Structural Equation Modeling and hierarchical Bayesian linear regression models in HRA. Finally, the research demonstrates the benefits of using student operators as a test platform for HRA research.

Vision-based aircraft guidance

NASA Technical Reports Server (NTRS)

Menon, P. K.

1993-01-01

Early research on the development of machine vision algorithms to serve as pilot aids in aircraft flight operations is discussed. The research is useful for synthesizing new cockpit instrumentation that can enhance flight safety and efficiency. With the present work as the basis, future research will produce low-cost instrument by integrating a conventional TV camera together with off-the=shelf digitizing hardware for flight test verification. Initial focus of the research will be on developing pilot aids for clear-night operations. Latter part of the research will examine synthetic vision issues for poor visibility flight operations. Both research efforts will contribute towards the high-speed civil transport aircraft program. It is anticipated that the research reported here will also produce pilot aids for conducting helicopter flight operations during emergency search and rescue. The primary emphasis of the present research effort is on near-term, flight demonstrable technologies. This report discusses pilot aids for night landing and takeoff and synthetic vision as an aid to low visibility landing.

A Fault-Oblivious Extreme-Scale Execution Environment (FOX)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Van Hensbergen, Eric; Speight, William; Xenidis, Jimi

IBM Research’s contribution to the Fault Oblivious Extreme-scale Execution Environment (FOX) revolved around three core research deliverables: • collaboration with Boston University around the Kittyhawk cloud infrastructure which both enabled a development and deployment platform for the project team and provided a fault-injection testbed to evaluate prototypes • operating systems research focused on exploring role-based operating system technologies through collaboration with Sandia National Labs on the NIX research operating system and collaboration with the broader IBM Research community around a hybrid operating system model which became known as FusedOS • IBM Research also participated in an advisory capacity with themore » Boston University SESA project, the core of which was derived from the K42 operating system research project funded in part by DARPA’s HPCS program. Both of these contributions were built on a foundation of previous operating systems research funding by the Department of Energy’s FastOS Program. Through the course of the X-stack funding we were able to develop prototypes, deploy them on production clusters at scale, and make them available to other researchers. As newer hardware, in the form of BlueGene/Q, came online, we were able to port the prototypes to the new hardware and release the source code for the resulting prototypes as open source to the community. In addition to the open source coded for the Kittyhawk and NIX prototypes, we were able to bring the BlueGene/Q Linux patches up to a more recent kernel and contribute them for inclusion by the broader Linux community. The lasting impact of the IBM Research work on FOX can be seen in its effect on the shift of IBM’s approach to HPC operating systems from Linux and Compute Node Kernels to role-based approaches as prototyped by the NIX and FusedOS work. This impact can be seen beyond IBM in follow-on ideas being incorporated into the proposals for the Exasacale Operating Systems/Runtime program.« less

Rapid Transit Car Maintenance Research Needs

DOT National Transportation Integrated Search

1982-12-01

This report identifies those car maintenance research needs that (in the judgement of the participating rail transit operators and suppliers) would produce results that would be applicable industry wide. Those research products should assist the oper...

Instructional Developer as Content Specialist: Three Case Studies Utilizing the Instructional Development-Operations Research Model.

ERIC Educational Resources Information Center

Faust, Stephen M.

1980-01-01

Presents a 3-phase model (content research, specification, delivery) for instructional development-operations research and describes its application in developing courses in zoology, geology, and paleontology. (MER)

Research and technology operating plan summary: Fiscal year 1975 research and technology program. [space programs, energy technology, and aerospace sciences

NASA Technical Reports Server (NTRS)

1975-01-01

Summaries are presented of Research and Technology Operating Plans currently in progress throughout NASA. Citations and abstracts of the operating plans are presented along with a subject index, technical monitor index, and responsible NASA organization index. Research programs presented include those carried out in the Office of Aeronautics and Space Technology, Office of Energy Programs, Office of Applications, Office of Space Sciences, Office of Tracking and Data Acquisition, and the Office of Manned Space Flight.

Practice Guidelines for Operative Performance Assessments.

PubMed

Williams, Reed G; Kim, Michael J; Dunnington, Gary L

2016-12-01

To provide recommended practice guidelines for assessing single operative performances and for combining results of operative performance assessments into estimates of overall operative performance ability. Operative performance is one defining characteristic of surgeons. Assessment of operative performance is needed to provide feedback with learning benefits to surgical residents in training and to assist in making progress decisions for residents. Operative performance assessment has been a focus of investigation over the past 20 years. This review is designed to integrate findings of this research into a set of recommended operative performance practices. Literature from surgery and from other pertinent research areas (psychology, education, business) was reviewed looking for evidence to inform practice guideline development. Guidelines were created along with a conceptual and scientific foundation for each guideline. Ten guidelines are provided for assessing individual operative performances and 10 are provided for combing data from individual operative performances into overall judgments of operative performance ability. The practice guidelines organize available information to be immediately useful to program directors, to support surgical training, and to provide a conceptual framework upon which to build as the base of pertinent knowledge expands through future research and development efforts.

Applying Web-Based Tools for Research, Engineering, and Operations

NASA Technical Reports Server (NTRS)

Ivancic, William D.

2011-01-01

Personnel in the NASA Glenn Research Center Network and Architectures branch have performed a variety of research related to space-based sensor webs, network centric operations, security and delay tolerant networking (DTN). Quality documentation and communications, real-time monitoring and information dissemination are critical in order to perform quality research while maintaining low cost and utilizing multiple remote systems. This has been accomplished using a variety of Internet technologies often operating simultaneously. This paper describes important features of various technologies and provides a number of real-world examples of how combining Internet technologies can enable a virtual team to act efficiently as one unit to perform advanced research in operational systems. Finally, real and potential abuses of power and manipulation of information and information access is addressed.

Abortion choices among women in Cambodia after introduction of a socially marketed medicated abortion product.

PubMed

Sotheary, Khim; Long, Dianna; Mundy, Gary; Madan, Yasmin; Blumenthal, Paul D

2017-02-01

To assess whether a social marketing initiative focusing on medicated abortion via a mifepristone/misoprostol "combipack" has contributed to reducing unsafe abortion in Cambodia. In a questionnaire-based cross-sectional study, annual household surveys were conducted across 13 Cambodian provinces in 2010, 2011, and 2012. One married woman of reproductive age who was not pregnant and did not wish to be within the next 2 years in each randomly selected household was approached for inclusion. Participants were interviewed using a structured questionnaire. The questionnaire was completed by 1843 women in 2010, 2068 in 2011, and 2059 in 2012. Manual vacuum aspiration was reported by 61 (72.6%) of 84 women surveyed in 2010 who reported an abortion in the previous 12 months, compared with only 28 (52.8%) of 53 in 2012 (P=0.001). The numbers of women undergoing medicated abortion increased from 22 (26.2%) of 84 in 2010 to 27 (49.1%) of 53 in 2012 (P=0.003), whereas the numbers undergoing unsafe abortion decreased from 4 (4.8%) in 2010 to 0 in 2012 (P=0.051). Social marketing of medication abortion coupled with provider training in clinical and behavioral change could have contributed to a reduction in the prevalence of unsafe abortion and shifted the types of abortion performed in Cambodia, while not increasing the overall number of abortions. © 2016 International Federation of Gynecology and Obstetrics.

Gastroprotective effect of Piper betle Linn. leaves grown in Sri Lanka.

PubMed

Arawwawala, L D A M; Arambewela, L S R; Ratnasooriya, W D

2014-01-01

Piper betle Linn. (Piperaceae) is used as a remedy for gastric ulcers in traditional medicinal systems in Sri Lanka. However, the gastroprotective activity has never been proven scientifically using betel leaves grown in Sri Lanka. To evaluate the gastroprotective activity of hot aqueous extract (HAE) and cold ethanolic extract (CEE) of P. betle in rats as the experimental model. Three doses (200, 300, and 500 mg/kg/bw) of both extracts were evaluated for the gastroprotective activity against ethanol induced gastric ulcers in rats. The parameters evaluated were (a) effects of HAE on mucus content adhering to the wall of the gastric mucosa, (b) acidity (total and free), (c) volume and (d) pH of the gastric juice. ORAL ADMINISTRATION OF HAE AND CEE PROVIDED MARKED DOSE DEPENDENT (HAE: r (2) = 0.97; CEE: r (2) = 0.96) and significant (P ≤ 0.05) protection against gastric damage caused by absolute ethanol. The gastroprotective effect of CEE was comparable with that of HAE. Further, gastroprotective activity of the highest dose of both extracts were significantly greater (P ≤ 0.05) than that of misoprostol, the reference drug. The HAE significantly (P ≤ 0.05) increased the mucus content adhering to the wall of the gastric mucosa and inhibited the volume of gastric acid. However, acidity (total and free) and pH of the gastric juice remained unaltered. It is concluded that both HAE and CEE of P. betle leaves have a strong gastroprotective activity.

Safe abortion information hotlines: An effective strategy for increasing women's access to safe abortions in Latin America.

PubMed

Drovetta, Raquel Irene

2015-05-01

This paper describes the implementation of five Safe Abortion Information Hotlines (SAIH), a strategy developed by feminist collectives in a growing number of countries where abortion is legally restricted and unsafe. These hotlines have a range of goals and take different forms, but they all offer information by telephone to women about how to terminate a pregnancy using misoprostol. The paper is based on a qualitative study carried out in 2012-2014 of the structure, goals and experiences of hotlines in five Latin American countries: Argentina, Chile, Ecuador, Peru and Venezuela. The methodology included participatory observation of activities of the SAIH, and in-depth interviews with feminist activists who offer these services and with 14 women who used information provided by these hotlines to induce their own abortions. The findings are also based on a review of materials obtained from the five hotline collectives involved: documents and reports, social media posts, and details of public demonstrations and statements. These hotlines have had a positive impact on access to safe abortions for women whom they help. Providing these services requires knowledge and information skills, but little infrastructure. They have the potential to reduce the risk to women's health and lives of unsafe abortion, and should be promoted as part of public health policy, not only in Latin America but also other countries. Additionally, they promote women's autonomy and right to decide whether to continue or terminate a pregnancy. Copyright © 2015. Published by Elsevier Ltd.

Factors and outcomes associated with the induction of labour in Latin America.

PubMed

Guerra, G V; Cecatti, J G; Souza, J P; Faúndes, A; Morais, S S; Gülmezoglu, A M; Parpinelli, M A; Passini, R; Carroli, G

2009-12-01

To describe the prevalence of labour induction, together with its risk factors and outcomes in Latin America. Analysis of the 2005 WHO global survey database. Eight selected Latin American countries. All women who gave birth during the study period in 120 participating institutions. Bivariate and multivariate analyses. Indications for labour induction per country, success rate per method, risk factors for induction, and maternal and perinatal outcomes. Of the 97,095 deliveries included in the survey, 11,077 (11.4%) were induced, with 74.2% occurring in public institutions, 20.9% in social security hospitals and 4.9% in private institutions. Induction rates ranged from 5.1% in Peru to 20.1% in Cuba. The main indications were premature rupture of membranes (25.3%) and elective induction (28.9%). The success rate of vaginal delivery was very similar for oxytocin (69.9%) and misoprostol (74.8%), with an overall success rate of 70.4%. Induced labour was more common in women over 35 years of age. Maternal complications included higher rates of perineal laceration, need for uterotonic agents, hysterectomy, ICU admission, hospital stay>7 days and increased need for anaesthetic/analgesic procedures. Some adverse perinatal outcomes were also higher: low 5-minute Apgar score, very low birthweight, admission to neonatal ICU and delayed initiation of breastfeeding. In Latin America, labour was induced in slightly more than 10% of deliveries; success rates were high irrespective of the method used. Induced labour is, however, associated with poorer maternal and perinatal outcomes than spontaneous labour.

