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.

Titrated oral misoprostol solution for induction of labour: a multi-centre, randomised trial.

PubMed

Hofmeyr, G J; Alfirevic, Z; Matonhodze, B; Brocklehurst, P; Campbell, E; Nikodem, V C

2001-09-01

To determine the effects of titrated oral misoprostol solution, compared with vaginal dinoprostone. Open, randomised clinical trial. Academic hospitals in South Africa and Liverpool, UK. Women undergoing induction of labour after 34 weeks of pregnancy were allocated by randomised, sealed opaque envelopes, to induction of labour with titrated oral misoprostol solution, or two doses of vaginal dinoprostone (2mg) administered six hours apart. Failure to deliver within 24 hours of randomisation was the primary outcome on which the sample size was based. The data were analysed by intention-to-treat. Six hundred and ninety-five women were randomly allocated: 346 to oral misoprostol and 349 to vaginal dinoprostone. There were no significant differences in substantive outcomes. Vaginal delivery within 24 hours was not achieved in 38% of women in the oral misoprostol group and 36% in the vaginal dinoprostone group (RR 1.08; 95% CI 0.89-1.31). The caesarean section rates were 16% and 20%, respectively (RR 0.80; 95% CI 0.58-1.11). Hyperstimulation with fetal heart rate changes occurred in 4% of women in the oral misoprostol group and 3% after vaginal dinoprostone (RR 1.32, 95% CI 0.59-2.98). The response to induction of labour in women with unfavourable cervices was somewhat slower with misoprostol when membranes were intact, and with dinoprostone when membranes were ruptured. There were no differences in neonatal outcome between the two groups. This new approach to oral misoprostol administration was successful in minimising the risk of uterine hyperstimulation, which has been a feature of misoprostol use for induction of labour, at the expense of a somewhat slower response in women with intact membranes and unfavourable cervices. Misoprostol is not registered for use in pregnant women, and further research is needed to confirm optimal and safe dosages.

Knowledge and provision of misoprostol among pharmacy workers in Senegal: a cross sectional study.

PubMed

Reiss, Kate; Footman, Katharine; Burke, Eva; Diop, Nafissatou; Ndao, Ramatoulaye; Mane, Babacar; van Min, Maaike; Ngo, Thoai D

2017-07-03

Making misoprostol widely available for management of postpartum haemorrhage (PPH) and post abortion care (PAC) is essential for reducing maternal mortality. Private pharmacies (thereafter called "pharmacies") are integral in supplying medications to the general public in Senegal. In the case of misoprostol, pharmacies are also the main supplier to public providers and therefore have a key role in increasing its availability. This study seeks to understand knowledge and provision of misoprostol among pharmacy workers in Dakar, Senegal. A cross-sectional survey was conducted in Dakar, Senegal. 110 pharmacy workers were interviewed face-to-face to collect information on their knowledge and practice relating to the provision of misoprostol. There are low levels of knowledge about misoprostol uses, registration status, treatment regimens and side effects among pharmacy workers, and corresponding low levels of training on its uses for reproductive health. Provision of misoprostol was low; of the 72% (n = 79) of pharmacy workers who had heard of the product, 35% (n = 27) reported selling it, though rarely for reproductive health indications. Almost half (49%, n = 25) of the respondents who did not sell misoprostol expressed willingness to do so. The main reasons pharmacy workers gave for not selling the product included stock outs (due to product unavailability from the supplier), perceived lack of demand and unwillingness to stock an abortifacient. Knowledge and availability of misoprostol in pharmacies in Senegal is low, posing potential challenges for delivery of post-abortion care and obstetric care. Training is required to address low levels of knowledge of misoprostol registration and uses among pharmacy workers. Barriers that prevent pharmacy workers from stocking misoprostol, including weaknesses in the supply chain and stigmatisation of the product must be addressed. Low reported sales for reproductive health indications also suggest limited prescribing of

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

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.

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.

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.

How to manage unresponsiveness to misoprostol in failed second trimester pregnancy termination.

PubMed

Pongsatha, Saipin; Tongsong, Theera

2013-01-01

To present the experience of management of second trimester pregnancy termination by misoprostol after failure to abort within 48 h of its use. A retrospective, cohort descriptive study was carried out in the Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University Thailand between 1998 and 2010. All women at 14-28 weeks of gestation who failed to abort using misoprostol within 48 h were included. Management of failed pregnancy termination among these women is described here. Of a total of 680 women undergoing termination of pregnancy, 68 (10%) failed to abort. Mean maternal age was 28.71 years and mean gestational age was 19.91 weeks. Further management after failure included additional administration of misoprostol only (19.1%), modified condom balloon technique only (17.7%), modified condom balloon technique plus other methods (16.1%), while 47.1% needed only oxytocin as necessary. The mean interval between initiation of termination and delivery was 96.97 h.   Failure of pregnancy termination using misoprostol can be successfully managed by introducing additional misoprostol, modified condom balloon technique and oxytocin infusion. These methods should be considered before proceeding to hysterotomy. © 2012 The Authors. Journal of Obstetrics and Gynaecology Research © 2012 Japan Society of Obstetrics and Gynecology.

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

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

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.

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

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.

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.

Misoprostol for postpartum hemorrhage prevention at home birth: an integrative review of global implementation experience to date

PubMed Central

2013-01-01

Background Hemorrhage continues to be a leading cause of maternal death in developing countries. The 2012 World Health Organization guidelines for the prevention and management of postpartum hemorrhage (PPH) recommend oral administration of misoprostol by community health workers (CHWs). However, there are several outstanding questions about distribution of misoprostol for PPH prevention at home births. Methods We conducted an integrative review of published research studies and evaluation reports from programs that distributed misoprostol at the community level for prevention of PPH at home births. We reviewed methods and cadres involved in education of end-users, drug administration, distribution, and coverage, correct and incorrect usage, and serious adverse events. Results Eighteen programs were identified; only seven reported all data of interest. Programs utilized a range of strategies and timings for distributing misoprostol. Distribution rates were higher when misoprostol was distributed at a home visit during late pregnancy (54.5-96.9%) or at birth (22.5-83.6%), compared to antenatal care (ANC) distribution at any ANC visit (22.5-49.1%) or late ANC visit (21.0-26.7%). Coverage rates were highest when CHWs and traditional birth attendants distributed misoprostol and lower when health workers/ANC providers distributed the medication. The highest distribution and coverage rates were achieved by programs that allowed self-administration. Seven women took misoprostol prior to delivery out of more than 12,000 women who were followed-up. Facility birth rates increased in the three programs for which this information was available. Fifty-one (51) maternal deaths were reported among 86,732 women taking misoprostol: 24 were attributed to perceived PPH; none were directly attributed to use of misoprostol. Even if all deaths were attributable to PPH, the equivalent ratio (59 maternal deaths/100,000 live births) is substantially lower than the reported maternal

Misoprostol for postpartum hemorrhage prevention at home birth: an integrative review of global implementation experience to date.

PubMed

Smith, Jeffrey Michael; Gubin, Rehana; Holston, Martine M; Fullerton, Judith; Prata, Ndola

2013-02-20

Hemorrhage continues to be a leading cause of maternal death in developing countries. The 2012 World Health Organization guidelines for the prevention and management of postpartum hemorrhage (PPH) recommend oral administration of misoprostol by community health workers (CHWs). However, there are several outstanding questions about distribution of misoprostol for PPH prevention at home births. We conducted an integrative review of published research studies and evaluation reports from programs that distributed misoprostol at the community level for prevention of PPH at home births. We reviewed methods and cadres involved in education of end-users, drug administration, distribution, and coverage, correct and incorrect usage, and serious adverse events. Eighteen programs were identified; only seven reported all data of interest. Programs utilized a range of strategies and timings for distributing misoprostol. Distribution rates were higher when misoprostol was distributed at a home visit during late pregnancy (54.5-96.9%) or at birth (22.5-83.6%), compared to antenatal care (ANC) distribution at any ANC visit (22.5-49.1%) or late ANC visit (21.0-26.7%). Coverage rates were highest when CHWs and traditional birth attendants distributed misoprostol and lower when health workers/ANC providers distributed the medication. The highest distribution and coverage rates were achieved by programs that allowed self-administration. Seven women took misoprostol prior to delivery out of more than 12,000 women who were followed-up. Facility birth rates increased in the three programs for which this information was available. Fifty-one (51) maternal deaths were reported among 86,732 women taking misoprostol: 24 were attributed to perceived PPH; none were directly attributed to use of misoprostol. Even if all deaths were attributable to PPH, the equivalent ratio (59 maternal deaths/100,000 live births) is substantially lower than the reported maternal mortality ratio in any of these

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

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

Optimal timing of misoprostol administration in nulliparous women undergoing office hysteroscopy: a randomized double-blind placebo-controlled study.

PubMed

Fouda, Usama M; Gad Allah, Sherine H; Elshaer, Hesham S

2016-07-01

To determine the optimal timing of vaginal misoprostol administration in nulliparous women undergoing office hysteroscopy. Randomized double-blind placebo-controlled study. University teaching hospital. One hundred twenty nulliparous patients were randomly allocated in a 1:1 ratio to the long-interval misoprostol group or the short-interval misoprostol group. In the long-interval misoprostol group, two misoprostol tablets (400 μg) and two placebo tablets were administered vaginally at 12 and 3 hours, respectively, before office hysteroscopy. In the short-interval misoprostol group, two placebo tablets and two misoprostol tablets (400 μg) were administered vaginally 12 and 3 hours, respectively, before office hysteroscopy. The severity of pain was assessed by the patients with the use of a 100-mm visual analog scale (VAS). The operators assessed the ease of the passage of the hysteroscope through the cervical canal with the use of a 100-mm VAS as well. Pain scores during the procedure were significantly lower in the long-interval misoprostol group (37.98 ± 13.13 vs. 51.98 ± 20.68). In contrast, the pain scores 30 minutes after the procedure were similar between the two groups (11.92 ± 7.22 vs. 13.3 ± 6.73). Moreover, the passage of the hysteroscope through the cervical canal was easier in the long-interval misoprostol group (48.9 ± 17.79 vs. 58.28 ± 21.85). Vaginal misoprostol administration 12 hours before office hysteroscopy was more effective than vaginal misoprostol administration 3 hours before office hysteroscopy in relieving pain experienced by nulliparous patients undergoing office hysteroscopy. NCT02316301. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Community-based distribution of misoprostol to prevent postpartum haemorrhage at home births: results from operations research in rural Ghana.

PubMed

Geller, S; Carnahan, L; Akosah, E; Asare, G; Agyemang, R; Dickson, R; Kapungu, C; Owusu-Ansah, L; Robinson, N; Mensah-Homiah, J

2014-02-01

To report on a rigorous distribution and monitoring plan to track misoprostol for community-based distribution to reduce postpartum haemorrhage (PPH) in rural Ghana. Operations research. Rural Ghana. Women in third trimester of pregnancy presenting to primary health centres (PHCs) for antenatal care (ANC). Ghana Health Service (GHS), Millennium Village Projects, and the University of Illinois at Chicago conducted an operations research study designed to assess the safety, feasibility, and acceptability of community-based distribution of misoprostol to prevent PPH at home deliveries in rural Ghana. One thousand doses (3000 tablets, 200 μg each) were obtained from the Family Health Division of GHS. Three 200-μg tablets of misoprostol (600 μg) in foil packets were packaged together in secured transparent plastic packets labelled with pictorial messages and distributed to midwives at seven PHCs for distribution to pregnant women. Correct use of misoprostol in home deliveries and retrieval of unused misoprostol doses, PPH rates and maternal mortality. Of the 999 doses distributed to midwives, 982 (98.3%) were successfully tracked, with a 1.7% lost to follow-up rate. Midwives distributed 654 doses to women at third-trimester ANC visits. Of women who had misoprostol to use at home, 81% had an institutional delivery and were able to return the misoprostol safely to the midwife. Of the women that used misoprostol, 99% used the misoprostol correctly. This study clearly demonstrates that misoprostol distributed antenatally to pregnant women can be used accurately and reliably by rural Ghanaian women, and should be considered for policy implementation across Ghana and other countries with high home birth rates and maternal mortality ratios. © 2013 Royal College of Obstetricians and Gynaecologists.

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.

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

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.

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.

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.

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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

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.

Misoprostol for the prevention of postpartum hemorrhage during home births in rural Lao PDR: establishing a pilot program for community distribution.

PubMed

Durham, Jo; Phengsavanh, Alongkone; Sychareun, Vanphanom; Hose, Isaac; Vongxay, Viengnakhone; Xaysomphou, Douangphachanh; Rickart, Keith

2018-01-01

The purpose of this study was to gather the necessary data to support the design and implementation of a pilot program for women who are unable to deliver in a healthcare facility in the Lao People's Democratic Republic (PDR), by using community distribution of misoprostol to prevent postpartum hemorrhage (PPH). The study builds on an earlier research that demonstrated both support and need for community-based distribution of misoprostol in Lao PDR. This qualitative study identified acceptability of misoprostol and healthcare system needs at varying levels to effectively distribute misoprostol to women with limited access to facility-based birthing. Interviews (n=25) were undertaken with stakeholders at the central, provincial, and district levels and with community members in five rural communities in Oudomxay, a province with high rates of maternal mortality. Focus group discussions (n=5) were undertaken in each community. Respondents agreed that PPH was the major cause of preventable maternal mortality with community distribution of misoprostol an acceptable and feasible interim preventative solution. Strong leadership, training, and community mobilization were identified as critical success factors. While several participants preferred midwives to distribute misoprostol, given the limited availability of midwives, there was a general agreement that village health workers or other lower level workers could safely administer misoprostol. Many key stakeholders, including women themselves, considered that these community-level staff may be able to provide misoprostol to women for self-administration, as long as appropriate education on its use was included. The collected data also helped identify appropriate educational messages and key indicators for monitoring and evaluation for a pilot program. The findings strengthen the case for a pilot program of community distribution of misoprostol to prevent PPH in remote communities where women have limited access to a

Misoprostol for the prevention of postpartum hemorrhage during home births in rural Lao PDR: establishing a pilot program for community distribution

PubMed Central

Durham, Jo; Phengsavanh, Alongkone; Sychareun, Vanphanom; Hose, Isaac; Vongxay, Viengnakhone; Xaysomphou, Douangphachanh; Rickart, Keith

2018-01-01

Purpose The purpose of this study was to gather the necessary data to support the design and implementation of a pilot program for women who are unable to deliver in a healthcare facility in the Lao People’s Democratic Republic (PDR), by using community distribution of misoprostol to prevent postpartum hemorrhage (PPH). The study builds on an earlier research that demonstrated both support and need for community-based distribution of misoprostol in Lao PDR. Methods This qualitative study identified acceptability of misoprostol and healthcare system needs at varying levels to effectively distribute misoprostol to women with limited access to facility-based birthing. Interviews (n=25) were undertaken with stakeholders at the central, provincial, and district levels and with community members in five rural communities in Oudomxay, a province with high rates of maternal mortality. Focus group discussions (n=5) were undertaken in each community. Results Respondents agreed that PPH was the major cause of preventable maternal mortality with community distribution of misoprostol an acceptable and feasible interim preventative solution. Strong leadership, training, and community mobilization were identified as critical success factors. While several participants preferred midwives to distribute misoprostol, given the limited availability of midwives, there was a general agreement that village health workers or other lower level workers could safely administer misoprostol. Many key stakeholders, including women themselves, considered that these community-level staff may be able to provide misoprostol to women for self-administration, as long as appropriate education on its use was included. The collected data also helped identify appropriate educational messages and key indicators for monitoring and evaluation for a pilot program. Conclusion The findings strengthen the case for a pilot program of community distribution of misoprostol to prevent PPH in remote communities

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.

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.

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

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.

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

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.

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.

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.

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.

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.

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

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.

Sublingual versus vaginal misoprostol for cervical dilatation 1 or 3 h prior to surgical abortion: a double-blinded RCT.

