Complementary therapies for labour and birth study: a randomised controlled trial of antenatal integrative medicine for pain management in labour

PubMed Central

Levett, Kate M; Smith, C A; Bensoussan, A; Dahlen, H G

2016-01-01

Objective To evaluate the effect of an antenatal integrative medicine education programme in addition to usual care for nulliparous women on intrapartum epidural use. Design Open-label, assessor blind, randomised controlled trial. Setting 2 public hospitals in Sydney, Australia. Population 176 nulliparous women with low-risk pregnancies, attending hospital-based antenatal clinics. Methods and intervention The Complementary Therapies for Labour and Birth protocol, based on the She Births and acupressure for labour and birth courses, incorporated 6 evidence-based complementary medicine techniques: acupressure, visualisation and relaxation, breathing, massage, yoga techniques, and facilitated partner support. Randomisation occurred at 24–36 weeks’ gestation, and participants attended a 2-day antenatal education programme plus standard care, or standard care alone. Main outcome measures Rate of analgesic epidural use. Secondary: onset of labour, augmentation, mode of birth, newborn outcomes. Results There was a significant difference in epidural use between the 2 groups: study group (23.9%) standard care (68.7%; risk ratio (RR) 0.37 (95% CI 0.25 to 0.55), p≤0.001). The study group participants reported a reduced rate of augmentation (RR=0.54 (95% CI 0.38 to 0.77), p<0.0001); caesarean section (RR=0.52 (95% CI 0.31 to 0.87), p=0.017); length of second stage (mean difference=−0.32 (95% CI −0.64 to 0.002), p=0.05); any perineal trauma (0.88 (95% CI 0.78 to 0.98), p=0.02) and resuscitation of the newborn (RR=0.47 (95% CI 0.25 to 0.87), p≤0.015). There were no statistically significant differences found in spontaneous onset of labour, pethidine use, rate of postpartum haemorrhage, major perineal trauma (third and fourth degree tears/episiotomy), or admission to special care nursery/neonatal intensive care unit (p=0.25). Conclusions The Complementary Therapies for Labour and Birth study protocol significantly reduced epidural use and caesarean section. This

Morning versus evening induction of labour for improving outcomes.

PubMed

Bakker, Jannet J H; van der Goes, Birgit Y; Pel, Maria; Mol, Ben Willem J; van der Post, Joris A M

2013-02-28

Induction of labour is a common intervention in obstetric practice. Traditionally, in most hospitals induction of labour with medication starts early in the morning, with the start of the working day for the day shift. In human and animal studies spontaneous onset of labour is proven to have a circadian rhythm with a preference for start of labour in the evening. Moreover, when spontaneous labour starts in the evening, the total duration of labour and delivery shortens and fewer obstetric interventions are needed. Based on these observations one might assume that starting induction of labour in the evening, in harmony with the circadian rhythm of natural birth, is more beneficial for both mother and child. To assess whether induction of labour starting in the evening, coinciding with the endogenous circadian rhythm, improves the outcome of labour compared with induction of labour starting in the early morning, organised to coincide with office hours. We contacted the Trials Search Co-ordinator to search the Cochrane Pregnancy and Childbirth Group's Trials Register (28 February 2012). In addition, we searched MEDLINE (1966 to 16 February 2012) and EMBASE (1980 to 16 February 2012). We included all published and unpublished randomised controlled trials. We excluded trials that employed quasi-random methods of treatment allocation. Two review authors independently assessed trials for inclusion and risk of bias. Two review authors independently extracted data. Data were checked for accuracy. Where necessary, we contacted study authors for additional information. The search resulted in 2693 articles that we screened on title and abstract for eligibility.Thirteen studies were selected for full text assessment. We included three randomised trials involving 1150 women. Two trials compared the administration of prostaglandins in the morning versus the evening in women with an unfavourable cervix, and one trial compared induction of labour in the morning versus the evening

Randomised controlled trial of labouring in water compared with standard of augmentation for management of dystocia in first stage of labour

PubMed Central

Cluett, Elizabeth R; Pickering, Ruth M; Getliffe, Kathryn; Saunders, Nigel James St George

2004-01-01

Objectives To evaluate the impact of labouring in water during first stage of labour on rates of epidural analgesia and operative delivery in nulliparous women with dystocia. Design Randomised controlled trial. Setting University teaching hospital in southern England. Participants 99 nulliparous women with dystocia (cervical dilation rate < 1 cm/hour in active labour) at low risk of complications. Interventions Immersion in water in birth pool or standard augmentation for dystocia (amniotomy and intravenous oxytocin). Main outcome measures Primary: epidural analgesia and operative delivery rates. Secondary: augmentation rates with amniotomy and oxytocin, length of labour, maternal and neonatal morbidity including infections, maternal pain score, and maternal satisfaction with care. Results Women randomised to immersion in water had a lower rate of epidural analgesia than women allocated to augmentation (47% v 66%, relative risk 0.71 (95% confidence interval 0.49 to 1.01), number needed to treat for benefit (NNT) 5). They showed no difference in rates of operative delivery (49% v 50%, 0.98 (0.65 to 1.47), NNT 98), but significantly fewer received augmentation (71% v 96%, 0.74 (0.59 to 0.88), NNT 4) or any form of obstetric intervention (amniotomy, oxytocin, epidural, or operative delivery) (80% v 98%, 0.81 (0.67 to 0.92), NNT 5). More neonates of women in the water group were admitted to the neonatal unit (6 v 0, P = 0.013), but there was no difference in Apgar score, infection rates, or umbilical cord pH. Conclusions Labouring in water under midwifery care may be an option for slow progress in labour, reducing the need for obstetric intervention, and offering an alternative pain management strategy. PMID:14744822

Hypnosis for induction of labour.

PubMed

Nishi, Daisuke; Shirakawa, Miyako N; Ota, Erika; Hanada, Nobutsugu; Mori, Rintaro

2014-08-14

Induction of labour using pharmacological and mechanical methods can increase complications. Complementary and alternative medicine methods including hypnosis may have the potential to provide a safe alternative option for the induction of labour. However, the effectiveness of hypnosis for inducing labour has not yet been fully evaluated. To assess the effect of hypnosis for induction of labour compared with no intervention or any other interventions. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2014), handsearched relevant conference proceedings, contacted key personnel and organisations in the field for published and unpublished references. All published and unpublished randomised controlled trials (RCTs) and cluster-RCTs of acceptable quality comparing hypnosis with no intervention or any other interventions, in which the primary outcome is to assess whether labour was induced. Two review authors assessed the one trial report that was identified (but was subsequently excluded). No RCTs or cluster-RCTs were identified from the search strategy. There was no evidence available from RCTs to assess the effect of hypnosis for induction of labour. Evidence from RCTs is required to evaluate the effectiveness and safety of this intervention for labour induction. As hypnosis may delay standard care (in case standard care is withheld during hypnosis), its use in induction of labour should be considered on a case-by-case basis.Future RCTs are required to examine the effectiveness and safety of hypnotic relaxation for induction of labour among pregnant women who have anxiety above a certain level. The length and timing of the intervention, as well as the staff training required, should be taken into consideration. Moreover, the views and experiences of women and staff should also be included in future RCTs.

Aromatherapy for pain management in labour.

PubMed

Smith, Caroline A; Collins, Carmel T; Crowther, Caroline A

2011-07-06

Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined currently available evidence supporting the use of aromatherapy for pain management in labour. To examine the effects of aromatherapy for pain management in labour on maternal and perinatal morbidity. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2010), The Cochrane Complementary Medicine Field's Trials Register (October 2010), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2010, Issue 4), MEDLINE (1966 to 31 October 2010), CINAHL (1980 to 31 October 2010), the Australian and New Zealand Trials Registry (31 October 2010), Chinese Clinical Trial Register (31 October 2010), Current Controlled Trials (31 October 2010), ClinicalTrials.gov (31 October 2010), ISRCTN Register (31 October 2010), National Center for Complementary and Alternative Medicine (NCCAM) (31 October 2010) and the WHO International Clinical Trials Registry Platform (31 October 2010). Randomised controlled trials comparing aromatherapy with placebo, no treatment or other non-pharmacological forms of pain management in labour. Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information. We included two trials (535 women) in the review. The trials found no difference between groups for the primary outcomes of pain intensity, assisted vaginal birth (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.48 to 2.28, one trial, 513 women; RR 0.83, 95% CI 0.06 to 11.70, one trial, 22 women), and caesarean section (RR 0.98, 95% CI 0.49 to 1.94, one trial, 513 women; RR 2.54, 95% CI 0.11 to 56.25, one trial, 22 women); there were more babies admitted to neonatal intensive care in the control group of one trial (RR 0.08, 95% CI 0.00 to 1.42, one trial, 513 women) but this

Massage, reflexology and other manual methods for pain management in labour.

PubMed

Smith, Caroline A; Levett, Kate M; Collins, Carmel T; Jones, Leanne

2012-02-15

Many women would like to avoid pharmacological or invasive methods of pain management in labour, and this may contribute towards the popularity of complementary methods of pain management. This review examined currently available evidence supporting the use of manual healing methods including massage and reflexology for pain management in labour. To examine the effects of manual healing methods including massage and reflexology for pain management in labour on maternal and perinatal morbidity. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2 of 4), MEDLINE (1966 to 30 June 2011), CINAHL (1980 to 30 June 2011), the Australian and New Zealand Clinical Trial Registry (30 June 2011), Chinese Clinical Trial Register (30 June 2011), Current Controlled Trials (30 June 2011), ClinicalTrials.gov, (30 June 2011) ISRCTN Register (30 June 2011), National Centre for Complementary and Alternative Medicine (NCCAM) (30 June 2011) and the WHO International Clinical Trials Registry Platform (30 June 2011). Randomised controlled trials comparing manual healing methods with standard care, no treatment, other non-pharmacological forms of pain management in labour or placebo. Two authors independently assessed trial quality and extracted data. We attempted to contact study authors for additional information. We included six trials, with data reporting on five trials and 326 women in the meta-analysis. We found trials for massage only. Less pain during labour was reported from massage compared with usual care during the first stage of labour (standardised mean difference (SMD) -0.82, 95% confidence interval (CI) -1.17 to -0.47), four trials, 225 women), and labour pain was reduced in one trial of massage compared with music (risk ratio (RR) 0.40, 95% CI 0.18 to 0.89, 101 women). One trial of massage compared with usual care found reduced anxiety during

Immersion in water during labour and birth.

PubMed

Cluett, Elizabeth R; Burns, Ethel; Cuthbert, Anna

2018-05-16

Water immersion during labour and birth is increasingly popular and is becoming widely accepted across many countries, and particularly in midwifery-led care settings. However, there are concerns around neonatal water inhalation, increased requirement for admission to neonatal intensive care unit (NICU), maternal and/or neonatal infection, and obstetric anal sphincter injuries (OASIS). This is an update of a review last published in 2011. To assess the effects of water immersion during labour and/or birth (first, second and third stage of labour) on women and their infants. We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (18 July 2017), and reference lists of retrieved trials. We included randomised controlled trials (RCTs) comparing water immersion with no immersion, or other non-pharmacological forms of pain management during labour and/or birth in healthy low-risk women at term gestation with a singleton fetus. Quasi-RCTs and cluster-RCTs were eligible for inclusion but none were identified. Cross-over trials were not eligible for inclusion. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two review authors assessed the quality of the evidence using the GRADE approach. This review includes 15 trials conducted between 1990 and 2015 (3663 women): eight involved water immersion during the first stage of labour; two during the second stage only; four during the first and second stages of labour, and one comparing early versus late immersion during the first stage of labour. No trials evaluated different baths/pools, or third-stage labour management. All trials were undertaken in a hospital labour ward setting, with a varying degree of medical intervention considered as routine practice. No study was carried out in a midwifery-led care setting. Most trial authors did not specify the

Use of wind-up fetal Doppler versus Pinard for fetal heart rate intermittent monitoring in labour: a randomised clinical trial

PubMed Central

Byaruhanga, R; Bassani, D G; Jagau, A; Muwanguzi, P; Montgomery, A L; Lawn, J E

2015-01-01

Objectives In resource-poor settings, the standard of care to inform labour management is the partograph plus Pinard stethoscope for intermittent fetal heart rate (FHR) monitoring. We compared FHR monitoring in labour using a novel, robust wind-up handheld Doppler with the Pinard as a primary screening tool for abnormal FHR on perinatal outcomes. Design Prospective equally randomised clinical trial. Setting The labour and delivery unit of a teaching hospital in Kampala, Uganda. Participants Of the 2042 eligible antenatal women, 1971 women in active term labour, following uncomplicated pregnancies, were randomised to either the standard of care or not. Intervention Intermittent FHR monitoring using Doppler. Primary outcome measures Incidence of FHR abnormality detection, intrapartum stillbirth and neonatal mortality prior to discharge. Results Age, parity, gestational age, mode of delivery and newborn weight were similar between study groups. In the Doppler group, there was a significantly higher rate of FHR abnormalities detected (incidence rate ratio (IRR)=1.61, 95% CI 1.13 to 2.30). However, in this group, there were also higher though not statistically significant rates of intrapartum stillbirths (IRR=3.94, 0.44 to 35.24) and neonatal deaths (IRR=1.38, 0.44 to 4.34). Conclusions Routine monitoring with a handheld Doppler increased the identification of FHR abnormalities in labour; however, our trial did not find evidence that this leads to a decrease in the incidence of intrapartum stillbirth or neonatal death. Trial registration number Clinical Trails.gov (1000031587). PMID:25636792

Labour dystocia--risk of recurrence and instrumental delivery in following labour--a population-based cohort study.

PubMed

Sandström, A; Cnattingius, S; Wikström, A K; Stephansson, O

2012-12-01

To investigate risk of recurrence of labour dystocia and mode of delivery in second labour after taking first labour and fetal and maternal characteristics into account. A population-based cohort study. The Swedish Medical Birth Register from 1992 to 2006. A total of 239 953 women who gave birth to their first and second singleton infants in cephalic presentation at ≥ 37 weeks of gestation with spontaneous onset of labour. We used logistic regression analysis to estimate crude and adjusted odds ratios. Labour dystocia and mode of delivery in second labour. Overall labour dystocia affected only 12% of women with previous dystocia. Regardless of mode of first delivery, rates of dystocia in the second labour were higher in women with than without previous dystocia, but were more pronounced in women with previous caesarean section (34%). Analyses with risk score groups for dystocia (risk factors were long interpregnancy interval, maternal age ≥ 35 years, obesity, short maternal stature, not cohabiting and post-term pregnancy) showed that risk of instrumental delivery in second labour increased with previous dystocia and increasing risk score. Among women with trial of labour after caesarean section with previous dystocia and a risk score of 3 or more, 66% had a vaginal instrumental or caesarean delivery (17 and 49%, respectively). In women with trial of labour after caesarean section without previous dystocia and a risk score of 0, corresponding risk was 32% (14 and 18%, respectively). Previous labour dystocia increases the risk of dystocia in subsequent delivery. Taking first labour and fetal and maternal characteristics into account is important in the risk assessments for dystocia and instrumental delivery in second labour. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

Complementary and alternative therapies for pain management in labour.

PubMed

Smith, C A; Collins, C T; Cyna, A M; Crowther, C A

2003-01-01

Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined currently available evidence supporting the use of alternative and complementary therapies for pain management in labour. To examine the effectiveness of complementary and alternative therapies for pain management in labour on maternal and perinatal morbidity. We searched the Cochrane Pregnancy and Childbirth Group trials register (July 2002), the Cochrane Controlled Trials Register (The Cochrane Library Issue 2, 2002), MEDLINE (1966 to July 2002), EMBASE (1980 to July 2002) and CINAHL (1980 to July 2002). The inclusion criteria included published and unpublished randomised controlled trials comparing complementary and alternative therapies with placebo, no treatment or pharmacological forms of pain management in labour. All women whether primiparous or multiparous, and in spontaneous or induced labour, in the first and second stage of labour were included. Meta-analysis was performed using relative risks for dichotomous outcomes and weighted mean differences for continuous outcomes. The outcome measures were maternal satisfaction, use of pharmacological pain relief and maternal and neonatal adverse outcomes. Seven trials involving 366 women and using different modalities of pain management were included in this review. The trials included one involving acupuncture (n = 100), one involving audio-analgesia (n = 25), one involving aromatherapy (n = 22), three trials of hypnosis (n = 189) and one trial of music (n = 30). The trial of acupuncture decreased the need for pain relief (relative risk (RR) 0.56, 95% confidence interval (CI) 0.39 to 0.81). Women receiving hypnosis were more satisfied with their pain management in labour compared with controls (RR 2.33, 95% CI 1.55 to 4.71). No differences were seen for women receiving aromatherapy, music or audio

The RESPITE trial: remifentanil intravenously administered patient-controlled analgesia (PCA) versus pethidine intramuscular injection for pain relief in labour: study protocol for a randomised controlled trial.

PubMed

Wilson, Matthew; MacArthur, Christine; Gao Smith, Fang; Homer, Leanne; Handley, Kelly; Daniels, Jane

2016-12-12

The commonest opioid used for pain relief in labour is pethidine (meperidine); however, its effectiveness has long been challenged and the drug has known side effects including maternal sedation, nausea and potential transfer across the placenta to the foetus. Over a third of women receiving pethidine require an epidural due to inadequate pain relief. Epidural analgesia increases the risk of an instrumental vaginal delivery and its associated effects. Therefore, there is a clear need for a safe, effective, alternative analgesic to pethidine. Evidence suggests that remifentanil patient-controlled analgesia (PCA) reduces epidural conversion rates compared to pethidine; however, no trial has yet investigated this as a primary endpoint. We are, therefore, comparing pethidine intramuscular injection to remifentanil PCA in a randomised controlled trial. Women in established labour, requesting systemic opioid pain relief, will be randomised to either intravenously administered remifentanil PCA (intervention) or pethidine intramuscular injection (control) in an unblinded, 1:1 individual randomised trial. Following informed consent, 400 women in established labour, who request systemic opioid pain relief, from NHS Trusts across England will undergo a minimised randomisation by a computer or automated telephone system to either pethidine or remifentanil. In order to balance the groups this minimisation is based on four parameters; parity (nulliparous versus multiparous), maternal age (<20, 20 < 30, 30 < 40, 40+ years), ethnicity (South Asian (Pakistani/Indian/Bangladeshi) versus Other) and induced versus spontaneous labour. The effectiveness of pain relief provided by each technique will be recorded every 30 min after time zero, until epidural placement, delivery or transfer to theatre, quantified by Visual Analogue Scale. Incidence of maternal side effects including sedation, delivery mode, foetal distress requiring delivery, neonatal status at delivery and rate of

Complementary and alternative therapies for pain management in labour.

PubMed

Smith, C A; Collins, C T; Cyna, A M; Crowther, C A

2006-10-18

Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined currently available evidence supporting the use of alternative and complementary therapies for pain management in labour. To examine the effects of complementary and alternative therapies for pain management in labour on maternal and perinatal morbidity. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (February 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2006, Issue 1), MEDLINE (1966 to February 2006), EMBASE (1980 to February 2006) and CINAHL (1980 to February 2006). The inclusion criteria included published and unpublished randomised controlled trials comparing complementary and alternative therapies (but not biofeedback) with placebo, no treatment or pharmacological forms of pain management in labour. All women whether primiparous or multiparous, and in spontaneous or induced labour, in the first and second stage of labour were included. Meta-analysis was performed using relative risks for dichotomous outcomes and mean differences for continuous outcomes. The outcome measures were maternal satisfaction, use of pharmacological pain relief and maternal and neonatal adverse outcomes. Fourteen trials were included in the review with data reporting on 1537 women using different modalities of pain management; 1448 women were included in the meta-analysis. Three trials involved acupuncture (n = 496), one audio-analgesia (n = 24), two trials acupressure (n = 172), one aromatherapy (n = 22), five trials hypnosis (n = 729), one trial of massage (n = 60), and relaxation (n = 34). The trials of acupuncture showed a decreased need for pain relief (relative risk (RR) 0.70, 95% confidence interval (CI) 0.49 to 1.00, two trials 288 women). Women taught self-hypnosis had decreased requirements for pharmacological

Effects of auriculotherapy on labour pain: a randomized clinical trial.

PubMed

Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

2016-01-01

Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de

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

Design of Phase II Non-inferiority Trials.

PubMed

Jung, Sin-Ho

2017-09-01

With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial. Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial. As a result, we often fail to open a non-inferiority phase III trial and a large number of non-inferiority clinical questions still remain unanswered. In this paper, we want to develop some designs for non-inferiority randomized phase II trials with feasible sample sizes. At first, we review a design method for non-inferiority phase III trials. Subsequently, we propose three different designs for non-inferiority phase II trials that can be used under different settings. Each method is demonstrated with examples. Each of the proposed design methods is shown to require a reasonable sample size for non-inferiority phase II trials. The three different non-inferiority phase II trial designs are used under different settings, but require similar sample sizes that are typical for phase II trials.

Epidural labour analgesia using Bupivacaine and Clonidine

PubMed Central

Syal, K; Dogra, RK; Ohri, A; Chauhan, G; Goel, A

2011-01-01

Background: To compare the effects of addition of Clonidine (60 μg) to Epidural Bupivacaine (0.125%) for labour analgesia, with regard to duration of analgesia, duration of labour, ambulation, incidence of instrumentation and caesarean section, foetal outcome, patient satisfaction and side effects. Patients & Methods: On demand, epidural labour analgesia was given to 50 nulliparous healthy term parturients (cephalic presentation), divided in two groups randomly. Group I received bupivacaine (0.125%) alone, whereas Group II received bupivacaine (0.125%) along with Clonidine (60 μg). 10 ml of 0.125% bupivacaine was injected as first dose and further doses titrated with patient relief (Numerical Rating Scale <3). Top ups were given whenever Numerical Rating Scale went above 5. Results: There was statistically significant prolongation of duration of analgesia in Group II, with no difference in duration of labour, ambulation, incidence of instrumentation and caesarean section or foetal outcome. Also clonidine gave dose sparing effect to bupivacaine and there was better patient satisfaction without any significant side effects in Group II. Conclusion: Clonidine is a useful adjunct to bupivacaine for epidural labour analgesia and can be considered as alternative to opioids. PMID:21804714

The influence of cold pack on labour pain relief and birth outcomes: a randomised controlled trial.

PubMed

Shirvani, Marjan Ahmad; Ganji, Zhila

2014-09-01

(1) To evaluate the influence of local cold on severity of labour pain and (2) to identify the effect of local cold on maternal and neonatal outcomes. Fear of labour pain results in an increase in pain and duration of labour, maternal discontent and demand for caesarean section. Regarding maternal and foetal complications of analgesic medications, the attention to application of nonpharmacological methods including cold therapy is increased. Randomised controlled trial. Sixty-four pregnant women, at initiation of active phase of labour, were allocated randomly to cold therapy and control groups (n = 64). Null parity, term pregnancy, presence of single foetus, cephalic presentation and completing informed consent were considered as inclusion criteria. Administration of analgesic and anaesthesia, foetal distress, skin lesions in regions of cold therapy and high-risk pregnancy provided exclusion criteria. Cold pack was applied over abdomen and back, for 10 minutes every 30 minutes during first phase of labour. Additionally, cold pack was placed over perineum, for 5 minutes every 15 minutes during second phase. Pain severity was assessed based on the visual analogue scale. The two groups were not significantly different considering demographic data, gestational age, foetal weight, rupture of membranes and primary severity of pain. Degree of pain was lower in cold therapy group during all parts of active phase and second stage. Duration of all phases was shorter in cold therapy group in all phases. Foetal heart rate, perineal laceration, type of birth, application of oxytocin and APGAR score were not significantly different between two groups. Labour pain is probably reduced based on gate theory using cold. Pain control by cold maybe improves labour progression without affecting mother and foetus adversely. Local cold therapy could be included in labour pain management. © 2013 John Wiley & Sons Ltd.