Where There Are (Few) Skilled Birth Attendants

PubMed Central

Prata, Ndola; Rowen, Tami; Bell, Suzanne; Walsh, Julia; Potts, Malcolm

2011-01-01

Recent efforts to reduce maternal mortality in developing countries have focused primarily on two long-term aims: training and deploying skilled birth attendants and upgrading emergency obstetric care facilities. Given the future population-level benefits, strengthening of health systems makes excellent strategic sense but it does not address the immediate safe-delivery needs of the estimated 45 million women who are likely to deliver at home, without a skilled birth attendant. There are currently 28 countries from four major regions in which fewer than half of all births are attended by skilled birth attendants. Sixty-nine percent of maternal deaths in these four regions can be attributed to these 28 countries, despite the fact that these countries only constitute 34% of the total population in these regions. Trends documenting the change in the proportion of births accompanied by a skilled attendant in these 28 countries over the last 15-20 years offer no indication that adequate change is imminent. To rapidly reduce maternal mortality in regions where births in the home without skilled birth attendants are common, governments and community-based organizations could implement a cost-effective, complementary strategy involving health workers who are likely to be present when births in the home take place. Training community-based birth attendants in primary and secondary prevention technologies (e.g. misoprostol, family planning, measurement of blood loss, and postpartum care) will increase the chance that women in the lowest economic quintiles will also benefit from global safe motherhood efforts. PMID:21608417

[A comparative study of effects of electroacupuncture with different stimulation parameters on medicine-induced abortion].

PubMed

Ma, Liang-xiao; Yang, Fang; Zhu, Jiang; He, Zhi-ping; Chen, Yan; Xu, Hong-yan; Liu, Yu-qi; Chen, Yin-ying

2008-07-01

To observe the effect of electroacupuncture (EA) with different stimulation parameters on medicine-induced abortion. One hundred and nine cases of early pregnancy who asked medicine-induced abortion were allocated to an EA group A (n = 37), an EA group B (n = 38) and a medication group (n = 34). Within 30-60 min after oral administration of Misoprostol, in the EA group A, EA was given at bilateral Hegu (LI 4) and Sanyinjiao (SP 6) with cluster waves of 100 Hz and in the EA group B, EA was given at Hegu (LI 4) for 20 min and then at Sanyinjiao (SP 6) for 5 min with continuous waves of 50 Hz. EA was not given to the medication group. The complete abortion rate, duration of eliminating embryonic sac, colporrhagia lasting time and abdominal pain condition were recorded. The complete abortion rate was 91.9% in the EA group A and 86.8% in the EA group B, which were higher than 82.4% in the medication group, with no significant differences between the 3 groups (P>0.05); the duration of eliminating embryonic sac and the colporrhagia lasting time in the two EA groups were significantly shorter than those in the medication group (P<0.05, P<0.01); alleviation of abdominal pain in the EA group B was better than the medication group (P<0.01) and the EA group A (P<0.05). Different stimulation parameters of EA have different effects on abortion.

Management of post abortion complications in Botswana -The need for a standardized approach.

PubMed

Melese, Tadele; Habte, Dereje; Tsima, Billy M; Mogobe, Keitshokile Dintle; Nassali, Mercy N

2018-01-01

Post abortion complications are the third leading cause of maternal death after hemorrhage and hypertension in Botswana where abortion is not legalized. This study aimed at assessing the management of post abortion complications in Botswana. A retrospective study was conducted at four hospitals in Botswana in 2014. Socio-demographic, patient management and outcomes data were extracted from patients' medical records. Descriptive statistics and chi-square test were used to analyze and present the data. A total of 619 patients' medical records were reviewed. The duration of hospital stay prior to uterine evacuation ranged from less than an hour to 480 hours. All the patients received either prophylactic or therapeutic antibiotics. Use of parenteral antibiotics was significantly associated with severity of abortion, second trimester abortion, use of blood products and the interval between management's decision and uterine evacuation. Uterine evacuation for retained products of conception was achieved by metallic curettage among 516 (83.4%) patients and by vacuum aspiration in 18 (2.9%). At all the study sites, Misoprostol or Oxytocin were used concurrently with surgical evacuation of the uterus. None use of analgesics or anesthetics in the four hospitals ranged between 12.4% to 28.8%. There is evidence of delayed patient care and prolonged hospital stay. Metallic curette was the primary method used for uterine evacuation across all the facilities. Pain management and antibiotics use was not standardized. A protocol has to be developed with the aim of standardizing post abortion care.

Medical abortion in early pregnancy: experience in China.

PubMed

Cheng, Linan

2006-07-01

When medical abortion was first introduced in China, prostaglandins (PGs) were used alone or in combination with Chinese herbs or steroid drugs, but the results were not satisfactory. Mifepristone is now produced in three companies in China and is commonly used with PGs for medical abortion. We performed a Chinese- and English-language literature review of medical abortion in early pregnancy in China. A large multicenter trial conducted in China showed that, when used with a PGF(2alpha) analogue, the complete abortion rate in women given multiple doses of mifepristone (total, 150 mg) was significantly higher than that in women given a single dose of 200 mg of mifepristone. Oral misoprostol (0.6 mg) with mifepristone is now the most commonly used regimen, with a complete abortion rate of over 93%. In China, medical abortion is currently restricted to pregnancies before 49 days, but some hospitals have recently extended the use of medical abortion to pregnancies beyond 49 days. Prolonged bleeding is the main medical abortion side effect and is more likely to occur if the blood levels of human chorionic gonadotrophin fall slowly or when the gestational sac is big. Prescription of testosterone propionate may reduce the duration of bleeding. Over 80% of Chinese women are satisfied with current medical abortion regimens and will choose medical abortion again if they need to terminate a future unwanted pregnancy. Currently, medical abortion is a safe, efficient and acceptable method for the termination of early pregnancy in China.

Prevention of nonsteroidal anti-inflammatory drug-associated gastrointestinal symptoms and ulcer complications.

PubMed

Peura, David A

2004-09-06

Nonsteroidal anti-inflammatory drugs (NSAIDs) produce symptoms of dyspepsia and peptic ulcer disease in up to 50% and up to 20%, respectively, of individuals taking them. Risk factors for NSAID-related gastric injury include age >70 years, history of ulcer disease, use of multiple agents (e.g., > or =2 NSAIDs, or an NSAID plus aspirin--even at cardioprotective doses), high doses of an NSAID, and concurrent use of corticosteroids or anticoagulants. In NSAID users, infection with Helicobacter pylori can produce additive or synergistic gastric mucosal injury. Several clinical strategies can decrease the risk for dyspepsia, ulceration, and the more serious complications in NSAID users. Proton pump inhibitor (PPI) co-therapy has been shown to lower the incidence of dyspepsia in those taking NSAIDs. In those with an active ulcer, PPI therapy produces ulcer healing even in "tough-to-treat" individuals who require ongoing NSAID therapy. Maintenance of ulcer healing is significantly greater in those who receive ongoing PPI treatment compared with placebo, and adverse events and treatment withdrawals are fewer compared with their occurrence in persons treated with misoprostol. In those not receiving aspirin therapy, the use of an NSAID that is a selective inhibitor of cyclooxygenase (COX)-2 may result in fewer gastrointestinal symptoms compared with a traditional agent; however, studies have failed to show any decrease in healthcare resource utilization (including outpatient or emergency room visits, hospitalization rate, or use of any resource) with COX-2-selective therapy.

Prostaglandin Analogous and Antioxidant Activity Mediated Gastroprotective Action of Tabernaemontana divaricata (L.) R. Br. Flower Methanolic Extract against Chemically Induced Gastric Ulcers in Rats

PubMed Central

Mat Jais, Abdul Manan; Afreen, Adiba

2013-01-01

The present study was conducted to evaluate the antiulcerogenic effect and recognize the basic mechanism of action of Tabernaemontana divaricata (L.) R. Br. flowers. T. divaricata flower methanolic extract (TDFME) was screened for antiulcer activity versus aspirin and ethanol induced gastric ulcers at three doses—125, 250, and 500 mg/kg—orally using misoprostol as a standard. Besides histopathological examination, seven parameters, that is, ulcer index, total protein, nonprotein sulphhydryls, mucin, catalase, malondialdehyde, and superoxide dismutase levels, were estimated. In addition to HPLC profiling, GC-MS analysis and electrospray ionization—high resolution mass spectral (ESI-HRMS) analysis of crude TDFME were carried out in an attempt to identify known phytochemicals present in the extract on the basis of m/z value. The results revealed a significant increase in the levels of catalase, superoxide dismutase, mucin, and nonprotein sulphhydryls, while they revealed a reduction in ulcer index, the levels of total protein, and malondialdehyde. Histopathological observations also demonstrated the protective effect. Though all the doses of TDFME exhibited gastroprotective function, higher doses were found to be more effective. Mass spectral analysis gave a few characteristic m/z values suggesting the presence of a few known indole alkaloids, while HPLC profiling highlighted the complexity of the extract. TDFME was found to exhibit its gastroprotective effect through antioxidant mechanism and by enhancing the production of gastric mucous. PMID:24350249

Mifepristone by prescription: a dream in the United States but reality in Australia.

PubMed

Grossman, Daniel; Goldstone, Philip

2015-09-01

The requirement that mifepristone be dispensed only by physicians in offices, clinics or hospitals - and not by prescription in pharmacies - has likely limited uptake by providers in the United States. However, in several other countries, provision by prescription in pharmacies is allowed, including in Australia. Mifepristone was first registered in Australia in 2012, and in 2015, a composite package including 200 mg mifepristone and four tablets of misoprostol 200 mcg was registered. Both were approved as Schedule 4 medications, which require prescribing by a physician and may be dispensed at pharmacies. As part of the registration for both products, a risk management plan was instituted that has several components. First, physicians must be certified to prescribe mifepristone. General practitioners wishing to become certified must complete online training that includes prescribing requirements and managing the medical abortion process; obstetrician-gynecologists are exempt from the online learning module. Pharmacists must also be certified in order to dispense the medication, although this does not require additional training. When a pharmacist receives a prescription for mifepristone, she or he must confirm through a secure website that the prescriber is certified. In every region of the country, there are more certified prescribers and dispensers of mifepristone than the number of facilities providing abortion care. The experience in Australia demonstrates the feasibility of mifepristone by prescription and should be a model for expanding access to early medical abortion in the United States. Copyright © 2015 Elsevier Inc. All rights reserved.

Management of post abortion complications in Botswana -The need for a standardized approach

PubMed Central

Habte, Dereje; Tsima, Billy M.; Mogobe, Keitshokile Dintle; Nassali, Mercy N.

2018-01-01

Background Post abortion complications are the third leading cause of maternal death after hemorrhage and hypertension in Botswana where abortion is not legalized. This study aimed at assessing the management of post abortion complications in Botswana. Methods A retrospective study was conducted at four hospitals in Botswana in 2014. Socio-demographic, patient management and outcomes data were extracted from patients’ medical records. Descriptive statistics and chi-square test were used to analyze and present the data. Result A total of 619 patients’ medical records were reviewed. The duration of hospital stay prior to uterine evacuation ranged from less than an hour to 480 hours. All the patients received either prophylactic or therapeutic antibiotics. Use of parenteral antibiotics was significantly associated with severity of abortion, second trimester abortion, use of blood products and the interval between management’s decision and uterine evacuation. Uterine evacuation for retained products of conception was achieved by metallic curettage among 516 (83.4%) patients and by vacuum aspiration in 18 (2.9%). At all the study sites, Misoprostol or Oxytocin were used concurrently with surgical evacuation of the uterus. None use of analgesics or anesthetics in the four hospitals ranged between 12.4% to 28.8%. Conclusion There is evidence of delayed patient care and prolonged hospital stay. Metallic curette was the primary method used for uterine evacuation across all the facilities. Pain management and antibiotics use was not standardized. A protocol has to be developed with the aim of standardizing post abortion care. PMID:29451883

Prostaglandin analogous and antioxidant activity mediated gastroprotective action of Tabernaemontana divaricata (L.) R. Br. flower methanolic extract against chemically induced gastric ulcers in rats.