PubMed

Sääv, Ingrid; Kopp Kallner, Helena; Fiala, Christian; Gemzell-Danielsson, Kristina

2015-06-01

Can sublingual administration of misoprostol 1 h prior to vacuum aspiration be more effective than vaginal administration and as effective as either route three 3 h prior to surgery? Sublingually administered misoprostol is superior to vaginally administered misoprostol when given 1 h pre operatively, and it is as effective as after a three 3 h priming interval with either route of administration. Misoprostol reduces complications and morbidity when used for cervical priming prior to surgical dilatation and vacuum aspiration in first trimester pregnancy. Despite the widespread use and extensive studies, the optimal route of administration of misoprostol before surgical abortion remains to be defined. The optimal priming interval after vaginal and sublingual administration of 400 mcg misoprostol has been reported to be 3 h. A longer interval will not improve dilatation but will increase the risk for bleeding and expulsion of the uterine contents before surgical evacuation. The pharmacokinetic properties of misoprostol indicate that sublingual compared with vaginal administration of misoprostol may result in a more rapid cervical priming effect. Women were randomized to four treatment groups and received 400 mcg misoprostol sublingually, or vaginally, 1 or 3 h prior to surgery. The study was a double-blinded RCT with regard to route of misoprostol administration but not the timing interval. The primary outcome was baseline cervical dilatation after misoprostol priming. The study was conducted between June 2007 and March 2014 and 184 women aged 18 years or older were recruited. Women were recruited among nulliparous women undergoing elective surgical first trimester abortion. Exclusion criteria were any contraindication for misoprostol, untreated genital infection, previous history of surgery to the cervix, or abnormal pregnancy. Gestational age was established by endovaginal ultrasound examination. The trial was conducted in a university hospital outpatient clinic

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.

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.

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.

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

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

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.

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 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.

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

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

Programmes for advance distribution of misoprostol to prevent post-partum haemorrhage: a rapid literature review of factors affecting implementation.

PubMed

Smith, Helen J; Colvin, Christopher J; Richards, Esther; Roberson, Jeffrey; Sharma, Geeta; Thapa, Kusum; Gülmezoglu, A Metin

2016-02-01

Recent efforts to prevent post-partum haemorrhage (PPH) in low-income countries have focused on providing women with access to oral misoprostol during home birth. The WHO recommends using lay health workers (LHWs) to administer misoprostol in settings where skilled birth attendants are not available. This review synthesizes current knowledge about the barriers and facilitators affecting implementation of advance community distribution of misoprostol to prevent PPH, where misoprostol may be self-administered or administered by an LHW.We searched for and summarized available empirical evidence, and collected primary data from programme stakeholders about their experiences of programme implementation.We present key outcomes and features of advanced distribution programmes that are in operation or have been piloted globally. We categorized factors influencing implementation into those that operate at the health system level, factors related to the community and policy context and those factors more closely connected to the end user.Debates around advance distribution have centred on the potential risks and benefits of making misoprostol available to pregnant women and community members during pregnancy for administration in the home. However, the risks of advance distribution appear manageable and the benefits of self-administration, especially for women who have little chance of expert care for PPH, are considerable. © The Author 2015. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine.

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.

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.

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

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.

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.

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.

Misoprostol versus antacid titration for preventing stress ulcers in postoperative surgical ICU patients.

PubMed Central

Zinner, M J; Rypins, E B; Martin, L R; Jonasson, O; Hoover, E L; Swab, E A; Fakouhi, T D

1989-01-01

Bleeding from gastroduodenal lesions is a potentially life-threatening complication in patients subjected to overwhelming physiologic stress. Titration of gastric contents with antacid was the first prophylactic treatment regimen proved to decrease the incidence of bleeding and remains the standard by which other methods are compared. We designed a prospective double-blind, double-placebo study comparing the effectiveness of antacid titration with fixed doses of a synthetic prostaglandin E1 analog (misoprostol) for preventing stress gastritis and bleeding. To assess the success of each treatment regimen, we did endoscopic examinations before operation, 72 hours after operation, and after the patient had completed the study. A total of 281 patients entered the study (140 misoprostol, 141 antacid). The two groups were comparable with respect to preoperative parameters and type of operation. We found no statistically significant differences between the two treatment groups concerning upper gastrointestinal tract lesions or serious adverse effects. No clinically evident upper gastrointestinal hemorrhage occurred in either group. Mean gastric pH, measured at two-hour intervals during the initial 72 hours, was maintained at 4.0 or higher in both groups. We conclude that fixed-dose misoprostol is as effective as intensive antacid titration in preventing stress ulcers and bleeding in surgical ICU patients. PMID:2510618

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.

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. �

[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.

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.

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

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 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.

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.

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.

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

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.

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

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.

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

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

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

[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.

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

Training traditional birth attendants to use misoprostol and an absorbent delivery mat in home births.

PubMed

Prata, Ndola; Quaiyum, Md Abdul; Passano, Paige; Bell, Suzanne; Bohl, Daniel D; Hossain, Shahed; Azmi, Ashrafi Jahan; Begum, Mohsina

2012-12-01

A 50-fold disparity in maternal mortality exists between high- and low-income countries, and in most contexts, the single most common cause of maternal death is postpartum hemorrhage (PPH). In Bangladesh, as in many other low-income countries, the majority of deliveries are conducted at home by traditional birth attendants (TBAs) or family members. In the absence of skilled birth attendants, training TBAs in the use of misoprostol and an absorbent delivery mat to measure postpartum blood loss may strengthen the ability of TBAs to manage PPH. These complementary interventions were tested in operations research among 77,337 home births in rural Bangladesh. The purpose of this study was to evaluate TBAs' knowledge acquisition, knowledge retention, and changes in attitudes and practices related to PPH management in home births after undergoing training on the use of misoprostol and the blood collection delivery mat. We conclude that the training was highly effective and that the two interventions were safely and correctly used by TBAs at home births. Data on TBA practices indicate adherence to protocol, and 18 months after the interventions were implemented, TBA knowledge retention remained high. This program strengthens the case for community-based use of misoprostol and warrants consideration of this intervention as a potential model for scale-up in settings where complete coverage of skilled birth attendants (SBAs) remains a distant goal. Copyright © 2012 Elsevier Ltd. All rights reserved.

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

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

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.

Implementing at-scale, community-based distribution of misoprostol tablets to mothers in the third stage of labor for the prevention of postpartum haemorrhage in Sokoto State, Nigeria: Early results and lessons learned

PubMed Central

Orobaton, Nosakhare; Abdulazeez, Jumare; Abegunde, Dele; Shoretire, Kamil; Maishanu, Abubakar; Ikoro, Nnenna; Fapohunda, Bolaji; Balami, Wapada; Beal, Katherine; Ganiyu, Akeem; Gwamzhi, Ringpon; Austin, Anne

2017-01-01

Background Postpartum haemorrhage (PPH) is a leading cause of maternal death in Sokoto State, Nigeria, where 95% of women give birth outside of a health facility. Although pilot schemes have demonstrated the value of community-based distribution of misoprostol for the prevention of PPH, none have provided practical insight on taking such programs to scale. Methods A community-based system for the distribution of misoprostol tablets (in 600ug) and chlorhexidine digluconate gel 7.1% to mother-newborn dyads was introduced by state government officials and community leaders throughout Sokoto State in April 2013, with the potential to reach an estimated 190,467 annual births. A simple outcome form that collected distribution and consumption data was used to assess the percentage of mothers that received misoprostol at labor through December 2014. Mothers’ conditions were tracked through 6 weeks postpartum. Verbal autopsies were conducted on associated maternal deaths. Results Misoprostol distribution was successfully introduced and reached mothers in labor in all 244 wards in Sokoto State. Community data collection systems were successfully operational in all 244 wards with reliable capacity to record maternal deaths. 70,982 women or 22% of expected births received misoprostol from April 2013 to December 2014. Between April and December 2013, 33 women (< 1%) reported that heavy bleeding persisted after misoprostol use and were promptly referred. There were a total of 11 deaths in the 2013 cohort which were confirmed as maternal deaths by verbal autopsies. Between January and December of 2014, a total 434 women (1.25%) that ingested misoprostol reported associated side effects. Conclusion It is feasible and safe to utilize government guidelines on results-based primary health care to successfully introduce community distribution of life saving misoprostol at scale to reduce PPH and improve maternal outcomes. Lessons from Sokoto State’s at-scale program implementation

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.

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.

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.

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.

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.

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

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.

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

Does self-administered vaginal misoprostol result in cervical ripening in postmenopausal women after 14 days of pre-treatment with estradiol? Trial protocol for a randomised, placebo-controlled sequential trial.

PubMed

Oppegaard, K S; Lieng, M; Berg, A; Istre, O; Qvigstad, E; Nesheim, B-I

2008-06-01

To compare the impact of 1000 micrograms of self-administered vaginal misoprostol versus self-administered vaginal placebo on preoperative cervical ripening after pre-treatment with estradiol vaginal tablets at home in postmenopausal women prior to day-care operative hysteroscopy. Randomised double-blind placebo-controlled sequential trial. The boundaries for the sequential trial were calculated on the primary outcomes of a difference of cervical dilatation > or = 1 millimetre, with the assumption of a type 1 error of 0.05 and a power of 0.95. Norwegian university teaching hospital. Postmenopausal women referred for day-care operative hysteroscopy. The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before day-care operative hysteroscopy. All women had administered a 25-microgram vaginal estradiol tablet daily for 14 days prior to the operation. Preoperative cervical dilatation (difference between misoprostol and placebo group, primary outcome), difference in dilatation before and after administration of misoprostol or placebo, number of women who achieve a preoperative cervical dilatation > or = 5 millimetres, acceptability, complications and side effects (secondary outcomes). Intra-operative findings and distribution of cervical dilatation in the two treatment groups: values are given as median (range) or n (%). Difference in dilatation before and after administration of misoprostol and placebo: values are given as median (range) of intraindividual differences. Percentage of women who achieve a cervical dilatation of > or = 5 mm, percentage of women who were difficult to dilate. Acceptability in the two treatment groups: values are given as completely acceptable n (%), fairly acceptable n (%), fairly unacceptable n (%), completely unacceptable n (%). Pain in the two treatment groups: pain was measured with a visual analogue scale ranging from 0 (no pain) to 10 (unbearable

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

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.

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.

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.

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

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

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

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

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.

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

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

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

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

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.

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

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.

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

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.

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.

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

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 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.

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

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 ...

[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

[Cytotec and abortion: the police, the vendors and women].

PubMed

Diniz, Debora; Madeiro, Alberto

2012-07-01

This paper analyzes the illegal trade in misoprostol, the medication predominantly used for abortion in Brazil. The study analyzed ten cases that came to the attention of the Public Prosecution Service for the Federal District between 2004 and 2010. The cases were organized into three categories: 1. women's stories; 2. profile of the vendors; 3. maternal mortality cases. The research was reviewed by an ethics committee. The main outcomes were: 1. young women in steady relationships use misoprostol in the home or with the assistance of drug vendors. Of the seven women indicted, three were reported on arrival at the public hospital to finalize abortion; 2. the drug vendors work at the community drugstore and are local agents for the sale of misoprostol. They instruct women on how to use the drug and how to prevent infections, but refuse to provide them with care in case of emergency. Traffickers operate via the internet and have a larger inventory of drugs; 3. there were two cases of maternal mortality due to the combination of high risk methods, such as a vaginal probe and misoprostol. The main causes for maternal mortality are the delay in seeking medical care, as the women fear criminal prosecution, and the combined use of misoprostol with high risk methods.

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.

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.

[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.

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

Preoperative ripening of the cervix before operative hysteroscopy.

PubMed

Al-Fozan, Haya; Firwana, Belal; Al Kadri, Hanan; Hassan, Samar; Tulandi, Togas

2015-04-23

Hysteroscopy is an operation in which the gynaecologist examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix. Almost 50% of hysteroscopic complications are related to difficulty with cervical entry. Potential complications include cervical tears, creation of a false passage, perforation, bleeding, or simply difficulty in entering the internal os (between the cervix and the uterus) with the hysteroscope. These complications may possibly be reduced with adequate preparation of the cervix (cervical ripening) prior to hysteroscopy. Cervical ripening agents include oral or vaginal prostaglandin, which can be synthetic (e.g misoprostol) or natural (e.g. dinoprostone) and vaginal osmotic dilators, which can be naturally occurring (e.g. laminaria) or synthetic. To determine whether preoperative cervical preparation facilitates cervical dilatation and reduces the complications of operative hysteroscopy in women undergoing the procedure for any condition. In August 2014 we searched sources including the Menstrual Disorders and Subfertility Group (MDSG) Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and reference lists of relevant articles. We searched for published and unpublished studies in any language. Two review authors independently selected randomised controlled trials (RCTs) of cervical ripening agents used before operative hysteroscopy in pre- and postmenopausal women. Cervical ripening agents could be compared to each other, placebo or no treatment. Data extraction and quality assessment were conducted independently by two review authors. The primary review outcomes were effectiveness of cervical dilatation (defined as the proportion of women requiring mechanical cervical dilatation) and intraoperative complications. Secondary outcomes were mean time required to dilate the cervix, preoperative pain, cervical width

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

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

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

[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.

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

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

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.

“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.

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.

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.

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

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

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.

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.

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.

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.

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

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

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

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.

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.

[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.

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

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

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.

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.

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

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

[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.

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.

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.

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.

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.

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.

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.

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:…

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

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

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

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.

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.

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

[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.

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

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.

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

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

Clinic-level introduction of medical abortion in Vietnam.

PubMed

Raghavan, Sheila; Ngoc, Nguyen thi Nhu; Shochet, Tara; Winikoff, Beverly

2012-10-01

To assess the efficacy of medical abortion and patient satisfaction in the clinic setting, in addition to determining healthcare providers' views. From 2006 to 2008, 2400 women were enrolled at 10 Vietnam Family Planning Association (VINAFPA) clinics in an operations research project. Participants took 200mg of oral mifepristone in the clinic and 400 μg of oral misoprostol 2 days later at home or in the clinic. Abortion status was assessed at follow-up. Furthermore, in 2006, 900 clinicians at 45 health facilities answered a knowledge, attitudes, and practices survey to capture providers' views. In total, 93.8% of participants had successful medical abortions. The majority (84.5%) administered misoprostol at home. Adverse effects included bleeding, pain/cramps, and nausea. Most women (92.6%) were satisfied/very satisfied with the method. Most providers who took the survey (85.6%) recommended that medical abortion be introduced at VINAFPA clinics. The operations research data demonstrate the safety, efficacy, and acceptability of medical abortion at VINAFPA clinics. The majority of surveyed providers endorsed adding medical abortion at their own facilities. Developing national guidelines for providing medical abortion at the clinic level is an important step in expanding access to services in Vietnam. Copyright © 2012 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

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

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

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.

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.

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.

[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.

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.

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.

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.

[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.

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.

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.

[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

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.

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

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.

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.

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.

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.

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.

[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.

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.

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

[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.

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.

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

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

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

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

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.

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.

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.

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

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.

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.

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

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

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.

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.

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

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.

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

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.

[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

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.

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

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.

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

[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.

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.

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.

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.

[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.

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

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

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.

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

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/

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

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

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.

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.

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.

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

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.

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.

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.

[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.

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.

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.

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.

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 effect of Piper betle Linn. leaves grown in Sri Lanka

PubMed Central

Arawwawala, L. D. A. M.; Arambewela, L. S. R.; Ratnasooriya, W. D.

2014-01-01

Background: 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. Objective: To evaluate the gastroprotective activity of hot aqueous extract (HAE) and cold ethanolic extract (CEE) of P. betle in rats as the experimental model. Materials and Methods: 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. Results: Oral administration of HAE and CEE provided marked dose dependent (HAE: r2 = 0.97; CEE: r2 = 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. Conclusion: It is concluded that both HAE and CEE of P. betle leaves have a strong gastroprotective activity. PMID:24812474

Anti-legal attitude toward abortion among abortion patients in the United States.