Sexual intercourse for cervical ripening and induction of labour.

PubMed

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

2001-01-01

The role of prostaglandins for cervical ripening and induction of labour has been examined extensively. Human semen is the biological source that is presumed to contain the highest prostaglandin concentration. The role of sexual intercourse in the initiation of labour is uncertain. The action of sexual intercourse in stimulating labour is unclear, it may in part be due to the physical stimulation of the lower uterine segment, or endogenous release of oxytocin as a result of orgasm or from the direct action of prostaglandins in semen. Furthermore nipple stimulation may be part of the process of initiation. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. To determine the effects of sexual intercourse for third trimester cervical ripening or induction of labour in comparison with other methods of induction. The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: November 2000. (1) clinical trials comparing sexual intercourse 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; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusion. A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involves a two-stage method of data extraction. There was one included study of 28 women which reported very limited data, from which no meaningful conclusions can be drawn. The role of sexual intercourse as a method of induction

Relaxation techniques for pain management in labour.

PubMed

Smith, Caroline A; Levett, Kate M; Collins, Carmel T; Crowther, Caroline A

2011-12-07

Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined currently available evidence supporting the use of relaxation therapies for pain management in labour. To examine the effects of relaxation methods for pain management in labour on maternal and perinatal morbidity. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2010), The Cochrane Complementary Medicine Field's Trials Register (November 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2010, Issue 4), MEDLINE (1966 to 30 November 2010), CINAHL (1980 to 30 November 2010), the Australian and New Zealand Clinical Trial Registry (30 November 2010), Chinese Clinical Trial Register (30 November 2010), Current Controlled Trials (30 November 2010), ClinicalTrials.gov, (30 November 2010) ISRCTN Register (30 November 2010), National Centre for Complementary and Alternative Medicine (NCCAM) (30 November 2010) and the WHO International Clinical Trials Registry Platform (30 November 2010). Randomised controlled trials comparing relaxation methods with standard care, no treatment, other non-pharmacological forms of pain management in labour or placebo. Three review authors independently assessed trials for inclusion and extracted data. Data were checked for accuracy. Two review authors independently assessed trial quality. We attempted to contact study authors for additional information. We included 11 studies (1374 women) in the review. Relaxation was associated with a reduction in pain intensity during the latent phase (mean difference (MD) -1.25, 95% confidence interval (CI) -1.97 to -0.53, one trial, 40 women) and active phase of labour (MD -2.48, 95% CI -3.13 to 0.83, two trials, 74 women). There was evidence of improved outcomes from relaxation instruction with increased satisfaction with pain

Piracetam for fetal distress in labour.

PubMed

Hofmeyr, G Justus; Kulier, Regina

2012-06-13

Piracetam is thought to promote the metabolism of brain cells when they are hypoxic. It has been used to prevent adverse effects of fetal distress. The objective of this review was to assess the effects of piracetam for suspected fetal distress in labour on method of delivery and perinatal morbidity. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (15 February 2012). Randomised trials of piracetam compared with placebo or no treatment for suspected fetal distress in labour. Both review authors assessed eligibility and trial quality. One study of 96 women was included. Piracetam compared with placebo was associated with a trend to reduced need for caesarean section (risk ratio 0.57, 95% confidence interval 0.32 to 1.03). There were no statistically significant differences between the piracetam and placebo group for neonatal morbidity (measured by neonatal respiratory distress) or Apgar score. There is not enough evidence to evaluate the use of piracetam for fetal distress in labour.

Complementary therapies for labour and birth study: a randomised controlled trial of antenatal integrative medicine for pain management in labour.

PubMed

Levett, Kate M; Smith, C A; Bensoussan, A; Dahlen, H G

2016-07-12

To evaluate the effect of an antenatal integrative medicine education programme in addition to usual care for nulliparous women on intrapartum epidural use. Open-label, assessor blind, randomised controlled trial. 2 public hospitals in Sydney, Australia. 176 nulliparous women with low-risk pregnancies, attending hospital-based antenatal clinics. The Complementary Therapies for Labour and Birth protocol, based on the She Births and acupressure for labour and birth courses, incorporated 6 evidence-based complementary medicine techniques: acupressure, visualisation and relaxation, breathing, massage, yoga techniques, and facilitated partner support. Randomisation occurred at 24-36 weeks' gestation, and participants attended a 2-day antenatal education programme plus standard care, or standard care alone. Rate of analgesic epidural use. Secondary: onset of labour, augmentation, mode of birth, newborn outcomes. There was a significant difference in epidural use between the 2 groups: study group (23.9%) standard care (68.7%; risk ratio (RR) 0.37 (95% CI 0.25 to 0.55), p≤0.001). The study group participants reported a reduced rate of augmentation (RR=0.54 (95% CI 0.38 to 0.77), p<0.0001); caesarean section (RR=0.52 (95% CI 0.31 to 0.87), p=0.017); length of second stage (mean difference=-0.32 (95% CI -0.64 to 0.002), p=0.05); any perineal trauma (0.88 (95% CI 0.78 to 0.98), p=0.02) and resuscitation of the newborn (RR=0.47 (95% CI 0.25 to 0.87), p≤0.015). There were no statistically significant differences found in spontaneous onset of labour, pethidine use, rate of postpartum haemorrhage, major perineal trauma (third and fourth degree tears/episiotomy), or admission to special care nursery/neonatal intensive care unit (p=0.25). The Complementary Therapies for Labour and Birth study protocol significantly reduced epidural use and caesarean section. This study provides evidence for integrative medicine as an effective adjunct to antenatal education, and contributes

Prophylactic versus therapeutic amnioinfusion for oligohydramnios in labour.

PubMed

Novikova, Natalia; Hofmeyr, G Justus; Essilfie-Appiah, George

2012-09-12

Amnioinfusion aims to relieve umbilical cord compression during labour by infusing a liquid into the uterine cavity. The objective of this review was to assess the effects of prophylactic amnioinfusion for women in labour with oligohydramnios, but not fetal heart deceleration, compared with therapeutic amnioinfusion only if fetal heart rate decelerations or thick meconium-staining of the liquor occur. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 February 2012). Randomised trials comparing prophylactic amnioinfusion in women in labour with oligohydramnios but not fetal heart rate deceleration in labour with therapeutic amnioinfusion. The authors assessed trial quality and extracted data. One randomized trial of 116 women was included. No differences were found in the rate of caesarean section (risk ratio 1.29, 95% confidence interval 0.60 to 2.74). There were no differences in cord arterial pH, oxytocin augmentation, neonatal pneumonia or postpartum endometritis. Prophylactic amnioinfusion was associated with increased intrapartum fever (risk ratio 3.48, 95% confidence interval 1.21 to 10.05). There appears to be no advantage of prophylactic amnioinfusion over therapeutic amnioinfusion carried out only when fetal heart rate decelerations or thick meconium-staining of the liquor occur.

Standard- or high-dose oxytocin for nulliparous women with confirmed delay in labour: quantitative and qualitative results from a pilot randomised controlled trial.

PubMed

Kenyon, S; Armstrong, N; Johnston, T; Walkinshaw, S; Petrou, S; Howman, A; Cheed, V; Markham, C; McNicol, S; Willars, J; Waugh, J

2013-10-01

Evidence suggests that a high dose of oxytocin for nulliparous women at 37-42 weeks of gestation with confirmed delay in labour increases spontaneous vaginal birth. We undertook a pilot study to test the feasibility of this treatment. Pilot double-blind randomised controlled trial. Three teaching hospitals in the UK. A total of 94 consenting nulliparous women at term with confirmed delay in labour were recruited, and 18 were interviewed. Women were assigned to either a standard (2 mU/min, increasing every 30 minutes to 32 mU/minute) or a high-dose regimen (4 mU/minute, increasing every 30 minutes to 64 mU/minutes) oxytocin by computer-generated randomisation. Simple descriptive statistics were used, as the sample size was insufficient to evaluate clinical outcomes. The constant comparative method was used to analyse the interviews. The main outcome measures: number of women eligible; maternal and neonatal birth; safety; maternal psychological outcomes and experiences; health-related quality of life outcomes using validated tools and data on health service resource use; incidence of suspected delay of labour (cervical dilatation of <2 cm after 4 hours, once labour is established); and incidence of confirmed delay of labour (progress of <1 cm on repeat vaginal examination after a period of 2 hours). We successfully developed systems to recruit eligible women in labour and to collect data. Rates of spontaneous vaginal birth (10/47 versus 12/47, RR 1.2, 95% CI 0.6-2.5) and caesarean section (15/47 versus 17/47, RR 1.1, 95% CI 0.6-2.0) were increased, and rates of instrumental birth were reduced (21/47 versus 17/47, RR 0.8, 95% CI 0.5-1.3). No evidence of increased harm for either mother or baby was found. The incidences of suspected delay (14%) and confirmed delay (11%) in labour were less than anticipated. Of those who did not go on to have delayed labour confirmed, all except one woman gave birth vaginally. A pilot trial assessing the efficacy of high-dose oxytocin

Epidural analgesia in labour and risk of caesarean delivery.

PubMed

Bannister-Tyrrell, Melanie; Ford, Jane B; Morris, Jonathan M; Roberts, Christine L

2014-09-01

A Cochrane Systematic Review of randomised controlled trials of epidural analgesia compared with other or no analgesia in labour reported no overall increased risk of caesarean delivery. However, many trials were affected by substantial non-compliance, and there are concerns about the external validity of some trials for contemporary maternity populations. We aimed to explore the association between epidural analgesia in labour and caesarean delivery in clinical practice and compare with findings from randomised controlled trials. Population-based cohort of pregnant women (n = 210 708) without major obstetrical complications who delivered a singleton live infant in hospitals in New South Wales, Australia, 2007-10. Data were obtained from linked, validated population-based data collections. Propensity score matching was used to examine the association between epidural analgesia in labour and caesarean delivery. Epidural analgesia in labour was used by a third (31.5%, n = 66 317) of the women, and 9.8% (n = 20 531) had a caesarean delivery. Epidural analgesia in labour was associated with increased risk of caesarean delivery {risk ratio [RR] 2.5, [95% confidence interval (CI) 2.5, 2.6]}. The association with epidural analgesia in labour was higher for caesarean delivery for failure to progress {RR 3.0, [95% CI 2.9, 3.0]} than for caesarean delivery for fetal distress {RR 1.9, [95% CI 1.8, 2.0]}. Epidural analgesia in labour is associated with caesarean delivery in a large maternity population. Population-based studies contribute important data about obstetrical care, when research settings and participants may not represent the clinical settings or broader population in which obstetrical interventions in labour are applied. © 2014 John Wiley & Sons Ltd.

Massage, reflexology and other manual methods for pain management in labour.

PubMed

Smith, Caroline A; Levett, Kate M; Collins, Carmel T; Dahlen, Hannah G; Ee, Carolyn C; Suganuma, Machiko

2018-03-28

Many women would like to avoid pharmacological or invasive methods of pain management in labour, and this may contribute towards the popularity of complementary methods of pain management. This review examined the evidence currently available on manual methods, including massage and reflexology, for pain management in labour. This review is an update of the review first published in 2012. To assess the effect, safety and acceptability of massage, reflexology and other manual methods to manage pain in labour. For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register (30 June 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 6), MEDLINE (1966 to 30 June 2017, CINAHL (1980 to 30 June 2017), the Australian New Zealand Clinical Trials Registry (4 August 2017), Chinese Clinical Trial Registry (4 August 2017), ClinicalTrials.gov, (4 August 2017), the National Center for Complementary and Integrative Health (4 August 2017), the WHO International Clinical Trials Registry Platform (ICTRP) (4 August 2017) and reference lists of retrieved trials. We included randomised controlled trials comparing manual methods with standard care, other non-pharmacological forms of pain management in labour, no treatment or placebo. We searched for trials of the following modalities: massage, warm packs, thermal manual methods, reflexology, chiropractic, osteopathy, musculo-skeletal manipulation, deep tissue massage, neuro-muscular therapy, shiatsu, tuina, trigger point therapy, myotherapy and zero balancing. We excluded trials for pain management relating to hypnosis, aromatherapy, acupuncture and acupressure; these are included in other Cochrane reviews. Two review authors independently assessed trial quality, extracted data and checked data for accuracy. We contacted trial authors for additional information. We assessed the quality of the evidence using the GRADE approach. We included a total of 14 trials; 10 of these (1055 women

A randomized clinical trial of care for women with preterm labour: home management versus hospital management.

PubMed

Goulet, C; Gévry, H; Lemay, M; Gauthier, R J; Lepage, L; Fraser, W; Polomeno, V

2001-04-03

Preterm labour occurs in about 10% of all pregnancies and is the most important cause of premature birth. Women with preterm labour are admitted to hospital to have the contractions stopped. Thereafter, many women remain in hospital until delivery. We conducted a randomized clinical trial to compare hospital care with home care of women who had been admitted to hospital for preterm labour. After they had received treatment for an acute episode of premature labour, women at 2 regional perinatal centres associated with teaching hospitals were randomly assigned to home care or hospital care. Eligible women (n = 250) were aged 18 years or older, lived within 50 km of the hospital, had a gestational age between 20 and 35 weeks, had no prior preterm delivery and were experiencing their first episode of preterm labour and first admission to hospital for preterm labour. Analysis was by intention to treat. There were no significant differences between the 2 groups in mean gestational age at delivery (home: 37.52 weeks, hospital: 37.50 weeks) or in mean birth weight (home: 2974 g, hospital: 3020 g). There were no significant differences between the 2 groups with respect to the proportions of babies born before term or the mean duration of neonatal hospital stay, neonatal intensive care unit stay and intermediate care nursery stay. The mean duration of the first stay in hospital for the women in the home group (3.8 days) was significantly shorter than the mean duration for women in the hospital group (6.1 days). In addition, the mean duration of all maternal stays in hospital was significantly shorter for the women in the home group (3.7 days) than in the hospital group (5.0 days). Home care management is an efficient and acceptable alternative to hospital care for women experiencing preterm labour.

Induction of labour for improving birth outcomes for women at or beyond term

PubMed Central

Gülmezoglu, A Metin; Crowther, Caroline A; Middleton, Philippa; Heatley, Emer

2014-01-01

Background As a pregnancy continues beyond term the risks of babies dying inside the womb or in the immediate newborn period increase. Whether a policy of labour induction at a predetermined gestational age can reduce this increased risk is the subject of this review. Objectives To evaluate the benefits and harms of a policy of labour induction at term or post-term compared with awaiting spontaneous labour or later induction of labour. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (31 March 2012). Selection criteria Randomised controlled trials conducted in women at or beyond term. The eligible trials were those comparing a policy of labour induction with a policy of awaiting spontaneous onset of labour. Cluster-randomised trials and cross-over trials are not included. Quasi-random allocation schemes such as alternation, case record numbers or open random-number lists were not eligible. Data collection and analysis Two review authors independently assessed trials for inclusion. Two review authors independently assessed trial quality and extracted data. Data were checked for accuracy. Outcomes are analysed in two main categories: gestational age and cervix status. Main results We included 22 trials reporting on 9383 women. The trials were generally at moderate risk of bias. Compared with a policy of expectant management, a policy of labour induction was associated with fewer (all-cause) perinatal deaths: risk ratio (RR) 0.31, 95% confidence interval (CI) 0.12 to 0.88; 17 trials, 7407 women. There was one perinatal death in the labour induction policy group compared with 13 perinatal deaths in the expectant management group. The number needed to treat to benefit (NNTB) with induction of labour in order to prevent one perinatal death was 410 (95% CI 322 to 1492). For the primary outcome of perinatal death and most other outcomes, no differences between timing of induction subgroups were seen; the majority of trials adopted

Fetal electrocardiogram (ECG) for fetal monitoring during labour.

PubMed

Neilson, James P

2015-12-21

Hypoxaemia during labour can alter the shape of the fetal electrocardiogram (ECG) waveform, notably the relation of the PR to RR intervals, and elevation or depression of the ST segment. Technical systems have therefore been developed to monitor the fetal ECG during labour as an adjunct to continuous electronic fetal heart rate monitoring with the aim of improving fetal outcome and minimising unnecessary obstetric interference. To compare the effects of analysis of fetal ECG waveforms during labour with alternative methods of fetal monitoring. The Cochrane Pregnancy and Childbirth Group's Trials Register (latest search 23 September 2015) and reference lists of retrieved studies. Randomised trials comparing fetal ECG waveform analysis with alternative methods of fetal monitoring during labour. One review author independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. One review author assessed the quality of the evidence using the GRADE approach. Seven trials (27,403 women) were included: six trials of ST waveform analysis (26,446 women) and one trial of PR interval analysis (957 women). The trials were generally at low risk of bias for most domains and the quality of evidence for ST waveform analysis trials was graded moderate to high. In comparison to continuous electronic fetal heart rate monitoring alone, the use of adjunctive ST waveform analysis made no obvious difference to primary outcomes: births by caesarean section (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.96 to 1.08; six trials, 26,446 women; high quality evidence); the number of babies with severe metabolic acidosis at birth (cord arterial pH less than 7.05 and base deficit greater than 12 mmol/L) (average RR 0.72, 95% CI 0.43 to 1.20; six trials, 25,682 babies; moderate quality evidence); or babies with neonatal encephalopathy (RR 0.61, 95% CI 0.30 to 1.22; six trials, 26,410 babies; high quality evidence). There were, however, on average

Relaxation techniques for pain management in labour.

PubMed

Smith, Caroline A; Levett, Kate M; Collins, Carmel T; Armour, Mike; Dahlen, Hannah G; Suganuma, Machiko

2018-03-28

Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute to the popularity of complementary methods of pain management. This review examined currently available evidence on the use of relaxation therapies for pain management in labour. This is an update of a review first published in 2011. To examine the effects of mind-body relaxation techniques for pain management in labour on maternal and neonatal well-being during and after labour. We searched Cochrane Pregnancy and Childbirth's Trials Register (9 May 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 5 2017), MEDLINE (1966 to 24 May 2017), CINAHL (1980 to 24 May 2017), the Australian New Zealand Clinical Trials Registry (18 May 2017), ClinicalTrials.gov (18 May 2017), the ISRCTN Register (18 May 2017), the WHO International Clinical Trials Registry Platform (ICTRP) (18 May 2017), and reference lists of retrieved studies. Randomised controlled trials (including quasi randomised and cluster trials) comparing relaxation methods with standard care, no treatment, other non-pharmacological forms of pain management in labour or placebo. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We attempted to contact study authors for additional information. We assessed evidence quality with GRADE methodology. This review update includes 19 studies (2519 women), 15 of which (1731 women) contribute data. Interventions examined included relaxation, yoga, music and mindfulness. Approximately half of the studies had a low risk of bias for random sequence generation and attrition bias. The majority of studies had a high risk of bias for performance and detection bias, and unclear risk of bias for, allocation concealment, reporting bias and other bias. We assessed the evidence from these studies as ranging from low to very low quality, and

Use of wind-up fetal Doppler versus Pinard for fetal heart rate intermittent monitoring in labour: a randomised clinical trial.

PubMed

Byaruhanga, R; Bassani, D G; Jagau, A; Muwanguzi, P; Montgomery, A L; Lawn, J E

2015-01-30

In resource-poor settings, the standard of care to inform labour management is the partograph plus Pinard stethoscope for intermittent fetal heart rate (FHR) monitoring. We compared FHR monitoring in labour using a novel, robust wind-up handheld Doppler with the Pinard as a primary screening tool for abnormal FHR on perinatal outcomes. Prospective equally randomised clinical trial. The labour and delivery unit of a teaching hospital in Kampala, Uganda. Of the 2042 eligible antenatal women, 1971 women in active term labour, following uncomplicated pregnancies, were randomised to either the standard of care or not. Intermittent FHR monitoring using Doppler. Incidence of FHR abnormality detection, intrapartum stillbirth and neonatal mortality prior to discharge. Age, parity, gestational age, mode of delivery and newborn weight were similar between study groups. In the Doppler group, there was a significantly higher rate of FHR abnormalities detected (incidence rate ratio (IRR)=1.61, 95% CI 1.13 to 2.30). However, in this group, there were also higher though not statistically significant rates of intrapartum stillbirths (IRR=3.94, 0.44 to 35.24) and neonatal deaths (IRR=1.38, 0.44 to 4.34). Routine monitoring with a handheld Doppler increased the identification of FHR abnormalities in labour; however, our trial did not find evidence that this leads to a decrease in the incidence of intrapartum stillbirth or neonatal death. Clinical Trails.gov (1000031587). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2).

PubMed

Bullens, Lauren M; Hulsenboom, Alexandra D J; Moors, Suzanne; Joshi, Rohan; van Runnard Heimel, Pieter J; van der Hout-van der Jagt, M Beatrijs; van den Heuvel, Edwin R; Guid Oei, S

2018-03-23

Perinatal asphyxia is, even in developed countries, one the major causes of neonatal morbidity and mortality. Therefore, if foetal distress during labour is suspected, one should try to restore foetal oxygen levels or aim for immediate delivery. However, studies on the effect of intrauterine resuscitation during labour are scarce. We designed a randomised controlled trial to investigate the effect of maternal hyperoxygenation on the foetal condition. In this study, maternal hyperoxygenation is induced for the treatment of foetal distress during the second stage of term labour. This study is a single-centre randomised controlled trial being performed in a tertiary hospital in The Netherlands. From among cases of a suboptimal or abnormal foetal heart rate pattern during the second stage of term labour, a total of 116 patients will be randomised to the control group, where normal care is provided, or to the intervention group, where before normal care 100% oxygen is supplied to the mother by a non-rebreathing mask until delivery. The primary outcome is change in foetal heart rate pattern. Secondary outcomes are Apgar score, mode of delivery, admission to the neonatal intensive care unit and maternal side effects. In addition, blood gas values and malondialdehyde are determined in umbilical cord blood. This study will be the first randomised controlled trial to investigate the effect of maternal hyperoxygenation for foetal distress during labour. This intervention should be recommended only as a treatment for intrapartum foetal distress, when improvement of the foetal condition is likely and outweighs maternal and neonatal side effects. EudraCT, 2015-001654-15; registered on 3 April 2015. Dutch Trial Register, NTR5461; registered on 20 October 2015.

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.

Hypnosis for pain management during labour and childbirth.