PubMed

Ali Khan, Mohammed Safwan; Mat Jais, Abdul Manan; Afreen, Adiba

2013-01-01

The present study was conducted to evaluate the antiulcerogenic effect and recognize the basic mechanism of action of Tabernaemontana divaricata (L.) R. Br. flowers. T. divaricata flower methanolic extract (TDFME) was screened for antiulcer activity versus aspirin and ethanol induced gastric ulcers at three doses--125, 250, and 500 mg/kg--orally using misoprostol as a standard. Besides histopathological examination, seven parameters, that is, ulcer index, total protein, nonprotein sulphhydryls, mucin, catalase, malondialdehyde, and superoxide dismutase levels, were estimated. In addition to HPLC profiling, GC-MS analysis and electrospray ionization--high resolution mass spectral (ESI-HRMS) analysis of crude TDFME were carried out in an attempt to identify known phytochemicals present in the extract on the basis of m/z value. The results revealed a significant increase in the levels of catalase, superoxide dismutase, mucin, and nonprotein sulphhydryls, while they revealed a reduction in ulcer index, the levels of total protein, and malondialdehyde. Histopathological observations also demonstrated the protective effect. Though all the doses of TDFME exhibited gastroprotective function, higher doses were found to be more effective. Mass spectral analysis gave a few characteristic m/z values suggesting the presence of a few known indole alkaloids, while HPLC profiling highlighted the complexity of the extract. TDFME was found to exhibit its gastroprotective effect through antioxidant mechanism and by enhancing the production of gastric mucous.

A review of international biobanks and networks: success factors and key benchmarks.

PubMed

Vaught, Jim; Kelly, Andrea; Hewitt, Robert

2009-09-01

Biobanks and biobanking networks are involved in varying degrees in the collection, processing, storage, and dissemination of biological specimens. This review outlines the approaches that 16 of the largest biobanks and biobanking networks in Europe, North America, Australia, and Asia have taken to collecting and distributing human research specimens and managing scientific initiatives while covering operating costs. Many are small operations that exist as either a single or a few freezers in a research laboratory, hospital clinical laboratory, or pathology suite. Larger academic and commercial biobanks operate to support large clinical and epidemiological studies. Operational and business models depend on the medical and research missions of their institutions and home countries. Some national biobanks operate with a centralized physical biobank that accepts samples from multiple locations. Others operate under a "federated" model where each institution maintains its own collections but agrees to list them on a central shared database. Some collections are "project-driven" meaning that specimens are collected and distributed to answer specific research questions. "General" collections are those that exist to establish a reference collection, that is, not to meet particular research goals but to be available to respond to multiple requests for an assortment of research uses. These individual and networked biobanking systems operate under a variety of business models, usually incorporating some form of partial cost recovery, while requiring at least partial public or government funding. Each has a well-defined biospecimen-access policy in place that specifies requirements that must be met-such as ethical clearance and the expertise to perform the proposed experiments-to obtain samples for research. The success of all of these biobanking models depends on a variety of factors including well-defined goals, a solid business plan, and specimen collections that are developed according to strict quality and operational controls.

REMOTE SENSING TECHNOLOGIES APPLICATIONS RESEARCH

EPA Science Inventory

Remote sensing technologies applications research supports the ORD Landscape Sciences Program (LSP) in two separate areas: operational remote sensing, and remote sensing research and development. Operational remote sensing is provided to the LSP through the use of current and t...

Legal Policy Optimizing Models

ERIC Educational Resources Information Center

Nagel, Stuart; Neef, Marian

1977-01-01

The use of mathematical models originally developed by economists and operations researchers is described for legal process research. Situations involving plea bargaining, arraignment, and civil liberties illustrate the applicability of decision theory, inventory modeling, and linear programming in operations research. (LBH)

The Development of Cockpit Display and Alerting Concepts for Interval Management (IM) in a Near-Term Environment

NASA Technical Reports Server (NTRS)

Baxley, Brian T.; Shay, Richard F.; Swieringa, Kurt A.

2014-01-01

The National Aeronautics and Space Administration (NASA) Langley Research Center (LaRC) Interval Management (IM) research team has conducted a wide spectrum of work in the recent past, ranging from development and testing of the concept, procedures, and algorithm. This document focuses on the research and evaluation of the IM pilot interfaces, cockpit displays, indications, and alerting concepts for conducting IM spacing operations. The research team incorporated knowledge of human factors research, industry standards for cockpit design, and cockpit design philosophies to develop innovative displays for conducting these spacing operations. The research team also conducted a series of human-in-the-loop (HITL) experiments with commercial pilots and air traffic controllers, in as realistic a high-density arrival operation environment as could be simulated, to evaluate the spacing guidance display features and interface requirements needed to conduct spacing operations.

Operating in "Strange New Worlds" and Measuring Success - Test and Evaluation in Complex Environments

NASA Technical Reports Server (NTRS)

Qualls, Garry; Cross, Charles; Mahlin, Matthew; Montague, Gilbert; Motter, Mark; Neilan, James; Rothhaar, Paul; Tran, Loc; Trujillo, Anna; Allen, B. Danette

2015-01-01

Software tools are being developed by the Autonomy Incubator at NASA's Langley Research Center that will provide an integrated and scalable capability to support research and non-research flight operations across several flight domains, including urban and mixed indoor-outdoor operations. These tools incorporate a full range of data products to support mission planning, approval, flight operations, and post-flight review. The system can support a number of different operational scenarios that can incorporate live and archived data streams for UAS operators, airspace regulators, and other important stakeholders. Example use cases are described that illustrate how the tools will benefit a variety of users in nominal and off-nominal operational scenarios. An overview is presented for the current state of the toolset, including a summary of current demonstrations that have been completed. Details of the final, fully operational capability are also presented, including the interfaces that will be supported to ensure compliance with existing and future airspace operations environments.

77 FR 18304 - Agency Information Collection; Activity Under OMB Review; Report of Financial and Operating...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-27

... Operating Statistics for Large Certificated Air Carriers AGENCY: Research & Innovative Technology... DEPARTMENT OF TRANSPORTATION Research & Innovative Technology Administration [Docket ID Number... Operating Statistics for Large Certificated Air Carriers. Form No.: BTS Form 41. Type Of Review...

Operational research on malaria control and elimination: a review of projects published between 2008 and 2013.

PubMed

Zhou, Shui-sen; Rietveld, Aafje E C; Velarde-Rodriguez, Mar; Ramsay, Andrew R; Zhang, Shao-sen; Zhou, Xiao-nong; Cibulskis, Richard E

2014-12-04

A literature review for operational research on malaria control and elimination was conducted using the term 'malaria' and the definition of operational research (OR). A total of 15 886 articles related to malaria were searched between January 2008 and June 2013. Of these, 582 (3.7%) met the definition of operational research. These OR projects had been carried out in 83 different countries. Most OR studies (77%) were implemented in Africa south of the Sahara. Only 5 (1%) of the OR studies were implemented in countries in the pre-elimination or elimination phase. The vast majority of OR projects (92%) were led by international or local research institutions, while projects led by National Malaria Control Programmes (NMCP) accounted for 7.8%. With regards to the topic under investigation, the largest percentage of papers was related to vector control (25%), followed by epidemiology/transmission (16.5%) and treatment (16.3%). Only 19 (3.8%) of the OR projects were related to malaria surveillance. Strengthening the capacity of NMCPs to conduct operational research and publish its findings, and improving linkages between NMCPs and research institutes may aid progress towards malaria elimination and eventual eradication world-wide.

The Golden Gate: Building Bridges Between Research and Operations

NASA Technical Reports Server (NTRS)

Schmidt, Lacey L.

2010-01-01

Previous research has discussed the ongoing dilemma of implementing research-based findings in an applied setting. This panel will discuss lessons learned from various examples where bridges have been forged between research and operations, and examine ways to promote and achieve similar collaborations in other areas in the future.

40 CFR 26.1603 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2012 CFR

2012-07-01

... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Operation of the Human Studies Review...

40 CFR 26.1603 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2010 CFR

2010-07-01

... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Operation of the Human Studies Review...

40 CFR 26.1605 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2014 CFR

2014-07-01

... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Operation of the Human Studies Review...

40 CFR 26.1605 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2013 CFR

2013-07-01

... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Operation of the Human Studies Review...

40 CFR 26.1603 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2011 CFR

2011-07-01

... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Operation of the Human Studies Review...

A Framework of Operating Models for Interdisciplinary Research Programs in Clinical Service Organizations

ERIC Educational Resources Information Center

King, Gillian; Currie, Melissa; Smith, Linda; Servais, Michelle; McDougall, Janette

2008-01-01

A framework of operating models for interdisciplinary research programs in clinical service organizations is presented, consisting of a "clinician-researcher" skill development model, a program evaluation model, a researcher-led knowledge generation model, and a knowledge conduit model. Together, these models comprise a tailored, collaborative…

NASA's aviation safety research and technology program

NASA Technical Reports Server (NTRS)

Fichtl, G. H.

1977-01-01

Aviation safety is challenged by the practical necessity of compromising inherent factors of design, environment, and operation. If accidents are to be avoided these factors must be controlled to a degree not often required by other transport modes. The operational problems which challenge safety seem to occur most often in the interfaces within and between the design, the environment, and operations where mismatches occur due to ignorance or lack of sufficient understanding of these interactions. Under this report the following topics are summarized: (1) The nature of operating problems, (2) NASA aviation safety research, (3) clear air turbulence characterization and prediction, (4) CAT detection, (5) Measurement of Atmospheric Turbulence (MAT) Program, (6) Lightning, (7) Thunderstorm gust fronts, (8) Aircraft ground operating problems, (9) Aircraft fire technology, (10) Crashworthiness research, (11) Aircraft wake vortex hazard research, and (12) Aviation safety reporting system.

Research to policy and practice change: is capacity building in operational research delivering the goods?

PubMed

Zachariah, Rony; Guillerm, Nathalie; Berger, Selma; Kumar, Ajay M V; Satyanarayana, Srinath; Bissell, Karen; Edginton, Mary; Hinderaker, Sven Gudmund; Tayler-Smith, Katie; Van den Bergh, Rafael; Khogali, Mohammed; Manzi, Marcel; Reid, Anthony J; Ramsay, Andrew; Reeder, John C; Harries, Anthony D

2014-09-01

Between 2009 and 2012, eight operational research capacity building courses were completed in Paris (3), Luxembourg (1), India (1), Nepal (1), Kenya (1) and Fiji (1). Courses had strict milestones that were subsequently adopted by the Structured Operational Research and Training InitiaTive (SORT IT) of the World Health Organization. We report on the numbers of enrolled participants who successfully completed courses, the number of papers published and their reported effect on policy and/or practice. Retrospective cohort study including a survey. Participant selection criteria ensured that only those proposing specific programme-related and relevant operational research questions were selected. Effects on policy and/or practice were assessed in a standardised manner by two independent reviewers. Of 93 enrolled participants from 31 countries (14 in Africa, 13 in Asia, two in Latin America and two in South Pacific), 83 (89%) completed their courses. A total of 96 papers were submitted to scientific journals of which 89 (93%) were published and 88 assessed for effect on policy and practice. There was a reported effect in 65 (74%) studies including changes to programme implementation (27), adaptation of monitoring tools (24) and changes to existing guidelines (20). Three quarters of published operational research studies from these structured courses had reported effects on policy and/or practice. It is important that this type of tracking becomes a standard component of operational research and research in general. © 2014 John Wiley & Sons Ltd.

Cognitive Performance in Operational Environments

NASA Technical Reports Server (NTRS)

Russo, Michael; McGhee, James; Friedler, Edna; Thomas, Maria

2005-01-01

Optimal cognition during complex and sustained operations is a critical component for success in current and future military operations. "Cognitive Performance, Judgment, and Decision-making" (CPJD) is a newly organized U.S. Army Medical Research and Materiel Command research program focused on sustaining operational effectiveness of Future Force Warriors by developing paradigms through which militarily-relevant, higher-order cognitive performance, judgment, and decision-making can be assessed and sustained in individuals, small teams, and leaders of network-centric fighting units. CPJD evaluates the impact of stressors intrinsic to military operational environments (e.g., sleep deprivation, workload, fatigue, temperature extremes, altitude, environmental/physiological disruption) on military performance, evaluates noninvasive automated methods for monitoring and predicting cognitive performance, and investigates pharmaceutical strategies (e.g., stimulant countermeasures, hypnotics) to mitigate performance decrements. This manuscript describes the CPJD program, discusses the metrics utilized to relate militarily applied research findings to academic research, and discusses how the simulated combat capabilities of a synthetic battle laboratory may facilitate future cognitive performance research.