PubMed

Thomas, Rachel G; Norris, Alison H; Gallo, Maria F

2017-11-01

To measure the prevalence of believing that abortion should be illegal in all or most cases among women obtaining an abortion in the United States and to identify correlates of holding this belief. Study population was drawn from the nationally-representative 2008 Abortion Patient Survey. The primary outcome was having an anti-legal abortion attitude, defined as agreeing that abortion should be illegal in all or most cases. We assessed potential correlates in bivariable and multivariable analyses using weights to account for the complex sampling. A total of 4769 abortion patients completed the survey module containing the question on abortion legality, of which 4492 (94.2%) had non-missing data for the outcome. Overall, 4.1% of patients (N=183) reported an anti-legal abortion attitude. Correlates of having anti-legal attitude included being married, at <200% federal poverty level, fundamentalist, contraception non-use, no abortion history, perceiving the pregnancy with ambivalence or as unintended, and using misoprostol or another product on their own to bring back their period or end the pregnancy. Abortion patients who do not believe abortion should be legal appear to differ substantially from women who are more supportive of legality. Findings raise important questions about this subset of patients, including whether possible discordance between patient beliefs and behavior could influence their use of medical abortion or other products. Some abortion patients do not agree with abortion legality, and this subset could experience a degree of cognitive dissonance, which could influence the method by which they seek to abort. Copyright © 2017 Elsevier Inc. All rights reserved.

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

Proton pump inhibitors for preventing non-steroidal anti-inflammatory drug induced gastrointestinal toxicity: a systematic review.

PubMed

Yang, Man; He, Min; Zhao, Miao; Zou, Bing; Liu, Jun; Luo, Ling-Min; Li, Qiu-Lan; He, Jun-Hui; Lei, Ping-Guang

2017-06-01

Proton pump inhibitors (PPIs) are recommended for preventing gastrointestinal lesions induced by non-steroidal anti-inflammatory drugs (NSAIDs). We performed this study: (1) to evaluate the effectiveness and safety of PPIs, (2) to explore the association between effectiveness and potential influential factors, and (3) to investigate the comparative effect of different PPIs. MEDLINE, EMBASE, and the Cochrane Library were searched to identify randomized controlled trials comparing different classes of PPIs, or comparing PPIs with placebo, H 2 receptor antagonists or misoprostol in NSAIDs users. Both pairwise meta-analysis and Bayesian network meta-analysis were performed. Analyses were based on 12,532 participants from 31 trials. PPIs were significantly more effective than placebo in reducing ulcer complications (relative risk [RR] = 0.29; 95% confidence interval [CI], 0.20 to 0.42) and endoscopic peptic ulcers (RR = 0.27; 95% CI, 0.22 to 0.33), with no subgroup differences according to class of NSAIDs, ulcer risk, history of previous ulcer disease, Helicobacter pylori infection, or age. To prevent one ulcer complication, 10 high risk patients and 268 moderate risk patients need PPI therapy. Network meta-analysis indicated that the effectiveness of different PPIs in reducing ulcer complications and endoscopic peptic ulcers is generally similar. PPIs significantly reduced gastrointestinal adverse events and the related withdrawals compared to placebo; there is no difference in safety between different PPIs. PPIs are effective and safe in preventing peptic ulcers and complications in a wide spectrum of patients requiring NSAID therapy. There is no major difference in the comparative effectiveness and safety between different PPIs.

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.

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

Assessment of completion of early medical abortion using a text questionnaire on mobile phones compared to a self-administered paper questionnaire among women attending four clinics, Cape Town, South Africa.

PubMed

Constant, Deborah; de Tolly, Katherine; Harries, Jane; Myer, Landon

2015-02-01

In-clinic follow-up to assess completion of medical abortion is no longer a requirement according to World Health Organization guidance, provided adequate counselling is given. However, timely recognition of ongoing pregnancy, complications or incomplete abortion, which require treatment, is important. As part of a larger trial, this study aimed to establish whether women having a medical abortion could self-assess whether their abortion was complete using an automated, interactive questionnaire on their mobile phones. All 469 participants received standard abortion care and all returnees filled in a self-assessment on paper at clinic follow-up 2-3 weeks later. The 234 women allocated to receive the phone messages were also asked to do a mobile phone assessment at home ten days post-misoprostol. Completion of the mobile assessment was tracked by computer and all completed assessments, paper and mobile, were compared to providers' assessments at clinic follow-up. Of the 226 women able to access the mobile phone assessment, 176 (78%) completed it; 161 of them (93%) reported it was easy to do so. Neither mobile nor paper self-assessments predicted all cases needing additional treatment at follow-up. Prediction of complete procedures was good; 71% of mobile assessments and 91% of paper assessments were accurate. We conclude that an interactive questionnaire assessing completion of medical abortion on mobile phones is feasible in the South African setting; however, it should be done later than day 10 and combined with an appropriate pregnancy test to accurately detect incomplete procedures. Copyright © 2015 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

Rebamipide helps defend against nonsteroidal anti-inflammatory drugs induced gastroenteropathy: a systematic review and meta-analysis.

PubMed

Zhang, Shaoheng; Qing, Qing; Bai, Yang; Mao, Hua; Zhu, Wei; Chen, Qikui; Zhang, Yali; Chen, Ye

2013-07-01

Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs (NSAIDs) has been perplexing most clinicians and users of NSAIDs. Rebamipide is increasingly advocated as a candidate option for the prevention of NSAIDs induced gastrointestinal mucosal injury. To assess the efficacy and the safety of rebamipide for the prevention and treatment of NSAID-induced gastroenteropathy. PubMed, Embase, Web of Science, Google Scholar, the Cochrane Library, Japan Science and Technology Information Aggregator, and China Biology Medicine Disc were searched up to December 2011. Randomized controlled trials (RCTs) recruiting subjects with co-prescriptions of NSAIDs and rebamipide were eligible. Efficacy and safety of rebamipide were reevaluated, and dichotomous data were pooled to obtain relative risk (RR) with a 95 % confidence interval. Heterogeneity and publication bias were assessed by the inconsistency index statistic and funnel plot analysis, respectively. The search identified 338 citations, and 15 RCTs including 965 individuals were eligible. In general, rebamipide acted better than placebo against short-term NSAID-induced gastroduodenal injury. Separate studies showed rebamipide was equal to or not superior to traditional strategies (including PPIs, H2RA and misoprostol treatment). Especially, rebamipide showed a beneficial effect against the small bowel damage (total RR = 2.70, 95 % confidence interval = 1.02-7.16, P = 0.045) when compared with placebo group. The average incidence of adverse events was about 36.1 % (0-70.0 %) but no serious event was recorded. Current evidences show rebamipide is effective and safe for defending against NSAID-induced gastroduodenal and lower-gastrointestinal injuries. However, more well-designed trials should be conducted to fully confirm the practical value of rebamipide.

"My friend who bought it for me, she has had an abortion before." The influence of Ghanaian women's social networks in determining the pathway to induced abortion.

PubMed

Rominski, Sarah D; Lori, Jody R; Morhe, Emmanuel Sk

2017-07-01

Even given the liberal abortion law in Ghana, abortion complications are a large contributor to maternal morbidity and mortality. This study sought to understand why young women seeking an abortion in a legally enabling environment chose to do this outside the formal healthcare system. Women being treated for complications arising from a self-induced abortion as well as for elective abortions at three hospitals in Ghana were interviewed. Community-based focus groups were held with women as well as men, separately. Interviews and focus group discussions were conducted until saturation was reached. A total of 18 women seeking care for complications from a self-induced abortion and 11 seeking care for an elective abortion interviewed. The women ranged in age from 13 to 35 years. There were eight focus groups; two with men and six with women. The reasons women self-induce are: (1) abortion is illegal; (2) attitudes of the healthcare workers; (3) keeping the pregnancy a secret; and (4) social network influence. The meta-theme of normalisation of self-inducing' an abortion was identified. When women are faced with an unplanned and unwanted pregnancy, they consult individuals in their social network whom they know have dealt with a similar situation. Misoprostol is widely available in Ghanaian cities and is successful at inducing an abortion for many women. In this way, self-inducing abortions using medication procured from pharmacists and chemical sellers has become normalised for women in Kumasi, Ghana. © Faculty of Sexual and Reproductive Healthcare of the Royal College of Obstetricians and Gynaecologists (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Hospital admission following induced abortion in Eastern Highlands Province, Papua New Guinea--a descriptive study.

PubMed

Vallely, Lisa M; Homiehombo, Primrose; Kelly-Hanku, Angela; Kumbia, Antonia; Mola, Glen D L; Whittaker, Andrea

2014-01-01

In Papua New Guinea abortion is restricted under the Criminal Code Act. While safe abortions should available in certain situations, frequently they are not available to the majority of women. Sepsis from unsafe abortion is a leading cause of maternal mortality. Our findings form part of a wider, mixed methods study designed to identify complications requiring hospital treatment for post abortion care and to explore the circumstances surrounding unsafe abortion. Through a six month prospective study we identified all women presenting to the Eastern Highlands Provincial Hospital following spontaneous and induced abortions. We undertook semi-structured interviews with women and reviewed individual case notes, extracting demographic and clinical information. Case notes were reviewed for 56% (67/119) of women presenting for post abortion care. At least 24% (28/119) of these admissions were due to induced abortion. Women presenting following induced abortions were significantly more likely to be younger, single, in education at the time of the abortion and report that the baby was unplanned and unwanted, compared to those reporting spontaneous abortion. Obtained illegally, misoprostol was the method most frequently used to end the pregnancy. Physical and mechanical means and traditional herbs were also widely reported. In a country with a low contraceptive prevalence rate and high unmet need for family planning, all reproductive age women need access to contraceptive information and services to avoid, postpone or space pregnancies. In the absence of this, women are resorting to unsafe means to end an unwanted pregnancy, putting their lives at risk and putting an increased strain on an already struggling health system. Women in this setting need access to safe, effective means of abortion.

[Medical abortion provided by telemedicine to women in Latin America: complications and their treatment].

PubMed

Larrea, Sara; Palència, Laia; Perez, Glòria

2015-01-01

To analyze reported complications and their treatment after a medical abortion with mifepristone and misoprostol provided by a telemedicine service to women living in Latin America. Observational study based on the registry of consultations in a telemedicine service. A total of 872 women who used the service in 2010 and 2011 participated in the study. The dependent variables were overall complications, hemorrhage, incomplete abortion, overall treatments, surgical evacuation, and antibiotics. Independent variables were age, area of residence, socioeconomic deprivation, previous children, pregnancies and abortions, and week of pregnancy. We fitted Poisson regression models with robust variance to estimate incidence ratios and 95% confidence intervals (95%CI). Complications were reported by 14.6% of the participants: 6.2% reported hemorrhage and 6.8% incomplete abortion. Nearly one-fifth (19.0%) received postabortion treatment: 10.9% had a surgical evacuation and 9.3% took antibiotics. Socioeconomic deprivation increased the risk of complications by 64% (95%CI: 15%-132%), and, among these, the risk of incomplete abortion by 82% (95%CI: 8%-206%) and the risk of surgical intervention by 62% (95%CI: 7%-144%). Previous pregnancies increased the risk of complications and, specifically, the risk of hemorrhage by 2.29 times (95%CI: 1.33-3.95%). Women with a pregnancy of 12 or more weeks had a 2.45 times higher risk of receiving medical treatment and a 2.94 times higher risk of taking antibiotics compared with women with pregnancies of 7 or less weeks. Medical abortion provided by telemedicine seems to be a safe and effective alternative in contexts where it is legally restricted. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

Effect of green and ripe Carica papaya epicarp extracts on wound healing and during pregnancy.

PubMed

Anuar, Nor Suhada; Zahari, Shafiyyah Solehah; Taib, Ibrahim Adham; Rahman, Mohammad Tariqur

2008-07-01

The traditional use of papaya to treat many diseases, especially skin conditions and its prohibition for consumption during pregnancy has prompted us to determine whether papaya extracts both from green and ripe fruits improve wound healing and also produce foetal toxicity. Aqueous extracts of green papaya epicarp (GPE) and ripe papaya epicarp (RPE) were applied on induced wounds on mice. GPE treatment induced complete healing in shorter periods (13 days) than that required while using RPE (17 days), sterile water (18 days) and Solcoseryl ointment (21 days). Extracts were administered orally (1 mg/g body weight/day) to pregnant mice from day 10 and onwards after conception. 3 (n=7) mice and 1 (n=6) mice given RPE and misoprostol, an abortive drug, respectively experienced embryonic resorption while this effect was observed in none of the mice given GPE (n=5) and water (n=5). The average body weight of live pups delivered by mice given GPE (1.12+/-0.04 g) was significantly lower than those delivered by mice given water (1.38+/-0.02 g). In SDS-PAGE, proteins were distributed in three bands (Mr range approximately 8-29 kDa). Band intensity at Mr approximately 28-29 kDa was higher in GPE than in RPE. In contrast, band intensity at low Mr (approximately 8 kDa) was found to be higher in RPE than in GPE. Notably, the band corresponding to Mr approximately 23-25 kDa was absent in RPE. These differences in composition may have contributed to the different wound healing and abortive effects of green and ripe papaya.

Medical students are afraid to include abortion in their future practices: in-depth interviews in Maharastra, India.

PubMed

Sjöström, Susanne; Essén, Birgitta; Gemzell-Danielsson, Kristina; Klingberg-Allvin, Marie

2016-01-12

Unsafe abortions are estimated to cause eight per-cent of maternal mortality in India. Lack of providers, especially in rural areas, is one reason unsafe abortions take place despite decades of legal abortion. Education and training in reproductive health services has been shown to influence attitudes and increase chances that medical students will provide abortion care services in their future practice. To further explore previous findings about poor attitudes toward abortion among medical students in Maharastra, India, we conducted in-depth interviews with medical students in their final year of education. We used a qualitative design conducting in-depth interviews with twenty-three medical students in Maharastra applying a topic guide. Data was organized using thematic analysis with an inductive approach. The participants described a fear to provide abortion in their future practice. They lacked understanding of the law and confused the legal regulation of abortion with the law governing gender biased sex selection, and concluded that abortion is illegal in Maharastra. The interviewed medical students' attitudes were supported by their experiences and perceptions from the clinical setting as well as traditions and norms in society. Medical abortion using mifepristone and misoprostol was believed to be unsafe and prohibited in Maharastra. The students perceived that nurse-midwives were knowledgeable in Sexual and Reproductive Health and many found that they could be trained to perform abortions in the future. To increase chances that medical students in Maharastra will perform abortion care services in their future practice, it is important to strengthen their confidence and knowledge through improved medical education including value clarification and clinical training.

Delivering Medical Abortion at Scale: A Study of the Retail Market for Medical Abortion in Madhya Pradesh, India

PubMed Central

Powell-Jackson, Timothy; Acharya, Rajib; Filippi, Veronique; Ronsmans, Carine

2015-01-01

Background Medical abortion (mifepristone and misoprostol) has the potential to contribute to reduced maternal mortality but little is known about the provision or quality of advice for medical abortion through the private retail sector. We examined the availability of medical abortion and the practices of pharmacists in India, where abortion has been legal since 1972. Methods We interviewed 591 pharmacists in 60 local markets in city, town and rural areas of Madhya Pradesh. One month later, we returned to 359 pharmacists with undercover patients who presented themselves unannounced as genuine customers seeking a medical abortion. Results Medical abortion was offered to undercover patients by 256 (71.3%) pharmacists and 24 different brands were identified. Two thirds (68.5%) of pharmacists stated that abortion was illegal in India. Only 106 (38.5%) pharmacists asked clients the timing of the last menstrual period and 38 (13.8%) requested to see a doctor’s prescription – a legal requirement in India. Only 59 (21.5%) pharmacists correctly advised patients on the gestational limit for medical abortion, 97 (35.3%) provided correct information on how many and when to take the tablets in a combination pack, and 78 (28.4%) gave accurate advice on where to seek care in case of complications. Advice on post-abortion family planning was almost nonexistent. Conclusions The retail market for medical abortion is extensive, but the quality of advice given to patients is poor. Although the contribution of medical abortion to women’s health in India is poorly understood, there is an urgent need to improve the practices of pharmacists selling medical abortion. PMID:25822656

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.