PubMed

Madden, Kelly; Middleton, Philippa; Cyna, Allan M; Matthewson, Mandy; Jones, Leanne

2012-11-14

This review is one in a series of Cochrane Reviews investigating pain management for childbirth. These reviews all contribute to an overview of systematic reviews of pain management for women in labour, and share a generic protocol. We examined the current evidence regarding the use of hypnosis for pain management during labour and childbirth. This review updates the findings regarding hypnosis from an earlier review of complementary and alternative therapies for pain management in labour into a stand-alone review. To examine the effectiveness and safety of hypnosis for pain management during labour and childbirth. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (11 January 2012) and the reference lists of primary studies and review articles. Randomised controlled trials and quasi-randomised controlled trials comparing preparation for labour using hypnosis and/or use of hypnosis during labour, with or without concurrent use of pharmacological or non-pharmacological pain relief methods versus placebo, no treatment or any analgesic drug or technique. Two assessors independently extracted data and assessed trial quality. Where possible we contacted study authors seeking additional information about data and methodology. We included seven trials randomising a total of 1213 women. All but one of the trials were at moderate to high risk of bias. Although six of the seven trials assessed antenatal hypnotherapy, there were considerable differences between these trials in timing and technique. One trial provided hypnotherapy during labour. No significant differences between women in the hypnosis group and those in the control group were found for the primary outcomes: use of pharmacological pain relief (average risk ratio (RR) 0.63, 95% confidence interval (CI) 0.39 to 1.01, six studies, 1032 women), spontaneous vaginal birth (average RR 1.35, 95% CI 0.93 to 1.96, four studies, 472 women) or satisfaction with pain relief (RR 1.06, 95% CI 0.94 to 1

A translational approach to studying preterm labour

PubMed Central

Tribe, Rachel Marie

2007-01-01

Preterm labour continues to be a major contributor to neonatal and infant morbidity. Recent data from the USA indicate that the number of preterm deliveries (including those associated with preterm labour) has risen in the last 20 years by 30%. This increase is despite considerable efforts to introduce new therapies for the prevention and treatment of preterm labour and highlights the need to assess research in this area from a fresh perspective. In this paper we discuss i) the limitations of our knowledge concerning prediction, prevention and treatment of preterm labour and ii) future multidisciplinary strategies for improving our approach. PMID:17570168

Transcutaneous electrical nerve stimulation (TENS) reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial.

PubMed

Santana, Licia Santos; Gallo, Rubneide Barreto Silva; Ferreira, Cristine Homsi Jorge; Duarte, Geraldo; Quintana, Silvana Maria; Marcolin, Alessandra Cristina

2016-01-01

In the active phase of the first stage of labour, does transcutaneous electrical nerve stimulation (TENS) relieve pain or change its location? Does TENS delay the request for neuraxial analgesia during labour? Does TENS produce any harmful effects in the mother or the foetus? Are women in labour satisfied with the care provided? Randomised trial with concealed allocation, assessor blinding for some outcomes, and intention-to-treat analysis. Forty-six low-risk, primigravida parturients with a gestational age > 37 weeks, cervical dilation of 4cm, and without the use of any medications from hospital admission until randomisation. The principal investigator applied TENS to the experimental group for 30minutes starting at the beginning of the active phase of labour. A second investigator assessed the outcomes in both the control and experimental groups. Both groups received routine perinatal care. The primary outcome was pain severity after the intervention period, which was assessed using the 100-mm visual analogue scale. Secondary outcomes included: pain location, duration of the active phase of labour, time to pharmacological labour analgesia, mode of birth, neonatal outcomes, and the participant's satisfaction with the care provided. After the intervention, a significant mean difference in change in pain of 15mm was observed favouring the experimental group (95% CI 2 to 27). The application of TENS did not alter the location or distribution of the pain. The mean time to pharmacological analgesia after the intervention was 5.0hours (95% CI 4.1 to 5.9) longer in the experimental group. The intervention did not significantly impact the other maternal and neonatal outcomes. Participants in both groups were satisfied with the care provided during labour. TENS produces a significant decrease in pain during labour and postpones the need for pharmacological analgesia for pain relief. NCT01600495. Copyright © 2015. Published by Elsevier B.V.

Transcutaneous electrical nerve stimulation (TENS) for pain management in labour

PubMed Central

Dowswell, Therese; Bedwell, Carol; Lavender, Tina; Neilson, James P

2014-01-01

Background Transcutaneous nerve stimulation (TENS) has been proposed as a means of reducing pain in labour. The TENS unit emits low-voltage electrical impulses which vary in frequency and intensity. During labour, TENS electrodes are generally placed on the lower back, although TENS may be used to stimulate acupuncture points or other parts of the body. The physiological mechanisms whereby TENS relieves pain are uncertain. TENS machines are frequently operated by women, which may increase a sense of control in labour. Objectives To assess the effects of TENS on pain in labour. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 April 2011) and reference lists of retrieved papers. Selection criteria Randomised controlled trials comparing women receiving TENS for pain management in labour versus routine care, alternative non-pharmacological methods of pain relief, or placebo devices. We included all types of TENS machines. Data collection and analysis Two review authors assessed for inclusion all trials identified by the search strategy, carried out data extraction and assessed risk of bias. We have recorded reasons for excluding studies. Main results Seventeen trials with 1466 women contribute data to the review. Thirteen examined TENS applied to the back, two to acupuncture points, and two to the cranium. Overall, there was little difference in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (average risk ratio 0.41, 95% confidence interval 0.31 to 0.54; measured in two studies). The majority of women using TENS said they would be willing to use it again in a future labour. Where TENS was used as an adjunct to epidural analgesia there was no evidence that it reduced pain. There was no consistent evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and babies. No

Assessment and support during early labour for improving birth outcomes.

PubMed

Kobayashi, Shinobu; Hanada, Nobutsugu; Matsuzaki, Masayo; Takehara, Kenji; Ota, Erika; Sasaki, Hatoko; Nagata, Chie; Mori, Rintaro

2017-04-20

The progress of labour in the early or latent phase is usually slow and may include painful uterine contractions. Women may feel distressed and lose their confidence during this phase. Support and assessment interventions have been assessed in two previous Cochrane Reviews. This review updates and replaces these two reviews, which have become out of date. To investigate the effectiveness of assessment and support interventions for women during early labour.In order to measure the effectiveness of the interventions, we compared the duration of labour, the rate of obstetrical interventions, and the rate of other maternal or neonatal outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (31 October 2016) and reference lists of retrieved studies. Randomised controlled trials of any assessment or support intervention in the latent phase of labour. We planned to include cluster-randomised trials if they were eligible. We did not include quasi-randomised trials. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We resolved any disagreement by discussion or by involving a third assessor. The quality of the evidence was assessed using the GRADE approach. We included five trials with a total of 10,421 pregnant women in this review update. The trials were conducted in the UK, Canada and America. The trials compared interventions in early labour versus usual care. We examined three comparisons: early labour assessment versus immediate admission to hospital; home visits by midwives versus usual care (telephone triage); and one-to-one structured midwifery care versus usual care. These trials were at moderate- risk of bias mainly because blinding women and staff to these interventions is not generally feasible. For important outcomes we assessed evidence using

Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial.

PubMed

2017-04-29

Continuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usefulness. We aimed to establish whether the addition of decision-support software to assist in the interpretation of cardiotocographs affected the number of poor neonatal outcomes. In this unmasked randomised controlled trial, we recruited women in labour aged 16 years or older having continuous electronic fetal monitoring, with a singleton or twin pregnancy, and at 35 weeks' gestation or more at 24 maternity units in the UK and Ireland. They were randomly assigned (1:1) to decision support with the INFANT system or no decision support via a computer-generated stratified block randomisation schedule. The primary outcomes were poor neonatal outcome (intrapartum stillbirth or early neonatal death excluding lethal congenital anomalies, or neonatal encephalopathy, admission to the neonatal unit within 24 h for ≥48 h with evidence of feeding difficulties, respiratory illness, or encephalopathy with evidence of compromise at birth), and developmental assessment at age 2 years in a subset of surviving children. Analyses were done by intention to treat. This trial is completed and is registered with the ISRCTN Registry, number 98680152. Between Jan 6, 2010, and Aug 31, 2013, 47 062 women were randomly assigned (23 515 in the decision-support group and 23 547 in the no-decision-support group) and 46 042 were analysed (22 987 in the decision-support group and 23 055 in the no-decision-support group). We noted no difference in the incidence of poor neonatal outcome between the groups-172 (0·7%) babies in the decision-support group compared with 171 (0·7%) babies in the no-decision-support group (adjusted risk ratio 1·01, 95% CI 0·82-1·25). At 2 years, no significant differences were noted in terms of developmental assessment. Use of computerised interpretation of cardiotocographs in women who have continuous electronic fetal

Intravenous fluids for reducing the duration of labour in low risk nulliparous women.

PubMed

Dawood, Feroza; Dowswell, Therese; Quenby, Siobhan

2013-06-18

Several factors may influence the progression of normal labour. It has been postulated that the routine administration of intravenous fluids to keep women adequately hydrated during labour may reduce the period of contraction and relaxation of the uterine muscle, and may ultimately reduce the duration of the labour. It has also been suggested that intravenous fluids may reduce caesarean sections (CS) for prolonged labour. However, the routine administration of intravenous fluids to labouring women has not been adequately elucidated although it is a widely-adopted policy, and there is no consensus on the type or volume of fluids that are required, or indeed, whether intravenous fluids are at all necessary. Women may be able to adequately hydrate themselves if they were allowed oral fluids during labour.Furthermore, excessive volumes of intravenous fluids may pose risks to both the mother and her newborn and different fluids are associated with different risks. To evaluate whether the routine administration of intravenous fluids to low-risk nulliparous labouring women reduces the duration of labour and to evaluate the safety of intravenous fluids on maternal and neonatal health. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (13 February 2013). Randomised controlled trials of intravenous fluid administration to spontaneously labouring low-risk nulliparous women. The review authors independently assessed trials for inclusion, trial quality and extracted data. We included nine randomised trials with 1781 women. Three trials had more than two treatment arms and were included in more than one comparison.Two trials compared women randomised to receive up to 250 mL/hour of Ringer's lactate solution as well as oral intake versus oral intake only. For women delivering vaginally, there was a reduction in the duration of labour in the Ringer's lactate group (mean difference (MD) -28.86 minutes, 95% confidence interval (CI) -47.41 to -10.30). There

Acupuncture or acupressure for induction of labour.

PubMed

Smith, Caroline A; Armour, Mike; Dahlen, Hannah G

2017-10-17

This is one of a series of reviews of methods of cervical ripening and labour induction. The use of complementary therapies is increasing. Women may look to complementary therapies during pregnancy and childbirth to be used alongside conventional medical practice. Acupuncture involves the insertion of very fine needles into specific points of the body. Acupressure is using the thumbs or fingers to apply pressure to specific points. The limited observational studies to date suggest acupuncture for induction of labour has no known adverse effects to the fetus, and may be effective. However, the evidence regarding the clinical effectiveness of this technique is limited. To determine, from the best available evidence, the effectiveness and safety of acupuncture and acupressure for third trimester cervical ripening or induction of labour. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2016), PubMed (1966 to 25 November 2016), ProQuest Dissertations & Theses (25 November 2016), CINAHL (25 November 2016), Embase (25 November 2016), the WHO International Clinical Trials Registry Portal (ICTRP) (3 October 2016), and bibliographies of relevant papers. Randomised controlled trials comparing acupuncture or acupressure, used for third trimester cervical ripening or labour induction, with placebo/no treatment or other methods on a predefined list of labour induction methods. Two review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked them for accuracy. The quality of the evidence was assessed using GRADE. This updated review includes 22 trials, reporting on 3456 women. The trials using manual or electro-acupuncture were compared with usual care (eight trials, 760 women), sweeping of membranes (one trial, 207 women), or sham controls (seven trials, 729 women). Trials using acupressure were compared with usual care (two trials, 151 women) or sham controls (two trials, 239 women). Many studies

Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour.

PubMed

Dowswell, Therese; Bedwell, Carol; Lavender, Tina; Neilson, James P

2009-04-15

Transcutaneous nerve stimulation (TENS) has been proposed as a means of reducing pain in labour. The TENS unit emits low-voltage electrical impulses which vary in frequency and intensity. During labour, TENS electrodes are generally placed on the lower back, although TENS may be used to stimulate acupuncture points or other parts of the body. The physiological mechanisms whereby TENS relieves pain are uncertain. The TENS unit is frequently operated by women, which may increase sense of control in labour. To assess the effects of TENS on pain in labour. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (November 2008). Randomised controlled trials comparing women receiving TENS for pain relief in labour versus routine care, alternative pharmacological methods of pain relief, or placebo devices. We included all types of TENS machines. Two review authors assessed for inclusion all trials identified by the search strategy, carried out data extraction and assessed risk of bias. We have recorded reasons for excluding studies. The search identified 25 studies; we excluded six and included 19 studies including 1671 women. Fifteen examined TENS applied to the back, two to acupuncture points and two to the cranium. Overall, there was little difference in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (risk ratio 0.41, 95% confidence interval 0.32 to 0.55). The majority of women using TENS said they would be willing to use it again in a future labour. Where TENS was used as an adjunct to epidural analgesia there was no evidence that it reduced pain. There was no consistent evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and babies. No adverse events were reported. There is only limited evidence that TENS reduces pain in labour and it does not seem to have any impact (either positive or

Randomised controlled trial of oxytocin alone versus oxytocin and ergometrine in active management of third stage of labour.

PubMed Central

McDonald, S J; Prendiville, W J; Blair, E

1993-01-01

OBJECTIVE--To compare intramuscular oxytocin alone and intramuscular oxytocin with ergometrine (Syntometrine) for their effect in reducing the risk of postpartum haemorrhage when both are used as part of the active management of the third stage of labour. DESIGN--Double blind, randomised controlled trial. SETTING--Two metropolitan teaching hospitals in Perth, Western Australia. SUBJECTS--All women who expected a vaginal birth during the period of the trial. Informed consent was obtained. MAIN OUTCOME MEASURES--Postpartum haemorrhage, nausea, vomiting, and increased blood pressure. RESULTS--3497 women were randomly allocated to receive oxytocin-ergometrine (n = 1730) or oxytocin (n = 1753). Rates of postpartum haemorrhage (> or = 500 ml or > or = 1000 ml) were similar in both arms (odds ratio 0.90 (0.82); 95% confidence interval 0.75 to 1.07 (0.59 to 1.14) at 500 ml (1000 ml) threshold). The use of oxytocin-ergometrine was associated with nausea, vomiting, and increased blood pressure. CONCLUSIONS--There are few advantages but several disadvantages for the routine use of oxytoxinergometrine when prophylactic active management of the third stage of labour is practised. Further investigation of dose-response for oxytocin may be warranted. PMID:8251842

The Complementary Therapies for Labour and Birth Study making sense of labour and birth - Experiences of women, partners and midwives of a complementary medicine antenatal education course.

PubMed

Levett, K M; Smith, C A; Bensoussan, A; Dahlen, H G

2016-09-01

to gain insight into the experiences of women, partners and midwives who participated in the Complementary Therapies for Labour and Birth Study, an evidence based complementary medicine (CM) antenatal education course. qualitative in-depth interviews and a focus group as part of the Complementary Therapies for Labour and Birth Study. thirteen low risk primiparous women and seven partners who had participated in the study group of a randomised controlled trial of the complementary therapies for labour and birth study, and 12 midwives caring for these women. The trial was conducted at two public hospitals, and through the Western Sydney University in Sydney, Australia. the Complementary Therapies for Labour and Birth (CTLB) protocol, based on the She Births® course and the Acupressure for labour and birth protocol, incorporated six evidence-based complementary medicine (CM) techniques; acupressure, relaxation, visualisation, breathing, massage, yoga techniques and incorporated facilitated partner support. Randomisation to the trial occurred at 24-36 weeks' gestation, and participants attended a two-day antenatal education programme, plus standard care, or standard care alone. the overarching theme identified in the qualitative data was making sense of labour and birth. Women used information about normal birth physiology from the course to make sense of labour, and to utilise the CM techniques to support normal birth and reduce interventions in labour. Women's, partners' and midwives' experience of the course and its use during birth gave rise to supporting themes such as: working for normal; having a toolkit; and finding what works. the Complementary Therapies for Labour and Birth Study provided women and their partners with knowledge to understand the physiology of normal labour and birth and enabled them to use evidence-based CM tools to support birth and reduce interventions. the Complementary Therapies for Labour and Birth Study introduces concepts of what

Elective repeat caesarean section versus induction of labour for women with a previous caesarean birth.

PubMed

Dodd, Jodie M; Crowther, Caroline A; Grivell, Rosalie M; Deussen, Andrea R

2014-12-19

When a woman has had a previous caesarean birth and requires induction of labour in a subsequent pregnancy there are two options for her care, an elective repeat caesarean or planned induction of labour. While there are risks and benefits for both elective repeat caesarean birth and planned induction of labour, current sources of information are limited to non-randomised cohort studies. Studies designed in this way have significant potential for bias and consequently any conclusions based on these results are limited in their reliability and should be interpreted with caution. To assess, using the best available evidence, the benefits and harms of elective repeat caesarean section and planned induction of labour for women with a previous caesarean birth, who require induction of labour in a subsequent pregnancy. We searched the Cochrane Pregnancy and Childbirth Group Trials Register (31 October 2014). Randomised controlled trials with reported data that compared outcomes in mothers and babies for women who planned an elective repeat caesarean section with outcomes in women who planned induction of labour, where a previous birth had been by caesarean. There was no data extraction performed. There were no randomised controlled trials identified. Both planned elective repeat caesarean section and planned induction of labour for women with a prior caesarean birth are associated with benefits and harms. Evidence for these care practices is drawn from non-randomised studies that are associated with potential bias. Any results and conclusions must therefore be interpreted with caution. Randomised controlled trials are required to provide the most reliable evidence regarding the benefits and harms of both planned elective repeat caesarean section and planned induction of labour for women with a previous caesarean birth.

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

PubMed

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

2003-05-01

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

Parenteral opioids for maternal pain management in labour.

PubMed

Smith, Lesley A; Burns, Ethel; Cuthbert, Anna

2018-06-05

Parenteral opioids (intramuscular and intravenous drugs including patient-controlled analgesia) are used for pain relief in labour in many countries throughout the world. This review is an update of a review first published in 2010. To assess the effectiveness, safety and acceptability to women of different types, doses and modes of administration of parenteral opioid analgesia in labour. A second objective is to assess the effects of opioids in labour on the baby in terms of safety, condition at birth and early feeding. We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (11 May 2017) and reference lists of retrieved studies. We included randomised controlled trials examining the use of intramuscular or intravenous opioids (including patient-controlled analgesia) for women in labour. Cluster-randomised trials were also eligible for inclusion, although none were identified. We did not include quasi-randomised trials. We looked at studies comparing an opioid with another opioid, placebo, no treatment, other non-pharmacological interventions (transcutaneous electrical nerve stimulation (TENS)) or inhaled analgesia. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of each evidence synthesis using the GRADE approach. We included 70 studies that compared an opioid with placebo or no treatment, another opioid administered intramuscularly or intravenously or compared with TENS applied to the back. Sixty-one studies involving more than 8000 women contributed data to the review and these studies reported on 34 different comparisons; for many comparisons and outcomes only one study contributed data. All of the studies were conducted in hospital settings, on healthy women with uncomplicated pregnancies at 37 to 42 weeks' gestation. We excluded studies focusing on women with pre

Upright versus lying down position in second stage of labour in nulliparous women with low dose epidural: BUMPES randomised controlled trial.

PubMed

2017-10-18

Objective  To determine whether being upright in the second stage of labour in nulliparous women with a low dose epidural increases the chance of spontaneous vaginal birth compared with lying down. Design  Multicentre pragmatic individually randomised controlled trial. Setting  41 UK hospital labour wards. Participants  3093 nulliparous women aged 16 or older, at term with a singleton cephalic presentation and in the second stage of labour with epidural analgesia. Interventions  Women were allocated to an upright or lying down position, using a secure web based randomisation service, stratified by centre, with no masking of participants or clinicians to the trial interventions. Main outcome measures  The primary outcome was spontaneous vaginal birth. Women were analysed in the groups into which they were randomly allocated, regardless of position recorded at any time during the second stage of labour (excluding women with no valid consent, who withdrew, or who did not reach second stage before delivery). Secondary outcomes included mode of birth, perineal trauma, infant Apgar score <4 at five minutes, admission to a neonatal unit, and longer term included maternal physical and psychological health, incontinence, and infant gross developmental delay. Results  Between 4 October 2010 and 31 January 2014, 3236 women were randomised and 3093 (95.6%) included in the primary analysis (1556 in the upright group and 1537 in the lying down group). Significantly fewer spontaneous vaginal births occurred in women in the upright group: 35.2% (548/1556) compared with 41.1% (632/1537) in the lying down group (adjusted risk ratio 0.86, 95% confidence interval 0.78 to 0.94). This represents a 5.9% absolute increase in the chance of spontaneous vaginal birth in the lying down group (number needed to treat 17, 95% confidence interval 11 to 40). No evidence of differences was found for most of the secondary maternal, neonatal, or longer term outcomes including instrumental

Reducing stillbirths: interventions during labour

PubMed Central

Darmstadt, Gary L; Yakoob, Mohammad Yawar; Haws, Rachel A; Menezes, Esme V; Soomro, Tanya; Bhutta, Zulfiqar A

2009-01-01

Background Approximately one million stillbirths occur annually during labour; most of these stillbirths occur in low and middle-income countries and are associated with absent, inadequate, or delayed obstetric care. The low proportion of intrapartum stillbirths in high-income countries suggests that intrapartum stillbirths are largely preventable with quality intrapartum care, including prompt recognition and management of intrapartum complications. The evidence for impact of intrapartum interventions on stillbirth and perinatal mortality outcomes has not yet been systematically examined. Methods We undertook a systematic review of the published literature, searching PubMed and the Cochrane Library, of trials and reviews (N = 230) that reported stillbirth or perinatal mortality outcomes for eight interventions delivered during labour. Where eligible randomised controlled trials had been published after the most recent Cochrane review on any given intervention, we incorporated these new trial findings into a new meta-analysis with the Cochrane included studies. Results We found a paucity of studies reporting statistically significant evidence of impact on perinatal mortality, especially on stillbirths. Available evidence suggests that operative delivery, especially Caesarean section, contributes to decreased stillbirth rates. Induction of labour rather than expectant management in post-term pregnancies showed strong evidence of impact, though there was not enough evidence to suggest superior safety for the fetus of any given drug or drugs for induction of labour. Planned Caesarean section for term breech presentation has been shown in a large randomised trial to reduce stillbirths, but the feasibility and consequences of implementing this intervention routinely in low-/middle-income countries add caveats to recommending its use. Magnesium sulphate for pre-eclampsia and eclampsia is effective in preventing eclamptic seizures, but studies have not demonstrated impact

Prolonging the duration of single-shot intrathecal labour analgesia with morphine: A systematic review.

PubMed

Al-Kazwini, Hadeel; Sandven, Irene; Dahl, Vegard; Rosseland, Leiv Arne

2016-10-01

Single-shot spinal with bupivacaine plus fentanyl or sufentanil is commonly used as analgesia during labour, but the short duration limits the clinical feasibility. Different drugs have been added to prolong the analgesic duration. The additional effect of intra-thecal morphine has been studied during labour pain as well as after surgery. We assessed whether adding morphine to intra-thecal bupivacaine+fentanyl or sufentanil prolongs pain relief during labour. Meta-analysis of placebo-controlled randomized clinical trials of analgesia prolongation after single-shot intrathecal morphine ≤250μg during labour when given in combination with bupivacaine+fentanyl or sufentanil. After identifying 461 references, 24 eligible studies were evaluated after excluding duplicate publications, case reports, studies of analgesia after caesarean delivery, and epidural labour analgesia. Mean duration in minutes was the primary outcome measure and was included in the calculation of the standardized mean difference. Duration was defined as the time between a single shot spinal until patient request of rescue analgesia. All reported side effects were registered. Results of individual trials were combined using a random effect model. Cochrane tool was used to assess risk of bias. Five randomized placebo-controlled clinical trials (286 patients) were included in the meta-analysis. A dose of 50-250μg intrathecal morphine prolonged labour analgesia by a mean of 60.6min (range 3-155min). Adding morphine demonstrated a medium beneficial effect as we found a pooled effect of standardized mean difference=0.57 (95% CI: -0.10 to 1.24) with high heterogeneity (I 2 =88.1%). However, the beneficial effect was statistically non-significant (z=1.66, p=0.096). The lower-bias trials showed a small statistically non-significant beneficial effect with lower heterogeneity. In influential analysis, that excluded one study at a time from the meta-analysis, the effect size appears unstable and the results

Protocol for a randomised controlled trial of fetal scalp blood lactate measurement to reduce caesarean sections during labour: the Flamingo trial [ACTRN12611000172909].