ATIS Market Research: A Survey of Operational Tests and University and Government Research

DOT National Transportation Integrated Search

1994-03-01

This report outlines research that examines the market for Advanced Traveler Information Systems (ATIS). The report includes detailed descriptions of Pathfinder, TravTek, and SmarTraveler ATIS operational tests. It includes basic background informati...

Bus operator safety : critical issues examination and model practices.

DOT National Transportation Integrated Search

2014-01-01

In this study, researchers at the National Center for Transit Research performed a multi-topic comprehensive : examination of bus operator-related critical safety and personal security issues. The goals of this research : effort were to: : 1. Identif...

OPERATIONS RESEARCH IN THE DESIGN OF MANAGEMENT INFORMATION SYSTEMS

DTIC Science & Technology

management information systems is concerned with the identification and detailed specification of the information and data processing...of advanced data processing techniques in management information systems today, the close coordination of operations research and data systems activities has become a practical necessity for the modern business firm.... information systems in which mathematical models are employed as the basis for analysis and systems design. Operations research provides a

The Research-to-Operations-to-Research Cycle at NOAA's Space Weather Prediction Center

NASA Astrophysics Data System (ADS)

Singer, H. J.

2017-12-01

The provision of actionable space weather products and services by NOAA's Space Weather Prediction Center relies on observations, models and scientific understanding of our dynamic space environment. It also depends on a deep understanding of the systems and capabilities that are vulnerable to space weather, as well as national and international partnerships that bring together resources, skills and applications to support space weather forecasters and customers. While these activities have been evolving over many years, in October 2015, with the release of the National Space Weather Strategy and National Space Weather Action Plan (NSWAP) by National Science and Technology Council in the Executive Office of the President, there is a new coordinated focus on ensuring the Nation is prepared to respond to and recover from severe space weather storms. One activity highlighted in the NSWAP is the Operations to Research (O2R) and Research to Operations (R2O) process. In this presentation we will focus on current R2O and O2R activities that advance our ability to serve those affected by space weather and give a vision for future programs. We will also provide examples of recent research results that lead to improved operational capabilities, lessons learned in the transition of research to operations, and challenges for both the science and operations communities.

Operation Duties on the F-15B Research Testbed

NASA Technical Reports Server (NTRS)

Truong, Samson S.

2010-01-01

This presentation entails what I have done this past summer for my Co-op tour in the Operations Engineering Branch. Activities included supporting the F-15B Research Testbed, supporting the incoming F-15D models, design work, and other operations engineering duties.

Supporting Students' Constructions of the Splitting Operation

ERIC Educational Resources Information Center

Norton, Anderson; Wilkins, Jesse L. M.

2013-01-01

Previous research has demonstrated the effectiveness of particular instructional practices that support students' constructions of the partitive unit fraction scheme and measurement concepts for fractions. Another body of research has demonstrated the power of a particular mental operation--the splitting operation--in supporting students'…

Statistics of Statisticians: Critical Mass of Statistics and Operational Research Groups

NASA Astrophysics Data System (ADS)

Kenna, Ralph; Berche, Bertrand

Using a recently developed model, inspired by mean field theory in statistical physics, and data from the UK's Research Assessment Exercise, we analyse the relationship between the qualities of statistics and operational research groups and the quantities of researchers in them. Similar to other academic disciplines, we provide evidence for a linear dependency of quality on quantity up to an upper critical mass, which is interpreted as the average maximum number of colleagues with whom a researcher can communicate meaningfully within a research group. The model also predicts a lower critical mass, which research groups should strive to achieve to avoid extinction. For statistics and operational research, the lower critical mass is estimated to be 9 ± 3. The upper critical mass, beyond which research quality does not significantly depend on group size, is 17 ± 6.

Airborne forest fire research

NASA Technical Reports Server (NTRS)

Mattingly, G. S.

1974-01-01

The research relating to airborne fire fighting systems is reviewed to provide NASA/Langley Research Center with current information on the use of aircraft in forest fire operations, and to identify research requirements for future operations. A literature survey, interview of forest fire service personnel, analysis and synthesis of data from research reports and independent conclusions, and recommendations for future NASA-LRC programs are included.

[Research progresses on ergonomics assessment and measurement methods for push-pull behavior].

PubMed

Zhao, Yan; Li, Dongxu; Guo, Shengpeng

2011-10-01

Pushing and pulling (P&P) is a common operating mode of operator's physical works, and plays an important role in evaluation of human behavior health and operation performance. At present, there are many research methods of P&P, and this article is a state-of-art review of the classification of P&P research methods, the various impact factors in P&P program, technical details of internal/external P&P force measurement and evaluation, the limitation of current research methods and the future developments in the ergonomics field.

Summary of Research 1997, Department of Operations Research.

DTIC Science & Technology

1999-01-01

for addressing warfighting problems. This capabil- ity is especially important at the present time when technology in general, and information...Universidad Nacional de Educacion a Distancia, 1993 Master of Science in Operations Research-September 1997 Advisor: W. Max Woods, Department of

12 CFR 261.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... scientific institution refers to an institution that is not operated on a “commercial” basis (as that term is used in this section) and that is operated solely for the purpose of conducting scientific research... education, or an institution of vocational education, which operates a program of scholarly research. (g...

12 CFR 261.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... scientific institution refers to an institution that is not operated on a “commercial” basis (as that term is used in this section) and that is operated solely for the purpose of conducting scientific research... education, or an institution of vocational education, which operates a program of scholarly research. (g...

Cognitive engineering models in space systems

NASA Technical Reports Server (NTRS)

Mitchell, Christine M.

1993-01-01

NASA space systems, including mission operations on the ground and in space, are complex, dynamic, predominantly automated systems in which the human operator is a supervisory controller. Models of cognitive functions in complex systems are needed to describe human performance and form the theoretical basis of operator workstation design, including displays, controls, and decision aids. Currently, there several candidate modeling methodologies. They include the Rasmussen abstraction/aggregation hierarchy and decision ladder, the goal-means network, the problem behavior graph, and the operator function model. The research conducted under the sponsorship of this grant focuses on the extension of the theoretical structure of the operator function model and its application to NASA Johnson mission operations and space station applications. The initial portion of this research consists of two parts. The first is a series of technical exchanges between NASA Johnson and Georgia Tech researchers. The purpose is to identify candidate applications for the current operator function model; prospects include mission operations and the Data Management System Testbed. The second portion will address extensions of the operator function model to tailor it to the specific needs of Johnson applications. At this point, we have accomplished two things. During a series of conversations with JSC researchers, we have defined the technical goal of the research supported by this grant to be the structural definition of the operator function model and its computer implementation, OFMspert. Both the OFM and OFMspert have matured to the point that they require infrastructure to facilitate use by researchers not involved in the evolution of the tools. The second accomplishment this year was the identification of the Payload Deployment and Retrieval System (PDRS) as a candidate system for the case study. In conjunction with government and contractor personnel in the Human-Computer Interaction Lab, the PDRS was identified as the most accessible system for the demonstration. Pursuant to this a PDRS simulation was obtained from the HCIL and an initial knowledge engineering effort was conducted to understand the operator's tasks in the PDRS application. The preliminary results of the knowledge engineering effort and an initial formulation of an operator function model (OFM) are contained in the appendices.

Prevalence of operator fatigue in winter maintenance operations.

PubMed

Camden, Matthew C; Medina-Flintsch, Alejandra; Hickman, Jeffrey S; Bryce, James; Flintsch, Gerardo; Hanowski, Richard J

2018-02-02

Similar to commercial motor vehicle drivers, winter maintenance operators are likely to be at an increased risk of becoming fatigued while driving due to long, inconsistent shifts, environmental stressors, and limited opportunities for sleep. Despite this risk, there is little research concerning the prevalence of winter maintenance operator fatigue during winter emergencies. The purpose of this research was to investigate the prevalence, sources, and countermeasures of fatigue in winter maintenance operations. Questionnaires from 1043 winter maintenance operators and 453 managers were received from 29 Clear Road member states. Results confirmed that fatigue was prevalent in winter maintenance operations. Over 70% of the operators and managers believed that fatigue has a moderate to significant impact on winter maintenance operations. Approximately 75% of winter maintenance operators reported to at least sometimes drive while fatigued, and 96% of managers believed their winter maintenance operators drove while fatigued at least some of the time. Furthermore, winter maintenance operators and managers identified fatigue countermeasures and sources of fatigue related to winter maintenance equipment. However, the countermeasures believed to be the most effective at reducing fatigue during winter emergencies (i.e., naps) were underutilized. For example, winter maintenance operators reported to never use naps to eliminate fatigue. These results indicated winter maintenance operations are impacted by operator fatigue. These results support the increased need for research and effective countermeasures targeting winter maintenance operator fatigue. Copyright © 2018 Elsevier Ltd. All rights reserved.

Safety management of complex research operations

NASA Technical Reports Server (NTRS)

Brown, W. J.

1981-01-01

Complex research and technology operations present many varied potential hazards which must be addressed in a disciplined independent safety review and approval process. The research and technology effort at the Lewis Research Center is divided into programmatic areas of aeronautics, space and energy. Potential hazards vary from high energy fuels to hydrocarbon fuels, high pressure systems to high voltage systems, toxic chemicals to radioactive materials and high speed rotating machinery to high powered lasers. A Safety Permit System presently covers about 600 potentially hazardous operations. The Safety Management Program described in this paper is believed to be a major factor in maintaining an excellent safety record at the Lewis Research Center.

Tutorial for Thermophysics Universal Research Framework

DTIC Science & Technology

2017-07-30

DS1V are compared in Section 3.4.5. 3.4.2 Description of the Example Problem In a fluid, disturbance information is communicated within a medium at the...Universal Research Framework development (TURF-DEV) package on a case-by-case basis. Brief descriptions of the operations are provided in Tables 4.1 and...of additional experimental (E) and research (R) operations included in TURF-DEV. Module Operation Description DSMC SPDistDirectDSMCCellMergeOp (R

77 FR 7613 - Dow Chemical Company; Dow Chemical TRIGA Research Reactor; Facility Operating License No. R-108

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... NUCLEAR REGULATORY COMMISSION [Docket No. 50-264; NRC-2012-0026] Dow Chemical Company; Dow Chemical TRIGA Research Reactor; Facility Operating License No. R-108 AGENCY: Nuclear Regulatory Commission... Facility Operating License No. R-108 (``Application''), which currently authorizes the Dow Chemical Company...

Hydrogen Infrastructure Testing and Research Facility Video (Text Version)

Science.gov Websites

grid integration, continuous code improvement, fuel cell vehicle operation, and renewable hydrogen stations. NRELs research on hydrogen safety provides guidance for safe operation, handling, and use of standards and testing fuel cell and hydrogen components for operation and safety. Building on NRELs Wind-to

Workshop on Instructional Features and Instructor/Operator Station Design for Training Systems.

ERIC Educational Resources Information Center

Ricard, G. L., Ed.; And Others

These 19 papers review current research and development work related to the operation of the instructor's station of training systems, with emphasis on developing functional station specifications applicable to a variety of simulation-based training situations. Topics include (1) instructional features; (2) instructor/operator station research and…

27 CFR 19.71 - Experimental or research operations by scientific institutions and colleges of learning.

Code of Federal Regulations, 2010 CFR

2010-04-01

... operations by scientific institutions and colleges of learning. 19.71 Section 19.71 Alcohol, Tobacco Products... Experimental or research operations by scientific institutions and colleges of learning. (a) General. The appropriate TTB officer may authorize any scientific university, college of learning, or institution of...

Space Operations Center system analysis study extension. Volume 4, book 2: SOC system analysis report

NASA Technical Reports Server (NTRS)

1982-01-01

The Space Operations Center (SOC) orbital space station research missions integration, crew requirements, SOC operations, and configurations are analyzed. Potential research and applications missions and their requirements are described. The capabilities of SOC are compared with user requirements. The SOC/space shuttle and shuttle-derived vehicle flight support operations and SOC orbital operations are described. Module configurations and systems options, SOC/external tank configurations, and configurations for geostationary orbits are described. Crew and systems safety configurations are summarized.