The gastric mucosal barrier.

PubMed

Clamp, J R; Ene, D

1989-01-01

The gastric mucosal barrier is a complex system made up of submucosal, epithelial and mucus elements. The mucus gel layer is a thick tenacious organized layer adherent to the epithelium. Despite these properties it is composed of more than 95% water, the organization being provided by long interacting glycoprotein molecules (mucus glycoprotein or mucin). These molecules are largely made up of carbohydrate which is present in large numbers of relatively small oligosaccharide units packed around the polypeptide core. This structure provides clues to the nature of the protection afforded by the mucus layer. For example, it is relatively resistant to proteolysis in the gastrointestinal tract; it retains water in an unstirred layer; the tangled glycoproteins exclude large molecules and the carbohydrate of the oligosaccharide units mirror that at the surface of the epithelial cell. Few biochemical studies have been carried out on the effect of ulcer-healing drugs on gastric mucus. Normal subjects were, therefore, given two weeks treatment with cimetidine, carbenoxolone or misoprostol and the secretions aspirated from the unstimulated and pentagastrin-stimulated stomach. The volume of secretion and weight and carbohydrate content of non-diffusable glycoconjugates were determined for each specimen, together with the proportion of high molecular mass mucin and qualitative and quantitative analyses of the glycopolypeptide. There were no significant differences between the results for each drug or without drug. This may be because normal subjects were studied who already have an effective mucosal barrier. In addition, it is likely that the process of mucus biosynthesis and secretion in a healthy individual is relatively resistant to the action of ulcer healing drugs.

Haemoglobin status and predictors of anaemia among pregnant women in Mpigi, Uganda.

PubMed

Ononge, Sam; Campbell, Oona; Mirembe, Florence

2014-10-10

Anaemia in pregnancy is a major public health problem especially in the low-income countries where it is highly prevalent. There has been no recent study in Uganda about the factors associated with anaemia in pregnancy. We aimed to assess the current haemoglobin (Hb) status and factors associated with anaemia (Hb < 11.0 g/dl) in pregnant women in Mpigi, Uganda. We assessed Hb levels of 2436 pregnant women at 28+ weeks of gestation at six health facilities, who were approached to participate in a stepped-wedge cluster-randomised trial of antenatal distribution of misoprostol (for self-administration after home birth or when oxytocin is not available). Women were administered a questionnaire and their baseline blood haemoglobin was examined using portable HemoCueR Hb 301 system. Predictors of anaemia were estimated using linear and logistic regression analysis. The mean Hb was 11.5 (± 1.38) g/dl and prevalence of anaemia (Hb < 11.0 g/dl) was 32.5% (95% CI 30.6%, 34.3%). After adjusting for measured confounders, factors associated with increased risk of anaemia in pregnancy were malaria infection (OR: 1.32, 95% CI: 1.11, 1.58), Human Immuno-deficiency Virus infection (OR: 2.13, 95% CI: 1.36, 2.90) and lack of iron supplementation (OR: 1.66, 95% CI: 1.36, 2.03). Intermittent presumptive treatment of malaria, maternal age and parity showed a weak association with anaemia in pregnancy The high prevalence of anaemia in pregnancy in our setting highlights the need to put more effort in the fight against malaria and HIV, and also ensure that pregnant women access iron supplements early in pregnancy.

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

Brainstem dysgenesis during the neonatal period: diagnosis and management.

PubMed

Castilla-Fernández, Yolanda; Boix, Héctor; Macaya, Alfons; Vázquez, Elida; Gratacòs, Margarida; Roig-Quilis, Manuel

2013-07-01

To report our neonatal management experience in patients who received a diagnosis of brainstem dysgenesis (BSD). This study retrospectively reviewed the medical records of 15 neonates with BSD diagnosed between 1984 and 2011. Data on the perinatal period, physical examination, laboratory findings, and management by systems were systematically analyzed. All cases were sporadic. Cocaine abuse and misoprostol use were recorded in two pregnancies. The reason for admission was prematurity (2 of 15), respiratory distress (8 of 15), gastroschisis (1 of 15), and abnormal neurological examination (4 of 15). Clinically, the most commonly affected cranial nerves were the 7th (13 of 15), 9th (11 of 15), 10th (8 of 15), 5th (7 of 15), 12th (7 of 15), 6th (3 of 15), 4th (1 of 15), and 3rd (1 of 15). Five patients required positive pressure ventilation during delivery room resuscitation, three had difficult airways, and two needed tracheostomy during admission. Most patients required nasogastric tube feeding shortly after birth, and four patients had a gastrostomy on discharge. Two patients died of respiratory and cardiac failure. Electromyography and nerve conduction velocity were used to exclude generalized neuromuscular disorders, and in conjunction with other neurophysiological and gastrointestinal tract studies, helped uncover the extent of brainstem involvement in most cases. Cranial magnetic resonance imaging supported the diagnosis in more than half of the patients. Early diagnosis of BSD is mainly clinical, difficult to establish unless suspected, and crucial to prevent complications. Neonatal care of patients with BSD requires a comprehensive approach that must take into consideration the etiological, anatomical, and pathogenic aspects contributing to the clinical manifestations of this disorder. Care should be provided by multidisciplinary teams, in which neonatologists, pediatric neurologists, nutritionists, physical therapists, and other professionals participate

Potential for control of detrusor smooth muscle spontaneous rhythmic contraction by cyclooxygenase products released by interstitial cells of Cajal

PubMed Central

Collins, Clinton; Klausner, Adam P; Herrick, Benjamin; Koo, Harry P; Miner, Amy S; Henderson, Scott C; Ratz, Paul H

2009-01-01

Interstitial cells of Cajal (ICCs) have been identified as pacemaker cells in the upper urinary tract and urethra, but the role of ICCs in the bladder remains to be determined. We tested the hypotheses that ICCs express cyclooxygenase (COX), and that COX products (prostaglandins), are the cause of spontaneous rhythmic contraction (SRC) of isolated strips of rabbit bladder free of urothelium. SRC was abolished by 10 μM indomethacin and ibuprofen (non-selective COX inhibitors). SRC was concentration-dependently inhibited by selective COX-1 (SC-560 and FR-122047) and COX-2 inhibitors (NS-398 and LM-1685), and by SC-51089, a selective antagonist for the PGE-2 receptor (EP) and ICI-192,605 and SQ-29,548, selective antagonists for thromboxane receptors (TP). The partial agonist/antagonist of the PGF-2α receptor (FP), AL-8810, inhibited SRC by ∼50%. Maximum inhibition was ∼90% by SC-51089, ∼80–85% by the COX inhibitors and ∼70% by TP receptor antagonists. In the presence of ibuprofen to abolish SRC, PGE-2, sulprostone, misoprostol, PGF-2α and U-46619 (thromboxane mimetic) caused rhythmic contractions that mimicked SRC. Fluorescence immunohistochemistry coupled with confocal laser scanning microscopy revealed that c-Kit and vimentin co-localized to interstitial cells surrounding detrusor smooth muscle bundles, indicating the presence of extensive ICCs in rabbit bladder. Co-localization of COX-1 and vimentin, and COX-2 and vimentin by ICCs supports the hypothesis that ICCs were the predominant cell type in rabbit bladder expressing both COX isoforms. These data together suggest that ICCs appear to be an important source of prostaglandins that likely play a role in regulation of SRC. Additional studies on prostaglandin-dependent SRC may generate opportunities for the application of novel treatments for disorders leading to overactive bladder. PMID:19243470

Hospital Admission following Induced Abortion in Eastern Highlands Province, Papua New Guinea – A Descriptive Study

PubMed Central

Vallely, Lisa M.; Homiehombo, Primrose; Kelly-Hanku, Angela; Kumbia, Antonia; Mola, Glen D. L.; Whittaker, Andrea

2014-01-01

Background In Papua New Guinea abortion is restricted under the Criminal Code Act. While safe abortions should available in certain situations, frequently they are not available to the majority of women. Sepsis from unsafe abortion is a leading cause of maternal mortality. Our findings form part of a wider, mixed methods study designed to identify complications requiring hospital treatment for post abortion care and to explore the circumstances surrounding unsafe abortion. Methods Through a six month prospective study we identified all women presenting to the Eastern Highlands Provincial Hospital following spontaneous and induced abortions. We undertook semi-structured interviews with women and reviewed individual case notes, extracting demographic and clinical information. Findings Case notes were reviewed for 56% (67/119) of women presenting for post abortion care. At least 24% (28/119) of these admissions were due to induced abortion. Women presenting following induced abortions were significantly more likely to be younger, single, in education at the time of the abortion and report that the baby was unplanned and unwanted, compared to those reporting spontaneous abortion. Obtained illegally, misoprostol was the method most frequently used to end the pregnancy. Physical and mechanical means and traditional herbs were also widely reported. Conclusion In a country with a low contraceptive prevalence rate and high unmet need for family planning, all reproductive age women need access to contraceptive information and services to avoid, postpone or space pregnancies. In the absence of this, women are resorting to unsafe means to end an unwanted pregnancy, putting their lives at risk and putting an increased strain on an already struggling health system. Women in this setting need access to safe, effective means of abortion. PMID:25329982

Estimation of Shear Wave Speed in the Rhesus Macaques Uterine Cervix

PubMed Central

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

2016-01-01

Cervical softness is a critical parameter in pregnancy. Clinically, preterm birth is associated with premature cervical softening and post-dates birth is associated with delayed cervical softening. In practice, the assessment of softness is subjective, based on digital examination. Fortunately, objective, quantitative techniques to assess softness and other parameters associated with microstructural cervical change are emerging. One of these is shear wave speed (SWS) estimation. In principle, this allows objective characterization of stiffness because waves travel more slowly in softer tissue. We are studying SWS in humans and rhesus macaques, the latter in order to accelerate translation from bench to bedside. For the current study, we estimated SWS in ex vivo cervices of rhesus macaques, n=24 nulliparous (never given birth) and n=9 multiparous (delivered at least 1 baby). Misoprostol (a prostaglandin used to soften human cervices prior to gynecological procedures) was administered to 13 macaques prior to necropsy (nulliparous: 7, multiparous: 6). SWS measurements were made at predetermined locations from the distal to proximal end of the cervix on both the anterior and posterior cervix, with 5 repeat measures at each location. The intent was to explore macaque cervical microstructure, including biological and spatial variability, to elucidate the similarities and differences between the macaque and the human cervix in order to facilitate future in vivo studies. We found that SWS is dependent on location in the normal nonpregnant macaque cervix, as in the human cervix. Unlike the human cervix, we detected no difference between ripened and unripened rhesus macaque cervix samples, nor nulliparous versus multiparous samples, although we observed a trend toward stiffer tissue in nulliparous samples. We found rhesus macaque cervix to be much stiffer than human, which is important for technique refinement. These findings are useful for guiding study of cervical

Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan.

PubMed

Platais, Ingrida; Tsereteli, Tamar; Comendant, Rodica; Kurbanbekova, Dilfuza; Winikoff, Beverly

2015-02-01

To evaluate the feasibility and acceptability of phone follow-up with a home semiquantitative pregnancy test and standardized checklist, and compare the alternative method of follow-up with in-clinic follow-up after medical abortion. Two thousand four hundred women undergoing medical abortion with mifepristone and misoprostol in Moldova and Uzbekistan were randomized to phone or clinic follow-up. All women in the clinic group returned to the clinic 2 weeks later. Women randomized to phone follow-up used a semiquantitative pregnancy test at the initial visit and repeated the test at home 2 weeks later when they also filled out a symptom checklist. Women were called at 2 weeks to review the test results and checklist. Participants who screened "positive" were referred to clinic to verify abortion completion. Most women in the phone group were successfully contacted on the phone (97.6%). Staff were unable to contact one woman in the phone follow-up group, and all women in clinic group returned to the clinic. The ongoing pregnancy rate was similar in both groups (0.4-0.6%), and the semiquantitative pregnancy test identified all ongoing pregnancies in the phone follow-up group. Women in the phone group found the test and checklist easy to use, and most (76.1%) preferred phone follow-up in the future. Overall, 92.8% of women in the phone group did not undergo in-clinic follow-up. Phone follow-up with a semiquantitative urine pregnancy test and symptom checklist is a feasible and a highly effective approach in identifying ongoing pregnancy after medical abortion. The semiquantitative pregnancy test can make home follow-up after medical abortion possible for many women and provide reassurance that ongoing pregnancies will be detected. Copyright © 2015 Elsevier Inc. All rights reserved.

Active management of third stage of labour, post–partum haemorrhage and maternal death rate in the Vanga Health Zone, Province of Bandundu, Democratic Republic of the Congo

PubMed Central

Ngolo, Jean-Robert Musiti; Maniati, Lucie Zikudieka

2010-01-01

ABSTRACT Background Post-partum haemorrhage (PPH) is the single largest cause of maternal death worldwide and a particular burden for developing countries. In Africa, about 33.9% of maternal deaths are due to PPH. In the Democratic Republic of the Congo (DRC), the prevalence of PPH is unknown. PPH can be prevented with active management of the third stage of labour (AMTSL). Objectives To describe the practice of AMTSL in Vanga Health Zone and to calculate the incidence of PPH in Vanga Health Zone. Method An intervention study with post-test-only design was conducted among health maternity wards using a data collection sheet to obtain information. All pregnant women attending Vanga Health maternity wards constituted the study population. Frequencies were determined for variables of interest. Results From April 2007 to March 2008, 6339 deliveries took place at Vanga Health maternity wards, representing 71% of the institutional delivery rate. The number of deliveries realised with the practice of (AMTSL) were 5562; 366 cases of PPH were reported, making an incidence of 5.77%. Three cases of maternal deaths – two of which were related to PPH – were reported during the study period, which means there was a decline of 70% compared with the previous two years. Conclusion The prevalence of PPH has been estimated to be 5.77%; PPH represents the cause of 67% of all maternal deaths. The extension of AMTSL practice, combined with the assurance of better supplies of oxytocin to enhance drug management, is strongly advised/suggested. As a number of births still take place outside the health maternity wards, the introduction of oral misoprostol could be considered a part of AMTSL for use by patients being treated by traditional midwives.

Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India.

PubMed

Stanton, Cynthia; Nand, Deepak Nitya; Koski, Alissa; Mirzabagi, Ellie; Brooke, Steve; Grady, Breanne; Mullany, Luke C

2014-11-13

Surveillance of drug quality for antibiotics, antiretrovirals, antimalarials and vaccines is better established than surveillance for maternal health drugs in low-income countries, particularly uterotonic drugs for the prevention and treatment of postpartum hemorrhage. The objectives of this study are to: assess private sector accessibility of four drugs used for uterotonic purposes (oxytocin, methylergometrine, misoprostol, valethamate bromide); and to assess potency of oxytocin and methylergometrine ampoules purchased by simulated clients. The study was conducted in Hassan and Bagalkot districts in Karnataka state and Agra and Gorakhpur districts in Uttar Pradesh state. A sample of 877 private pharmacies was selected (using a stratified, systematic sampling with random start), among which 847 were successfully visited. The target sample size for assessment of accessibility was 50 pharmacies per drug, per district. The target sample size for potency assessment was 100 purchases each of oxytocin and methylergometrine across all districts. Successful drug purchases varied by state. In Agra and Gorakhpur, 90%-100% of visits for each of the drugs resulted in a purchase. In Bagalkot and Hassan, only 29%-52% of visits for each drug resulted in a purchase. Regarding potency, the percent of active pharmaceutical ingredient was assessed using United States Pharmacopeia monograph #33 for both drugs; 193 and 188 ampoules of oxytocin and methylergometrine, respectively, were assessed. The percent of oxytocin ampoules outside manufacturer specification ranged from 33%-40% in Karnataka and from 22%-50% in Uttar Pradesh. In Bagalkot and Hassan, 96% and 100% of the methylergometrine ampoules were outside manufacturer specification, respectively. In Agra and Gorakhpur, 54% and 44% were outside manufacturer specification, respectively. Private sector accessibility of uterotonic drugs in study districts in Karnataka warrants attention. Most importantly, interventions to assure

Pain perception during levonorgestrel-releasing intrauterine device insertion in nulliparous women: a systematic review.