PubMed

East, Christine E; Kane, Stefan C; Davey, Mary-Ann; Kamlin, C Omar; Brennecke, Shaun P

2015-11-03

The rate of caesarean sections around the world is rising each year, reaching epidemic proportions. Although many caesarean sections are performed for concerns about fetal welfare on the basis of abnormal cardiotocography, the majority of babies are shown to be well at birth, meaning that the operation, with its inherent short and long term risks, could have been avoided without compromising the baby's health. Previously, fetal scalp blood sampling for pH estimation was performed in the context of an abnormal cardiotocograph, to improve the identification of babies in need of expedited delivery. This test has largely been replaced by lactate measurement, although its validity is yet to be established through a randomised controlled trial. This study aims to test the hypothesis that the performance of fetal scalp blood lactate measurement for women in labour with an abnormal cardiotocograph will reduce the rate of birth by caesarean section from 38 % to 25 % (a 35 % relative reduction). Prospective unblinded randomised controlled trial conducted at a single tertiary perinatal centre. Women labouring with a singleton fetus in cephalic presentation at 37 or more weeks' gestation with ruptured membranes and with an abnormal cardiotocograph will be eligible. Participants will be randomised to one of two groups: fetal monitoring by cardiotocography alone, or cardiotocography augmented by fetal scalp blood lactate analysis. Decisions regarding the timing and mode of delivery will be made by the treating team, in accordance with hospital protocols. The primary study endpoint is caesarean section with secondary outcomes collected from maternal, fetal and neonatal clinical course and morbidities. A cost effectiveness analysis will also be performed. A sample size of 600 will provide 90 % power to detect the hypothesised difference in the proportion of women who give birth by caesarean section. This world-first trial is adequately powered to determine the impact of fetal

Randomised trial of amnioinfusion during labour with meconium stained amniotic fluid.

PubMed

Rathor, Asmita Muthal; Singh, Ruchira; Ramji, S; Tripathi, Reva

2002-01-01

To assess the effect of amnioinfusion during labour with meconium stained amniotic fluid on caesarean section rate and perinatal outcome. Prospective randomised controlled study. A tertiary care teaching hospital in India. Women in labour at term with meconium stained amniotic fluid. Two hundred women in labour with > or = 37 weeks gestation, single cephalic presentation with moderate or thick meconium were randomised to control and amnioinfusion groups at a 1:1 ratio. Amnioinfusion was performed using 500 mL of normal saline over a period of 30 minutes in a study group. The control group received routine care. Both groups had intermittent auscultation of fetal heart rate during labour. The primary outcome measure was caesarean section rate. Secondary outcome measures were meconium aspiration syndrome, 1 minute and 5 minute apgar < 7, hypoxic ischaemic encephalopathy, neonatal intensive care unit admission, meconium at the level of vocal cords. The caesarean section rate in the amnioinfusion group was less than the control group (RR 0.47; 95% CI 0.24-0.93). Amnioinfusion was associated with a significant decrease in the incidence of meconium at the vocal cords (P = 0.001); improvement in 1 minute apgar scores (P < 0.05), respiratory distress (P = 0.002) and fewer admissions to nursery compared with the controls. This sample size was inadequate to study the impact on meconium aspiration syndrome. Amnioinfusion in an under resourced labour ward decreases caesarean section rates and fetal morbidity.

Hypnosis for pain management during labour and childbirth.

PubMed

Madden, Kelly; Middleton, Philippa; Cyna, Allan M; Matthewson, Mandy; Jones, Leanne

2016-05-19

This review is one in a series of Cochrane reviews investigating pain management for childbirth. These reviews all contribute to an overview of systematic reviews of pain management for women in labour, and share a generic protocol. This review updates an earlier version of the review of the same title. To examine the effectiveness and safety of hypnosis for pain management during labour and childbirth. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2015) and the reference lists of primary studies and review articles. Randomised controlled trials (RCTs) and quasi-RCTS comparing preparation for labour using hypnosis and/or use of hypnosis during labour, with or without concurrent use of pharmacological or non-pharmacological pain relief methods versus placebo, no treatment or any analgesic drug or technique. Two review authors independently extracted data and assessed trial quality. Where possible we contacted study authors seeking additional information about data and methodology. We included nine trials randomising a total of 2954 women. The risk of bias in trials was variable, there were several well-designed large trials and some trials where little was reported about trial design. Although eight of the nine trials assessed antenatal hypnotherapy, there were considerable differences between these trials in timing and technique. One trial provided hypnotherapy during labour. In this updated review we compared hypnosis interventions with all control groups (main comparison) and also with specific control conditions: standard care (nine RCTs), supportive counselling (two RCTs) and relaxation training (two RCTs).In the main comparison, women in the hypnosis group were less likely to use pharmacological pain relief or analgesia than those in the control groups, (average risk ratio (RR) 0.73, 95% CI 0.57 to 0.94, eight studies, 2916 women; very low-quality evidence; random-effects model). There were no clear differences between

Phase-II trials in osteosarcoma recurrences: A systematic review of past experience.

PubMed

Omer, Natacha; Le Deley, Marie-Cécile; Piperno-Neumann, Sophie; Marec-Berard, Perrine; Italiano, Antoine; Corradini, Nadège; Bellera, Carine; Brugières, Laurence; Gaspar, Nathalie

2017-04-01

The most appropriate design of Phase-II trials evaluating new therapies in osteosarcoma remains poorly defined. To study consistency in phase-II clinical trials evaluating new therapies for osteosarcoma recurrences with respect to eligibility criteria, response assessment, end-points, statistical design and reported results. Systematic review of clinical trials registered on clinicaltrials.gov, clinicaltrialsregister.eu and French National Cancer Institute website or referenced in PubMed and American Society of Clinical Oncology websites, between 2003 and 2016, using the following criteria: (osteosarcoma OR bone sarcoma) AND (Phase-II). Among the 99 trials identified, 80 were Phase-II, 17 I/II and 2 II/III, evaluating mostly targeted therapy (n = 40), and chemotherapy alone (n = 26). Results were fully (n = 28) or partially (abstract, n = 6) published. Twenty-four trials were dedicated to osteosarcoma, 22 had an osteosarcoma stratum. Twenty-eight out of 99 trials refer to the age range observed at recurrence (28%). Overall, 65 trials were run in multicentre settings, including 17 international trials. Only 9 trials were randomised. The primary end-point was tumour response in 71 trials (response rate, n = 40 or best response, n = 31), with various definitions (complete + partial ± minor response and stable disease), mainly evaluated with RECIST criteria (n = 69); it was progression-free survival in 24 trials and OS in 3. In single-arm trials evaluating response rate, the null hypothesis tested (when available, n = 12) varied from 5% to 25%. No robust historical data can currently be derived from past efficacy Phase-II trials. There is an urgent need to develop international randomised Phase-II trials across all age ranges with standardised primary end-point. Copyright © 2017 Elsevier Ltd. All rights reserved.

Maternal positions and mobility during first stage labour

PubMed Central

Lawrence, Annemarie; Lewis, Lucy; Hofmeyr, G Justus; Dowswell, Therese; Styles, Cathy

2014-01-01

Background It is more common for women in the developed world, and those in low-income countries giving birth in health facilities, to labour in bed. There is no evidence that this is associated with any advantage for women or babies, although it may be more convenient for staff. Observational studies have suggested that if women lie on their backs during labour this may have adverse effects on uterine contractions and impede progress in labour. Objectives The purpose of the review is to assess the effects of encouraging women to assume different upright positions (including walking, sitting, standing and kneeling) versus recumbent positions (supine, semi-recumbent and lateral) for women in the first stage of labour on length of labour, type of delivery and other important outcomes for mothers and babies. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (November 2008). Selection criteria Randomised and quasi-randomised trials comparing women randomised to upright versus recumbent positions in the first stage of labour. Data collection and analysis We used methods described in the Cochrane Handbook for Systematic Reviews of Interventions for carrying out data collection, assessing study quality and analysing results. A minimum of two review authors independently assessed each study. Main results The review includes 21 studies with a total of 3706 women. Overall, the first stage of labour was approximately one hour shorter for women randomised to upright as opposed to recumbent positions (MD −0.99, 95% CI −1.60 to −0.39). Women randomised to upright positions were less likely to have epidural analgesia (RR 0.83 95% CI 0.72 to 0.96).There were no differences between groups for other outcomes including length of the second stage of labour, mode of delivery, or other outcomes related to the wellbeing of mothers and babies. For women who had epidural analgesia there were no differences between those randomised to upright

Women's experiences of outpatient induction of labour with remote continuous monitoring.

PubMed

O'Brien, Ediri; Rauf, Zubair; Alfirevic, Zarko; Lavender, Tina

2013-04-01

to gain insight into women's experiences and preferences for induction in the home as part of a trial investigating the feasibility and acceptability of outpatient induction of labour with remote monitoring. a qualitative study using semi-structured individual interviews. Interview transcripts were subjected to thematic analysis to identify the dominant themes regarding women's experiences of outpatient induction. a large maternity hospital in the North West of England. fifteen women who participated in the main trial of outpatient induction of labour with remote continuous monitoring. three main themes were identified; the need for women to 'labour within their comfort zone'; their desire to achieve 'the next best thing to a normal labour' and the importance of a 'virtual presence' to offer remote reassurance. women's preference for the outpatient setting of induction of labour is dominated by their need to labour within their comfort zone. Outpatient induction offered women the familiarity and freedom of the home environment, and the resulting physical and emotional comforts helped women cope better with their labour and improved their birth experiences. While remote monitoring offered some reassurance, women still depended on effective communication from hospital staff to provide the virtual presence of a health professional in the home. the combination of slow-release prostaglandin and a remote monitoring device may provide low risk women with an improved induction and labour experience. While ongoing studies continue to explore further the safety of interventions at home, this study has importantly considered women's views and confirmed that induction at home is not only acceptable to women but also that the outpatient experience is preferable to long inpatient inductions. Copyright © 2012 Elsevier Ltd. All rights reserved.

Single-arm phase II trial design under parametric cure models.

PubMed

Wu, Jianrong

2015-01-01

The current practice of designing single-arm phase II survival trials is limited under the exponential model. Trial design under the exponential model may not be appropriate when a portion of patients are cured. There is no literature available for designing single-arm phase II trials under the parametric cure model. In this paper, a test statistic is proposed, and a sample size formula is derived for designing single-arm phase II trials under a class of parametric cure models. Extensive simulations showed that the proposed test and sample size formula perform very well under different scenarios. Copyright © 2015 John Wiley & Sons, Ltd.

Outpatient versus inpatient induction of labour for improving birth outcomes.

PubMed

Kelly, Anthony J; Alfirevic, Zarko; Ghosh, Arpita

2013-11-12

More than 20% of women undergo induction of labour in some countries. The different methods used to induce labour have been the focus of previous reviews, but the setting in which induction takes place (hospital versus outpatient settings) may have implications for maternal satisfaction and costs. It is not known whether some methods of induction that are effective and safe in hospital are suitable in outpatient settings. To assess the effects on outcomes for mothers and babies of induction of labour for women managed as outpatients versus inpatients. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2013). Published and unpublished randomised and quasi-randomised trials in which inpatient and outpatient methods of cervical ripening or induction of labour have been compared. Two review authors independently assessed trial reports for inclusion. Two review authors carried out data extraction and assessment of risk of bias independently. We included four trials, with a combined total of 1439 women in the review; each trial examined a different method of induction and we were unable to pool the results from trials.1. Vaginal PGE2 (two studies including 1028 women). There were no differences between women managed as outpatients versus inpatients for most review outcomes. There was no evidence of a difference between the likelihood of women requiring instrumental delivery in either setting (risk ratio (RR) 1.29; 95% confidence interval (CI) 0.79 to 2.13). The overall length of hospital stay was similar in the two groups.2. Controlled release PGE2 10 mg (one study including 300 women). There was no evidence of differences between groups for most review outcomes, including success of induction. During the induction period itself, women in the outpatient group were more likely to report high levels of satisfaction with their care (satisfaction rated seven or more on a nine-point scale, RR 1.42; 95% CI 1.11 to 1.81), but satisfaction scores

Early versus late initiation of epidural analgesia for labour.

PubMed

Sng, Ban Leong; Leong, Wan Ling; Zeng, Yanzhi; Siddiqui, Fahad Javaid; Assam, Pryseley N; Lim, Yvonne; Chan, Edwin S Y; Sia, Alex T

2014-10-09

Pain during childbirth is arguably the most severe pain some women may experience in their lifetime. Epidural analgesia is an effective form of pain relief during labour. Many women have concerns regarding its safety. Furthermore, epidural services and anaesthetic support may not be available consistently across all centres. Observational data suggest that early initiation of epidural may be associated with an increased risk of caesarean section, but the same findings were not seen in recent randomised controlled trials. More recent guidelines suggest that in the absence of a medical contraindication, maternal request is a sufficient medical indication for pain relief during labour. The choice of analgesic technique, agent, and dosage is based on many factors, including patient preference, medical status, and contraindications. There is no systematically reviewed evidence on the maternal and foetal outcomes and safety of this practice. This systematic review aimed to summarise the effectiveness and safety of early initiation versus late initiation of epidural analgesia in women. We considered the obstetric and fetal outcomes relevant to women and side effects of the treatments, including risk of caesarean section, instrumental birth and time to birth. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (12 February 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 1), MEDLINE (January 1966 to February 2014), Embase (January 1980 to February 2014) and reference lists of retrieved studies. We included all randomised controlled trials involving women undergoing epidural labour analgesia that compared early initiation versus late initiation of epidural labour analgesia. Two review authors independently assessed trials for inclusion, extracted the data and assessed the trial quality. Data were checked for accuracy. We included nine studies with a total of 15,752 women.The overall risk of bias of

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

Prophylactic versus therapeutic amnioinfusion for oligohydramnios in labour.

PubMed

Hofmeyr, G J

2000-01-01

Amnioinfusion aims to relieve umbilical cord compression during labour by infusing a liquid into the uterine cavity. The objective of this review was to assess the effects of prophylactic amnioinfusion for oligohydramnios compared with therapeutic amnioinfusion only if fetal heart rate decelerations or thick meconium-staining of the liquor occur. The Cochrane Pregnancy and Childbirth Group trials register and Cochrane Controlled Trials Register were searched. Date of last search: October 1997. Randomised trials comparing prophylactic with therapeutic amnioinfusion in women with oligohydramnios but not fetal heart rate deceleration in labour. The reviewer assessed trial quality and extracted data. Two studies of 285 women were included. No differences were found in the rate of caesarean section (relative risk 0.98, 95% confidence interval 0.58 to 1.66), or forceps delivery. There were no difference in Apgar scores, cord arterial pH, oxytocin augmentation, meconium aspiration, neonatal pneumonia or postpartum endometritis. Prophylactic amnioinfusion was associated with increased intrapartum fever (relative risk 3.48, 95% confidence interval 1.21 to 10.05). There appears to be no advantage of prophylactic amnioinfusion over therapeutic amnioinfusion carried out only when fetal heart rate decelerations or thick meconium-staining of the liquor occur.

Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations

PubMed Central

Butler, Javed; Hamo, Carine E.; Udelson, James E.; O’Connor, Christopher; Sabbah, Hani N.; Metra, Marco; Shah, Sanjiv J.; Kitzman, Dalane W.; Teerlink, John; Bernstein, Harold S.; Brooks, Gabriel; Depre, Christophe; DeSouza, Mary M.; Dinh, Wilfried; Donovan, Mark; Frische-Danielson, Regina; Frost, Robert J.; Garza, Dahlia; Gohring, Udo-Michael; Hellawell, Jennifer; Hsia, Judith; Ishihara, Shiro; Kay-Mugford, Patricia; Koglin, Joerg; Kozinn, Marc; Larson, Christopher J.; Mayo, Martha; Gan, Li-Ming; Mugnier, Pierrre; Mushonga, Sekayi; Roessig, Lothar; Russo, Cesare; Salsali, Afshin; Satler, Carol; Shi, Victor; Ticho, Barry; van der Laan, Michael; Yancy, Clyde; Stockbridge, Norman; Gheorghiade, Mihai

2017-01-01

The increasing burden and the continued suboptimal outcomes for patients with heart failure underlines the importance of continued research to develop novel therapeutics for this disorder. This can only be accomplished with successful translation of basic science discoveries into direct human application through effective clinical trial design and execution that results in a substantially improved clinical course and outcomes. In this respect, phase II clinical trials play a pivotal role in determining which of the multitude of potential basic science discoveries should move to the large and expansive registration trials in humans. A critical examination of the phase II trials in heart failure reveals multiple shortcomings in their concept, design, execution, and interpretation. To further a dialogue regarding the challenges and potential for improvement and the role of phase II trials in patients with heart failure, the Food and Drug Administration facilitated a meeting on October 17th 2016 represented by clinicians, researchers, industry members, and regulators. This document summarizes the discussion from this meeting and provides key recommendations for future directions. PMID:28356300

Prevention of preterm delivery with vaginal progesterone in women with preterm labour (4P): randomised double-blind placebo-controlled trial.

PubMed

Martinez de Tejada, B; Karolinski, A; Ocampo, M C; Laterra, C; Hösli, I; Fernández, D; Surbek, D; Huespe, M; Drack, G; Bunader, A; Rouillier, S; López de Degani, G; Seidenstein, E; Prentl, E; Antón, J; Krähenmann, F; Nowacki, D; Poncelas, M; Nassif, J C; Papera, R; Tuma, C; Espoile, R; Tiberio, O; Breccia, G; Messina, A; Peker, B; Schinner, E; Mol, B W; Kanterewicz, L; Wainer, V; Boulvain, M; Othenin-Girard, V; Bertolino, M V; Irion, O

2015-01-01

To evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour. Multicentre, randomised, double-blind, placebo-controlled trial. Twenty-nine centres in Switzerland and Argentina. A total of 385 women with preterm labour (24(0/7) to 33(6/7) weeks of gestation) treated with acute tocolysis. Participants were randomly allocated to either 200 mg daily of self-administered vaginal progesterone or placebo within 48 hours of starting acute tocolysis. Primary outcome was delivery before 37 weeks of gestation. Secondary outcomes were delivery before 32 and 34 weeks, adverse effects, duration of tocolysis, re-admissions for preterm labour, length of hospital stay, and neonatal morbidity and mortality. The study was ended prematurely based on results of the intermediate analysis. Preterm birth occurred in 42.5% of women in the progesterone group versus 35.5% in the placebo group (relative risk [RR] 1.2; 95% confidence interval [95% CI] 0.93-1.5). Delivery at <32 and <34 weeks did not differ between the two groups (12.9 versus 9.7%; [RR 1.3; 95% CI 0.7-2.5] and 19.7 versus 12.9% [RR 1.5; 95% CI 0.9-2.4], respectively). The duration of tocolysis, hospitalisation, and recurrence of preterm labour were comparable between groups. Neonatal morbidity occurred in 44 (22.8%) cases on progesterone versus 35 (18.8%) cases on placebo (RR: 1.2; 95% CI 0.82-1.8), whereas there were 4 (2%) neonatal deaths in each study group. There is no evidence that the daily administration of 200 mg vaginal progesterone decreases preterm birth or improves neonatal outcome in women with preterm labour. © 2014 Royal College of Obstetricians and Gynaecologists.

Effect of spontaneous pushing versus Valsalva pushing in the second stage of labour on mother and fetus: a systematic review of randomised trials.

PubMed

Prins, M; Boxem, J; Lucas, C; Hutton, E

2011-05-01

To critically evaluate any benefit or harm for the mother and her baby of Valsalva pushing versus spontaneous pushing in the second stage of labour. Electronic databases from MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials were systematically searched (last search May 2010). The reference lists of retrieved studies were searched by hand and an internet hand search of master theses and dissertations was performed. No date or language restriction was used. Randomised controlled trials that compared instructed pushing with spontaneous pushing in the second stage of labour were considered. Studies were evaluated independently for methodological quality and appropriateness for inclusion by two authors (MP and JB). The primary outcome was instrumental/operative delivery. Other outcomes were length of labour, any perineal repair, bladder function, maternal satisfaction. Infant outcomes included low Apgar score < 7 after 5 minutes, umbilical arterial pH <7.2, admission to neonatal intensive care unit and serious neonatal morbidity or perinatal death. Three randomised controlled studies covering 425 primiparous women met the inclusion criteria. Women who used epidural analgesia were excluded in all three studies. No statistical difference was identified in the number of instrumental/operative deliveries (three studies; 425 women; relative risk 0.70; 95% CI 0.34-1.43), perineal repair, postpartum haemorrhage. Length of labour was significantly shorter in women who used the Valsalva pushing technique (three studies; 425 women; mean difference 18.59 minutes; 95% CI 0.46-36.73 minutes). Neonatal outcomes did not differ significantly. Urodynamic factors measured 3 months postpartum were negatively affected by Valsalva pushing. Measures of first urge to void and bladder capacity were decreased (one study; 128 women; mean difference respectively 41.50 ml, 95% CI 8.40-74.60, and 54.60 ml, 95% CI 13.31-95.89). The evidence from our review does not

Does acupuncture used in nulliparous women reduce time from prelabour rupture of membranes at term to active phase of labour? A randomised controlled trial.

PubMed

Selmer-Olsen, Tone; Lydersen, Stian; Mørkved, Siv

2007-01-01

To assess if acupuncture influences the onset of labour and the need for induction after prelabour rupture of membranes (PROM) in nulliparous women. Further, to investigate a possible effect of acupuncture on the woman's wellbeing. In a randomised controlled trial (RCT), 106 nulliparous women with PROM were allocated to an acupuncture group (AG) or a control group (CG). The outcome measures were time from PROM to onset of active phase of labour, and rate of inductions if labour was absent after 2 days. The women's self-reported wellbeing was registered on a Visual Analogue Scale (VAS). There was no statistically significant difference between the 2 groups regarding time from PROM to active phase (median times in AG versus CG: 15 versus 20.5 h, p=0.34). Additionally, there was no difference between the 2 groups in the need for induction. We found no significant differences in self-reported wellbeing, but the women receiving acupuncture considered their treatment to be more positive than the controls (p=0.003). No adverse effects were reported. Acupuncture treatment used in nulliparas after PROM showed no significant effect in reducing time to active labour or in reducing rate of inductions. There was no change in wellbeing as a result of acupuncture, but it was considered positive to receive this kind of treatment while waiting for labour to begin.

Outpatient versus inpatient induction of labour for improving birth outcomes.