7 CFR 1207.344 - Operating reserve.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan Expenses and Assessments § 1207.344 Operating reserve. The...

7 CFR 1207.344 - Operating reserve.

Code of Federal Regulations, 2014 CFR

2014-01-01

... AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan Expenses and Assessments § 1207.344 Operating reserve. The...

7 CFR 1207.344 - Operating reserve.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan Expenses and Assessments § 1207.344 Operating reserve. The...

7 CFR 1207.344 - Operating reserve.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan Expenses and Assessments § 1207.344 Operating reserve. The...

7 CFR 1207.344 - Operating reserve.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan Expenses and Assessments § 1207.344 Operating reserve. The...

Characteristics of Operational Space Weather Forecasting: Observations and Models

NASA Astrophysics Data System (ADS)

Berger, Thomas; Viereck, Rodney; Singer, Howard; Onsager, Terry; Biesecker, Doug; Rutledge, Robert; Hill, Steven; Akmaev, Rashid; Milward, George; Fuller-Rowell, Tim

2015-04-01

In contrast to research observations, models and ground support systems, operational systems are characterized by real-time data streams and run schedules, with redundant backup systems for most elements of the system. We review the characteristics of operational space weather forecasting, concentrating on the key aspects of ground- and space-based observations that feed models of the coupled Sun-Earth system at the NOAA/Space Weather Prediction Center (SWPC). Building on the infrastructure of the National Weather Service, SWPC is working toward a fully operational system based on the GOES weather satellite system (constant real-time operation with back-up satellites), the newly launched DSCOVR satellite at L1 (constant real-time data network with AFSCN backup), and operational models of the heliosphere, magnetosphere, and ionosphere/thermosphere/mesophere systems run on the Weather and Climate Operational Super-computing System (WCOSS), one of the worlds largest and fastest operational computer systems that will be upgraded to a dual 2.5 Pflop system in 2016. We review plans for further operational space weather observing platforms being developed in the context of the Space Weather Operations Research and Mitigation (SWORM) task force in the Office of Science and Technology Policy (OSTP) at the White House. We also review the current operational model developments at SWPC, concentrating on the differences between the research codes and the modified real-time versions that must run with zero fault tolerance on the WCOSS systems. Understanding the characteristics and needs of the operational forecasting community is key to producing research into the coupled Sun-Earth system with maximal societal benefit.

The four free-operant freedoms

PubMed Central

Lindsley, Ogden R.

1996-01-01

This article reviews early free-operant conditioning laboratory research and applications. The seldom-mentioned four free-operant freedoms are described for the first time in detail. Most current behavior analysts do not realize that the freedom to form responses and the freedom to speed responses were crucial steps in designing free-operant operanda in the 1950s. These four freedoms were known by the laboratory researchers of the 1950s to the point that, along with operanda design, Sidman (1960) did not feel the need to detail them in his classic, Tactics of Scientific Research. The dimensions of freedom in the operant were so well understood and accepted in the 1950s that most thought it redundant to use the term free operant. These issues are reviewed in some detail for younger behavior analysts who did not have the opportunity of learning them firsthand. PMID:22478258

Development, Application, and Transition of Aerosol and Trace Gas Products Derived from Next-Generation Satellite Observations to Operations

NASA Technical Reports Server (NTRS)

Berndt, Emily; Naeger, Aaron; Zavodsky, Bradley; McGrath, Kevin; LaFontaine, Frank

2016-01-01

NASA Short-term Prediction Research and Transition (SPoRT) Center has a history of successfully transitioning unique observations and research capabilities to the operational weather community to improve short-term forecasts. SPoRTstrives to bridge the gap between research and operations by maintaining interactive partnerships with end users to develop products that match specific forecast challenges, provide training, and assess the products in the operational environment. This presentation focuses on recent product development, application, and transition of aerosol and trace gas products to operations for specific forecasting applications. Recent activities relating to the SPoRT ozone products, aerosol optical depth composite product, sulfur dioxide, and aerosol index products are discussed.

NASA Conference on Aircraft Operating Problems: A Compilation of the Papers Presented

NASA Technical Reports Server (NTRS)

1965-01-01

This compilation includes papers presented at the NASA Conference on Aircraft Operating Problems held at the Langley Research Center on May 10 - 12, 1965. Contributions were made by representatives of the Ames Research Center, the Flight Research Center, end the Langley Research Center of NASA, as well as by representatives of the Federal Aviation Agency.

Selected Research Abstracts of Published and Unpublished Reports Pertaining to the Food Service Industry, Including Recommendations for Research Needs.

ERIC Educational Resources Information Center

Nejelski, Leo

The 251 research abstracts, dated 1956-1968, are arranged under these areas: (1) Industry Statistics and Feasbility Studies, (2) Merchandising, (3) Purchasing, (4) Facilities Design and Operations Analysis, (5) Commissary Operations, (6) Finance and Cost Control, and (7) Personnel Management. Research gaps, determined through interviews with…

Operations Research as a Metaphor for Evaluation. Research on Evaluation Program Paper and Report Series.

ERIC Educational Resources Information Center

Page, Ellis B.

One of a series of research reports examining objective principles successfully used in other fields which can lend integrity and legitimacy to evaluation, this report presents an overview of operations research (OR) as a potential source of evaluation methodology. The nature of the methods common to this discipline are summarized and the…

Operational Test and Evaluation Manual

DTIC Science & Technology

2011-06-28

Fiscal Office manages all funds received throughout the year for Operations and Maintenance Marine Corps (O&MMC); Research , Development, Test, and... Research , Development, and Acquisition) Assistant Secretary of the Navy ( Research , Development, and Acquisition) (ASN (RDA)) is the DOD’s Component...entire acquisition cycle (SECNAV 2008). This accumulation of data starts with early research and developmental testing and Other tests and

Recommended operating procedure No. 51: Glass source assessment sampling system (glass SASS). Final report, Jul 90-Jan 91

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grote, R.A.

1991-05-01

The report is a recommended operating procedure (ROP), prepared for use in research activities conducted by EPA's Air and Energy Engineering Research Laboratory (AEERL). The method described is applicable to the stack sampling of flue gas from a rotary kiln and to associated equipment of AEERL's Combustion Research Branch. It has been the standard method of sampling kiln flue gas due to the transient nature of the puff development and its capability to sample the maximum volume over the shortest time period. ROPs describe non-routine or experimental research operations where some judgment in application may be warranted. ROPs may notmore » be applicable to activities conducted by other research groups, and should not be used in place of standard operating procedures. Use of ROPs must be accompanied by an understanding of the purpose and scope. Questions should be directed to the author.« less

10 CFR 1703.107 - Fees for record requests.

Code of Federal Regulations, 2013 CFR

2013-01-01

... which is operated solely for the purpose of conducting scientific research the results of which are not... educational or noncommercial scientific institution, whose purpose is scholarly or scientific research, or a... education, and an institution of vocational education, which operates a program of scholarly research...

10 CFR 1703.107 - Fees for record requests.

Code of Federal Regulations, 2014 CFR

2014-01-01

... which is operated solely for the purpose of conducting scientific research the results of which are not... educational or noncommercial scientific institution, whose purpose is scholarly or scientific research, or a... education, and an institution of vocational education, which operates a program of scholarly research...

10 CFR 1703.107 - Fees for record requests.

Code of Federal Regulations, 2012 CFR

2012-01-01

... which is operated solely for the purpose of conducting scientific research the results of which are not... educational or noncommercial scientific institution, whose purpose is scholarly or scientific research, or a... education, and an institution of vocational education, which operates a program of scholarly research...

13 CFR 500.107 - Freedom of Information Act.

Code of Federal Regulations, 2014 CFR

2014-01-01

... institution of vocational education that operates a program of scholarly research. (6) Noncommercial... used in this section) and which is operated solely for the purpose of conducting scientific research..., whose purpose is scholarly or scientific research. The first 100 pages of duplication, however, will be...

13 CFR 500.107 - Freedom of Information Act.

Code of Federal Regulations, 2012 CFR

2012-01-01

... institution of vocational education that operates a program of scholarly research. (6) Noncommercial... used in this section) and which is operated solely for the purpose of conducting scientific research..., whose purpose is scholarly or scientific research. The first 100 pages of duplication, however, will be...

13 CFR 400.107 - Freedom of Information Act.

Code of Federal Regulations, 2014 CFR

2014-01-01

... institution of vocational education that operates a program of scholarly research. (6) Noncommercial... used in this section) and which is operated solely for the purpose of conducting scientific research..., whose purpose is scholarly or scientific research. The first 100 pages of duplication, however, will be...

13 CFR 500.107 - Freedom of Information Act.

Code of Federal Regulations, 2013 CFR

2013-01-01

... institution of vocational education that operates a program of scholarly research. (6) Noncommercial... used in this section) and which is operated solely for the purpose of conducting scientific research..., whose purpose is scholarly or scientific research. The first 100 pages of duplication, however, will be...

13 CFR 400.107 - Freedom of Information Act.

Code of Federal Regulations, 2013 CFR

2013-01-01

... institution of vocational education that operates a program of scholarly research. (6) Noncommercial... used in this section) and which is operated solely for the purpose of conducting scientific research..., whose purpose is scholarly or scientific research. The first 100 pages of duplication, however, will be...

13 CFR 400.107 - Freedom of Information Act.

Code of Federal Regulations, 2012 CFR

2012-01-01

... institution of vocational education that operates a program of scholarly research. (6) Noncommercial... used in this section) and which is operated solely for the purpose of conducting scientific research..., whose purpose is scholarly or scientific research. The first 100 pages of duplication, however, will be...

78 FR 20696 - NASA Advisory Council; Human Exploration and Operations Committee; Research Subcommittee; Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-042] NASA Advisory Council; Human Exploration and Operations Committee; Research Subcommittee; Meeting AGENCY: National Aeronautics and Space... topics: --Overview of Research in Space Life and Physical Sciences --Space Station and Future Exploration...

NASA Langley and NLR Research of Distributed Air/Ground Traffic Management

NASA Technical Reports Server (NTRS)

Ballin, Mark G.; Hoekstra, Jacco M.; Wing, David J.; Lohr, Gary W.

2002-01-01

Distributed Air/Ground Traffic Management (DAG-TM) is a concept of future air traffic operations that proposes to distribute information, decision-making authority, and responsibility among flight crews, the air traffic service provider, and aeronautical operational control organizations. This paper provides an overview and status of DAG-TM research at NASA Langley Research Center and the National Aerospace Laboratory of The Netherlands. Specific objectives of the research are to evaluate the technical and operational feasibility of the autonomous airborne component of DAG-TM, which is founded on the operational paradigm of free flight. The paper includes an overview of research approaches, the airborne technologies under development, and a summary of experimental investigations and findings to date. Although research is not yet complete, these findings indicate that free flight is feasible and will significantly enhance system capacity and safety. While free flight cannot alone resolve the complex issues faced by those modernizing the global airspace, it should be considered an essential part of a comprehensive air traffic management modernization activity.

Infusion of innovative technologies for mission operations

NASA Astrophysics Data System (ADS)

Donati, Alessandro

2010-11-01

The Advanced Mission Concepts and Technologies Office (Mission Technologies Office, MTO for short) at the European Space Operations Centre (ESOC) of ESA is entrusted with research and development of innovative mission operations concepts systems and provides operations support to special projects. Visions of future missions and requests for improvements from currently flying missions are the two major sources of inspiration to conceptualize innovative or improved mission operations processes. They include monitoring and diagnostics, planning and scheduling, resource management and optimization. The newly identified operations concepts are then proved by means of prototypes, built with embedded, enabling technology and deployed as shadow applications in mission operations for an extended validation phase. The technology so far exploited includes informatics, artificial intelligence and operational research branches. Recent outstanding results include artificial intelligence planning and scheduling applications for Mars Express, advanced integrated space weather monitoring system for the Integral space telescope and a suite of growing client applications for MUST (Mission Utilities Support Tools). The research, development and validation activities at the Mission technologies office are performed together with a network of research institutes across Europe. The objective is narrowing the gap between enabling and innovative technology and space mission operations. The paper first addresses samples of technology infusion cases with their lessons learnt. The second part is focused on the process and the methodology used at the Mission technologies office to fulfill its objectives.