PubMed

Anthoulakis, Christos; Iordanidou, Eirini; Vatopolou, Anastasia

2018-06-08

Intrauterine devices (IUDs) still remain underused in adolescents. Pain during insertion may prevent adolescents to opt for a levonorgestrel (LNG) - releasing IUD. This study aimed to conduct a systematic review, following the PRISMA guidelines, and critically appraise published data with respect to the efficacy of various substances (analgesics or not) in preventing pain during LNG-IUD insertion in nulliparous women as a proxy for adolescents. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: A comprehensive computerized systematic literature search of all English language studies between 2006 and 2016 was performed in PubMed, EMBASE, Scopus, Evidence Based Medicine Reviews (Cochrane Database and Cochrane Central Register of Controlled Trials), and Google Scholar. Relevant article reference lists were hand searched. Computerised database search revealed 31 citations of relevance, 9 of which with a total of 355 treated women and 345 controls fulfilled the inclusion/exclusion criteria. In women treated with misoprostol (n=150) versus placebo (n=145), the median visual analog scale (VAS) score ± standard deviation (SD) were 5.7 ± 2.1 versus 5.1 ± 2.2, respectively. In the abovementioned population, there was a non-significant change in VAS score (OR=1.44, 95%CI 0.86-2.40). In women treated with lidocaine (n=140) versus placebo (n=136), the median VAS score ± SD were 4.6 ± 2.1 versus 5.8 ± 2, respectively. In the aforementioned population, there was a significant decrease in VAS score (OR=0.12, 95%CI 0.02-0.91). In nulliparous women, lidocaine treatment seems to be a reasonable choice. However, further studies are required to examine the different routes and modes of administration as well as optimal quantities. Copyright © 2018. Published by Elsevier Inc.

Placental Histomorphology in a Case of Double Trisomy 48,XXX,+18.

PubMed

Shah, Sujal I; Dyer, Lisa; Stanek, Jerzy

2018-01-01

Approximately 50% of early spontaneous abortions are found to have chromosomal abnormalities. In these cases, certain histopathologic abnormalities are suggestive of, although not diagnostic for, the presence of chromosomal abnormalities. However, placental histomorphology in cases of complex chromosomal abnormalities, including double trisomies, is virtually unknown. We present the case of a 27-year-old G3P22002 female presenting at 19 weeks and 1 day of gestation by last menstrual period for scheduled prenatal visit. Ultrasound revealed a single fetus without heart tones and adequate amniotic fluid. Limited fetal measurements were consistent with estimated gestational age of 17 weeks. Labor was induced with misoprostol due to fetal demise. Autopsy revealed an immature female fetus with grade 1-2 maceration. The ears were low-set and posteriorly rotated. The fingers were short bilaterally, and the right foot showed absence of the second and third digits. Evaluation of the organs showed predominantly marked autolysis consistent with retained stillbirth. Placental examination revealed multiple findings, including focal pseudovillous papilliform trophoblastic proliferation of the undersurface of the chorionic plate and clustering of perpendicularly oriented sclerotic chorionic villi in the chorion laeve, which have not been previously reported in cases of chromosomal abnormalities. Karyotype of placental tissue revealed a 48,XXX,+18 karyotype and the same double trisomy of fetal thymic tissue by FISH. In addition to convoluted outlines of chorionic villi, villous trophoblastic pseudoinclusions, and clusters of villous cytotrophoblasts, the previously unreported focal pseudovillous papilliform trophoblastic proliferation of the undersurface of the chorionic plate and clustering of perpendicularly oriented sclerotic chorionic villi in the chorion laeve were observed in this double trisomy case. More cases have to be examined to show if the histology is specific for

Placental Histomorphology in a Case of Double Trisomy 48,XXX,+18

PubMed Central

2018-01-01

Background Approximately 50% of early spontaneous abortions are found to have chromosomal abnormalities. In these cases, certain histopathologic abnormalities are suggestive of, although not diagnostic for, the presence of chromosomal abnormalities. However, placental histomorphology in cases of complex chromosomal abnormalities, including double trisomies, is virtually unknown. Case Report We present the case of a 27-year-old G3P22002 female presenting at 19 weeks and 1 day of gestation by last menstrual period for scheduled prenatal visit. Ultrasound revealed a single fetus without heart tones and adequate amniotic fluid. Limited fetal measurements were consistent with estimated gestational age of 17 weeks. Labor was induced with misoprostol due to fetal demise. Autopsy revealed an immature female fetus with grade 1-2 maceration. The ears were low-set and posteriorly rotated. The fingers were short bilaterally, and the right foot showed absence of the second and third digits. Evaluation of the organs showed predominantly marked autolysis consistent with retained stillbirth. Placental examination revealed multiple findings, including focal pseudovillous papilliform trophoblastic proliferation of the undersurface of the chorionic plate and clustering of perpendicularly oriented sclerotic chorionic villi in the chorion laeve, which have not been previously reported in cases of chromosomal abnormalities. Karyotype of placental tissue revealed a 48,XXX,+18 karyotype and the same double trisomy of fetal thymic tissue by FISH. Conclusion In addition to convoluted outlines of chorionic villi, villous trophoblastic pseudoinclusions, and clusters of villous cytotrophoblasts, the previously unreported focal pseudovillous papilliform trophoblastic proliferation of the undersurface of the chorionic plate and clustering of perpendicularly oriented sclerotic chorionic villi in the chorion laeve were observed in this double trisomy case. More cases have to be examined to show if

Methods for assessing pre-induction cervical ripening

PubMed Central

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

2015-01-01

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

An innovation for improving maternal, newborn and child health (MNCH) service delivery in Jigawa State, northern Nigeria: a qualitative study of stakeholders' perceptions about clinical mentoring.

PubMed

Okereke, Ekechi; Tukur, Jamilu; Aminu, Amina; Butera, Jean; Mohammed, Bello; Tanko, Mustapha; Yisa, Ibrahim; Obonyo, Benson; Egboh, Mike

2015-02-15

An effective capacity building process for healthcare workers is required for the delivery of quality health care services. Work-based training can be applied for the capacity building of health care workers while causing minimum disruption to service delivery within health facilities. In 2012, clinical mentoring was introduced into the Jigawa State Health System through collaboration between the Jigawa State Ministry of Health and the Partnership for Transforming Health Systems Phase 2 (PATHS2). This study evaluates the perceptions of different stakeholders about clinical mentoring as a strategy for improving maternal, newborn and child health service delivery in Jigawa State, northern Nigeria. Interviews were conducted in February 2013 with different stakeholders within Jigawa State in Northern Nigeria. There were semi-structured interviews with 33 mentored health care workers as well as the health facility departmental heads for Obstetrics and Pediatrics in the selected clinical mentoring health facilities. In-depth interviews were also conducted with the clinical mentors and two senior government health officials working within the Jigawa State Ministry of Health. The qualitative data were audio-recorded; transcribed and thematically analysed. The study findings suggest that clinical mentoring improved service delivery within the clinical mentoring health facilities. Significant improvements in the professional capacity of mentored health workers were observed by clinical mentors, heads of departments and the mentored health workers. Best practices were introduced with the support of the clinical mentors such as appropriate baseline investigations for pediatric patients, the use of magnesium sulphate and misoprostol for the management of eclampsia and post-partum hemorrhage respectively. Government health officials indicate that clinical mentoring has led to more emphasis on the need for the provision of better quality health services. Stakeholders report that

Co-prescription of gastroprotective agents and their efficacy in elderly patients taking nonsteroidal anti-inflammatory drugs: a systematic review of observational studies.

PubMed

Medlock, Stephanie; Eslami, Saeid; Askari, Marjan; Taherzadeh, Zhila; Opondo, Dedan; de Rooij, Sophia E; Abu-Hanna, Ameen

2013-10-01

Guidelines recommend prescribing gastroprotective agents (proton pump inhibitors, misoprostol) to older patients (primarily ≥65 years old) taking nonsteroidal anti-inflammatory drugs (NSAIDs) to prevent gastrointestinal ulcers. Older individuals are underrepresented in clinical trials of these agents. We systematically reviewed evidence from observational studies on the use of gastroprotective agents in elderly patients and their ability to prevent NSAID-related ulcers in this population. We performed a systematic search of Embase and MEDLINE and identified 23 observational studies that focused on elderly patients and reported data on co-prescription of gastroprotective agents and NSAIDs and/or the effectiveness of the agents in preventing gastrointestinal events in NSAID users. We collected data on rates of co-prescription and NSAID-related gastrointestinal events in patients with and without gastroprotection. A median of 24% (range, 10%-69%) of elderly patients taking NSAIDs received a co-prescription for gastroprotective agents; this percentage was only slightly higher in the oldest age groups. All studies of efficacy showed a positive effect of gastroprotection. However, the adjusted results were not suitable for synthesis, and the 5 studies reporting unadjusted results were too heterogeneous for meta-analysis (I(2) = 97%). The studies differed in outcomes, definitions of co-prescription, and differences in baseline risk factors between patients with and without gastroprotection. None of the studies assessed adverse effects of gastroprotective agents. The 2 cost-effectiveness studies reached opposing conclusions. In a systematic review, the observational evidence for the efficacy of gastroprotective agents in preventing NSAID-associated gastrointestinal events was in agreement with results of randomized controlled trials. However, because of heterogeneity of included studies, it is not clear what the effect would be if more patients were treated, or at what

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.

Management of incomplete abortion in South African public hospitals.

PubMed

Brown, H C; Jewkes, R; Levin, J; Dickson-Tetteh, K; Rees, H

2003-04-01

To describe the current management of incomplete abortion in South African public hospitals and to discuss the extent to which management is clinically appropriate. A multicentre, prospective descriptive study. South African public hospitals that manage gynaecological emergencies. Hospitals were selected using a stratified random sampling method. All women who presented to the above sampled hospitals with incomplete abortion during the three week data collection period in 2000 were included. A data collection sheet was completed at the time of discharge for each woman admitted with a diagnosis of incomplete, complete, missed or inevitable abortion during the study period. Information gathered included demographic data, clinical signs and symptoms at admission, medical management, surgical management, anaestetic management, use of blood products and antibiotics and complications. Three clinical severity categories were used for the purpose of data analysis and interpretation. Detail of medical management, detail of surgical management, use of blood products and antibiotics, methods of analgesia and anaesthesia used, and use of abortifacients. There is a trend towards low cost technology such as the use of manual vacuum aspiration and sedation anaesthesia; however, this is mainly limited to the better resourced tertiary hospitals linked to academic units. The use of antibiotics and blood products has decreased but much of the use is inappropriate. The use of abortifacients does include some use of misoprostol but merely as an adjunct to surgical evacuation. The management of incomplete abortion remains a problem in South Africa, a low income country that is still managing a common clinical problem with costly interventions. The evidence of a trend towards low cost technology is promising, albeit limited to tertiary centres. This study has given us information as how to best address this problem. More training in low cost methods is needed, targeting in particular the

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

Comparing office and telephone follow-up after medical abortion.

PubMed

Chen, Melissa J; Rounds, Kacie M; Creinin, Mitchell D; Cansino, Catherine; Hou, Melody Y

2016-08-01

Compare proportion lost to follow-up, successful abortion, and staff effort in women who choose office or telephone-based follow-up evaluation for medical abortion at a teaching institution. We performed a chart review of all medical abortions provided in the first three years of service provision. Women receiving mifepristone and misoprostol could choose office follow-up with an ultrasound evaluation one to two weeks after mifepristone or telephone follow-up with a scheduled telephone interview at one week post abortion and a second telephone call at four weeks to review the results of a home urine pregnancy test. Of the 176 medical abortion patients, 105 (59.7%) chose office follow-up and 71 (40.3%) chose telephone follow-up. Office evaluation patients had higher rates of completing all required follow-up compared to telephone follow-up patients (94.3% vs 84.5%, respectively, p=.04), but proportion lost to follow-up was similar in both groups (4.8% vs 5.6%, respectively, p=1.0). Medical abortion efficacy was 94.0% and 92.5% in women who chose office and telephone follow-up, respectively. We detected two (1.2%) ongoing pregnancies, both in the office group. Staff rescheduled 15.0% of appointments in the office group. For the telephone follow-up cohort, staff made more than one phone call to 43.9% and 69.4% of women at one week and four weeks, respectively. Proportion lost to follow-up is low in women who have the option of office or telephone follow-up after medical abortion. Women who choose telephone-based evaluation compared to office follow-up may require more staff effort for rescheduling of contact, but overall outcomes are similar. Although women who choose telephone evaluation may require more rescheduling of contact as compared to office follow-up, having alternative follow-up options may decrease the proportion of women who are lost to follow-up. Copyright © 2016 Elsevier Inc. All rights reserved.

Overview and guidelines of off-label use of methotrexate in ectopic pregnancy: report by CNGOF.

PubMed

Marret, Henri; Fauconnier, Arnaud; Dubernard, Gil; Misme, Hélène; Lagarce, Laurence; Lesavre, Magali; Fernandez, Hervé; Mimoun, Camille; Tourette, Claire; Curinier, Sandra; Rabishong, Benoit; Agostini, Aubert

2016-10-01

Our objective is to describe off-label use of methotrexate in ectopic pregnancy treatment using evidence based medicine. The patient group includes all women with a pregnancy outside the usual endometrium, or of unknown location. Method used was a Medline search on ectopic pregnancy managed using methotrexate treatment; evidence synthesis was done based on this current literature analysis. Level of evidence (LE) were given according to the centre for evidence base medicine rules. Grade was proposed for guidelines but no recommendation was possible as misoprostol is off label use for all the indications studied. In the absence of any contraindication, the protocol recommended for medical treatment of ectopic pregnancy is a single intramuscular injection of methotrexate (MTX) at a dosage of 1mg/kg or 50mg/m(2) (Grade A). It can be repeated once at the same dose should the hCG concentration not fall sufficiently. Pretreatment laboratory results must include a complete blood count and kidney and liver function tests (in accordance with its marketing authorization). MTX is an alternative to conservative treatment such as laparoscopic salpingotomy for uncomplicated tubal pregnancy (Grade A) with pretreatment hCG levels≤5000IU/l (Grade B). Expectant management is preferred for hCG levels<1000IU/l or in the process of spontaneous decreasing (Grade B). Intramuscular MTX is also recommended after the failure of surgical salpingotomy (Grade C) or immediately after surgery, if monitoring is not possible. Except in special circumstances, a local insitu ultrasound-guided MTX injection is not recommended for unruptured tubal pregnancies (Grade B). In situ MTX is an option for treating cervical, interstitial, or cesarean-scar pregnancies (Grade C). In pregnancies of unknown location persisting more than 10days in an asymptomatic woman who has an hCG level>2000IU/l, routine MTX treatment is an option. MTX is not indicated for combination with treatments such as mifepristone or

Priority Medicines for Maternal and Child Health: A Global Survey of National Essential Medicines Lists

PubMed Central

Hill, Suzanne; Yang, Annie; Bero, Lisa

2012-01-01

Background In April 2011, the World Health Organization (WHO) published a list of “priority medicines” for maternal and child health based on 1) the global burden of disease and 2) evidence of efficacy and safety. The objective of this study was to examine the occurrence of these priority medicines on national essential medicines lists. Methods and Findings All essential medicines lists published since 1999 were selected from the WHO website collection. The most-up-to date list for each country was then selected, resulting in 89 unique country lists. Each list was evaluated for inclusion of medicines (chemical entity, concentration, and dosage form) on the Priority Medicines List. There was global variation in the listing of the Priority Medicines. The most frequently listed medicine was paracetamol, on 94% (84/89) of lists. Sodium chloride, gentamicin and oral rehydration solution were on 93% (83/89) of lists. The least frequently listed medicine was the children's antimalarial rectal artesunate, on 8% of lists (7/89); artesunate injection was on 16% (14/89) of lists. Pediatric artemisinin combination therapy, as dispersible tablets or flexible oral solid dosage form, appeared on 36% (32/89) of lists. Procaine benzylpenicillin, for treatment of pediatric pneumonia and neonatal sepsis, was on 50% (45/89) of the lists. Zinc, for treatment of diarrhoea in children, was included on only 15% (13/89) of lists. For prevention and treatment of postpartum hemorrhage in women, oxytocin was more prevalent on the lists than misoprostol; they were included on 55 (62%) and 31 (35%) of lists, respectively. Cefixime, for treatment of uncomplicated anogenital gonococcal infection in woman was on 26% (23/89) of lists. Magnesium sulfate injection for treatment of severe pre-eclampsia and eclampsia was on 50% (45/89) of the lists. Conclusions The findings suggest that countries need to urgently amend their lists to provide all priority medicines as part of the efforts to improve

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

Genetic Syndromes, Maternal Diseases and Antenatal Factors Associated with Autism Spectrum Disorders (ASD).