PubMed

Kelly, Anthony J; Alfirevic, Zarko; Dowswell, Therese

2009-04-15

More than 20% of women undergo induction of labour in some countries. The different methods used to induce labour have been the focus of previous reviews, but the setting in which induction takes place (hospital versus outpatient settings) may have implications for maternal satisfaction and costs. It is not known whether some methods of induction that are effective and safe in hospital are suitable in outpatient settings. To assess the effects on outcomes for mothers and babies of induction of labour for women managed as outpatients versus inpatients. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (December 2008). Published and unpublished randomised and quasi-randomised trials in which inpatient and outpatient methods of cervical ripening or induction of labour have been compared. Two review authors independently assessed trial reports for inclusion. Two review authors carried out data extraction and assessment of risk of bias independently. We included three trials, with a combined total of 612 women in the review; each examined a different method of induction and we were unable to pool the results from trials.1. Vaginal PGE2 (One study including 201 women). There were no differences between women managed as out- versus inpatients for most review outcomes. Women in the outpatient group were more likely to have instrumental deliveries (risk ratio (RR) 1.74; 95% confidence interval (CI) 1.03 to 2.93). The overall length of hospital stay was similar in the two groups.2. Controlled release PGE2 10mg (one study including 300 women). There was no evidence of differences between groups for most review outcomes, including success of induction. During the induction period itself, women in the outpatient group were more likely to report high levels of satisfaction with their care (satisfaction rated seven or more on a nine-point scale RR 1.42; 95% CI 1.11 to 1.81), but satisfaction scores measured postnatally were similar in the two groups.3

Pain management for women in labour: an overview of systematic reviews.

PubMed

Jones, Leanne; Othman, Mohammad; Dowswell, Therese; Alfirevic, Zarko; Gates, Simon; Newburn, Mary; Jordan, Susan; Lavender, Tina; Neilson, James P

2012-03-14

The pain that women experience during labour is affected by multiple physiological and psychosocial factors and its intensity can vary greatly.  Most women in labour require pain relief. Pain management strategies include non-pharmacological interventions (that aim to help women cope with pain in labour) and pharmacological interventions (that aim to relieve the pain of labour). To summarise the evidence from Cochrane systematic reviews on the efficacy and safety of non-pharmacological and pharmacological interventions to manage pain in labour. We considered findings from non-Cochrane systematic reviews if there was no relevant Cochrane review. We searched the Cochrane Database of Systematic Reviews (The Cochrane Library 2011, Issue 5), The Cochrane Database of Abstracts of Reviews of Effects (The Cochrane Library 2011, Issue 2 of 4), MEDLINE (1966 to 31 May 2011) and EMBASE (1974 to 31 May 2011) to identify all relevant systematic reviews of randomised controlled trials of pain management in labour. Each of the contributing Cochrane reviews (nine new, six updated) followed a generic protocol with 13 common primary efficacy and safety outcomes. Each Cochrane review included comparisons with placebo, standard care or with a different intervention according to a predefined hierarchy of interventions. Two review authors extracted data and assessed methodological quality, and data were checked by a third author. This overview is a narrative summary of the results obtained from individual reviews. We identified 15 Cochrane reviews (255 included trials) and three non-Cochrane reviews (55 included trials) for inclusion within this overview. For all interventions, with available data, results are presented as comparisons of: 1. Intervention versus placebo or standard care; 2. Different forms of the same intervention (e.g. one opioid versus another opioid); 3. One type of intervention versus a different type of intervention (e.g. TENS versus opioid). Not all reviews

Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome?

PubMed Central

2012-01-01

Background Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth). Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the “progesterone” group having a lower incidence of preterm birth. Methods/Design The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 – 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks), improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites. Discussion OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome. Trial registration ISRCTN14568373 PMID

Package of care for active management in labour for reducing caesarean section rates in low-risk women.

PubMed

Brown, Heather C; Paranjothy, Shantini; Dowswell, Therese; Thomas, Jane

2013-09-16

Approximately 15% of women have caesarean sections (CS) and while the rate varies, the number is increasing in many countries. This is of concern because higher CS rates do not confer additional health gain but may adversely affect maternal health and have implications for future pregnancies. Active management of labour has been proposed as a means of reducing CS rates. This refers to a package of care including strict diagnosis of labour, routine amniotomy, oxytocin for slow progress and one-to-one support in labour. To determine whether active management of labour reduces CS rates in low-risk women and improves satisfaction. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (16 April 2013). Randomised controlled trials comparing low-risk women receiving a predefined package of care (active management) with women receiving routine (variable) care. Trials where slow progress had been diagnosed before entry into the trial were excluded. At least two review authors extracted data. We assessed included studies for risk of bias. We included seven trials, with a total of 5390 women. The quality of studies was mixed. The CS rate was slightly lower in the active management group compared with the group that received routine care, but this difference did not reach statistical significance (RR 0.88, 95% CI 0.77 to 1.01). However, in one study there was a large number of post-randomisation exclusions. On excluding this study, CS rates in the active management group were statistically significantly lower than in the routine care group (RR 0.77 95% CI 0.63 to 0.94). More women in the active management group had labours lasting less than 12 hours, but there was wide variation in length of labour within and between trials. There were no differences between groups in use of analgesia, rates of assisted vaginal deliveries or maternal or neonatal complications. Only one trial examined maternal satisfaction; the majority of women (over 75%) in both groups

Labour analgesia: Recent advances

PubMed Central

Pandya, Sunil T

2010-01-01

Advances in the field of labour analgesia have tread a long journey from the days of ether and chloroform in 1847 to the present day practice of comprehensive programme of labour pain management using evidence-based medicine. Newer advances include introduction of newer techniques like combined spinal epidurals, low-dose epidurals facilitating ambulation, pharmacological advances like introduction of remifentanil for patient-controlled intravenous analgesia, introduction of newer local anaesthetics and adjuvants like ropivacaine, levobupivacaine, sufentanil, clonidine and neostigmine, use of inhalational agents like sevoflourane for patient-controlled inhalational analgesia using special vaporizers, all have revolutionized the practice of pain management in labouring parturients. Technological advances like use of ultrasound to localize epidural space in difficult cases minimizes failed epidurals and introduction of novel drug delivery modalities like patient-controlled epidural analgesia (PCEA) pumps and computer-integrated drug delivery pumps have improved the overall maternal satisfaction rate and have enabled us to customize a suitable analgesic regimen for each parturient. Recent randomized controlled trials and Cochrane studies have concluded that the association of epidurals with increased caesarean section and long-term backache remains only a myth. Studies have also shown that the newer, low-dose regimes do not have a statistically significant impact on the duration of labour and breast feeding and also that these reduce the instrumental delivery rates thus improving maternal and foetal safety. Advances in medical technology like use of ultrasound for localizing epidural space have helped the clinicians to minimize the failure rates, and many novel drug delivery modalities like PCEA and computer-integrated PCEA have contributed to the overall maternal satisfaction and safety. PMID:21189877

Obstructed labour.

PubMed

Neilson, J P; Lavender, T; Quenby, S; Wray, S

2003-01-01

Obstructed labour is an important cause of maternal deaths in communities in which undernutrition in childhood is common resulting in small pelves in women, and in which there is no easy access to functioning health facilities with the capability of carrying out operative deliveries. Obstructed labour also causes significant maternal morbidity in the short term (notably infection) and long term (notably obstetric fistulas). Fetal death from asphyxia is also common. There are differences in the behaviour of the uterus during obstructed labour, depending on whether the woman has delivered previously. The pattern in primigravid women (typically diminishing contractility with risk of infection and fistula) may result from tissue acidosis, whereas in parous women, contractility may be maintained with the risk of uterine rupture. Ultimately, tackling the problem of obstructed labour will require universal adequate nutritional intake from childhood and the ability to access adequately equipped and staffed clinical facilities when problems arise in labour. These seem still rather distant aspirations. In the meantime, strategies should be implemented to encourage early recognition of prolonged labour and appropriate clinical responses. The sequelae of obstructed labour can be an enormous source of human misery and the prevention of obstetric fistulas, and skilled treatment if they do occur, are important priorities in regions where obstructed labour is still common.

Maximizing return on socioeconomic investment in phase II proof-of-concept trials.

PubMed

Chen, Cong; Beckman, Robert A

2014-04-01

Phase II proof-of-concept (POC) trials play a key role in oncology drug development, determining which therapeutic hypotheses will undergo definitive phase III testing according to predefined Go-No Go (GNG) criteria. The number of possible POC hypotheses likely far exceeds available public or private resources. We propose a design strategy for maximizing return on socioeconomic investment in phase II trials that obtains the greatest knowledge with the minimum patient exposure. We compare efficiency using the benefit-cost ratio, defined to be the risk-adjusted number of truly active drugs correctly identified for phase III development divided by the risk-adjusted total sample size in phase II and III development, for different POC trial sizes, powering schemes, and associated GNG criteria. It is most cost-effective to conduct small POC trials and set the corresponding GNG bars high, so that more POC trials can be conducted under socioeconomic constraints. If δ is the minimum treatment effect size of clinical interest in phase II, the study design with the highest benefit-cost ratio has approximately 5% type I error rate and approximately 20% type II error rate (80% power) for detecting an effect size of approximately 1.5δ. A Go decision to phase III is made when the observed effect size is close to δ. With the phenomenal expansion of our knowledge in molecular biology leading to an unprecedented number of new oncology drug targets, conducting more small POC trials and setting high GNG bars maximize the return on socioeconomic investment in phase II POC trials. ©2014 AACR.

Malignant pleural mesothelioma: a phase II trial with docetaxel.

PubMed

Vorobiof, D A; Rapoport, B L; Chasen, M R; Abratt, R P; Cronje, N; Fourie, L; McMichael, G; Hacking, D

2002-03-01

Current cytotoxic therapy has been of limited benefit to patients with malignant pleural mesothelioma. Single agent chemotherapy has been extensively evaluated in small series of phase II clinical trials, with disappointing responses. Docetaxel, an effective taxane in the treatment of advanced breast cancer and non-small-cell lung cancer, was administered intravenously at a dose of 100 mg/m2 every 3 weeks to 30 chemotherapy naive patients with malignant pleural mesothelioma in a prospective multi-institutional phase II clinical trial. An objective response rate (partial responses) of 10% was documented. Additionally, 21% of the patients had minor responses (intention-to-treat analysis). Three patients died within 2 weeks post-first cycle of therapy, although only one patient's death was directly attributed to the investigational drug, whilst in the majority of the patients, manageable and treatable toxicities were encountered. In this phase II clinical trial, docetaxel proved to be mildly effective in the treatment of patients with malignant pleural mesothelioma.

Date fruit consumption at term: Effect on length of gestation, labour and delivery.

PubMed

Razali, Nuguelis; Mohd Nahwari, Siti Hayati; Sulaiman, Sofiah; Hassan, Jamiyah

2017-07-01

Labour induction and augmentation with Prostaglandin and Oxytocin are well established as standard practice worldwide. They are safe when used judiciously, but may be associated with maternal and neonatal morbidities. Other safer alternatives have been studied including dates consumption during late pregnancy with various outcomes. The aim of this randomised controlled trial was to investigate the effect of date fruit consumption during late pregnancy on the onset of labour and need for induction or augmentation of labour. A total of 154 nulliparous women with an uncomplicated singleton pregnancy were randomly allocated to either dates-consumer (77) or control group (77). The women in the dates-consumer group had significantly less need for augmentation of labour and longer intervention to delivery interval. There was no significant difference in the onset of spontaneous labour. Dates consumption reduces the need for labour augmentation but does not expedite the onset of labour. Impact statement • Dates fruit consumption during late pregnancy has been shown to positively affect the outcome of labour and delivery. In this study, date consumption reduced the need for labour augmentation with oxytocin but did not expedite the onset of labour. Therefore, dates consumption in late pregnancy is a safe supplement to be considered as it reduced the need for labour intervention without any adverse effect on the mother and child. This further supports the finding of earlier studies.

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

Transcription Analysis of the Myometrium of Labouring and Non-Labouring Women

PubMed Central

Hutchinson, James L.; Hibbert, Nanette; Freeman, Tom C.; Saunders, Philippa T. K.; Norman, Jane E.

2016-01-01

An incomplete understanding of the molecular mechanisms that initiate normal human labour at term seriously hampers the development of effective ways to predict, prevent and treat disorders such as preterm labour. Appropriate analysis of large microarray experiments that compare gene expression in non-labouring and labouring gestational tissues is necessary to help bridge these gaps in our knowledge. In this work, gene expression in 48 (22 labouring, 26 non-labouring) lower-segment myometrial samples collected at Caesarean section were analysed using Illumina HT-12 v4.0 BeadChips. Normalised data were compared between labouring and non-labouring groups using traditional statistical methods and a novel network graph approach. We sought technical validation with quantitative real-time PCR, and biological replication through inverse variance-weighted meta-analysis with published microarray data. We have extended the list of genes suggested to be associated with labour: Compared to non-labouring samples, labouring samples showed apparent higher expression at 960 probes (949 genes) and apparent lower expression at 801 probes (789 genes) (absolute fold change ≥1.2, rank product percentage of false positive value (RP-PFP) <0.05). Although half of the women in the labouring group had received pharmaceutical treatment to induce or augment labour, sensitivity analysis suggested that this did not confound our results. In agreement with previous studies, functional analysis suggested that labour was characterised by an increase in the expression of inflammatory genes and network analysis suggested a strong neutrophil signature. Our analysis also suggested that labour is characterised by a decrease in the expression of muscle-specific processes, which has not been explicitly discussed previously. We validated these findings through the first formal meta-analysis of raw data from previous experiments and we hypothesise that this represents a change in the composition of

Cardiotocography versus intermittent auscultation of fetal heart on admission to labour ward for assessment of fetal wellbeing.

PubMed

Devane, Declan; Lalor, Joan G; Daly, Sean; McGuire, William; Smith, Valerie

2012-02-15

The admission cardiotocograph (CTG) is a commonly used screening test consisting of a short (usually 20 minutes) recording of the fetal heart rate (FHR) and uterine activity performed on the mother's admission to the labour ward. To compare the effects of admission CTG with intermittent auscultation of the FHR on maternal and infant outcomes for pregnant women without risk factors on their admission to the labour ward. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (17 May 2011) (CENTRAL) (The Cochrane Library 2011 Issue 2 of 4), MEDLINE (1966 to 17 May 2011), CINAHL (1982 to 17 May 2011), Dissertation Abstracts (1980 to 17 May 2011) and the reference list of retrieved papers. All randomised and quasi-randomised trials comparing admission CTG with intermittent auscultation of the FHR for pregnant women between 37 and 42 completed weeks of pregnancy and considered to be at low risk of intrapartum fetal hypoxia and of developing complications during labour. Two authors independently assessed trial eligibility and quality, and extracted data. Data were checked for accuracy. We included four trials involving more than 13,000 women. All four studies included women in labour. Overall, the studies were at low risk of bias. Although not statistically significant using a strict P < 0.05 criterion, data are consistent with women allocated to admission CTG having, on average, a higher probability of an increase in incidence of caesarean section than women allocated to intermittent auscultation (risk ratio (RR) 1.20, 95% confidence interval (CI) 1.00 to 1.44, four trials, 11,338 women, T² = 0.00, I² = 0%). There was no significant difference in the average treatment effect across included trials between women allocated to admission CTG and women allocated to intermittent auscultation in instrumental vaginal birth (RR 1.10, 95% CI 0.95 to 1.27, four trials, 11,338 women, T² = 0.01, I² = 38%) and fetal and neonatal deaths (RR 1.01, 95% CI 0.30 to 3

Cardiotocography versus intermittent auscultation of fetal heart on admission to labour ward for assessment of fetal wellbeing.

PubMed

Devane, Declan; Lalor, Joan G; Daly, Sean; McGuire, William; Cuthbert, Anna; Smith, Valerie

2017-01-26

The admission cardiotocograph (CTG) is a commonly used screening test consisting of a short (usually 20 minutes) recording of the fetal heart rate (FHR) and uterine activity performed on the mother's admission to the labour ward. This is an update of a review published in 2012. To compare the effects of admission cardiotocography with intermittent auscultation of the FHR on maternal and infant outcomes for pregnant women without risk factors on their admission to the labour ward. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register to 30 November 2016 and we planned to review the reference list of retrieved papers All randomised and quasi-randomised trials comparing admission CTG with intermittent auscultation of the FHR for pregnant women between 37 and 42 completed weeks of pregnancy and considered to be at low risk of intrapartum fetal hypoxia and of developing complications during labour. Two authors independently assessed trial eligibility and quality, and extracted data. Data were checked for accuracy. We included no new trials in this update. We included four trials involving more than 13,000 women which were conducted in the UK and Ireland and included women in labour. Three trials were funded by the hospitals where the trials took place and one trial was funded by the Scottish government. No declarations of interest were made in two trials; the remaining two trials did not mention declarations of interest. Overall, the studies were assessed as low risk of bias. Results reported in the 2012 review remain unchanged.Although not statistically significant using a strict P < 0.05 criterion, data were consistent with women allocated to admission CTG having, on average, a higher probability of an increase in incidence of caesarean section than women allocated to intermittent auscultation (risk ratio (RR) 1.20, 95% confidence interval (CI) 1.00 to 1.44, 4 trials, 11,338 women, I² = 0%, moderate quality evidence). There was no clear difference

Package of care for active management in labour for reducing caesarean section rates in low-risk women

PubMed Central

Brown, Heather C; Paranjothy, Shantini; Dowswell, Therese; Thomas, Jane

2014-01-01

Background Approximately 15% of women have caesarean sections (CS) and while the rate varies, the number is increasing in many countries. This is of concern because higher CS rates do not confer additional health gain but may adversely affect maternal health and have implications for future pregnancies. Active management of labour has been proposed as a means of reducing CS rates. This refers to a package of care including strict diagnosis of labour, routine amniotomy, oxytocin for slow progress and one to one support in labour. Objectives To determine whether active management of labour reduces CS rates in low-risk women and improves satisfaction. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (February 2008), MEDLINE (1966 to December 2007), EMBASE (1980 to 2007), MIDIRS (1985 to 2007) and CINAHL (1982 to 2007). Selection criteria Randomised controlled trials comparing low-risk women receiving a predefined package of care (active management) with women receiving routine (variable) care. Trials where slow progress had been diagnosed before entry into the trial were excluded. Data collection and analysis At least two review authors extracted data. We assessed included studies for risk of bias. Main results We included seven trials, with a total of 5390 women. The quality of studies was mixed. The CS rate was slightly lower in the active management group compared to the group that received routine care, but this difference did not reach statistical significance (RR 0.88, 95% CI 0.77 to 1.01). However, in one study there was a large number of post-randomisation exclusions. On excluding this study, CS rates in the active management group were statistically significantly lower than in the routine care group (RR 0.77 95% CI 0.63 to 0.94). More women in the active management group had labours lasting less than twelve hours, but there was wide variation in length of labour within and between trials. There were no differences

Fundal pressure during the second stage of labour.

PubMed

Hofmeyr, G Justus; Vogel, Joshua P; Cuthbert, Anna; Singata, Mandisa

2017-03-07

Fundal pressure during the second stage of labour (also known as the 'Kristeller manoeuvre') involves application of manual pressure to the uppermost part of the uterus directed towards the birth canal, in an attempt to assist spontaneous vaginal birth and avoid prolonged second stage or the need for operative birth. Fundal pressure has also been applied using an inflatable belt. Fundal pressure is widely used, however methods of its use vary widely. Despite strongly held opinions in favour of and against the use of fundal pressure, there is limited evidence regarding its maternal and neonatal benefits and harms. There is a need for objective evaluation of the effectiveness and safety of fundal pressure in the second stage of labour. To determine if fundal pressure is effective in achieving spontaneous vaginal birth, and preventing prolonged second stage or the need for operative birth, and to explore maternal and neonatal adverse effects related to fundal pressure. We searched Cochrane Pregnancy and Childbirth's Trials Register (30 November 2016) and reference lists of retrieved studies. Randomised and quasi-randomised controlled trials of fundal pressure (manual or by inflatable belt) versus no fundal pressure in women in the second stage of labour with singleton cephalic presentation. Two or more review authors independently assessed potential studies for inclusion and quality. We extracted data using a pre-designed form. We entered data into Review Manager 5 software and checked for accuracy. Nine trials are included in this updated review. Five trials (3057 women) compared manual fundal pressure versus no fundal pressure. Four trials (891 women) compared fundal pressure by means of an inflatable belt versus no fundal pressure. It was not possible to blind women and staff to this intervention. We assessed two trials as being at high risk of attrition bias and another at high risk of reporting bias. All other trials were low or unclear for other risk of bias

Restricting oral fluid and food intake during labour.

PubMed

Singata, Mandisa; Tranmer, Joan; Gyte, Gillian M L

2013-08-22

Restricting fluids and foods during labour is common practice across many birth settings with some women only being allowed sips of water or ice chips. Restriction of oral intake may be unpleasant for some women, and may adversely influence their experience of labour. To determine the benefits and harms of oral fluid or food restriction during labour. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2013) and reference lists of retrieved studies. Randomised controlled trials (RCTs) and quasi-RCTs of restricting fluids and food for women in labour compared with women free to eat and drink. Two review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. We identified 19 studies of which we included five, involving 3130 women. We excluded eight studies, one awaits classification and five are ongoing studies. All the included studies looked at women in active labour and at low risk of potentially requiring a general anaesthetic. One study looked at complete restriction versus giving women the freedom to eat and drink at will; two studies looked at water only versus giving women specific fluids and foods and two studies looked at water only versus giving women carbohydrate drinks.When comparing any restriction of fluids and food versus women given some nutrition in labour, the meta-analysis was dominated by one study undertaken in a highly medicalised environment. There were no statistically significant differences identified in: caesarean section (average risk ratio (RR) 0.89, 95% confidence interval (CI) 0.63 to 1.25, five studies, 3103 women), operative vaginal births (average RR 0.98, 95% CI 0.88 to 1.10, five studies, 3103 women) and Apgar scores less than seven at five minutes (average RR 1.43, 95% CI 0.77 to 2.68, four studies, 2902 infants), nor in any of the other outcomes assessed. Women's views were not assessed. The pooled data were insufficient to assess the

Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial-the EOLE study protocol.

PubMed

Barasinski, Chloé; Vendittelli, Françoise

2016-12-20

The scientific data currently available do not allow any definitive conclusion to be reached about what type of pushing should be recommended to women during the second stage of labour. The objective of this trial is to assess and compare the effectiveness of directed open-glottis pushing versus directed closed-glottis pushing. Secondary objectives are to assess, according to the type of pushing: immediate maternal and neonatal morbidity, intermediate-term maternal pelvic floor morbidity, uncomplicated birth, and women's satisfaction at 4 weeks post partum. This multicentre randomised clinical trial compares directed closed-glottis pushing (Valsalva) versus directed open-glottis pushing during the second stage of labour in 4 hospitals of France. The study population includes pregnant women who received instruction in both types of pushing, have no previous caesarean delivery, are at term and have a vaginal delivery planned. Randomisation takes place during labour once cervical dilation ≥7 cm. The principal end point is assessed by a composite criterion: spontaneous delivery without perineal lesion (no episiotomy or spontaneous second-degree, third-degree or fourth-degree lacerations). We will need to recruit 125 women per group. The primary analysis will be by intention-to-treat analysis, with the principal results reported as crude relative risks (RRs) with their 95% CIs. A multivariate analysis will be performed to take prognostic and confounding factors into account to obtain adjusted RRs. This study was approved by a French Institutional Review Board (Comité de Protection des Personnes Sud Est 6:N°AU1168). Results will be reported in peer-reviewed journals and at scientific meetings. This study will make it possible to assess the effectiveness of 2 types of directed pushing used in French practice and to assess their potential maternal, fetal and neonatal effects. Findings from the study will be useful for counselling pregnant women before and during

[Prognostic value of chosen parameters of mechanical and bioelectrical uterine activity in prediction of threatening preterm labour].