Ship Operations, Maintenance, Repair and Upgrade for the R/V KILO MOANA

DTIC Science & Technology

2017-07-20

From - To) 07/20/2017 Final Technical Report 03/19/2014 to 03/31/2017 4. TITLE AND SUBTITLE Sa. CONTRACT NUMBER Ship Operations, Maintenance , Repair...NUMBER Office of Research Services 2440 Campus Road , Box 368 Honolulu, Hawai’i 96822-2234 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10...Office of Naval Research. 15. SUBJECT TERMS Research vessel, operation, maintenance , repair. 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF a

An intelligent automated command and control system for spacecraft mission operations

NASA Technical Reports Server (NTRS)

Stoffel, A. William

1994-01-01

The Intelligent Command and Control (ICC) System research project is intended to provide the technology base necessary for producing an intelligent automated command and control (C&C) system capable of performing all the ground control C&C functions currently performed by Mission Operations Center (MOC) project Flight Operations Team (FOT). The ICC research accomplishments to date, details of the ICC, and the planned outcome of the ICC research, mentioned above, are discussed in detail.

Mod-2 wind turbine field operations experiment

NASA Technical Reports Server (NTRS)

Gordon, L. H.

1985-01-01

The three-machine, 7.5 MW Goodnoe Hills located near Goldendale, Washington and is now in a research/experimental operations phase that offers a unique opportunity to study the effects of single and multiple wind turbines interacting with each other, the power grid; and the environment. Following a brief description of the turbine and project history, this paper addresses major problem areas and research and development test results. Field operations, both routine and nonroutine, are discussed. Routine operation to date has produced over 13,379,000 KWh of electrical energy during 11,064 hr of rotation. Nonroutine operation includes suspended activities caused by a crack in the low speed shaft that necessitated a redesign and reinstallation of this assembly on all three turbines. With the world's largest cluster back in full operation, two of the turbines will be operated over the next years to determine their value as energy producer. The third unit will be used primarily for conducting research tests requiring configuration changes to better understand the wind turbine technology. Technical areas summarized pertain to system performance and enhancements. Specific research tests relating to acoustics, TV interference, and wake effects conclude the paper.

An Unconventional Path Toward the Operational Leveraging of Research-Grade Environmental Satellites

NASA Astrophysics Data System (ADS)

Miller, S.; Hawkins, J.; Turk, J.

2007-12-01

The traditional and proper path followed in transitioning research applications to operational support entails a rigorous gamut of quality control, testing, validation, technical documentation, and software optimization. In times of dire need when observations are in high demand and resources are few, however, convention must sometimes give way to outside-of-the-box thinking. Here, considerations made for manageable compromises forge a pathway to accelerated transition of developing technologies. Such was the case in Coalition mobilizations immediately following the 9/11 attacks, when the United States Office of Naval Research issued a challenge to the environmental research and development community to expedite the delivery of any and all capabilities bearing support relevance to mission planners and executors involved in the increasingly likely military response. It was under this directive that the Naval Research Laboratory's (NRL) Satellite Meteorological Applications Section reconfigured its base research program and internal processing infrastructure to effectively transform itself into an agile operational production system for rapid transition of value-added satellite environmental characterization products centered around next-generation 'research grade' satellite observing systems. Integral to this transformation was the coincident establishment of the Near Real-Time Processing Effort (NRTPE) coordinated among members of the National Oceanic and Atmospheric Administration (NOAA), the National Aeronautics and Space Administration (NASA), and Department of Defense (DoD; Air Force and Navy participants) working in a 'badgeless environment'. The NRTPE provided a portal for acquisition of NASA's MODerate resolution Imaging Spectroradiometer (MODIS) data at 2-4 hr latency worldwide. By virtue of NRTPE modifications to the Terra and Aqua satellite telemetry downlinks and transmission across the high-speed Defense Research/Engineering Network, data previously relegated to research-only pursuits suddenly became operationally viable for mission planning purposes. Through close coordination with Fleet Numerical Meteorology/Oceanography Center (FNMOC), NRL leveraged these NRTPE MODIS and other research satellite datasets to infuse unprecedented operational capabilities (e.g., dust detection, low clouds and fog, snow cover, natural color imagery)--making these and other products available on the 'Satellite Focus' secure internet web page at precisely the time of highest need. Post deployment reports from aircraft carrier groups engaged in Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) give testimony to the utility and impact of these resources. This paper describes the chain of events leading to an unlikely success story in the leveraging of research satellite data. Illustrative examples from Satellite Focus, as well as from the NexSat web page (public analog), are presented. The positive outcome of this activity suggests a new paradigm for future observing systems whereby operational utility is evaluated well in advance of their implementation on formal operational platforms. These demonstrations help users anticipate (and provide feedback to developers concerning) the capabilities and limitations of next-generation sensors--addressing in part the 'missing link' between higher-risk research sensors and tried-and-true (off the shelf) technology appropriate for operational systems.

P. W. Botha and the Space Research Corporation: Clandestine Operations and the Rise of a New Order in South Africa.

DTIC Science & Technology

1986-01-01

AD-lE ?93 P M BOTHA AND THE SPACE RESEARCH CORPORATION : Vi2 CLANDESTINE OPERATIONS AND T.. (U) DEFENSE INTELLIGENCE N COLL WASHINGTON DC R J RAE JAN...4. -. ~ %. 4 .5-’ ’-~ MICRflCOP’ CH~’iT .45 %’ .. q V -. St ~ APPROVAL SHEET f Title of Thesis: P.W. Both& and the Space Research Corporation ...34 ***.- ABSTRACT Title of Thesis: P.W. Botha, Military Intelligence and the Space Research Corporation : Clandestine Operations and the Rise of a New Order in South

An Overview of Current Capabilities and Research Activities in the Airspace Operations Laboratory at NASA Ames Research Center

NASA Technical Reports Server (NTRS)

Prevot, Thomas; Smith, Nancy M.; Palmer, Everett; Callantine, Todd; Lee, Paul; Mercer, Joey; Homola, Jeff; Martin, Lynne; Brasil, Connie; Cabrall, Christopher

2014-01-01

The Airspace Operations Laboratory at NASA Ames conducts research to provide a better understanding of roles, responsibilities, and requirements for human operators and automation in future air traffic management (ATM) systems. The research encompasses developing, evaluating, and integrating operational concepts and technologies for near-, mid-, and far-term air traffic operations. Current research threads include efficient arrival operations, function allocation in separation assurance and efficient airspace and trajectory management. The AOL has developed powerful air traffic simulation capabilities, most notably the Multi Aircraft Control System (MACS) that is used for many air traffic control simulations at NASA and its partners in government, academia and industry. Several additional NASA technologies have been integrated with the AOL's primary simulation capabilities where appropriate. Using this environment, large and small-scale system-level evaluations can be conducted to help make near-term improvements and transition NASA technologies to the FAA, such as the technologies developed under NASA's Air Traffic Management Demonstration-1 (ATD-1). The AOL's rapid prototyping and flexible simulation capabilities have proven a highly effective environment to progress the initiation of trajectory-based operations and support the mid-term implementation of NextGen. Fundamental questions about accuracy requirements have been investigated as well as realworld problems on how to improve operations in some of the most complex airspaces in the US. This includes using advanced trajectory-based operations and prototype tools for coordinating arrivals to converging runways at Newark airport and coordinating departures and arrivals in the San Francisco and the New York metro areas. Looking beyond NextGen, the AOL has started exploring hybrid human/automation control strategies as well as highly autonomous operations in the air traffic control domain. Initial results indicate improved capacity, low operator workload, good situation awareness and acceptability for controllers teaming with autonomous air traffic systems. While much research and development needs to be conducted to make such concepts a reality, these approaches have the potential to truly transform the airspace system towards increased mobility, safe and efficient growth in global operations and enabling many of the new vehicles and operations that are expected over the next decades. This paper describes how the AOL currently contributes to the ongoing air transportation transformation.

NASA/FAA/NCAR Supercooled Large Droplet Icing Flight Research: Summary of Winter 1996-1997 Flight Operations

NASA Technical Reports Server (NTRS)

Miller, Dean; Ratvasky, Thomas; Bernstein, Ben; McDonough, Frank; Strapp, J. Walter

1998-01-01

During the winter of 1996-1997, a flight research program was conducted at the NASA-Lewis Research Center to study the characteristics of Supercooled Large Droplets (SLD) within the Great Lakes region. This flight program was a joint effort between the National Aeronautics and Space Administration (NASA), the National Center for Atmospheric Research (NCAR), and the Federal Aviation Administration (FAA). Based on weather forecasts and real-time in-flight guidance provided by NCAR, the NASA-Lewis Icing Research Aircraft was flown to locations where conditions were believed to be conducive to the formation of Supercooled Large Droplets aloft. Onboard instrumentation was then used to record meteorological, ice accretion, and aero-performance characteristics encountered during the flight. A total of 29 icing research flights were conducted, during which "conventional" small droplet icing, SLD, and mixed phase conditions were encountered aloft. This paper will describe how flight operations were conducted, provide an operational summary of the flights, present selected experimental results from one typical research flight, and conclude with practical "lessons learned" from this first year of operation.

Operations Management: Is There a Disconnect between Journal Article Content and Employer Needs?

ERIC Educational Resources Information Center

Singer, Marc G.; Welborn, Cliff A.

2014-01-01

The authors sought to determine whether topics researched by academicians in the field of operations management were aligned with the knowledge, skills, and abilities (KSAs) employers were seeking from potential employees. Twenty-eight research topics were identified in the operations management literature and were compared to the KSAs derived…

Research and Technology Operating Plan Summary, Fiscal Year 1972 Research and Technology Program

NASA Technical Reports Server (NTRS)

1971-01-01

The NASA Research and Technology program for FY 1972 is presented. It is a compilation of the summary portions of each of the RTOPs (Research and Technology Operating Plan) used for management review and control of research currently in progress throughout NASA. The RTOP Summary is designed to facilitate communication and coordination among concerned technical personnel in government, in industry, and in universities.

7 CFR 3411.10 - Establishment and operation of peer review groups.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION SERVICE, DEPARTMENT OF AGRICULTURE NATIONAL RESEARCH INITIATIVE COMPETITIVE GRANTS PROGRAM Scientific Peer Review of Research Grant Applications § 3411.10 Establishment and operation of peer review groups. Subject to § 3411.5, the Administrator shall adopt procedures...

7 CFR 3400.10 - Establishment and operation of peer review groups.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION SERVICE, DEPARTMENT OF AGRICULTURE SPECIAL RESEARCH GRANTS PROGRAM Scientific Peer Review of Research Grant Applications § 3400.10 Establishment and operation of peer review groups. Subject to § 3400.5, the Administrator will adopt procedures for the...

Maritime SOF in the Littorals: Theoretical Principles for Successful Littoral Special Operations

DTIC Science & Technology

2016-06-01

10 5. How Will Maritime SOF Operate in the Littorals? ..................14 B. RESEARCH QUESTION...117 2. Future Research ...thank all the professors, researchers , and personnel at NPS for making this an excellent and unique learning experience. We have also received a lot

Adapting operational research training to the Rwandan context: the Intermediate Operational Research Training programme

PubMed Central

Odhiambo, Jackline; Amoroso, Cheryl L.; Barebwanuwe, Peter; Warugaba, Christine; Hedt-Gauthier, Bethany L.