PubMed

Ornoy, Asher; Weinstein-Fudim, Liza; Ergaz, Zivanit

2016-01-01

Autism spectrum disorder (ASD) affecting about 1% of all children is associated, in addition to complex genetic factors, with a variety of prenatal, perinatal, and postnatal etiologies. In addition, ASD is often an important clinical presentation of some well-known genetic syndromes in human. We discuss these syndromes as well as the role of the more important prenatal factors affecting the fetus throughout pregnancy which may also be associated with ASD. Among the genetic disorders we find Fragile X, Rett syndrome, tuberous sclerosis, Timothy syndrome, Phelan-McDermid syndrome, Hamartoma tumor syndrome, Prader-Willi and Angelman syndromes, and a few others. Among the maternal diseases in pregnancy associated with ASD are diabetes mellitus (PGDM and/or GDM), some maternal autoimmune diseases like antiphospholipid syndrome (APLS) with anti-β2GP1 IgG antibodies and thyroid disease with anti-thyroid peroxidase (TPO) antibodies, preeclampsia and some other autoimmune diseases with IgG antibodies that might affect fetal brain development. Other related factors are maternal infections (rubella and CMV with fetal brain injuries, and possibly Influenza with fever), prolonged fever and maternal inflammation, especially with changes in a variety of inflammatory cytokines and antibodies that cross the placenta and affect the fetal brain. Among the drugs are valproic acid, thalidomide, misoprostol, and possibly SSRIs. β2-adrenergic receptor agonists and paracetamol have also lately been associated with increased rate of ASD but the data is too preliminary and inconclusive. Associations were also described with ethanol, cocaine, and possibly heavy metals, heavy smoking, and folic acid deficiency. Recent studies show that heavy exposure to pesticides and air pollution, especially particulate matter < 2.5 and 10 μm in diameter (PM2.5 and PM10) during pregnancy is also associated with ASD. Finally, we have to remember that many of the associations mentioned in this review are

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

Moving from legality to reality: how medical abortion methods were introduced with implementation science in Zambia.

PubMed

Fetters, Tamara; Samandari, Ghazaleh; Djemo, Patrick; Vwallika, Bellington; Mupeta, Stephen

2017-02-16

Although abortion is technically legal in Zambia, the reality is far more complicated. This study describes the process and results of galvanizing access to medical abortion where abortion has been legal for many years, but provision severely limited. It highlights the challenges and successes of scaling up abortion care using implementation science to document 2 years of implementation. An intervention between the Ministry of Health, University Teaching Hospital and the international organization Ipas, was established to introduce medical abortion and to address the lack of understanding and implementation of the country's abortion law. An implementation science model was used to evaluate effectiveness and glean lessons for other countries about bringing safe and legal abortion services to scale. The intervention involved the provision of Comprehensive Abortion Care services in 28 public health facilities in Zambia for a 2 year period, August 2009 to September 2011. The study focused on three main areas: building health worker capacity in public facilities and introducing medical abortion, working with pharmacists to provide improved information on medical abortion, and community engagement and mobilization to increase knowledge of abortion services and rights through stronger health system and community partnerships. After 2 years, 25 of 28 sites provided abortion services, caring for more than 13,000 women during the intervention. For the first time, abortion was decentralized, 19% of all abortion care was performed in health centers. At the end of the intervention, all providing facilities had managers supportive of continuing legal abortion services. When asked about the impact of medical abortion provision, a number of providers reported that medical abortion improved their ability to provide affordable safe abortion. In neighboring pharmacies only 19% of mystery clients visiting them were offered misoprostol for purchase at baseline, this increased to 47

Unsafe abortion in Kenya: a cross-sectional study of abortion complication severity and associated factors.

PubMed

Ziraba, Abdhalah Kasiira; Izugbara, Chimaraoke; Levandowski, Brooke A; Gebreselassie, Hailemichael; Mutua, Michael; Mohamed, Shukri F; Egesa, Caroline; Kimani-Murage, Elizabeth W

2015-02-15

Complications due to unsafe abortion cause high maternal morbidity and mortality, especially in developing countries. This study describes post-abortion complication severity and associated factors in Kenya. A nationally representative sample of 326 health facilities was included in the survey. All regional and national referral hospitals and a random sample of lower level facilities were selected. Data were collected from 2,625 women presenting with abortion complications. A complication severity indicator was developed as the main outcome variable for this paper and described by women's socio-demographic characteristics and other variables. Ordered logistic regression models were used for multivariable analyses. Over three quarters of abortions clients presented with moderate or severe complications. About 65% of abortion complications were managed by manual or electronic vacuum aspiration, 8% by dilation and curettage, 8% misoprostol and 19% by forceps and fingers. The odds of having moderate or severe complications for mistimed pregnancies were 43% higher than for wanted pregnancies (OR, 1.43; CI 1.01-2.03). For those who never wanted any more children the odds for having a severe complication was 2 times (CI 1.36-3.01) higher compared to those who wanted the pregnancy then. Women who reported inducing the abortion had 2.4 times higher odds of having a severe complication compared to those who reported that it was spontaneous (OR, 2.39; CI 1.72-3.34). Women who had a delay of more than 6 hours to get to a health facility had at least 2 times higher odds of having a moderate/severe complication compared to those who sought care within 6 hours from onset of complications. A delay of 7-48 hours was associated with OR, 2.12 (CI 1.42-3.17); a delay of 3-7 days OR, 2.01 (CI 1.34-2.99) and a delay of more than 7 days, OR 2.35 (CI 1.45-3.79). Moderate and severe post-abortion complications are common in Kenya and a sizeable proportion of these are not properly managed

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

Genetic Syndromes, Maternal Diseases and Antenatal Factors Associated with Autism Spectrum Disorders (ASD)

PubMed Central

Ornoy, Asher; Weinstein- Fudim, Liza; Ergaz, Zivanit

2016-01-01

Autism spectrum disorder (ASD) affecting about 1% of all children is associated, in addition to complex genetic factors, with a variety of prenatal, perinatal, and postnatal etiologies. In addition, ASD is often an important clinical presentation of some well-known genetic syndromes in human. We discuss these syndromes as well as the role of the more important prenatal factors affecting the fetus throughout pregnancy which may also be associated with ASD. Among the genetic disorders we find Fragile X, Rett syndrome, tuberous sclerosis, Timothy syndrome, Phelan–McDermid syndrome, Hamartoma tumor syndrome, Prader-Willi and Angelman syndromes, and a few others. Among the maternal diseases in pregnancy associated with ASD are diabetes mellitus (PGDM and/or GDM), some maternal autoimmune diseases like antiphospholipid syndrome (APLS) with anti-β2GP1 IgG antibodies and thyroid disease with anti-thyroid peroxidase (TPO) antibodies, preeclampsia and some other autoimmune diseases with IgG antibodies that might affect fetal brain development. Other related factors are maternal infections (rubella and CMV with fetal brain injuries, and possibly Influenza with fever), prolonged fever and maternal inflammation, especially with changes in a variety of inflammatory cytokines and antibodies that cross the placenta and affect the fetal brain. Among the drugs are valproic acid, thalidomide, misoprostol, and possibly SSRIs. β2-adrenergic receptor agonists and paracetamol have also lately been associated with increased rate of ASD but the data is too preliminary and inconclusive. Associations were also described with ethanol, cocaine, and possibly heavy metals, heavy smoking, and folic acid deficiency. Recent studies show that heavy exposure to pesticides and air pollution, especially particulate matter < 2.5 and 10 μm in diameter (PM2.5 and PM10) during pregnancy is also associated with ASD. Finally, we have to remember that many of the associations mentioned in this review are

Mobile phone messages to provide support to women during the home phase of medical abortion in South Africa: a randomised controlled trial.

PubMed

Constant, Deborah; de Tolly, Katherine; Harries, Jane; Myer, Landon

2014-09-01

Home use of misoprostol for medical abortion is more convenient for many women than in-clinic use but requires management of abortion symptoms at home without provider backup. This study evaluated whether automated text messages to women undergoing medical abortion can reduce anxiety and emotional discomfort, and whether the messages can better prepare women for symptoms they experience. A multisite randomized controlled trial was conducted in which women undergoing early medical abortion were allocated to receive standard of care (SOC) only (n=235) or SOC+a messaging intervention (n=234). Consenting women were interviewed at the clinic after taking mifepristone and again at their follow-up clinic visit 2-3 weeks later; the intervention group received text messages over the duration of this period. Emotional outcomes were evaluated using the Hospital Anxiety and Depression Scale, Adler's 12-item emotional scale and the Impact of Event Scale-Revised. Preparedness for the abortion symptoms and overall satisfaction with the procedure were assessed using 4-point Likert-type scales. Between baseline and follow-up, anxiety decreased more (p=0.013), and less emotional stress was experienced (adjusted for baseline anxiety, p=0.015), in the intervention compared to the SOC group. Participants in the intervention group were also more likely to report that they felt very well prepared for the bleeding (p<0.001), pain (p=0.042) and side effects (p=0.027) they experienced. Acceptability and other negative emotions relating to the abortion did not differ between study groups. Ninety-nine percent of the intervention group stated that they would recommend the messages to a friend having the same procedure. Text messages to women following mifepristone administration for early medical abortion may assist them in managing symptoms and appear highly acceptable to recipients. This randomized controlled trial provides evidence for the effectiveness of text messages following

Non-steroidal anti-inflammatory and cytoprotective drug co-prescription in general practice. A general practitioner-based survey in France.

PubMed

Clinard, F; Bardou, M; Sgro, C; Lefevre, N; Raphael, F; Paille, F; Dumas, M; Hillon, P; Bonithon-Kopp, C

2001-12-01

Non-steroidal anti-inflammatory drugs (NSAIDs) represent one of the most frequently prescribed drugs. Gastrointestinal damage, the most common side effect of NSAIDs. can be limited by the prescription of cytoprotective agents. In order to assess determinants of NSAID-associated cytoprotective agent prescriptions in primary care practice, we performed a general practitioner (GP)-based study. After a 2-month intensive information campaign, the participation of all GPs of the Côte d'Or (France) administrative area was requested. During a 2-month period, GPs had to return a mailed questionnaire on NSAID prescription for up to ten consecutive patients aged over 18 years who required NSAIDs. This 30-item questionnaire included questions about the patient, the type of NSAID and the GP. GP participation rate was 24%, and 791 prescriptions were provided. GPs who participated in the study were representative of GPs of the area in terms of sex, time elapsed since graduation and GP practice area. Around 80% of the patients included in the study were under the age of 65 years. The proportion of prescriptions combining NSAIDs and gastroprotective agents was 29.5%. Omeprazole accounted for 58% of the coprescriptions and misoprostol for 29%. Independent determinants associated with the co-prescription of a cytoprotective agent were age [odds ratio (OR) 4.1; confidence interval (CI) 95% 2.3 7.4], previous history of poor NSAID tolerance (OR 10.4; CI 95% 5.8-18.6), previous history of moderate to severe digestive disorders (OR 13.4; CI 95% 5.1 35.4) and indication for chronic illness (OR 1.8, CI 95% 1.1-3.1). Prescriptions of cytoprotective drugs were in conformity with official guidelines for 78.3% of the patients. Although around 60% of the patients with risk factors for poor tolerance received a gastroprotective drug, 50% of the patients over 65 years did not receive it. Conversely, nearly 12% of the patients with no risk factors were prescribed cytoprotective agents. Patient

Assessment of primary health care facilities' service readiness in Nigeria.

PubMed

Oyekale, Abayomi Samuel

2017-03-01

Effective delivery of healthcare services requires availability of adequate infrastructure, diagnostic medical equipment, drugs and well-trained medical personnel. In Nigeria, poor funding and mismanagement often characterize healthcare service delivery thereby affecting coverage and quality of healthcare services. Therefore, the state of service delivery in Nigeria's health sector has come under some persistent criticisms. This paper analyzed service readiness of Primary Health Care (PHC) facilities in Nigeria with focus on availability of some essential drugs and medical equipment. Service Delivery Indicator (SDI) data for PHC in Nigeria were used. The data were collected from 2480 healthcare facilities from 12 states in the Nigeria's 6 geopolitical zones between 2013 and 2014. Data were analyzed with descriptive statistics, Principal Component Analysis (PCA) and Ordinary Least Square regression. Medical disposables such as hand gloves and male condoms were reported to be available in 77.18 and 44.03% of all the healthcare facilities respectively, while immunization services were provided by 86.57%. Functional stethoscopes were reported by 77.22% of the healthcare facilities, while only 68.10% had sphygmomanometers. In the combined healthcare facilities, availability of some basic drugs such as Azithromycin, Nifedipine, Dexamethasone and Misoprostol was low with 10.48, 25.20, 21.94 and 17.06%, respectively, while paracetamol and folic acid both had high availability with 74.31%. Regression results showed that indices of drug and medical equipment availability increased significantly (p < 0.05) among states in southern Nigeria and with presence of some power sources (electricity, generators, batteries and solar), but decreased among dispensaries/health posts. Travel time to headquarters and rural facilities significantly reduced indices of equipment availability (p < 0.05). It was concluded that for Nigeria to ensure better equity in access to healthcare

Serum human chorionic gonadotropin (hCG) trend within the first few days after medical abortion: a prospective study.

PubMed

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

2017-03-01

To prospectively describe the decline in serum human chorionic gonadotropin (hCG) in the first 5 days after complete medical abortion and evaluate the influence of initial hCG and gestational duration. We conducted a prospective, physiologic study of women ≤63 days gestation who underwent medical abortion with 200 mg mifepristone and 800 mcg buccal misoprostol. We stratified enrollment into two gestational cohorts, <49 days and 49-63 days, to ensure gestational variability. We collected serum quantitative hCG values on Day 1 (day of mifepristone), Day 3, Day 5 and a routine follow up hCG on Days 7-14. We calculated the percent hCG decline from Day 1 to each repeat measure and evaluated trends based on initial serum hCG level and gestation. We enrolled 66 women; 59 were protocol-adherent and included in our analysis. Mean gestation on Day 1 was 49 days and mean baseline hCG was 72,332 IU. Fifty-seven subjects (97%) had a complete medical abortion without further intervention. The mean serum hCG decline among subjects with complete medical abortion was 70.0±10.6% [range 36.9-98.6%] on Day 3 and 91.4±4.4% [range 68.4-97.7%] on Day 5. The mean serum hCG decline from Day 1 to routine follow-up on Days 7-9 was 97.1±1.7% [range 92.4-99.2%], from Day 1 to Day 10-11 was 98.5±1.4% [range 94.7-99.6%] and from Day 1 to Day 12-14 was 98.7±2.8% [range 86.7-99.9%]. There was no difference in percent hCG decline stratified by initial hCG or gestation. There is a rapid and predictable decline in serum hCG as early as Day 5 after complete medical abortion through 63 days gestation. Rate of hCG decline is not affected by initial hCG or gestational duration. For women who require confirmation of complete abortion sooner than 1 week after mifepristone, due to patient preference, logistical constraints or in the setting of pregnancy of unconfirmed location, a single repeat hCG on Day 5 may be clinically useful. Copyright © 2016 Elsevier Inc. All rights reserved.

Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial

PubMed Central

Paul, Mandira; Iyengar, Kirti; Essén, Birgitta; Gemzell-Danielsson, Kristina; Iyengar, Sharad D.; Bring, Johan; Soni, Sunita; Klingberg-Allvin, Marie

2015-01-01

Background Studies evaluating acceptability of simplified follow-up after medical abortion have focused on high-resource or urban settings where telephones, road connections, and modes of transport are available and where women have formal education. Objective To investigate women’s acceptability of home-assessment of abortion and whether acceptability of medical abortion differs by in-clinic or home-assessment of abortion outcome in a low-resource setting in India. Design Secondary outcome of a randomised, controlled, non-inferiority trial. Setting Outpatient primary health care clinics in rural and urban Rajasthan, India. Population Women were eligible if they sought abortion with a gestation up to 9 weeks, lived within defined study area and agreed to follow-up. Women were ineligible if they had known contraindications to medical abortion, haemoglobin < 85mg/l and were below 18 years. Methods Abortion outcome assessment through routine clinic follow-up by a doctor was compared with home-assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet. A computerized random number generator generated the randomisation sequence (1:1) in blocks of six. Research assistants randomly allocated eligible women who opted for medical abortion (mifepristone and misoprostol), using opaque sealed envelopes. Blinding during outcome assessment was not possible. Main Outcome Measures Women’s acceptability of home-assessment was measured as future preference of follow-up. Overall satisfaction, expectations, and comparison with previous abortion experiences were compared between study groups. Results 731 women were randomized to the clinic follow-up group (n = 353) or home-assessment group (n = 378). 623 (85%) women were successfully followed up, of those 597 (96%) were satisfied and 592 (95%) found the abortion better or as expected, with no difference between study groups. The majority, 355 (57%) women, preferred home-assessment in the event of a future

Comparative satisfaction of receiving medical abortion service from nurses and auxiliary nurse-midwives or doctors in Nepal: results of a randomized trial.

PubMed

Tamang, Anand; Shah, Iqbal H; Shrestha, Pragya; Warriner, I K; Wang, Duolao; Thapa, Kusum; My Huong, N T; Meirik, Olav

2017-12-16

Early first-trimester medical abortion (MA) service (≤ 63 days) has been provided by doctors and nurses under doctors' supervision since 2009 in Nepal. This paper assesses whether MA services provided by specifically trained and certified nurses and auxiliary nurse-midwives independently from doctors' supervision, is considered as satisfactory by women as those provided by doctors. The data come from a multi-center, randomized, controlled equivalence trial conducted between April 2009 and March 2010 in five district hospitals in Nepal. Women seeking MA were randomly assigned to doctors or nurses and auxiliary nurse-midwives(ANMs).Eligible women were administered 200 mg mifepristone orally followed by 800 μg misoprostol vaginally two days later by their assigned providers and followed up 10-14 days later. At the follow-up visit women's reported satisfaction with MA service they received was measured. Of 1295 women screened for eligibility, 535 were randomly assigned to a doctor and 542 to a nurse or ANM. Nineteen women were lost-to-follow up in the former group and 27 were lost-to-follow up or did not complete the acceptability interview in the latter group. This study is, therefore, based on516womenin the doctor's group and 515 women in the nurse or ANM group. All women in the nurse or ANM group reported being satisfied or highly satisfied by MA compared to 99% in the doctor's group. Satisfaction was similar regardless of the type of provider; 38% among nurse or ANM and 35% among the doctor group were "highly satisfied", and 62% and 64%, respectively, were "satisfied". Women's experiences such as 'less than expected amount or duration of bleeding following MA', 'shorter than expected duration of the abortion process', and 'able to manage symptoms', were found to be associated with women's higher satisfaction with MA. Counseling and information on the method, potential complications of MA and post-abortion contraception was nearly universal. No statistically

Drug therapies for reducing gastric acidity in people with cystic fibrosis.

PubMed

Ng, Sze May; Francini, Angelo J

2012-04-18

of respiratory function and one trial reported an adverse effect with prostaglandin E2 analogue misoprostol. No trials have been identified assessing the effectiveness of these agents in improving quality of life, the complications of increased gastric acidity, or survival. Trials have shown limited evidence that agents that reduce gastric acidity are associated with improvement in gastro-intestinal symptoms and fat absorption. Currently, there is insufficient evidence to indicate whether there is an improvement in nutritional status, lung function, quality of life, or survival. We therefore recommend that large, multicentre, randomised controlled clinical trials are undertaken to evaluate these interventions.

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

Nitric oxide donors for cervical ripening and induction of labour.

PubMed

Kelly, Anthony J; Munson, Christopher; Minden, Lucy

2011-06-15

Sometimes it is necessary to bring on labour artificially because of safety concerns for the mother or baby. This review is one of a series of reviews of methods of labour induction using a standardised protocol.Induction of labour occurs in approximately 20% of pregnancies in the UK. The ideal agent for induction of labour would induce cervical ripening without causing uterine contractions. Currently most commonly used cervical ripening or induction agents result in uterine activity or contractions, or both. Cervical ripening without uterine contractility could occur safely in an outpatient setting and it may be expected that this would result in greater maternal satisfaction and lower costs. To determine the effects of nitric oxide (NO) donors for third trimester cervical ripening or induction of labour, in comparison with placebo or no treatment or other treatments from a predefined hierarchy. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 December 2010) and the reference lists of trial reports and reviews. Clinical trials comparing NO donors for cervical ripening or labour induction to other methods listed above it on a predefined list of methods of labour induction. The trials include some form of random allocation to either group; and report one or more of the prestated outcomes. NO donors (isosorbide mononitrate, nitroglycerin and sodium nitroprusside) are compared to other methods listed above it on a predefined list of methods of labour induction. This review is part of a series of reviews focusing on methods of induction of labour. Three review authors independently assessed trials for inclusion, assessed risk of bias and extracted data. We considered 19 trials; we included 10 (including a total of 1889 women) trials, excluded eight trials and one trial report is awaiting classification. Included studies compared NO donors to placebo, vaginal prostaglandin E2, intracervical PGE2 and vaginal misoprostol. All included studies

Risk factors associated with NSAID-induced upper gastrointestinal bleeding resulting in hospital admissions: A cross-sectional, retrospective, case series analysis in valencia, spain

PubMed Central

Marco, José Luis; Amariles, Pedro; Boscá, Beatriz; Castelló, Ana

2007-01-01

Abstract Background NSAIDs are a significant cause of drug-related hospital admissions and deaths. The therapeutic effects of NSAIDs have been associated with the risk for developing adverse events, mainly in the gastrointestinal tract. Objectives The focus of this study was to identify the most common risk factors associated with NSAID-induced upper gastrointestinal bleeding (UGIB) resulting in hospital admissions. A secondary end point was the relationship between use of gastroprotective treatment and relevant risk factors to NSAID-induced UGIB in the selected population. Methods This study was a cross-sectional, retrospective, case-series analysis of NSAID-induced UGIB resulting in hospital admission to the Requena General Hospital, Valencia, Spain, occurring from 1997 to 2005. International Classification of Diseases, Ninth Revision, Clinical Modification codes were used to identify UGIB admissions associated with NSAIDs. To estimate the probability of association between UGIB and the use of NSAIDs, the Naranjo adverse drug reaction probability was used. Patients were categorized as high-risk to develop UGIB if they met ≥1 of the following risk criteria (relevant risk factors): aged ≥65 years (age risk factor); peptic ulcer disease or NSAID gastropathy occurring in the year before their hospital admission (history risk factor); and concomitant use of other NSAIDs, systemic corticoids, oral anticoagulants, or platelet aggregation inhibitors (concomitant medication risk factor). Patients were categorized as candidates to use gastroprotections if they met ≥1 of the relevant risk factors. Patients were categorized as users of gastroprotective treatment if they used proton pump inhibitors, histamine H2-receptor antagonists, or misoprostol at hospital admission. Results This study comprised 209 cases of NSAID-induced UGIB (129 men, 80 women: mean [SD] age, 71.5 [13.8] years; 128 [61.2%] receiving acetyl salicylic acid [ASA], with 72 [34.4%] receiving low

Drug therapies for reducing gastric acidity in people with cystic fibrosis.

PubMed

Ng, Sze May; Franchini, Angelo J

2014-07-13

that reduce gastric acidity improved gastro-intestinal symptoms such as abdominal pain; seven trials reported significant improvement in measures of fat malabsorption; and two trials reported no significant improvement in nutritional status. Only one trial reported measures of respiratory function and one trial reported an adverse effect with prostaglandin E2 analogue misoprostol. No trials have been identified assessing the effectiveness of these agents in improving quality of life, the complications of increased gastric acidity, or survival. Trials have shown limited evidence that agents that reduce gastric acidity are associated with improvement in gastro-intestinal symptoms and fat absorption. Currently, there is insufficient evidence to indicate whether there is an improvement in nutritional status, lung function, quality of life, or survival. Furthermore, due to the unclear risks of bias in the included trials, we are unable to make firm conclusions based on the evidence reported therein. We therefore recommend that large, multicentre, randomised controlled clinical trials are undertaken to evaluate these interventions.

Gastroprotective and ulcer healing effects of Piptadeniastrum Africanum on experimentally induced gastric ulcers in rats.

PubMed

Ateufack, Gilbert; Domgnim Mokam, Elisabeth Carol; Mbiantcha, Marius; Dongmo Feudjio, Rostand Breuil; David, Nana; Kamanyi, Albert

2015-07-08

Gastric peptic ulcer is one of the common disorders of gastrointestinal tract, which occur due to an imbalance between the offensive and defensive factors. It is an illness that affects a considerable number of people worldwide. This study was conducted to evaluate the antiulcerogenic and antiulcer effects and recognize the basic mechanism of action of Piptadeniastrum africanum stem bark extracts. The aqueous and methanol extracts of Piptadeniastrum africanum were administered at the doses 125, 250 and 500 mg/kg to evaluate their effects on gastric ulcer induced by the HCl/ethanol mixture, indomethacin and acetic acid in Wistar strain male adult rats, aged between 12 and 16 weeks and weighing between 180 and 220 g. Ranitidine, Maalox and Misoprostol were used as standard drugs. Histopathological examination and nitric oxide level were performed to evaluate the basic mechanism of action of Piptadeniastrum africanum. Phytochemical screening was carried out to identify known phytochemicals present in these extracts. The aqueous and methanol extracts of stem bark of Piptadeniastrum africanum significantly inhibited (p < 0.01) gastric ulceration induced by HCl/ethanol to the percentages of inhibition of 81.38; 98.75 and 100 % for the aqueous extract and then 75.83, 89.76 and 96.52 % for the methanol extract, and with the Indomethacin-induced ulcers, aqueous and methanol extracts of bark of Piptadeniastrum africanum reduce significantly (p < 0.01) induced gastric lesions in rats, with percentage of cure 35.75; 52.33 and 98.58 % for the aqueous extract, and 33.7; 51.97; and 65.93 to the methanol extract. The results revealed a significant reduction of ulcerated surface in both extracts and increase of nitric oxide (NO) level with methanol extract. When compared to methanol extract, aqueous extract showed more pronounced effects, corresponding to percentages of healing of 59. 92; 84.12 and 59.65 % for the aqueous extract; and 70.43; 55.49 and 57.59 % for the

Pregnancy loss: French clinical practice guidelines.

PubMed

Huchon, C; Deffieux, X; Beucher, G; Capmas, P; Carcopino, X; Costedoat-Chalumeau, N; Delabaere, A; Gallot, V; Iraola, E; Lavoue, V; Legendre, G; Lejeune-Saada, V; Leveque, J; Nedellec, S; Nizard, J; Quibel, T; Subtil, D; Vialard, F; Lemery, D

2016-06-01

In intrauterine pregnancies of uncertain viability with a gestational sac without a yolk sac (with a mean of three orthogonal transvaginal ultrasound measurements <25mm), the suspected pregnancy loss should only be confirmed after a follow-up scan at least 14 days later shows no embryo with cardiac activity (Grade C). In intrauterine pregnancies of uncertain viability with an embryo <7mm on transvaginal ultrasound, the suspected pregnancy loss should only be confirmed after a follow-up scan at least 7 days later (Grade C). In pregnancies of unknown location after transvaginal ultrasound (i.e. not visible in the uterus), a threshold of at least 3510IU/l for the serum human chorionic gonadotrophin assay is recommended; above that level, a viable intrauterine pregnancy can be ruled out (Grade C). Postponing conception after an early miscarriage in women who want a new pregnancy is not recommended (Grade A). A work-up for women with recurrent pregnancy loss should include the following: diabetes (Grade A), antiphospholipid syndrome (Grade A), hypothyroidism with anti-thyroid peroxidase (anti-TPO) and anti-thyroglobulin (anti-Tg) antibodies (Grade A), vitamin deficiencies (B9, B12) (Grade C), hyperhomocysteinaemia (Grade C), hyperprolactinaemia (Grade B), diminished ovarian reserve (Grade C), and a uterine malformation or an acquired uterine abnormality amenable to surgical treatment (Grade C). The treatment options recommended for women with a missed early miscarriage are vacuum aspiration (Grade A) or misoprostol (Grade B); and the treatment options recommended for women with an incomplete early miscarriage are vacuum aspiration (Grade A) or expectant management (Grade A). In the absence of both chorioamnionitis and rupture of the membranes, women with a threatened late miscarriage and an open cervix, with or without protrusion of the amniotic sac into the vagina, should receive McDonald cerclage, tocolysis with indomethacin, and antibiotics (Grade C). Among women

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

Drug therapies for reducing gastric acidity in people with cystic fibrosis.

PubMed

Ng, Sze May; Moore, Helen S

2016-08-22

included trials were generally not reported adequately enough to allow judgements on risk of bias.However, one trial found that drug therapies that reduce gastric acidity improved gastro-intestinal symptoms such as abdominal pain; seven trials reported significant improvement in measures of fat malabsorption; and two trials reported no significant improvement in nutritional status. Only one trial reported measures of respiratory function and one trial reported an adverse effect with prostaglandin E2 analogue misoprostol. No trials have been identified assessing the effectiveness of these agents in improving quality of life, the complications of increased gastric acidity, or survival. Trials have shown limited evidence that agents that reduce gastric acidity are associated with improvement in gastro-intestinal symptoms and fat absorption. Currently, there is insufficient evidence to indicate whether there is an improvement in nutritional status, lung function, quality of life, or survival. Furthermore, due to the unclear risks of bias in the included trials, we are unable to make firm conclusions based on the evidence reported therein. We therefore recommend that large, multicentre, randomised controlled clinical trials are undertaken to evaluate these interventions.

Methods of term labour induction for women with a previous caesarean section.