PubMed

Zietek, Jerzy; Sikora, Jerzy; Horoba, Krzysztof; Matonia, Adam; Jezewski, Janusz; Magnucki, Jacek; Kobielska, Lucyna

2009-03-01

To record and analyse bioelectrical activity of the uterine muscle in the course of physiological pregnancy, labour and threatening premature labour; to define which parameters from the analysis of both electrohysterogram and mechanical activity signal allow us to predict threatening premature labour. Material comprised 62 pregnant women: Group I--27 patients in their first physiological pregnancy, Group II--21 patients in their first pregnancy with symptoms of threatening premature labour, and Group III--14 patients in the first labour period. The on-line analysis of the mechanical (TOCO) and electrical (EHG) contraction activity relied on determination of quantitative parameters of detected uterine contractions. The obtained statistical results demonstrated a possibility to differentiate between Group I and II through the amplitude and contraction area for EHG signal, and only the contraction amplitude for TOCO signal. Additionally, significant differentiating parameters for electrohysterogram are: contraction power and its median frequency. Analyzing Group I and III, significant differences were noted for contraction amplitude and area obtained both from EHG and TOCO signals. Similarly, the contraction power (from EHG) enables us to assign the contractions either to records from Group I or to labour type. There was no significant difference noted between Group II and III. Identification of pregnant women at risk of premature labour should lead to their inclusion in rigorous perinatal surveillance. This requires novel, more sensitive methods that are able to detect early symptoms of the uterine contraction activity increase. Electrohysterography provides complete information on principles of bioelectrical uterine activity. Quantitative parameters of EHG analysis enable the detection of records (contractions) with the symptoms of premature uterine contraction activity.

Pyridoxine (vitamin B6) supplementation during pregnancy or labour for maternal and neonatal outcomes.

PubMed

Salam, Rehana A; Zuberi, Nadeem F; Bhutta, Zulfiqar A

2015-06-03

Vitamin B6 plays vital roles in numerous metabolic processes in the human body, such as nervous system development and functioning. It has been associated with some benefits in non-randomised studies, such as higher Apgar scores, higher birthweights, and reduced incidence of pre-eclampsia and preterm birth. Recent studies also suggest a protection against certain congenital malformations. To evaluate the clinical effects of vitamin B6 supplementation during pregnancy and/or labour. We searched the Cochrane Pregnancy and Childbirth Group Trials Register (31 March 2015) and reference lists of retrieved studies. We included randomised controlled trials comparing vitamin B6 administration in pregnancy and/or labour with: placebos, no supplementations, or supplements not containing vitamin B6. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. For this update, we assessed methodological quality of the included trials using risk of bias and the GRADE approach. Four trials (1646 women) were included. The method of randomisation was unclear in all four trials and allocation concealment was reported in only one trial. Two trials used blinding of participants and outcomes. Vitamin B6 as oral capsules or lozenges resulted in decreased risk of dental decay in pregnant women (capsules: risk ratio (RR) 0.84; 95% confidence interval (CI) 0.71 to 0.98; one trial, n = 371, low quality of evidence; lozenges: RR 0.68; 95% CI 0.56 to 0.83; one trial, n = 342, low quality of evidence). A small trial showed reduced mean birthweights with vitamin B6 supplementation (mean difference -0.23 kg; 95% CI -0.42 to -0.04; n = 33; one trial). We did not find any statistically significant differences in the risk of eclampsia (capsules: n = 1242; three trials; lozenges: n = 944; one trial), pre-eclampsia (capsules n = 1197; two trials, low quality of evidence; lozenges: n = 944; one trial, low-quality evidence) or low Apgar

Parenteral opioids for maternal pain management in labour

PubMed Central

Ullman, Roz; Smith, Lesley A; Burns, Ethel; Mori, Rintaro; Dowswell, Therese

2014-01-01

Background Parenteral opioids are used for pain relief in labour in many countries throughout the world. Objectives To assess the acceptability, effectiveness and safety of different types, doses and modes of administration of parenteral opioids given to women in labour. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 April 2011) and reference lists of retrieved studies. Selection criteria We included randomised controlled trials examining the use of intramuscular or intravenous opioids (including patient controlled analgesia) for women in labour. We looked at studies comparing an opioid with another opioid, placebo, other non-pharmacological interventions (TENS) or inhaled analgesia. Data collection and analysis At least two review authors independently assessed study eligibility, collected data and assessed risk of bias. Main results We included 57 studies involving more than 7000 women that compared an opioid with placebo, another opioid administered intramuscularly or intravenously or compared with TENS to the back. The 57 studies reported on 29 different comparisons, and for many outcomes only one study contributed data. Overall, the evidence was of poor quality regarding the analgesic effect of opioids, satisfaction with analgesia, adverse effects and harm to women and babies. There were few statistically significant results. Many of the studies had small sample sizes, and low statistical power. Overall findings indicated that parenteral opioids provided some pain relief and moderate satisfaction with analgesia in labour, although up to two-thirds of women who received opioids reported moderate or severe pain and/or poor or moderate pain relief one or two hours after administration. Opioid drugs were associated with maternal nausea, vomiting and drowsiness, although different opioid drugs were associated with different adverse effects. There was no clear evidence of adverse effects of opioids on the newborn. We

Effects of early augmentation of labour with amniotomy and oxytocin in nulliparous women: a meta-analysis.

PubMed

Fraser, W; Vendittelli, F; Krauss, I; Bréart, G

1998-02-01

To estimate the effects among nulliparae of early augmentation with amniotomy and oxytocin on caesarean delivery, and on other indicators of maternal and neonatal morbidity including transfusion. Apgar score < 7 at 5 minutes, and admission to the special care nursery. Meta-analysis. Published studies were identified through manual and computerised searches. Two unpublished studies were identified through direct communication with the investigators. Twelve trials were identified which compared a policy of early labour augmentation including amniotomy followed by oxytocin with a less active form of management. Two methodologically unacceptable studies were excluded. Studies were grouped according to whether they admitted only women with abnormal progress (therapy trials: n = 3) or accepted women with normal labour (prevention trials: n = 7). Unstratified analysis did not provide support for the hypothesis that early augmentation reduces the risk of caesarean section (typical odds ratio [OR] 0.9; 95% CI 0.7-1.1). The typical odds ratio for prevention trials was similar to that obtained in the unstratified analysis (typical OR 0.9, 95% CI 0.7-1.2). Although only a small number of women have been randomised in therapy trials, a trend toward a reduction in the rate of caesarean section with early intervention was seen in this group (typical OR 0.6, 95% CI 0.2-1.4). Early augmentation does not appear to provide benefit over a more conservative form of management in the context of care of nulliparous women with mild delays in the progress of labour. In the context of established delay in labour, an active policy of augmentation may reduce the risk of caesarean section. However, only three small trials have been performed in this context, and they do not have adequate power to allow firm conclusions to be drawn.

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.

Fundal pressure during the second stage of labour.

PubMed

Verheijen, Evelyn C; Raven, Joanna H; Hofmeyr, G Justus

2009-10-07

Fundal pressure during the second stage of labour involves application of manual pressure to the uppermost part of the uterus directed towards the birth canal in an attempt to assist spontaneous vaginal delivery and avoid prolonged second stage or the need for operative delivery. Fundal pressure has also been applied using an inflatable girdle. A survey in the United States found that 84% of the respondents used fundal pressure in their obstetric centres.There is little evidence to demonstrate that the use of fundal pressure is effective to improve maternal and/or neonatal outcomes. Several anecdotal reports suggest that fundal pressure is associated with maternal and neonatal complications: for example, uterine rupture, neonatal fractures and brain damage. There is a need for objective evaluation of the effectiveness and safety of fundal pressure in the second stage of labour. To determine the benefits and adverse effects of fundal pressure in the second stage of labour. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (November 2008). Randomised and quasi-randomised controlled trials of fundal pressure versus no fundal pressure in women in the second stage of labour with singleton cephalic presentation. Three review authors independently assessed for inclusion all the potential studies. We extracted the data using a pre-designed form. We entered data into Review Manager software and checked for accuracy. We excluded two of three identified trials from the analyses for methodological reasons. This left no studies on manual fundal pressure. We included one study (500 women) of fundal pressure by means of an inflatable belt versus no fundal pressure to reduce operative delivery rates. The methodological quality of the included study was good.Use of the inflatable belt did not change the rate of operative deliveries (RR 0.94, 95% CI 0.80 to 1.11). Fetal outcomes in terms of five-minute Apgar scores below seven (RR 4.62, 95% CI 0.22 to 95

The use of transcutaneous electrical nerve stimulation (TENS) for pain relief in labour: a review of the evidence.

PubMed

Bedwell, Carol; Dowswell, Therese; Neilson, James P; Lavender, Tina

2011-10-01

to assess the effects of transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. studies were identified from a search of the Cochrane Pregnancy and Childbirth Group's Trials Register (November 2008). randomised controlled trials comparing women receiving TENS for pain relief in labour vs routine care or placebo devices. All types of TENS machines were included. two review authors assessed all trials identified by the search strategy, carried out data extraction and assessed risk of bias. 14 studies including 1256 women were included: 11 examined TENS applied to the back, two to acupuncture points and one to the cranium. Overall, there was little difference in satisfaction with pain relief or in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (risk ratio 0.41, 95% confidence interval 0.32-0.55). The majority of women using TENS would use it again in a future labour. There was no evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and infants. No adverse events were reported. there is only limited evidence that TENS reduces pain in labour and it does not seem to have any impact on other outcomes for mothers or infants. The use of TENS at home in early labour has not been evaluated. Although the guidelines of the National Institute for Health and Clinical Excellence recommend that TENS should not be offered to women in labour, women appear to be choosing it and midwives are supporting them in their choice. Given the absence of adverse effects and the limited evidence base, it seems unreasonable to deny women that choice. More robust studies of effectiveness are needed. Copyright © 2009 Elsevier Ltd. All rights reserved.

Vaginal progesterone as maintenance treatment after an episode of preterm labour (PROMISE) study: a multicentre, double-blind, randomised, placebo-controlled trial.

PubMed

Palacio, M; Cobo, T; Antolín, E; Ramirez, M; Cabrera, F; Mozo de Rosales, F; Bartha, J L; Juan, M; Martí, A; Oros, D; Rodríguez, À; Scazzocchio, E; Olivares, J M; Varea, S; Ríos, J; Gratacós, E

2016-11-01

To evaluate whether maintenance treatment with vaginal progesterone after an arrested preterm labour reduces the incidence of preterm delivery. Multicentre, randomised, double-blind, placebo-controlled trial. Twelve tertiary care centres in Spain. A total of 265 women with singleton pregnancy, preterm labour successfully arrested with tocolytic treatment, and cervical length of <25 mm. Randomisation was stratified by gestational age (from 24.0 to <31.0 weeks of gestation and from 31.0 to <34.0 weeks of gestation) and centre. Patients were randomly assigned, in a 1 : 1 ratio, to either daily vaginal capsules of 200 mg progesterone or placebo until delivery or 36.6 weeks of gestation, whichever occurred first. Primary outcome was delivery before 34.0 and 37.0 weeks of gestation. Secondary outcomes were discharge-to-delivery time, readmissions because of preterm labour, emergency service use, and neonatal morbidity and mortality. From June 2008 through June 2012, 1419 women were screened: 472 met the inclusion criteria and 265 were randomised. The final analysis included 258 women: 126 in the progesterone group and 132 in the placebo group. There were no significant differences between the progesterone and placebo groups in terms of delivery at <34 weeks of gestation [9/126 (7.1%) versus 10/132 (7.6%), P = 0.91] or <37 weeks of gestation [36/126 (28.6%) versus 29/132 (22.0%), P = 0.22]. There were no differences observed between groups when considering the two strata of gestational age at inclusion. A maintenance treatment of 200 mg of daily vaginal progesterone capsules in women discharged home after an episode of arrested preterm labour did not significantly reduce the rate of preterm delivery. Maintenance progesterone in 258 women after arrested PTL showed no benefit. © 2016 Royal College of Obstetricians and Gynaecologists.

Phase II cancer clinical trials for biomarker-guided treatments.

PubMed

Jung, Sin-Ho

2018-01-01

The design and analysis of cancer clinical trials with biomarker depend on various factors, such as the phase of trials, the type of biomarker, whether the used biomarker is validated or not, and the study objectives. In this article, we demonstrate the design and analysis of two Phase II cancer clinical trials, one with a predictive biomarker and the other with an imaging prognostic biomarker. Statistical testing methods and their sample size calculation methods are presented for each trial. We assume that the primary endpoint of these trials is a time to event variable, but this concept can be used for any type of endpoint.

Do maternal pushing techniques during labour affect obstetric or neonatal outcomes?

PubMed

Barasinski, C; Lemery, D; Vendittelli, F

2016-10-01

To assess, through a literature review, the maternal and neonatal morbidity associated with the type of pushing used during the second stage of labour. We searched the Cochrane Library and the Medline database for randomised controlled trials from 1980 to 2015, using the following keywords: "delivery", "birth", "birthing", "bearing down, coached, uncoached, pushing", "second and stage and labour", "randomised controlled trials" and "meta-analysis". Seven randomised controlled trials were found. Interventions varied between the studies. In the intervention groups, open-glottis pushing was spontaneous or coached. The groups did not differ for perineal injuries, episiotomies or type of birth. Impact on pelvic floor structure varied between the studies. Only one study found a better 5-minute Apgar score and a better umbilical artery pH in the "open glottis" group. The low methodological quality of the studies and the differences between the protocols do not justify a recommendation of a particular pushing technique. Further studies appear necessary to study outcomes with each of these techniques. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Effect of partogram use on outcomes for women in spontaneous labour at term

PubMed Central

Lavender, Tina; Hart, Anna; Smyth, Rebecca MD

2014-01-01

Background The partogram (sometimes known as partograph) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partogram is to provide a pictorial overview of labour, to alert midwives and obstetricians to deviations in maternal or fetal wellbeing and labour progress. Charts often contain pre-printed alert and action lines. An alert line represents the slowest 10% of primigravid women’s labour progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour. Objectives To determine the effect of use of partogram on perinatal and maternal morbidity and mortality. To determine the effect of partogram design on perinatal and maternal morbidity and mortality. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (31 May 2012). Selection criteria Randomised and quasi-randomised controlled trials involving a comparison of partogram with no partogram, or comparison between different partogram designs. Data collection and analysis Three review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining authors assessed the studies independently. Main results We have included six studies involving 7706 women in this review; two studies assessed partogram versus no partogram and the remainder assessed different partogram designs. There was no evidence of any difference between partogram and no partogram in caesarean section (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.24 to 1.70); instrumental vaginal delivery (RR 1.00, 95% CI 0.85 to 1.17) or Apgar score less than seven at five minutes (RR 0.77, 95% CI 0.29 to 2.06) between the groups. When compared to a four-hour action line, women in the two-hour action line group were more likely to require oxytocin augmentation (RR 1.14, 95% CI 1.05 to 1.22). When the three- and

Oxytocin versus no treatment or delayed treatment for slow progress in the first stage of spontaneous labour.

PubMed

Bugg, George J; Siddiqui, Farah; Thornton, Jim G

2013-06-23

Slow progress in the first stage of spontaneous labour is associated with an increased caesarean section rate and fetal and maternal morbidity. Oxytocin has long been advocated as a treatment for slow progress in labour but it is unclear to what extent it improves the outcomes for that labour and whether it actually reduces the caesarean section rate or maternal and fetal morbidity. This review will address the use of oxytocin and whether it improves the outcomes for women who are progressing slowly in labour compared to situations where it is not used or where its administration is delayed. To determine if the use of oxytocin for the treatment of slow progress in the first stage of spontaneous labour is associated with a reduction in the incidence of caesarean sections, or maternal and fetal morbidity compared to situations where it is not used or where its administration is delayed. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (23 February 2013) and bibliographies of relevant papers. Randomised controlled trials which compared oxytocin with either placebo, no treatment or delayed oxytocin in the active stage of spontaneous labour in low-risk women at term. Two authors independently assessed studies for inclusion, assessed risk of bias and extracted data. We sought additional information from trial authors. We included eight studies in the review involving a total of 1338 low-risk women in the first stage of spontaneous labour at term. Two comparisons were made; 1) the use of oxytocin versus placebo or no treatment (three trials); 2) the early use of oxytocin versus its delayed use (five trials). There were no significant differences in the rates of caesarean section or instrumental vaginal delivery in either comparison. Early use of oxytocin resulted in an increase in uterine hyperstimulation associated with fetal heart changes. However, the early use of oxytocin versus its delayed use resulted in no significant differences in a range

Terbutaline pump maintenance therapy after threatened preterm labour for reducing adverse neonatal outcomes.

PubMed

Chawanpaiboon, Saifon; Laopaiboon, Malinee; Lumbiganon, Pisake; Sangkomkamhang, Ussanee S; Dowswell, Therese

2014-03-23

After successful inhibition of threatened preterm labour women are at high risk of recurrent preterm labour. Terbutaline pump maintenance therapy has been used to reduce adverse neonatal outcomes. This review replaces an earlier Cochrane review, published in 2002, which is no longer being updated by the team. To determine the effectiveness of terbutaline pump maintenance therapy after threatened preterm labour in reducing adverse neonatal outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2014) and reference lists of retrieved studies. Randomised controlled trials comparing terbutaline pump therapy with alternative therapy, placebo, or no therapy after arrest of threatened preterm labour. Two review authors independently assessed the studies for inclusion and then extracted data as eligible for inclusion in qualitative and quantitative synthesis (meta-analysis). Four studies were included with a total of 234 women randomised. The overall methodological quality of the included studies was mixed; two studies provided very little information on study methods, there was high sample attrition in one study and in three studies the risk of performance bias was high. We found no strong evidence that terbutaline maintenance therapy offered any advantages over saline placebo or oral terbutaline maintenance therapy in reducing adverse neonatal outcomes by prolonging pregnancy among women with arrested preterm labour. The mean difference (MD) for gestational age at birth was -0.14 weeks (95% confidence interval (CI) -1.66 to 1.38) for terbutaline pump therapy compared with saline placebo pump for two trials combined. One trial reported a risk ratio (RR) of 1.17 (95% CI 0.79 to 1.73) for preterm birth (less than 37 completed weeks) and a RR of 0.97 (95% CI 0.51 to 1.84) of very preterm birth (less than 34 completed weeks) for terbutaline pump compared with saline placebo pump. We found no evidence that terbutaline pump therapy was

Bayesian adaptive phase II screening design for combination trials.

PubMed

Cai, Chunyan; Yuan, Ying; Johnson, Valen E

2013-01-01

Trials of combination therapies for the treatment of cancer are playing an increasingly important role in the battle against this disease. To more efficiently handle the large number of combination therapies that must be tested, we propose a novel Bayesian phase II adaptive screening design to simultaneously select among possible treatment combinations involving multiple agents. Our design is based on formulating the selection procedure as a Bayesian hypothesis testing problem in which the superiority of each treatment combination is equated to a single hypothesis. During the trial conduct, we use the current values of the posterior probabilities of all hypotheses to adaptively allocate patients to treatment combinations. Simulation studies show that the proposed design substantially outperforms the conventional multiarm balanced factorial trial design. The proposed design yields a significantly higher probability for selecting the best treatment while allocating substantially more patients to efficacious treatments. The proposed design is most appropriate for the trials combining multiple agents and screening out the efficacious combination to be further investigated. The proposed Bayesian adaptive phase II screening design substantially outperformed the conventional complete factorial design. Our design allocates more patients to better treatments while providing higher power to identify the best treatment at the end of the trial.

Bayesian adaptive phase II screening design for combination trials

PubMed Central

Cai, Chunyan; Yuan, Ying; Johnson, Valen E

2013-01-01

Background Trials of combination therapies for the treatment of cancer are playing an increasingly important role in the battle against this disease. To more efficiently handle the large number of combination therapies that must be tested, we propose a novel Bayesian phase II adaptive screening design to simultaneously select among possible treatment combinations involving multiple agents. Methods Our design is based on formulating the selection procedure as a Bayesian hypothesis testing problem in which the superiority of each treatment combination is equated to a single hypothesis. During the trial conduct, we use the current values of the posterior probabilities of all hypotheses to adaptively allocate patients to treatment combinations. Results Simulation studies show that the proposed design substantially outperforms the conventional multiarm balanced factorial trial design. The proposed design yields a significantly higher probability for selecting the best treatment while allocating substantially more patients to efficacious treatments. Limitations The proposed design is most appropriate for the trials combining multiple agents and screening out the efficacious combination to be further investigated. Conclusions The proposed Bayesian adaptive phase II screening design substantially outperformed the conventional complete factorial design. Our design allocates more patients to better treatments while providing higher power to identify the best treatment at the end of the trial. PMID:23359875

A two-stage patient enrichment adaptive design in phase II oncology trials.

PubMed

Song, James X

2014-01-01

Illustrated is the use of a patient enrichment adaptive design in a randomized phase II trial which allows the evaluation of treatment benefits by the biomarker expression level and makes interim adjustment according to the pre-specified rules. The design was applied to an actual phase II metastatic hepatocellular carcinoma (HCC) trial in which progression-free survival (PFS) in two biomarker-defined populations is evaluated at both interim and final analyses. As an extension, a short-term biomarker is used to predict the long-term PFS in a Bayesian model in order to improve the precision of hazard ratio (HR) estimate at the interim analysis. The characteristics of the extended design are examined in a number of scenarios via simulations. The recommended adaptive design is shown to be useful in a phase II setting. When a short-term maker which correlates with the long-term PFS is available, the design can be applied in smaller early phase trials in which PFS requires longer follow-up. In summary, the adaptive design offers flexibility in randomized phase II patient enrichment trials and should be considered in an overall personalized healthcare (PHC) strategy. Copyright © 2013 Elsevier Inc. All rights reserved.

Comparison effect of oral propranolol and oxytocin versus oxytocin only on induction of labour in nulliparous women (a double blind randomized trial).

PubMed

Moghadam, Ashraf Direkvand; Jaafarpour, Molouk; Khani, Ali

2013-11-01

Today, research on new methods for preventing caesarean sections owing to labour induction, have been requested in obstetric practice, because of the increased morbidity related to caesarean section. Therefore, the aim of this study was to compare the effect of Oral Propranolol and Oxytocin versus Oxytocin only on induction of labour in nulliparous women. A double blind randomized controlled trial was performed at the Ilam Mostafa Hospital, Ilam, Iran, from March 2010 to March 2011 on 146 nulliparous pregnant women who had gestational age of 40-42 weeks of pregnancy and a Bishop score of ≤5. Participants were divided in two groups (with 73 participants in each group). In the first group (placebo plus Oxytocin group = 73), Oxytocin was used for the induction of labour. In the second group (Propranolol plus Oxytocin group = 73 cases), before the use of Oxytocin, 20 mg Propranolol was administrated orally and then the Oxytocin was initiated. Twenty mg Propranolol was repeated after 8 hours if good contraction was not obtained. The mean duration for obtaining good contractions was significantly shorter in the Propranolol group than in the placebo group, on both the first and second day of induction (p<.05). The mean duration of latent phase was shorter in the first in Propranolol group (p<.05). In Propranolol plus Oxytocine group, frequency of cesarean deliveries significantly decreased than in the placebo plus Oxytocin group (21% versus 39.7%). No significant differences in neonate outcome, such as Apgar scores of minutes 1 and 5 and need of admissions to NICU, were found between the groups (p>.05) DISCUSSION AND CONCLUSION: Our study showed that oral Propranolol was effective for labour induction and that it could decrease the frequency of caesarean deliveries without producing any adverse effects on mothers or neonates.

Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care

PubMed Central

Wei, Shuqin; Wo, Bi Lan; Qi, Hui-Ping; Xu, Hairong; Luo, Zhong-Cheng; Roy, Chantal; Fraser, William D

2014-01-01

Background Caesarean section rates are over 20% in many developed countries. The main diagnosis contributing to the high rate in nulliparae is dystocia or prolonged labour. The present review assesses the effects of a policy of early amniotomy with early oxytocin administration for the prevention of, or the therapy for, delay in labour progress. Objectives To estimate the effects of early augmentation with amniotomy and oxytocin for prevention of, or therapy for, delay in labour progress on the caesarean birth rate and on indicators of maternal and neonatal morbidity. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (15 February 2012), MEDLINE (1966 to 15 February 2012), EMBASE (1980 to 15 February 2012), CINAHL (1982 to 15 February 2012), MIDIRS (1985 to February 2012) and contacted authors for data from unpublished trials. Selection criteria Randomized and quasi-randomized controlled trials that compared oxytocin and amniotomy with expectant management. Data collection and analysis Three review authors extracted data independently. We stratified the analyses into ’Prevention Trials’ and ’Therapy Trials’ according to the status of the woman at the time of randomization. Participants in the ’Prevention Trials’ were unselected women, without slow progress in labour, who were randomized to a policy of early augmentation or to routine care. In ’Treatment Trials’ women were eligible if they had an established delay in labour progress. Main results For this update, we have included a further two new clinical trials. This updated review includes 14 trials, randomizing a total of 8033 women. The unstratified analysis found early intervention with amniotomy and oxytocin to be associated with a modest reduction in the risk of caesarean section; however, the confidence interval (CI) included the null effect (risk ratio (RR) 0.89; 95% CI 0.79 to 1.01; 14 trials; 8033 women). In prevention trials, early augmentation was

Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT): a multicentre, open-label randomised controlled trial.

PubMed

Koopmans, Corine M; Bijlenga, Denise; Groen, Henk; Vijgen, Sylvia M C; Aarnoudse, Jan G; Bekedam, Dick J; van den Berg, Paul P; de Boer, Karin; Burggraaff, Jan M; Bloemenkamp, Kitty W M; Drogtrop, Addy P; Franx, Arie; de Groot, Christianne J M; Huisjes, Anjoke J M; Kwee, Anneke; van Loon, Aren J; Lub, Annemiek; Papatsonis, Dimitri N M; van der Post, Joris A M; Roumen, Frans J M E; Scheepers, Hubertina C J; Willekes, Christine; Mol, Ben W J; van Pampus, Maria G

2009-09-19

Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity. We undertook a multicentre, parallel, open-label randomised controlled trial in six academic and 32 non-academic hospitals in the Netherlands between October, 2005, and March, 2008. We enrolled patients with a singleton pregnancy at 36-41 weeks' gestation, and who had gestational hypertension or mild pre-eclampsia. Participants were randomly allocated in a 1:1 ratio by block randomisation with a web-based application system to receive either induction of labour or expectant monitoring. Masking of intervention allocation was not possible. The primary outcome was a composite measure of poor maternal outcome--maternal mortality, maternal morbidity (eclampsia, HELLP syndrome, pulmonary oedema, thromboembolic disease, and placental abruption), progression to severe hypertension or proteinuria, and major post-partum haemorrhage (>1000 mL blood loss). Analysis was by intention to treat and treatment effect is presented as relative risk. This study is registered, number ISRCTN08132825. 756 patients were allocated to receive induction of labour (n=377 patients) or expectant monitoring (n=379). 397 patients refused randomisation but authorised use of their medical records. Of women who were randomised, 117 (31%) allocated to induction of labour developed poor maternal outcome compared with 166 (44%) allocated to expectant monitoring (relative risk 0.71, 95% CI 0.59-0.86, p<0.0001). No cases of maternal or neonatal death or eclampsia were recorded. Induction of labour is associated with improved maternal outcome and should be advised for women with mild hypertensive disease beyond 37 weeks' gestation. ZonMw.

Health Activities Project (HAP), Trial Edition II.

ERIC Educational Resources Information Center

Buller, Dave; And Others

Contained within this Health Activities Project (HAP) trial edition (set II) are a teacher information folio and numerous student activity folios which center around the idea that students in grades 5-8 can control their own health and safety. Each student folio is organized into a Synopsis, Health Background, Materials, Setting Up, and Activities…

Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial.

PubMed

Juraskova, I; Butow, P; Bonner, C; Bell, M L; Smith, A B; Seccombe, M; Boyle, F; Reaby, L; Cuzick, J; Forbes, J F

2014-07-08

Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial. The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up). Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS-DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up. This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation.

Effects of obstetric gel on the process and duration of labour in pregnant women: Randomised controlled trial.

PubMed

Seval, Mehmet Murat; Yüce, Tuncay; Yakıştıran, Betül; Şükür, Yavuz Emre; Özmen, Batuhan; Atabekoğlu, Cem; Koç, Acar; Söylemez, Feride

2017-08-01

The present study investigated maternal and neonatal outcomes in pregnant women who used obstetric lubricant gels during active labour. This prospective randomised controlled study included 180 pregnant women. Women were randomly assigned to two groups during the first-stage of labour. Pregnant women in the obstetric gel group received standard antepartum care plus vaginal application of obstetric gel. Women in the control group received standard antepartum care without obstetric gel. Mean duration of the second stage of labour was significantly shorter in the obstetric gel group than control group (45 ± 34 min vs. 58 ± 31 min, respectively; p = .005). Mean APGAR values at 5 min were significantly higher in the obstetric gel group (9.5 ± 0.6 vs. 9.2 ± 0.7; p = .0014). Among nulliparous women, mean duration of the second stage of labour was significantly shorter in the gel group than control group (53 ± 52 min vs. 83 ± 45 min, respectively; p = .003). Using obstetric gel at the beginning of the first stage decreases the length of the second stage of labour, particularly in nulliparous women, and may be associated with an improved APGAR score at 5 min. Impact statement A limited number of studies in the literature have demonstrated that obstetric gels shorten the second stage of labour and are protective for the pelvic floor. The results of this study show that using obstetric gel shortens the second stage of labour in only nulliparous, but not multiparous women. In addition, a significant improvement in the 5 min APGAR score was seen in the neonates of women who used obstetric gel. The application of obstetric gels during the labour of nulliparous women may be a useful clinical practice and may have a widespread use in the future.

The Pain of Labour

PubMed Central

Labor, Simona

2008-01-01

Labour is an emotional experience and involves both physiological and psychological mechanisms. The pain of labour is severe but despite this its memory diminishes with time. Labour pain has two components: visceral pain which occurs during the early first stage and the second stage of childbirth, and somatic pain which occurs during the late first stage and the second stage. The pain of labour in the first stage is mediated by T10 to L1 spinal segments, whereas that in the second stage is carried by T12 to L1, and S2 to S4 spinal segments. Pain relief in labour is complex and often challenging without regional analgesia. Effective management of labour pain plays a relatively minor role in a woman's satisfaction with childbirth. PMID:26526404

Analysis of phase II studies on targeted agents and subsequent phase III trials: what are the predictors for success?

PubMed

Chan, John K; Ueda, Stefanie M; Sugiyama, Valerie E; Stave, Christopher D; Shin, Jacob Y; Monk, Bradley J; Sikic, Branimir I; Osann, Kathryn; Kapp, Daniel S

2008-03-20

To identify the characteristics of phase II studies that predict for subsequent "positive" phase III trials (those that reached the proposed primary end points of study or those wherein the study drug was superior to the standard regimen investigating targeted agents in advanced tumors. We identified all phase III clinical trials of targeted therapies against advanced cancers published from 1985 to 2005. Characteristics of the preceding phase II studies were reviewed to identify predictive factors for success of the subsequent phase III trial. Data were analyzed using the chi(2) test and logistic regression models. Of 351 phase II studies, 167 (47.6%) subsequent phase III trials were positive and 184 (52.4%) negative. Phase II studies from multiple rather than single institutions were more likely to precede a successful trial (60.4% v 39.4%; P < .001). Positive phase II results were more likely to lead to a successful phase III trial (50.8% v 22.5%; P = .003). The percentage of successful trials from pharmaceutical companies was significantly higher compared with academic, cooperative groups, and research institutes (89.5% v 44.2%, 45.2%, and 46.3%, respectively; P = .002). On multivariate analysis, these factors and shorter time interval between publication of phase II results and III study publication were independent predictive factors for a positive phase III trial. In phase II studies of targeted agents, multiple- versus single-institution participation, positive phase II trial, pharmaceutical company-based trials, and shorter time period between publication of phase II to phase III trial were independent predictive factors of success in a phase III trial. Investigators should be cognizant of these factors in phase II studies before designing phase III trials.

Amnioinfusion for meconium-stained liquor in labour.

PubMed

Hofmeyr, G J

2000-01-01

Amnioinfusion aims to prevent or relieve umbilical cord compression during labour by infusing a solution into the uterine cavity. It is also thought to dilute meconium when present in the amniotic fluid and so reduce the risk of meconium aspiration. However it may be that the mechanism of effect is that it corrects oligohydramnios (reduced amniotic fluid), for which thick meconium staining is a marker. The objective of this review was to assess the effects of amnioinfusion for meconium-stained liquor on perinatal outcome. The Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register were searched. Randomised trials comparing amnioinfusion with no amnioinfusion for women in labour with moderate or thick meconium-staining of the amniotic fluid. Eligibility and trial quality were assessed by one reviewer. Ten studies, most involving small numbers of participants, were included. Under standard perinatal surveillance, amnioinfusion was associated with a reduction in the following: heavy meconium staining of the liquor (relative risk 0.03, 95% confidence interval 0.01 to 0.15); variable fetal heart rate deceleration (relative risk 0.47, 95% confidence interval 0.24 to 0. 90); and a trend to reduced caesarean section overall (relative risk 0.83, 95% confidence interval 0.69 to 1.00). No perinatal deaths were reported. Under limited perinatal surveillance, amnioinfusion was associated with a reduction in the following: meconium aspiration syndrome (relative risk 0.24, 95% confidence interval 0. 12 to 0.48); neonatal hypoxic ischaemic encephalopathy (relative risk 0.07, 95% confidence interval 0.01 to 0.56) and neonatal ventilation or intensive care unit admission (relative risk 0.56, 95% confidence interval 0.39 to 0.79); there was a trend towards reduced perinatal mortality (relative risk 0.34, 95% confidence interval 0.11 to 1.06). Amnioinfusion is associated with improvements in perinatal outcome, particularly in settings where

Amnioinfusion for meconium-stained liquor in labour.

PubMed

Hofmeyr, G J

2002-01-01

Amnioinfusion aims to prevent or relieve umbilical cord compression during labour by infusing a solution into the uterine cavity. It is also thought to dilute meconium when present in the amniotic fluid and so reduce the risk of meconium aspiration. However, it may be that the mechanism of effect is that it corrects oligohydramnios (reduced amniotic fluid), for which thick meconium staining is a marker. The objective of this review was to assess the effects of amnioinfusion for meconium-stained liquor on perinatal outcome. The Cochrane Pregnancy and Childbirth Group trials register (October 2001) and the Cochrane Controlled Trials Register (Issue 3, 2001) were searched. Randomised trials comparing amnioinfusion with no amnioinfusion for women in labour with moderate or thick meconium-staining of the amniotic fluid. Eligibility and trial quality were assessed by one reviewer. Twelve studies, most involving small numbers of participants, were included. Under standard perinatal surveillance, amnioinfusion was associated with a reduction in the following: heavy meconium staining of the liquor (relative risk 0.03, 95% confidence interval 0.01 to 0.15); variable fetal heart rate deceleration (relative risk 0.65, 95% confidence interval 0.49 to 0.88); and reduced caesarean section overall (relative risk 0.82, 95% confidence interval 0.69 to 1.97). No perinatal deaths were reported. Under limited perinatal surveillance, amnioinfusion was associated with a reduction in the following: meconium aspiration syndrome (relative risk 0.24, 95% confidence interval 0.12 to 0.48); neonatal hypoxic ischaemic encephalopathy (relative risk 0.07, 95% confidence interval 0.01 to 0.56) and neonatal ventilation or intensive care unit admission (relative risk 0.56, 95% confidence interval 0.39 to 0.79); there was a trend towards reduced perinatal mortality (relative risk 0.34, 95% confidence interval 0.11 to 1.06). Amnioinfusion is associated with improvements in perinatal outcome

Phase I/II adaptive design for drug combination oncology trials

PubMed Central

Wages, Nolan A.; Conaway, Mark R.

2014-01-01

Existing statistical methodology on dose finding for combination chemotherapies has focused on toxicity considerations alone in finding a maximum tolerated dose combination to recommend for further testing of efficacy in a phase II setting. Recently, there has been increasing interest in integrating phase I and phase II trials in order to facilitate drug development. In this article, we propose a new adaptive phase I/II method for dual-agent combinations that takes into account both toxicity and efficacy after each cohort inclusion. The primary objective, both within and at the conclusion of the trial, becomes finding a single dose combination with an acceptable level of toxicity that maximizes efficacious response. We assume that there exist monotone dose–toxicity and dose–efficacy relationships among doses of one agent when the dose of other agent is fixed. We perform extensive simulation studies that demonstrate the operating characteristics of our proposed approach, and we compare simulated results to existing methodology in phase I/II design for combinations of agents. PMID:24470329

Elective induction versus spontaneous labour in Latin America

PubMed Central

Guerra, Gláucia Virgínia; Souza, João Paulo; Faúndes, Aníbal; Morais, Sirlei Siani; Gülmezoglu, Ahmet Metin; Passini, Renato; Parpinelli, Mary Angela; Carroli, Guillermo

2011-01-01

Abstract Objective To assess the frequency of elective induction of labour and its determinants in selected Latin America countries; quantify success in attaining vaginal delivery, and compare rates of caesarean and adverse maternal and perinatal outcomes after elective induction versus spontaneous labour in low-risk pregnancies. Methods Of 37 444 deliveries in women with low-risk pregnancies, 1847 (4.9%) were electively induced. The factors associated with adverse maternal and perinatal outcomes among cases of spontaneous and induced onset of labour were compared. Odds ratios for factors potentially associated with adverse outcomes were calculated, as were the relative risks of having an adverse maternal or perinatal outcome (both with their 95% confidence intervals). Adjustment using multiple logistic regression models followed these analyses. Findings Of 11 077 cases of induced labour, 1847 (16.7%) were elective. Elective inductions occurred in 4.9% of women with low-risk pregnancies (37 444). Oxytocin was the most common method used (83% of cases), either alone or combined with another. Of induced deliveries, 88.2% were vaginal. The most common maternal adverse events were: (i) a higher postpartum need for uterotonic drugs, (ii) a nearly threefold risk of admission to the intensive care unit; (iii) a fivefold risk of postpartum hysterectomy, and (iv) an increased need for anaesthesia/analgesia. Perinatal outcomes were satisfactory except for a 22% higher risk of delayed breastfeeding (i.e. initiation between 1 hour and 7 days postpartum). Conclusion Caution is mandatory when indicating elective labour induction because the increased risk of maternal and perinatal adverse outcomes is not outweighed by clear benefits. PMID:21897486

Improving decision making about clinical trial participation – a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial

PubMed Central

Juraskova, I; Butow, P; Bonner, C; Bell, M L; Smith, A B; Seccombe, M; Boyle, F; Reaby, L; Cuzick, J; Forbes, J F

2014-01-01

Background: Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial. Methods: The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up). Results: Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS–DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up. Conclusions: This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation. PMID:24892447

Outdoor Biology Instructional Strategies Trial Edition. Set II.

ERIC Educational Resources Information Center

Fairwell, Kay, Ed.; And Others

The 24 activities in the Outdoor Biology Instructional Strategies (OBIS) Trial Edition Set II use living organisms such as crabs, birds, crayfish, lichens, and insects to investigate biological interrelationships, organism behavior, and species density to promote greater environmental and sensory awareness. The activities, designed primarily for…

Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers.

PubMed

Liu, Yu-Hsiang; Chang, Mei-Yueh; Chen, Chung-Hey

2010-04-01

The purpose of the study was to investigate the effects of music on pain reaction and anxiety during labour. Music therapy has been used on clinical medicine. Only few scientific studies validate the value on labour women. Randomised controlled trial. Sixty primiparas expected to have a normal spontaneous delivery were randomly assigned to either the experimental group (n = 30) or the control group (n = 30). The experimental group received routine care and music therapy, whereas the control group received routine care only. A self-report visual analogue scale for pain and a nurse-rated present behavioural intensity were used to measure labour pain. Anxiety was measured with a visual analogue scale for anxiety and finger temperature. Pain and anxiety between groups were compared during the latent phase (2-4 cm cervical dilation) and active phase (5-7 cm) separately. Our results revealed that compared with the control group, the experimental group had significantly lower pain, anxiety and a higher finger temperature during the latent phase of labour. However, no significant differences were found between the two groups on all outcome measures during the active phase. This study provides evidence for the use of music as an empirically based intervention of women for labour pain and anxiety during the latent phase of labour. The findings support that music listening is an acceptable and non-medical coping strategy for labouring women. Especially, apply in reducing the pain and anxiety for women who are at the early phase of labour.

Intravenous oxytocin alone for cervical ripening and induction of labour

PubMed Central

Alfirevic, Zarko; Kelly, Anthony J; Dowswell, Therese

2014-01-01

Background Oxytocin is the commonest induction agent used worldwide. It has been used alone, in combination with amniotomy or following cervical ripening with other pharmacological or non-pharmacological methods. Objectives To determine the effects of oxytocin alone for third trimester cervical ripening and induction of labour in comparison with other methods of induction of labour or placebo/no treatment. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (January 2009) and bibliographies of relevant papers. Selection criteria Randomised and quasi-randomised trials comparing intravenous oxytocin with placebo or no treatment, or with prostaglandins (vaginal or intracervical) for third trimester cervical ripening or labour induction. Data collection and analysis Two review authors independently assessed eligibility and carried out data extraction. Main results Sixty-one trials (12,819 women) are included. When oxytocin inductions were compared with expectant management, fewer women failed to deliver vaginally within 24 hours (8.4% versus 53.8%, risk ratio (RR) 0.16, 95% confidence interval (CI) 0.10 to 0.25). There was a significant increase in the number of women requiring epidural analgesia (RR 1.10, 95% CI 1.04 to 1.17). Fewer women were dissatisfied with oxytocin induction in the one trial reporting this outcome (5.9% versus 13.7%, RR 0.43, 95% CI 0.33 to 0.56). Compared with vaginal prostaglandins, oxytocin increased unsuccessful vaginal delivery within 24 hours in the two trials reporting this outcome (70% versus 21%, RR 3.33, 95% CI 1.61 to 6.89). There was a small increase in epidurals when oxytocin alone was used (RR 1.09, 95% CI 1.01 to 1.17). Most of the studies included women with ruptured membranes, and there was some evidence that vaginal prostaglandin increased infection in mothers (chorioamnionitis RR 0.66, 95% CI 0.47 to 0.92) and babies (use of antibiotics RR 0.68, 95% CI 0.53 to 0.87). These data should be

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

PubMed

Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

2017-01-01

Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Quality of reporting was assessed using the Key Methodological Score. 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.

Labour circulation and the urban labour process.

PubMed

Standing, G

1986-01-01

The author investigates aspects of labor circulation, which he defines as "temporary movement between geographical areas for work or in search of work....[He attempts to determine] what roles have been played by labour circulation in the development of urban-industrial labour forces in the transition to industrial capitalism." Factors considered include the exploitation and oppression of labor migrants; the industrial-urban labor reserve; urban socioeconomic stratification and discrimination by age, sex, or race; the division of labor; and policy options. excerpt

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

Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour.

PubMed

Sng, Ban Leong; Zeng, Yanzhi; de Souza, Nurun Nisa A; Leong, Wan Ling; Oh, Ting Ting; Siddiqui, Fahad Javaid; Assam, Pryseley N; Han, Nian-Lin R; Chan, Edwin Sy; Sia, Alex T

2018-05-17

Childbirth may cause the most severe pain some women experience in their lifetime. Epidural analgesia is an effective form of pain relief during labour and is considered to be the reference standard. Traditionally epidural analgesia has been delivered as a continuous infusion via a catheter in the epidural space, with or without the ability for the patient to supplement the analgesia received by activating a programmable pump to deliver additional top-up doses, known as patient-controlled epidural analgesia (PCEA). There has been interest in delivering maintenance analgesic medication via bolus dosing (automated mandatory bolus - AMB) instead of the traditional continuous basal infusion (BI); recent randomized controlled trials (RCTs) have shown that the AMB technique leads to improved analgesia and maternal satisfaction. To assess the effects of automated mandatory bolus versus basal infusion for maintaining epidural analgesia in labour. We searched CENTRAL, MEDLINE, Embase, the World Health Organization International Clinial Trials Registry Platform (WHO-ICTRP) and ClinicalTrials.gov on 16 January 2018. We screened the reference lists of all eligible trials and reviews. We also contacted authors of included studies in this field in order to identify unpublished research and trials still underway, and we screened the reference lists of the included articles for potentially relevant articles. We included all RCTs that compared the use of bolus dosing AMB with continuous BI for providing pain relief during epidural analgesia for labour in women. We used the standard methodological procedures expected by Cochrane. Our primary outcomes were: risk of breakthrough pain with the need for anaesthetic intervention; risk of caesarean delivery; risk of instrumental delivery. Secondary outcomes included: duration of labour; local anaesthetic consumption. We used GRADE to assess the certainty of evidence for each outcome. We included 12 studies with a total of 1121 women. Ten

Magnesium sulphate for preventing preterm birth in threatened preterm labour.

PubMed

Crowther, Caroline A; Brown, Julie; McKinlay, Christopher J D; Middleton, Philippa

2014-08-15

Magnesium sulphate has been used in some settings as a tocolytic agent to inhibit uterine activity in women in preterm labour with the aim of preventing preterm birth. To assess the effects of magnesium sulphate therapy given to women in threatened preterm labour with the aim of preventing preterm birth and its sequelae. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (last searched 31 January 2014). Randomised controlled trials of magnesium sulphate as the only tocolytic, administered by any route, compared with either placebo, no treatment or alternative tocolytic therapy (not magnesium sulphate) to women considered to be in preterm labour. At least two review authors assessed trial eligibility and risk of bias and undertook data extraction independently. The 37 included trials (total of 3571 women and over 3600 babies) were generally of moderate to high risk of bias. Antenatal magnesium sulphate was compared with either placebo, no treatment, or a range of alternative tocolytic agents.For the primary outcome of giving birth within 48 hours after trial entry, no significant differences were seen between women who received magnesium sulphate and women who did not (whether placebo/no alternative tocolytic drug, betamimetics, calcium channel blockers, cox inhibitors, prostaglandin inhibitors, or human chorionic gonadotropin) (19 trials, 1913 women). Similarly for the primary outcome of serious infant outcome, there were no significant differences between the infants exposed to magnesium sulphate and those not (whether placebo/no alternative tocolytic drug, betamimetics, calcium channel blockers, cox inhibitors, prostaglandin inhibitors, human chorionic gonadotropin or various tocolytic drugs) (18 trials; 2187 babies). No trials reported the outcome of extremely preterm birth. In the seven trials that reported serious maternal outcomes, no events were recorded.In the group treated with magnesium sulphate compared with women receiving

Does oral carbohydrate supplementation improve labour outcome? A systematic review and individual patient data meta-analysis.