2017-01-01

ABSTRACT Background: Promoting national health research agendas in low- and middle-income countries (LMICs) requires adequate numbers of individuals with skills to initiate and conduct research. Recently, non-governmental organizations (NGOs) have joined research capacity building efforts to increase research leadership by LMIC nationals. Partners In Health, an international NGO operating in Rwanda, implemented its first Intermediate Operational Research Training (IORT) course to cultivate Rwandan research talent and generate evidence to improve health care delivery. Objective: This paper describes the implementation of IORT to share experiences with other organizations interested in developing similar training programmes. Methods: The Intermediate Operational Research Training utilized a deliverable-driven training model, using learning-by-doing pedagogy with intensive hands-on mentorship to build research skills from protocol development to scientific publication. The course had short (two-day) but frequent training sessions (seven sessions over eight months). Trainees were clinical and programme staff working at the district level who were paired to jointly lead a research project. Results: Of 10 trainees admitted to the course from a pool of 24 applicants, nine trainees completed the course with five research projects published in peer-reviewed journals. Strengths of the course included supportive national and institutional research capacity guidelines, building from a successful training model, and trainee commitment. Challenges included delays in ethical review, high mentorship workload of up to 250 hours of practicum mentorship, lack of access to literature in subscription journals and high costs of open access publication. Conclusions: The IORT course was an effective way to support the district-based government and NGO staff in gaining research skills, as well as answering research questions relevant to health service delivery at district hospitals. Other NGOs should build on successful programmes while adapting course elements to address context-specific challenges. Mentorship for LMIC trainees is critical for effectiveness of research capacity building initiatives. PMID:29119872

Adapting operational research training to the Rwandan context: the Intermediate Operational Research Training programme.

PubMed

Odhiambo, Jackline; Amoroso, Cheryl L; Barebwanuwe, Peter; Warugaba, Christine; Hedt-Gauthier, Bethany L

2017-01-01

Promoting national health research agendas in low- and middle-income countries (LMICs) requires adequate numbers of individuals with skills to initiate and conduct research. Recently, non-governmental organizations (NGOs) have joined research capacity building efforts to increase research leadership by LMIC nationals. Partners In Health, an international NGO operating in Rwanda, implemented its first Intermediate Operational Research Training (IORT) course to cultivate Rwandan research talent and generate evidence to improve health care delivery. This paper describes the implementation of IORT to share experiences with other organizations interested in developing similar training programmes. The Intermediate Operational Research Training utilized a deliverable-driven training model, using learning-by-doing pedagogy with intensive hands-on mentorship to build research skills from protocol development to scientific publication. The course had short (two-day) but frequent training sessions (seven sessions over eight months). Trainees were clinical and programme staff working at the district level who were paired to jointly lead a research project. Of 10 trainees admitted to the course from a pool of 24 applicants, nine trainees completed the course with five research projects published in peer-reviewed journals. Strengths of the course included supportive national and institutional research capacity guidelines, building from a successful training model, and trainee commitment. Challenges included delays in ethical review, high mentorship workload of up to 250 hours of practicum mentorship, lack of access to literature in subscription journals and high costs of open access publication. The IORT course was an effective way to support the district-based government and NGO staff in gaining research skills, as well as answering research questions relevant to health service delivery at district hospitals. Other NGOs should build on successful programmes while adapting course elements to address context-specific challenges. Mentorship for LMIC trainees is critical for effectiveness of research capacity building initiatives.

Integrating research into operational practice

PubMed Central

Ross, Alastair

2015-01-01

Research and development can be classified into three categories: technology adoption, technology extension, and knowledge and technology creation. In general, technology adoption is embedded in operational forensic science laboratory practice but the latter two categories require partnerships with industry and/or academia both to conduct the research and implement the outcomes. In a 2012 survey, Australian and New Zealand forensic science laboratories identified a number of ‘roadblocks’ to undertaking research and operationalizing research outcomes. These included insufficient time and funding, a lack of in-house research experience and the absence of a tangible research culture. Allied to this is that, increasingly, forensic science research is conducted in a ‘commercial in confidence’ environment and the outcomes are not readily or cost-effectively available to be integrated into operational forensic science laboratories. The paper is predominantly reflective of the current situation in Australia and New Zealand PMID:26101286

Overview of the Life Science Glovebox (LSG) Facility and the Research Performed in the LSG

NASA Technical Reports Server (NTRS)

Cole, J. Michael; Young, Yancy

2016-01-01

The Life Science Glovebox (LSG) is a rack facility currently under development with a projected availability for International Space Station (ISS) utilization in the FY2018 timeframe. Development of the LSG is being managed by the Marshal Space Flight Center (MSFC) with support from Ames Research Center (ARC) and Johnson Space Center (JSC). The MSFC will continue management of LSG operations, payload integration, and sustaining following delivery to the ISS. The LSG will accommodate life science and technology investigations in a "workbench" type environment. The facility has a.Ii enclosed working volume that is held at a negative pressure with respect to the crew living area. This allows the facility to provide two levels of containment for handling Biohazard Level II and lower biological materials. This containment approach protects the crew from possible hazardous operations that take place inside the LSG work volume. Research investigations operating inside the LSG are provided approximately 15 cubic feet of enclosed work space, 350 watts of28Vdc and l IOVac power (combined), video and data recording, and real time downlink. These capabilities will make the LSG a highly utilized facility on ISS. The LSG will be used for biological studies including rodent research and cell biology. The LSG facility is operated by the Payloads Operations Integration Center at MSFC. Payloads may also operate remotely from different telescience centers located in the United States and different countries. The Investigative Payload Integration Manager (IPIM) is the focal to assist organizations that have payloads operating in the LSG facility. NASA provides an LSG qualification unit for payload developers to verify that their hardware is operating properly before actual operation on the ISS. This poster will provide an overview of the LSG facility and a synopsis of the research that will be accomplished in the LSG. The authors would like to acknowledge Ames Research Center, Johnson Space Center, Teledyne Brown Engineering, MOOG-Bradford Engineering and the entire LSG Team for their inputs into this abstract.

Youth in the New South Africa. Towards Policy Formulation. Main Report of the Co-operative Research Programme: South African Youth.

ERIC Educational Resources Information Center

Van Zyl Slabbert, F., Ed.; And Others

In view of the sweeping political and social changes in South Africa, the Human Sciences Research Council and other agencies established the Co-operative Research Programme: South African Youth, a program to undertake research on the problems, challenges, and opportunities facing South African youth. This report presents the information base of…

Research and development portfolio of the sustainability science team national sustainable operations USDA Forest Service

Treesearch

Trista Patterson; David Nicholls; Jonathan Long

2015-01-01

The Sustainability Science Team (SST) of the U.S. Department of Agriculture (USDA) Forest Service Sustainable Operations Initiative is a 18-member virtual research and development team, located across five regions and four research stations of the USDA Forest Service. The team provides research, publication, systems analysis, and decision support to the Sustainable...

Experience Transitioning Models and Data at the NOAA Space Weather Prediction Center

NASA Astrophysics Data System (ADS)

Berger, Thomas

2016-07-01

The NOAA Space Weather Prediction Center has a long history of transitioning research data and models into operations and with the validation activities required. The first stage in this process involves demonstrating that the capability has sufficient value to customers to justify the cost needed to transition it and to run it continuously and reliably in operations. Once the overall value is demonstrated, a substantial effort is then required to develop the operational software from the research codes. The next stage is to implement and test the software and product generation on the operational computers. Finally, effort must be devoted to establishing long-term measures of performance, maintaining the software, and working with forecasters, customers, and researchers to improve over time the operational capabilities. This multi-stage process of identifying, transitioning, and improving operational space weather capabilities will be discussed using recent examples. Plans for future activities will also be described.

Human Factors for Situation Assessment in Grid Operations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Guttromson, Ross T.; Schur, Anne; Greitzer, Frank L.

2007-08-08

Executive Summary Despite advances in technology, power system operators must assimilate overwhelming amounts of data to keep the grid operating. Analyses of recent blackouts have clearly demonstrated the need to enhance the operator’s situation awareness (SA). The long-term objective of this research is to integrate valuable technologies into the grid operator environment that support decision making under normal and abnormal operating conditions and remove non-technical barriers to enable the optimum use of these technologies by individuals working alone and as a team. More specifically, the research aims to identify methods and principles to increase SA of grid operators in themore » context of system conditions that are representative or common across many operating entities and develop operationally relevant experimental methods for studying technologies and operational practices which contribute to SA. With increasing complexity and interconnectivity of the grid, the scope and complexity of situation awareness have grown. New paradigms are needed to guide research and tool development aimed to enhance and improve operations. In reviewing related research, operating practices, systems, and tools, the present study established a taxonomy that provides a perspective on research and development surrounding power grid situation awareness and clarifies the field of human factors/SA for grid operations. Information sources that we used to identify critical factors underlying SA included interviews with experienced operational personnel, available historical summaries and transcripts of abnormal conditions and outages (e.g., the August 14, 2003 blackout), scientific literature, and operational policies/procedures and other documentation. Our analysis of August 2003 blackout transcripts and interviews adopted a different perspective than previous analyses of this material, and we complemented this analysis with additional interviews. Based on our analysis and a broad literature review, we advocate a new perspective on SA in terms of sensemaking, also called situated or ecological decision making, where the focus of the investigation is to understand why the decision maker(s) experienced the situation the way they did, or why what they saw made sense to them at the time. This perspective is distinct from the traditional branch of human factors research in the field which focuses more on ergonomics and the transactional relationship between the human operator and the systems. Consistent with our findings from the literature review, we recognized an over-arching need to focus SA research on issues surrounding the concept of shared knowledge; e.g., awareness of what is happening in adjacent areas as well as one’s own area of responsibility. Major findings were: a) Inadequate communication/information sharing is pervasive, b) Information is available, but not used. Many tools and mechanisms exist for operators to build awareness of the physical grid system, yet the transcripts reveal that they still need to call and exchange information with operators of neighboring areas to improve or validate their SA. The specific types of information that they request are quite predictable and, in most cases, cover information that could be available to both operators and reliability coordinators through readily available displays or other data sources, c) Shared Knowledge is Required on Operations/Actions as Well as Physical Status. In an ideal, technologically and organizationally perfect world, every control room and every reliability coordinator may have access to complete data across all regional control areas and yet, there would still be reason for the operators to call each other to gain and improve their SA of power grid operations, and d) Situation Awareness as sensemaking and shared knowledge.« less

From Research to Operations: Integrating Components of an Advanced Diagnostic System with an Aspect-Oriented Framework

NASA Technical Reports Server (NTRS)

Fletcher, Daryl P.; Alena, Richard L.; Akkawi, Faisal; Duncavage, Daniel P.

2004-01-01

This paper presents some of the challenges associated with bringing software projects from the research world into an operationa1 environment. While the core functional components of research-oriented software applications can have great utility in an operational setting, these applications often lack aspects important in an operational environment such as logging and security. Furthermore, these stand-alone applications, sometimes developed in isolation from one another, can produce data products useful to other applications in a software ecosystem.

Operations Research / Operations Analysis Orientation Course Curriculum for NATO Nations (Programme d’initiation a la recherche / l’analyse operationnelle pour les pays de l’OTAN)

DTIC Science & Technology

2014-09-01

The NATO Science and Technology Organization Science & Technology (S& T ) in the NATO context is defined as the selective and rigorous...generation and application of state-of-the-art, validated knowledge for defence and security purposes. S& T activities embrace scientific research...engineering, operational research and analysis, synthesis, integration and validation of knowledge derived through the scientific method. In NATO, S& T is

Leveraging ISI Multi-Model Prediction for Navy Operations: Proposal to the Office of Naval Research

DTIC Science & Technology

2014-09-30

ISI Multi-Model Prediction for Navy Operations: Proposal to the Office of Naval Research PI: James L. Kinter III Director, Center for Ocean-Land...TYPE 3. DATES COVERED 00-00-2014 to 00-00-2014 4. TITLE AND SUBTITLE Leveraging ISI Multi-Model Prediction for Navy Operations: Proposal to the ... Office of Naval Research 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f

Nextgen Technologies for Mid-Term and Far-Term Air Traffic Control Operations

NASA Technical Reports Server (NTRS)

Prevot, Thomas

2009-01-01

This paper describes technologies for mid-term and far-term air traffic control operations in the Next Generation Air Transportation System (NextGen). The technologies were developed and evaluated with human-in-the-loop simulations in the Airspace Operations Laboratory (AOL) at the NASA Ames Research Center. The simulations were funded by several research focus areas within NASA's Airspace Systems program and some were co-funded by the FAA's Air Traffic Organization for Planning, Research and Technology.

30 CFR 251.8 - Inspection and reporting requirements for activities under a permit.

Code of Federal Regulations, 2011 CFR

2011-07-01

... exploration or scientific research activities under a permit. They will determine whether operations are... operations. (2) You must submit a final report of exploration or scientific research activities under a... scientific research activities were conducted. Identify the lines of geophysical traverses and their...