PubMed

West, Helen M; Jozwiak, Marta; Dodd, Jodie M

2017-06-09

Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is preferable to avoid adverse outcomes. This is an update of a review that was published in 2013. To assess the benefits and harms associated with different methods used to induce labour in women who have had a previous caesarean birth. We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2016) and reference lists of retrieved studies. Randomised controlled trials (RCTs) comparing any method of third trimester cervical ripening or labour induction, with placebo/no treatment or other methods in women with prior caesarean section requiring labour induction in a subsequent pregnancy. Two review authors independently assessed studies for inclusion and trial quality, extracted data, and checked them for accuracy. Eight studies (data from 707 women and babies) are included in this updated review. Meta-analysis was not possible because studies compared different methods of labour induction. All included studies had at least one design limitation (i.e. lack of blinding, sample attrition, other bias, or reporting bias). One study stopped prematurely due to safety concerns. Vaginal PGE2 versus intravenous oxytocin (one trial, 42 women): no clear differences for caesarean section (risk ratio (RR) 0.67, 95% confidence interval (CI) 0.22 to 2.03, evidence graded low), serious neonatal morbidity or perinatal death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low), serious maternal morbidity or death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low). Also no clear differences between groups for the reported secondary outcomes. The GRADE outcomes vaginal delivery not achieved within 24 hours, and uterine hyperstimulation with fetal heart rate changes were not reported. Vaginal misoprostol versus intravenous oxytocin (one trial, 38 women): this trial stopped early because one woman who

Nitric oxide donors for cervical ripening and induction of labour.

PubMed

Ghosh, Arpita; Lattey, Katherine R; Kelly, Anthony J

2016-12-05

Sometimes it is necessary to bring on labour artificially because of safety concerns for the mother or baby. This review is one of a series of reviews of methods of labour induction using a standardised protocol. To determine the effects of NO donors (isosorbide mononitrate (ISMN), isosorbide dinitrate (ISDN), nitroglycerin and sodium nitroprusside) for third trimester cervical ripening or induction of labour, in comparison with placebo or no treatment or other treatments from a predefined hierarchy. We searched Cochrane Pregnancy and Childbirth's Trials Register (15 August 2016) and the reference lists of trial reports. Clinical trials comparing NO donors for cervical ripening or labour induction with other methods listed above it on a predefined list of methods of labour induction. Interventions include NO donors (isosorbide mononitrate, isosorbide dinitrate, nitroglycerin and sodium nitroprusside) compared with other methods listed above it on a predefined list of methods of labour induction. This review is part of a series of reviews focusing on methods of induction of labour, based on a generic protocol. Three review authors independently assessed trials for inclusion, assessed risk of bias and extracted data. In this update, the quality of the evidence for the main comparison was assessed using the GRADE approach. We included 23 trials (including a total of 4777 women). Included studies compared NO donors with placebo, vaginal prostaglandin E2 (PGE2), intracervical PGE2, vaginal misoprostol and intracervical Foley catheter. The majority of the included studies were assessed as being at low risk of bias. Nitric oxide versus placebo There was no evidence of a difference for any of the primary outcomes analysed: vaginal delivery not achieved in 24 hours (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.83 to 1.15; one trial, 238 women; low-quality evidence), uterine hyperstimulation with fetal heart rate (FHR) changes (RR 0.09, 95% CI 0.01 to 1.62; two

Prostaglandins for management of retained placenta.

PubMed

Grillo-Ardila, Carlos F; Ruiz-Parra, Ariel I; Gaitán, Hernando G; Rodriguez-Malagon, Nelcy

2014-05-16

Retained placenta affects 0.5% to 3% of women following delivery and it is a major cause of maternal death due to postpartum haemorrhage. Usually, retained placenta has been managed by manual removal or curettage under anaesthesia, which may be associated with haemorrhage, infection and uterine perforation. Medical management to facilitate the delivery of the retained placenta could be a safe alternative avoiding surgical intervention. To assess the effectiveness and safety of prostaglandins for the management of retained placenta. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 December 2013), LILACS (1982 to 1 December 2013), SciELO (1998 to 1 December 2013), Web of Science (2001 to 1 December 2013), openSIGLE (1997 to 1 December 2013), World Health Organization International Clinical Trials Registry Platform (ICTRP) (1 December 2013) and the metaRegister of Controlled Trials (mRCT) (1 December 2013). We also contacted authors of included studies and reviewed the reference lists of retrieved studies. Randomised controlled clinical trials comparing the use of prostaglandins (or prostaglandin analogues) with placebo, expectant management, tocolytic drugs, any other prostaglandins or surgical interventions for the management of retained placenta after vaginal delivery of singleton live infants of 20 or more weeks of gestation. Two review authors independently assessed trials for inclusion and assessed trial quality. Two review authors independently extracted data. Data were checked for accuracy. Any disagreements were resolved through consensus or consultation with a third review author when required. Authors of the included studies were contacted for additional information. We included three trials, involving 244 women. The studies were considered to be at high risk of bias.The prostaglandins used were PG E2 analogue (sulprostone) in 50 participants and PG E1 analogue (misoprostol) in 194 participants at a dose of 250 mcg and 800 mcg

Postpartum hemorrhage: incidence, risk factors, and outcomes in a low-resource setting.

PubMed

Ngwenya, Solwayo

2016-01-01

patients. Three-quarters (75.7%) of the cases had NVD. The majority of the cases (77.0%) had an identifiable risk factor for developing primary PPH. The most identifiable risk factor for primary PPH was pregnancy-induced hypertension followed by prolonged labor. Uterine atony was the most common cause of postpartum hemorrhage (82.4%). The women who delivered by NVD, who were diagnosed with a PPH, and who lost an estimated 500-1,000 mL of blood were 73.2%; 25% lost 1,000-1,500 mL of blood, and 1.8% lost more than 1,500 mL of blood. The women who delivered by lower-segment cesarean section, who were diagnosed with a PPH, and who lost an estimated 1,000-1,500 mL of blood were 77.8%, and 22.2% bled an estimated 1,500 mL of blood or more. The majority of the cases of primary PPH (94.6%) survived the condition and 5.4% died. The incidence of PPH at Mpilo Central Hospital was 1.6% during the study period, lower than that reported elsewhere in similar setting in the literature. This study, therefore, is important as it documents for the first time for this maternity unit and for a Zimbabwean setting, the incidence of one of the most important causes of global maternal deaths. Future studies should involve the effect on maternal outcomes of PPH following widespread introduction of misoprostol therapy into practice. This data can help in mobilizing global efforts to improve women's health.

[Evaluation of the efficacy and safety of Foley catheter pre-induction of labor].

PubMed

Jagielska, Iwona; Kazdepka-Ziemińska, Anita; Janicki, Radosław; Fórmaniak, Jacek; Walentowicz-Sadłecka, Małgorzata; Grabiec, Marek

2013-03-01

Labor induction is being increasingly used (15-30% of pregnancies). The most common indications include late pregnancy preeclampsia, intrauterine fetal growth retardation (IUGR), hypertension. Preinduction by speeding up the ripening of the cervix increases the chances of successful induction. There are mechanical and pharmacological methods of pre-induction: the Foley catheter hygroscopic dilators, prostaglandin gel, misoprostol. There are various schemes of labor pre-induction and the differences relate primarily to duration of catheter time, amniotomy or the start of the oxytocin. Numerous studies on pre-induction and induction of labor aimed to compare the efficacy of these different methods. The effectiveness of the Foley catheter is usually assessed by comparing cervical maturity (Bishop score) and ripening of the cervix, evaluated in centimeters, before and after removing the cathetec time to labor since pre-induction and the number of births. In order to select the appropriate method, its safety for the mother and the fetus/newborn needs to be assessed. According to most authors, the use of a Foley catheter does not cause over-stimulation of the uterus, does not increase the risk of rupture or intrauterine infection, and does not adversely affect the fetus and newborn. To assess the efficacy and safety of labor pre-induction using a Foley catheter The study included 109 women hospitalized between 03.01.2011 and 11.30.2011, who underwent labor pre-induction with a Foley catheter The inclusion criteria were: one fetal pregnancy longitudinal cephalic fetal position, completed 36 weeks of pregnancy fetal bladder preserved, Bishop score < 5 points. The exclusion criteria were: placenta previa, uterine infection, unexplained bleeding, abnormal fetal heart rate, and other reasons preventing vaginal delivery such as fetal weight above 4500 g. Vaginal swabs for the presence of Streptococcus agalactiae (GBS) were obtained from each patient. In case of a positive

Proton-pump inhibitor utilization associated with the change to nonpreferred formulary status for esomeprazole in the TRICARE formulary.

PubMed

Linton, Andrea; Bacon, Thomas; Peterson, Michael

2009-01-01

inhibitor (PPI) esomeprazole in the third copayment tier on the TRICARE formulary on July 17, 2005. The change to nonpreferred formulary status for esomeprazole included a $13 copayment increase (from $9.00 to $22.00) for either a 30-day supply purchased from a community pharmacy or a 90-day supply purchased from the mail-order pharmacy and a $0 copayment if obtained from a military pharmacy but with a prior authorization (PA) requirement. The change to nonpreferred formulary status was designed to encourage the use of PPIs other than esomeprazole and to increase the use of the mail-order pharmacy for esomeprazole purchases. To quantify changes in (a) the TRICARE beneficiary utilization of esomeprazole relative to other PPIs and (b) the pharmacy settings used for filling esomeprazole prescriptions following implementation of a copayment increase and nonpreferred formulary status for esomeprazole. A census of outpatient pharmacy fill records for prescription acid-reducing medications (PPIs, histamine-2 blockers, misoprostol, and sucralfate) obtained by beneficiaries aged 18 years or older from January 1, 2005, through December 31, 2006, was examined. Interrupted time series regression analyses without a control group were used to compare the utilization of esomeprazole relative to other PPIs, as well as the pharmacy setting used to obtain esomeprazole, in the months before and after the formulary change. The rates of continued esomeprazole use, switching to other prescription PPIs (lansoprazole, omeprazole, pantoprazole, and rabeprazole), switching to non-PPI prescription acid-reducing drugs, and discontinued prescription acid-reducing medication use among existing esomeprazole users (i.e., beneficiaries who obtained esomeprazole as the last PPI fill before the formulary change) were calculated overall and for each pharmacy setting used prior to the formulary change. Over the 24-month study period from January 1, 2005, through December 31, 2006, the total numbers of

Endometrial ablation in the management of abnormal uterine bleeding.

PubMed

Laberge, Philippe; Leyland, Nicholas; Murji, Ally; Fortin, Claude; Martyn, Paul; Vilos, George; Leyland, Nicholas; Wolfman, Wendy; Allaire, Catherine; Awadalla, Alaa; Dunn, Sheila; Heywood, Mark; Lemyre, Madeleine; Marcoux, Violaine; Potestio, Frank; Rittenberg, David; Singh, Sukhbir; Yeung, Grace

2015-04-01

visceral injury. (III-B) 7. With resectoscopic endometrial ablation, if uterine perforation has been ruled out acute hemorrhage may be managed by using intrauterine Foley balloon tamponade, injecting intracervical vasopressors, or administering rectal misoprostol. (III-B) 8. If repeat endometrial ablation (EA) is considered following non-resectoscopic or resectoscopic EA, it should be performed by a hysteroscopic surgeon with direct visualization of the cavity. Patients should be counselled about the increased risk of complications with repeat EA. (II-2A) 9. If significant intracavitary pathology is present, resectoscopic endometrial ablation combined with hysteroscopic myomectomy or polypectomy should be considered in a non-fertility sparing setting. (II-3A).

Antifibrinolytic drugs for treating primary postpartum haemorrhage.

PubMed

Shakur, Haleema; Beaumont, Danielle; Pavord, Sue; Gayet-Ageron, Angele; Ker, Katharine; Mousa, Hatem A

2018-02-20

(20,212 women) compared intravenous (IV) TXA with placebo or standard care and were conducted in acute hospital settings (labour ward, emergency department) (in high-, middle- and low-income countries).One other trial (involving 200 women) was conducted in Iran and compared IV TXA with rectal misoprostol, but did not report on any of this review's primary or GRADE outcomes. There were no trials that assessed EACA, aprotinin or aminomethylbenzoic acid.Standard care plus IV TXA for the treatment of primary PPH compared with placebo or standard care aloneTwo trials (20,212 women) assessed the effect of TXA for the treatment of primary PPH compared with placebo or standard care alone. The larger of these (The WOMAN trial) contributed over 99% of the data and was assessed as being at low risk of bias. The quality of the evidence varied for different outcomes, Overall, evidence was mainly graded as moderate to high quality.The data show that IV TXA reduces the risk of maternal death due to bleeding (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.65 to 1.00; two trials, 20,172 women; quality of evidence: moderate). The quality of evidence was rated as moderate due to imprecision of effect estimate. The effect was more evident in women given treatment between one and three hours after giving birth with no apparent reduction when given after three hours (< one hour = RR 0.80, 95% CI 0.55 to 1.16; one to three hours = RR 0.60, 95% CI 0.41 to 0.88; > three hours = RR 1.07, 95% 0.76 to 1.51; test for subgroup differences: Chi² = 4.90, df = 2 (P = 0.09), I² = 59.2%). There was no heterogeneity in the effect by mode of birth (test for subgroup differences: Chi² = 0.01, df = 1 (P = 0.91), I² = 0%). There were fewer deaths from all causes in women receiving TXA, although the 95% CI for the effect estimate crosses the line of no effect (RR 0.88, 95% CI 0.74 to 1.05; two trials, 20,172 women, quality of evidence: moderate). Results from one trial with 151 women suggest that

The management of uterine leiomyomas.

PubMed

Vilos, George A; Allaire, Catherine; Laberge, Philippe-Yves; Leyland, Nicholas

2015-02-01

progesterone receptor modulators and gonadotropin-releasing hormone analogues are effective at correcting anemia and should be considered preoperatively in anemic patients. (I-A) 8. Use of vasopressin, bupivacaine and epinephrine, misoprostol, peri-cervical tourniquet, or gelatin-thrombin matrix reduce blood loss at myomectomy and should be considered. (I-A) 9. Uterine artery occlusion by embolization or surgical methods may be offered to selected women with symptomatic uterine fibroids who wish to preserve their uterus. Women choosing uterine artery occlusion for the treatment of fibroids should be counselled regarding possible risks, including the likelihood that fecundity and pregnancy may be impacted. (II-3A) 10. In women who present with acute uterine bleeding associated with uterine fibroids, conservative management with estrogens, selective progesterone receptor modulators, antifibrinolytics, Foley catheter tamponade, and/or operative hysteroscopic intervention may be considered, but hysterectomy may become necessary in some cases. In centres where available, intervention by uterine artery embolization may be considered. (III-B).

Intra-Articular Viscosupplementation With Hylan G-F 20 To Treat Osteoarthritis of the Knee

PubMed Central

2005-01-01

Executive Summary Objective To assess the effectiveness and cost-effectiveness of hylan G-F 20 as a substitute for existing treatments for pain due to osteoarthritis (OA) of the knee, other viscosupplementation devices, and/or as an adjunct to conventional therapy. Hylan G-F 20 (brand name Synvisc, which is manufactured by Genzyme) is a high molecular weight derivative of hyaluronan, a component of joint synovial fluid. It acts as a lubricant and shock absorber. It is administered by injection into the joint space to treat pain associated with OA of the knee. Although the injection procedure is an insured service in Ontario, the device, hylan G-F 20, is not. Clinical Need Osteoarthritis is prevalent in 10% to 12% of Ontario adults, and exceeds 40% in Ontario residents aged 65 years and older. About one-half of these people have mild, moderate, or severe OA of the knee. Conventional treatment involves a combination of nonpharmacological management (e.g., weight loss, exercise, social support, and patient education), drugs, (e.g., acetaminophen, COX-2 inhibitors, nonsteroidal anti-inflammatory drugs with/without misoprostol, intra-articular glucocorticoids, opioids, and topical analgesics) and surgical interventions, such as debridement and total knee replacement, when pharmacological management fails. The growing burden of OA of the knee in the aging Ontario population combined with recent safety concerns about COX-2 inhibitors and long wait times for total joint replacement is placing pressure on the demand for new, effective technologies to manage the pain of OA. The Technology Hylan G-F 20 is derived from rooster comb hyaluronan (HA). At the time of writing, eight viscosupplement hyaluronic products are licensed in Canada. Hylan G-F 20 is distinguished from the other products by its chemical structure (i.e., cross-linked hyaluronan, hence hylan) and relatively higher molecular weight, which may bestow greater therapeutic viscoelastic properties. A complete