Applying ABC Analysis to the Navy’s Inventory Management System

DTIC Science & Technology

2014-09-01

degree of MASTER OF SCIENCE IN OPERATIONS RESEARCH from the NAVAL POSTGRADUATE SCHOOL September 2014 Author: Benjamin May...Chair, Department of Operations Research iv THIS PAGE INTENTIONALLY LEFT BLANK v ABSTRACT ABC Analysis is an inventory categorization technique...FUTURE RESEARCH ..................................................................................75  LIST OF REFERENCES

44 CFR 5.42 - Fees to be charged-categories of requesters.

Code of Federal Regulations, 2014 CFR

2014-10-01

... section and which is operated solely for the purpose of conducting scientific research, the results of... scientific research, the fee policy of FEMA is to levy reproduction charges only, excluding charges for the... operates a program or programs of scholarly research. Noncommercial scientific institution refers to an...

44 CFR 5.42 - Fees to be charged-categories of requesters.

Code of Federal Regulations, 2012 CFR

2012-10-01

... section and which is operated solely for the purpose of conducting scientific research, the results of... scientific research, the fee policy of FEMA is to levy reproduction charges only, excluding charges for the... operates a program or programs of scholarly research. Noncommercial scientific institution refers to an...

UTM Safely Enabling UAS Operations in Low-Altitude Airspace

NASA Technical Reports Server (NTRS)

Kopardekar, Parimal

2017-01-01

Conduct research, development and testing to identify airspace operations requirements to enable large-scale visual and beyond visual line of sight UAS operations in the low-altitude airspace. Use build-a-little-test-a-little strategy remote areas to urban areas Low density: No traffic management required but understanding of airspace constraints. Cooperative traffic management: Understanding of airspace constraints and other operations. Manned and unmanned traffic management: Scalable and heterogeneous operations. UTM construct consistent with FAAs risk-based strategy. UTM research platform is used for simulations and tests. UTM offers path towards scalability.

UTM Safely Enabling UAS Operations in Low-Altitude Airspace

NASA Technical Reports Server (NTRS)

Kopardekar, Parimal H.

2016-01-01

Conduct research, development and testing to identify airspace operations requirements to enable large-scale visual and beyond visual line of sight UAS operations in the low-altitude airspace. Use build-a-little-test-a-little strategy remote areas to urban areas Low density: No traffic management required but understanding of airspace constraints. Cooperative traffic management: Understanding of airspace constraints and other operations. Manned and unmanned traffic management: Scalable and heterogeneous operations. UTM construct consistent with FAAs risk-based strategy. UTM research platform is used for simulations and tests. UTM offers path towards scalability.

Research & Technology Report Goddard Space Flight Center

NASA Technical Reports Server (NTRS)

Soffen, Gerald A. (Editor); Truszkowski, Walter (Editor); Ottenstein, Howard (Editor); Frost, Kenneth (Editor); Maran, Stephen (Editor); Walter, Lou (Editor); Brown, Mitch (Editor)

1995-01-01

The main theme of this edition of the annual Research and Technology Report is Mission Operations and Data Systems. Shifting from centralized to distributed mission operations, and from human interactive operations to highly automated operations is reported. The following aspects are addressed: Mission planning and operations; TDRSS, Positioning Systems, and orbit determination; hardware and software associated with Ground System and Networks; data processing and analysis; and World Wide Web. Flight projects are described along with the achievements in space sciences and earth sciences. Spacecraft subsystems, cryogenic developments, and new tools and capabilities are also discussed.

Operational Status of the International Space Station Plasma Contactor Hollow Cathode Assemblies July 2001 to May 2013

NASA Technical Reports Server (NTRS)

Kamhawi, Hani; Yim, John T.; Patterson, Michael J.; Dalton, Penni J.

2013-01-01

The International Space Station has onboard two Aerojet Rocketdyne developed plasma contactor units that perform the function of charge control. The plasma contactor units contain NASA Glenn Research Center developed hollow cathode assemblies. NASA Glenn Research Center monitors the on-orbit operation of the flight hollow cathode assemblies. As of May 31, 2013, HCA.001-F has been ignited and operated 123 times and has accumulated 8072 hours of operation, whereas, HCA.003-F has been ignited and operated 112 times and has accumulated 9664 hours of operation. Monitored hollow cathode ignition times and anode voltage magnitudes indicate that they continue to operate nominally.

Operational Status of the International Space Station Plasma Contactor Hollow Cathode Assemblies from July 2011 to May 2013

NASA Technical Reports Server (NTRS)

Kamhawi, Hani; Yim, John T.; Patterson, Michael J.; Dalton, Penni J.

2014-01-01

The International Space Station has onboard two Aerojet Rocketdyne developed plasma contactor units that perform the function of charge control. The plasma contactor units contain NASA Glenn Research Center developed hollow cathode assemblies. NASA Glenn Research Center monitors the onorbit operation of the flight hollow cathode assemblies. As of May 31, 2013, HCA.001-F has been ignited and operated 123 times and has accumulated 8072 hours of operation, whereas, HCA.003-F has been ignited and operated 112 times and has accumulated 9664 hours of operation. Monitored hollow cathode ignition times and anode voltage magnitudes indicate that they continue to operate nominally.

42 CFR 93.102 - Applicability.

Code of Federal Regulations, 2013 CFR

2013-10-01

... training, such as the operation of tissue and data banks and the dissemination of research information; (ii..., such as the operation of tissue and data banks or the dissemination of research information; and (v...

42 CFR 93.102 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-10-01

... training, such as the operation of tissue and data banks and the dissemination of research information; (ii..., such as the operation of tissue and data banks or the dissemination of research information; and (v...

42 CFR 93.102 - Applicability.

Code of Federal Regulations, 2014 CFR

2014-10-01

... training, such as the operation of tissue and data banks and the dissemination of research information; (ii..., such as the operation of tissue and data banks or the dissemination of research information; and (v...

42 CFR 93.102 - Applicability.

Code of Federal Regulations, 2012 CFR

2012-10-01

... training, such as the operation of tissue and data banks and the dissemination of research information; (ii..., such as the operation of tissue and data banks or the dissemination of research information; and (v...

42 CFR 93.102 - Applicability.

Code of Federal Regulations, 2011 CFR

2011-10-01

... training, such as the operation of tissue and data banks and the dissemination of research information; (ii..., such as the operation of tissue and data banks or the dissemination of research information; and (v...

Syphilis

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

An inventory of aeronautical ground research facilities. Volume 1: Wind tunnels

NASA Technical Reports Server (NTRS)

Pirrello, C. J.; Hardin, R. D.; Heckart, M. V.; Brown, K. R.

1971-01-01

A survey of wind tunnel research facilities in the United States is presented. The inventory includes all subsonic, transonic, and hypersonic wind tunnels operated by governmental and private organizations. Each wind tunnel is described with respect to size, mechanical operation, construction, testing capabilities, and operating costs. Facility performance data are presented in charts and tables.

Leveraging ISI Multi-Model Prediction for Navy Operations: Proposal to the Office of Naval Research

DTIC Science & Technology

2013-09-30

Operations: Proposal to the Office of Naval Research” PI: Benjamin Kirtman University of Miami – RSMAS Meteorology and Physical Oceanography...Prediction for Navy Operations: Proposal to the Office of Naval Research 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d

Intelligent Command and Control Systems for Satellite Ground Operations

NASA Technical Reports Server (NTRS)

Mitchell, Christine M.

1999-01-01

This grant, Intelligent Command and Control Systems for Satellite Ground Operations, funded by NASA Goddard Space Flight Center, has spanned almost a decade. During this time, it has supported a broad range of research addressing the changing needs of NASA operations. It is important to note that many of NASA's evolving needs, for example, use of automation to drastically reduce (e.g., 70%) operations costs, are similar requirements in both government and private sectors. Initially the research addressed the appropriate use of emerging and inexpensive computational technologies, such as X Windows, graphics, and color, together with COTS (commercial-off-the-shelf) hardware and software such as standard Unix workstations to re-engineer satellite operations centers. The first phase of research supported by this grant explored the development of principled design methodologies to make effective use of emerging and inexpensive technologies. The ultimate performance measures for new designs were whether or not they increased system effectiveness while decreasing costs. GT-MOCA (The Georgia Tech Mission Operations Cooperative Associate) and GT-VITA (Georgia Tech Visual and Inspectable Tutor and Assistant), whose latter stages were supported by this research, explored model-based design of collaborative operations teams and the design of intelligent tutoring systems, respectively. Implemented in proof-of-concept form for satellite operations, empirical evaluations of both, using satellite operators for the former and personnel involved in satellite control operations for the latter, demonstrated unequivocally the feasibility and effectiveness of the proposed modeling and design strategy underlying both research efforts. The proof-of-concept implementation of GT-MOCA showed that the methodology could specify software requirements that enabled a human-computer operations team to perform without any significant performance differences from the standard two-person satellite operations team. GT-VITA, using the same underlying methodology, the operator function model (OFM), and its computational implementation, OFMspert, successfully taught satellite control knowledge required by flight operations team members. The tutor structured knowledge in three ways: declarative knowledge (e.g., What is this? What does it do?), procedural knowledge, and operational skill. Operational skill is essential in real-time operations. It combines the two former knowledge types, assisting a student to use them effectively in a dynamic, multi-tasking, real-time operations environment. A high-fidelity simulator of the operator interface to the ground control system, including an almost full replication of both the human-computer interface and human interaction with the dynamic system, was used in the GT-MOCA and GT-VITA evaluations. The GT-VITA empirical evaluation, conducted with a range of'novices' that included GSFC operations management, GSFC operations software developers, and new flight operations team members, demonstrated that GT-VITA effectively taught a wide range of knowledge in a succinct and engaging manner.

Critical operations capabilities in a high cost environment: a multiple case study

NASA Astrophysics Data System (ADS)

Sansone, C.; Hilletofth, P.; Eriksson, D.

2018-04-01

Operations capabilities have been a popular research area for many years and several frameworks have been proposed in the literature. The current frameworks do not take specific contexts into consideration, for instance a high cost environment. This research gap is of particular interest since a manufacturing relocation process has been ongoing the last decades, leading to a huge amount of manufacturing being moved from high to low cost environments. The purpose of this study is to identify critical operations capabilities in a high cost environment. The two research questions were: What are the critical operations capabilities dimensions in a high cost environment? What are the critical operations capabilities in a high cost environment? A multiple case study was conducted and three Swedish manufacturing firms were selected. The study was based on the investigation of an existing framework of operations capabilities. The main dimensions of operations capabilities included in the framework were: cost, quality, delivery, flexibility, service, innovation and environment. Each of the dimensions included two or more operations capabilities. The findings confirmed the validity of the framework and its usefulness in a high cost environment and a new operations capability was revealed (employee flexibility).

Operational Changes in a Shared Resource Laboratory with the Use of a Product Lifecycle Management Approach: A Case Study.

PubMed

Hexley, Philip; Smith, Victoria; Wall, Samantha

2016-04-01

Shared Resource Laboratories (SRLs) provide investigators access to necessary scientific and resource expertise to leverage complex technologies fully for advancing high-quality biomedical research in a cost-effective manner. At the University of Nebraska Medical Center, the Flow Cytometry Research Facility (FCRF) offered access to exceptional technology, but the methods of operation were outdated and unsustainable. Whereas technology has advanced and the institute has expanded, the operations at the facility remained unchanged for 35 yr. To rectify this, at the end of 2013, we took a product lifecycle management approach to affect large operational changes and align the services offered with the SRL goal of education, as well as to provide service to researchers. These disruptive operational changes took over 10 mo to complete and allowed for independent end-user acquisition of flow cytometry data. The results have been monitored for the past 12 mo. The operational changes have had a positive impact on the quality of research, increased investigator-facility interaction, reduced stress of facility staff, and increased overall use of the resources. This product lifecycle management approach to facility operations allowed us to conceive of, design, implement, and monitor effectively the changes at the FCRF. This approach should be considered by SRL management when faced with the need for operationally disruptive measures.