PubMed

Malin, G L; Bugg, G J; Thornton, J; Taylor, M A; Grauwen, N; Devlieger, R; Kardel, K R; Kubli, M; Tranmer, J E; Jones, N W

2016-03-01

Labour is a period of significant physical activity. The importance of carbohydrate intake to improve outcome has been recognised in sports medicine and general surgery. To assess the effect of oral carbohydrate supplementation on labour outcomes. MEDLINE (1966-2014), Embase, the Cochrane Library and clinical trial registries. Randomised controlled trials (RCT) of women randomised to receive oral carbohydrate in labour (<6 cm dilated), versus placebo or standard care. Authors were contacted to provide data. Individual patient data meta-analyses were performed to calculate pooled risk ratios (RR) and 95% confidence intervals (CI). Eight RCTs met the inclusion criteria. Six authors responded, four supplied data (n = 691). Three studies used isotonic drinks (one placebo-controlled, two compared with standard care), and one an advice booklet regarding carbohydrate intake. The mean difference in energy intake between the intervention and control groups was small [three studies, 195 kilocalories (kcal), 95% CI 118-273]. There was no difference in the risk of caesarean section (RR 1.15, 95% CI 0.83- 1.61), instrumental birth (RR 1.26, 95% CI 0.96-1.66) or syntocinon augmentation (RR 0.99, 95% CI 0.86-1.13). Length of labour was similar (mean difference -3.15 minutes, 95% CI -35.14 to 41.95). Restricting the analysis to primigravid women did not affect the result. Oral carbohydrates did not increase the risk of vomiting (RR 1.09, 95% CI 0.78-1.52) or 1-minute Apgar score <7 (RR 1.23, 95% CI 0.82-1.83). Oral carbohydrate supplements in small quantities did not alter labour outcome. Oral carbohydrate does not affect labour. But the difference between intervention and control equals 10 teaspoons sugar. © 2016 Royal College of Obstetricians and Gynaecologists.

WITHDRAWN: Amnioinfusion for meconium-stained liquor in labour.

PubMed

Hofmeyr, G Justus

2009-01-21

Amnioinfusion aims to prevent or relieve umbilical cord compression during labour by infusing a solution into the uterine cavity. It is also thought to dilute meconium when present in the amniotic fluid and so reduce the risk of meconium aspiration. However, it may be that the mechanism of effect is that it corrects oligohydramnios (reduced amniotic fluid), for which thick meconium staining is a marker. The objective of this review was to assess the effects of amnioinfusion for meconium-stained liquor on perinatal outcome. The Cochrane Pregnancy and Childbirth Group trials register (October 2001) and the Cochrane Controlled Trials Register (Issue 3, 2001) were searched. Randomised trials comparing amnioinfusion with no amnioinfusion for women in labour with moderate or thick meconium-staining of the amniotic fluid. Eligibility and trial quality were assessed by one reviewer. Twelve studies, most involving small numbers of participants, were included. Under standard perinatal surveillance, amnioinfusion was associated with a reduction in the following: heavy meconium staining of the liquor (relative risk 0.03, 95% confidence interval 0.01 to 0.15); variable fetal heart rate deceleration (relative risk 0.65, 95% confidence interval 0.49 to 0.88); and reduced caesarean section overall (relative risk 0.82, 95% confidence interval 0.69 to 1.97). No perinatal deaths were reported. Under limited perinatal surveillance, amnioinfusion was associated with a reduction in the following: meconium aspiration syndrome (relative risk 0.24, 95% confidence interval 0.12 to 0.48); neonatal hypoxic ischaemic encephalopathy (relative risk 0.07, 95% confidence interval 0.01 to 0.56) and neonatal ventilation or intensive care unit admission (relative risk 0.56, 95% confidence interval 0.39 to 0.79); there was a trend towards reduced perinatal mortality (relative risk 0.34, 95% confidence interval 0.11 to 1.06). Amnioinfusion is associated with improvements in perinatal outcome

At What Price? A Cost-Effectiveness Analysis Comparing Trial of Labour after Previous Caesarean versus Elective Repeat Caesarean Delivery

PubMed Central

Fawsitt, Christopher G.; Bourke, Jane; Greene, Richard A.; Everard, Claire M.; Murphy, Aileen; Lutomski, Jennifer E.

2013-01-01

Background Elective repeat caesarean delivery (ERCD) rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland. Methods Using a decision analytic model, a cost-effectiveness analysis (CEA) was performed where the measure of health gain was quality-adjusted life years (QALYs) over a six-week time horizon. A review of international literature was conducted to derive representative estimates of adverse maternal health outcomes following a trial of labour after caesarean (TOLAC) and ERCD. Delivery/procedure costs derived from primary data collection and combined both “bottom-up” and “top-down” costing estimations. Results Maternal morbidities emerged in twice as many cases in the TOLAC group than the ERCD group. However, a TOLAC was found to be the most-effective method of delivery because it was substantially less expensive than ERCD (€1,835.06 versus €4,039.87 per women, respectively), and QALYs were modestly higher (0.84 versus 0.70). Our findings were supported by probabilistic sensitivity analysis. Conclusions Clinicians need to be well informed of the benefits and risks of TOLAC among low risk women. Ideally, clinician-patient discourse would address differences in length of hospital stay and postpartum recovery time. While it is premature advocate a policy of TOLAC across maternity units, the results of the study prompt further analysis and repeat iterations, encouraging future studies to synthesis previous research and new and relevant evidence under a single

Validation of a prediction model for predicting the probability of morbidity related to a trial of labour in Quebec.

PubMed

Chaillet, Nils; Bujold, Emmanuel; Dubé, Eric; Grobman, William A

2012-09-01

Pregnant women with a history of previous Caesarean section face the decision either to undergo an elective repeat Caesarean section (ERCS) or to attempt a trial of labour with the goal of achieving a vaginal birth after Caesarean (VBAC). Both choices are associated with their own risks of maternal and neonatal morbidity. We aimed to determine the external validity of a prediction model for the success of trial of labour after Caesarean section (TOLAC) that could help these women in their decision-making. We used a perinatal database including 185,437 deliveries from 32 obstetrical centres in Quebec between 2007 and 2011 and selected women with one previous Caesarean section who were eligible for a TOLAC. We compared the frequency of maternal and neonatal morbidity between women who underwent TOLAC and those who underwent an ERCS according to the probability of success of TOLAC calculated from a published model of prediction. Of 8508 eligible women, including 3113 who underwent TOLAC, both maternal and neonatal morbidities became less frequent as the predicted chance of VBAC increased (P < 0.05). Women undergoing a TOLAC were more likely to have maternal morbidity than those who underwent an ERCS when the predicted probability of VBAC was less than 60% (relative risk [RR] 2.3; 95% CI 1.4 to 4.0); conversely, maternal morbidity was not different between the two groups when the predicted probability of VBAC was at least 60% (RR 0.8; 95% CI 0.6 to 1.1). Neonatal morbidity was similar between groups when the probability of VBAC success was 70% or greater (RR 1.2; 95% CI 0.9 to 1.5). The use of a prediction model for TOLAC success could be useful in the prediction of TOLAC success and perinatal morbidity in a Canadian population. Neither maternal nor neonatal morbidity are increased with a TOLAC when the probability of VBAC success is at least 70%.

Intermittent auscultation (IA) of fetal heart rate in labour for fetal well-being.

PubMed

Martis, Ruth; Emilia, Ova; Nurdiati, Detty S; Brown, Julie

2017-02-13

The goal of fetal monitoring in labour is the early detection of a hypoxic baby. There are a variety of tools and methods available for intermittent auscultation (IA) of the fetal heart rate (FHR). Low- and middle-income countries usually have only access to a Pinard/Laënnec or the use of a hand-held Doppler device. Currently, there is no robust evidence to guide clinical practice on the most effective IA tool to use, timing intervals and length of listening to the fetal heart for women during established labour. To evaluate the effectiveness of different tools for IA of the fetal heart rate during labour including frequency and duration of auscultation. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (19 September 2016), contacted experts and searched reference lists of retrieved articles. All published and unpublished randomised controlled trials (RCTs) or cluster-RCTs comparing different tools and methods used for intermittent fetal auscultation during labour for fetal and maternal well-being. Quasi-RCTs, and cross-over designs were not eligible for inclusion. All review authors independently assessed eligibility, extracted data and assessed risk of bias for each trial. Data were checked for accuracy. We included three studies (6241 women and 6241 babies), but only two studies are included in the meta-analyses (3242 women and 3242 babies). Both were judged as high risk for performance bias due to the inability to blind the participants and healthcare providers to the interventions. Evidence was graded as moderate to very low quality; the main reasons for downgrading were study design limitations and imprecision of effect estimates. Intermittent Electronic Fetal Monitoring (EFM) using Cardiotocography (CTG) with routine Pinard (one trial)There was no clear difference between groups in low Apgar scores at five minutes (reported as < six at five minutes after birth) (risk ratio (RR) 0.66, 95% confidence interval (CI) 0.24 to 1.83, 633

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review

PubMed Central

Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

2017-01-01

Background Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. Data sources A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010–2015). Study eligibility criteria All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Intervention Quality of reporting was assessed using the Key Methodological Score. Results 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Limitations Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. Conclusions & implications of key findings This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials

A Bayesian-frequentist two-stage single-arm phase II clinical trial design.

PubMed

Dong, Gaohong; Shih, Weichung Joe; Moore, Dirk; Quan, Hui; Marcella, Stephen

2012-08-30

It is well-known that both frequentist and Bayesian clinical trial designs have their own advantages and disadvantages. To have better properties inherited from these two types of designs, we developed a Bayesian-frequentist two-stage single-arm phase II clinical trial design. This design allows both early acceptance and rejection of the null hypothesis ( H(0) ). The measures (for example probability of trial early termination, expected sample size, etc.) of the design properties under both frequentist and Bayesian settings are derived. Moreover, under the Bayesian setting, the upper and lower boundaries are determined with predictive probability of trial success outcome. Given a beta prior and a sample size for stage I, based on the marginal distribution of the responses at stage I, we derived Bayesian Type I and Type II error rates. By controlling both frequentist and Bayesian error rates, the Bayesian-frequentist two-stage design has special features compared with other two-stage designs. Copyright © 2012 John Wiley & Sons, Ltd.

Amnioinfusion for meconium-stained liquor in labour.

PubMed

Hofmeyr, G Justus; Xu, Hairong

2010-01-20

Amnioinfusion is thought to dilute meconium present in the amniotic fluid and so reduce the risk of meconium aspiration. To assess the effects of amnioinfusion for meconium-stained liquor on perinatal outcome. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (May 2009). Randomised trials comparing amnioinfusion with no amnioinfusion for women in labour with moderate or thick meconium-staining of the amniotic fluid. Two review authors assessed eligibility and trial quality, and extracted data, independently. Thirteen studies of variable quality (4143 women) are included.Subgroup analysis was performed for studies from settings with limited facilities to monitor the baby's condition during labour and intervene effectively, and settings with standard peripartum surveillance.Settings with standard peripartum surveillance: there was considerable heterogeneity for several outcomes. There was no significant reduction in the primary outcomes meconium aspiration syndrome, perinatal death or severe morbidity, and maternal death or severe morbidity. There was a reduction in caesarean sections (CSs) for fetal distress but not overall. Meconium below the vocal cords diagnosed by laryngoscopy was reduced, as was neonatal ventilation or neonatal intensive care unit admission, but there was no significant reduction in perinatal deaths or other morbidity. Planned sensitivity analysis excluding trials with greater risk of bias resulted in an absence of benefits for any of the outcomes studied.Settings with limited peripartum surveillance: two studies (855 women) were included. In the amnioinfusion group there was a reduction in CS for fetal distress and overall; meconium aspiration syndrome (RR 0.25, 95% CI 0.13 to 0.47), and neonatal ventilation or neonatal intensive care unit admission; and a trend towards reduced perinatal mortality (RR 0.37, 95% CI 0.13 to 1.01). In one of the studies, meconium below the vocal cords was reduced and, in the other

Quality of labour neuraxial analgesia and maternal satisfaction at a tertiary care teaching hospital: a prospective observational study.

PubMed

Clivatti, Jefferson; Siddiqui, Naveed; Goel, Akash; Shaw, Melissa; Crisan, Ioana; Carvalho, Jose C A

2013-08-01

Current labour analgesia practices are evidence-based; however, such evidence often originates in controlled trials, the results of which may not be readily applicable in the context of day-to-day clinical practice. The objective of this study was to evaluate the effectiveness of and maternal satisfaction with the neuraxial labour analgesia regimen provided at a tertiary care teaching hospital. All women with a viable pregnancy who requested neuraxial analgesia for labour during November 2011 at our institution were approached to participate in this prospective study. Patients were managed as per departmental routine based on a patient-controlled epidural analgesia regimen with a maintenance solution of 0.0625% bupivacaine and fentanyl 2 μg·mL(-1). Demographic and obstetric data, characteristics of the neuraxial analgesia, pain scores, side effects, and complications were recorded. After delivery, patients completed a satisfaction questionnaire. All 332 eligible women were approached, and 294 completed the study. Most women received epidural analgesia and considered its placement comfortable. A large number of women reported having experienced pain during the first or second stages of labour (38% and 26%, respectively). Although 24.4% of women required top-ups both by nurses and physicians, adjustment in the local anesthetic maintenance concentration was made in only 7.8% of the cases. Most women (92%) were satisfied with the quality of analgesia. Unintentional dural puncture occurred in three (1%) cases, and there were no cases of intravascular catheter insertion or systemic local anesthetic toxicity. Overweight women (body mass index 25-30 kg·m(-2)) (adjusted odds ratio [AOR] = 2.56; 95% confidence interval [CI]: 1.1 to 5.97), those undergoing induced labour (AOR = 2.4; 95% CI: 1.2 to 5.2), and those requiring top-ups by the anesthesiologist (AOR = 5.08; 95% CI: 2.31 to 11.11) were associated with more dissatisfaction with pain control during the first stage

Embodied labour in music work.

PubMed

Pettinger, Lynne

2015-06-01

This paper frames the work of performance as embodied labour in order to understand the contingent production of particular music performances. It is an interdisciplinary account that sits at the intersection of the sociology of work, culture and the body. The concept of embodied labour is developed with reference to the complex account of materiality - of bodies and things - present in Tim Ingold's account of skill. This material account of skill is used to inform use to develop already of well established conceptualizations of body labour: craft, emotional and aesthetic labour through a reading of how these dimensions of embodied labour make possible the work of performance. © London School of Economics and Political Science 2015.

'Soothing the ring of fire': Australian women's and midwives' experiences of using perineal warm packs in the second stage of labour.

PubMed

Dahlen, Hannah G; Homer, Caroline S E; Cooke, Margaret; Upton, Alexis M; Nunn, Rosalie A; Brodrick, Belinda S

2009-04-01

to determine women's and midwives' experiences of using perineal warm packs in the second stage of labour. as part of a randomised controlled trial (Warm Pack Trial), women and midwives were asked to complete questionnaires about the effects of the warm packs on pain, perineal trauma, comfort, feelings of control, satisfaction and intentions for use during future births. two hospitals in Sydney, Australia. a randomised controlled trial was undertaken. In the late second stage of labour, nulliparous women (n=717) giving birth were randomly allocated to having warm packs (n=360) applied to their perineum or standard care (n=357). Standard care was defined as any second stage practice carried out by midwives that did not include the application of warm packs to the perineum. Three hundred and two nulliparous women randomised to receive warm packs (84%) received the treatment. Questionnaires were completed by 266 (88%) women who received warm packs, and 270 (89%) midwives who applied warm packs to these women. warm, moist packs were applied to the perineum in the late second stage of labour. warm packs were highly acceptable to both women and midwives as a means of relieving pain during the late second stage of labour. Almost the same number of women (79.7%) and midwives (80.4%) felt that the warm packs reduced perineal pain during the birth. Both midwives and women were positive about using warm packs in the future. The majority of women (85.7%) said that they would like to use perineal warm packs again for their next birth and would recommend them to friends (86.1%). Likewise, 91% of midwives were positive about using the warm packs, with 92.6% considering using them in the future as part of routine care in the second stage of labour. responses to questionnaires, eliciting experiences of women and midwives involved in the Warm Pack Trial, demonstrated that the practice of applying perineal warm packs in the late second stage of labour was highly acceptable and

Sino-implant (II) - a levonorgestrel-releasing two-rod implant: systematic review of the randomized controlled trials

PubMed Central

Steiner, Markus J.; Lopez, Laureen M.; Grimes, David A.; Cheng, Linan; Shelton, Jim; Trussell, James; Farley, Timothy M.M.; Dorflinger, Laneta

2013-01-01

Background Sino-implant (II) is a subdermal contraceptive implant manufactured in China. This two-rod levonorgestrel-releasing implant has the same amount of active ingredient (150 mg levonorgestrel) and mechanism of action as the widely available contraceptive implant Jadelle. We examined randomized controlled trials of Sino-implant (II) for effectiveness and side effects. Study design We searched electronic databases for studies of Sino-implant (II), and then restricted our review to randomized controlled trials. The primary outcome of this review was pregnancy. Results Four randomized trials with a total of 15,943 women assigned to Sino-implant (II) had first-year probabilities of pregnancy ranging from 0.0% to 0.1%. Cumulative probabilities of pregnancy during the four years of the product's approved duration of use were 0.9% and 1.06% in the two trials that presented date for four-year use. Five-year cumulative probabilities of pregnancy ranged from 0.7% to 2.1%. In one trial, the cumulative probability of pregnancy more than doubled during the fifth year (from 0.9% to 2.1%), which may be why the implant is approved for four years of use in China. Five-year cumulative probabilities of discontinuation due to menstrual problems ranged from 12.5% to 15.5% for Sino-implant (II). Conclusions Sino-implant (II) is one of the most effective contraceptives available today. These available clinical data, combined with independent laboratory testing, and the knowledge that 7 million women have used this method since 1994, support the safety and effectiveness of Sino-implant (II). The lower cost of Sino-implant (II) compared with other subdermal implants could improve access to implants in resource-constrained settings. PMID:20159174

Rational Clinical Experiment: Assessing Prior Probability and Its Impact on the Success of Phase II Clinical Trials

PubMed Central

Halperin, Daniel M.; Lee, J. Jack; Dagohoy, Cecile Gonzales; Yao, James C.

2015-01-01

Purpose Despite a robust clinical trial enterprise and encouraging phase II results, the vast minority of oncologic drugs in development receive regulatory approval. In addition, clinicians occasionally make therapeutic decisions based on phase II data. Therefore, clinicians, investigators, and regulatory agencies require improved understanding of the implications of positive phase II studies. We hypothesized that prior probability of eventual drug approval was significantly different across GI cancers, with substantial ramifications for the predictive value of phase II studies. Methods We conducted a systematic search of phase II studies conducted between 1999 and 2004 and compared studies against US Food and Drug Administration and National Cancer Institute databases of approved indications for drugs tested in those studies. Results In all, 317 phase II trials were identified and followed for a median of 12.5 years. Following completion of phase III studies, eventual new drug application approval rates varied from 0% (zero of 45) in pancreatic adenocarcinoma to 34.8% (24 of 69) for colon adenocarcinoma. The proportion of drugs eventually approved was correlated with the disease under study (P < .001). The median type I error for all published trials was 0.05, and the median type II error was 0.1, with minimal variation. By using the observed median type I error for each disease, phase II studies have positive predictive values ranging from less than 1% to 90%, depending on primary site of the cancer. Conclusion Phase II trials in different GI malignancies have distinct prior probabilities of drug approval, yielding quantitatively and qualitatively different predictive values with similar statistical designs. Incorporation of prior probability into trial design may allow for more effective design and interpretation of phase II studies. PMID:26261263

InterGeo II: International Geographical Achievement Test. Field Trials Report and Test (Secondary Schools, Grade 8).

ERIC Educational Resources Information Center

Niemz, Gunter; Stoltman, Joseph P.

InterGeo II, a project of the Commission on Geographical Education (CGE) of the International Geographical Union (IGU), has developed a broadly based, field-trialed testing instrument for making cross-national comparisons of achievement in geography. Field trials of InterGeo II were held in 23 countries. Data were analyzed for national achievement…

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

Calcium channel blockers for inhibiting preterm labour and birth.

PubMed

Flenady, Vicki; Wojcieszek, Aleena M; Papatsonis, Dimitri N M; Stock, Owen M; Murray, Linda; Jardine, Luke A; Carbonne, Bruno

2014-06-05

Preterm birth is a major contributor to perinatal mortality and morbidity, affecting around 9% of births in high-income countries and an estimated 13% of births in low- and middle-income countries. Tocolytics are drugs used to suppress uterine contractions for women in preterm labour. The most widely used tocolytic are the betamimetics, however, these are associated with a high frequency of unpleasant and sometimes severe maternal side effects. Calcium channel blockers (CCBs) (such as nifedipine) may have similar tocolytic efficacy with less side effects than betamimetics. Oxytocin receptor antagonists (ORAs) (e.g. atosiban) also have a low side-effect profile. To assess the effects on maternal, fetal and neonatal outcomes of CCBs, administered as a tocolytic agent, to women in preterm labour. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (12 November 2013). All published and unpublished randomised trials in which CCBs were used for tocolysis for women in labour between 20 and 36 completed weeks' gestation. Two review authors independently assessed trial eligibility, undertook quality assessment and data extraction. Results are presented using risk ratio (RR) for categorical data and mean difference (MD) for data measured on a continuous scale with the 95% confidence interval (CI). The number needed to treat to benefit (NNTB) and the number needed to treat to harm (NNTH) were calculated for categorical outcomes that were statistically significantly different. This update includes 26 additional trials involving 2511 women, giving a total of 38 included trials (3550 women). Thirty-five trials used nifedipine as the CCB and three trials used nicardipine. Blinding of intervention and outcome assessment was undertaken in only one of the trials (a placebo controlled trial). However, objective outcomes defined according to timing of birth and perinatal mortality were considered to have low risk of detection bias.Two small trials comparing CCBs

Labour Disputes of Gifted Employees

ERIC Educational Resources Information Center

van der Waal, Ido; Nauta, Noks; Lindhout, Rebecca

2013-01-01

This article describes a study on labour disputes of gifted people. Fifty-five gifted people, who have had one or more labour disputes, which resulted in their staying at home and filling out an online survey. Face-to-face interviews were held with seven respondents with more than two labour disputes. In this article, we describe the results of…

Eliminating child labour in Malawi: a British American Tobacco corporate responsibility project to sidestep tobacco labour exploitation

PubMed Central

Otañez, M G; Muggli, M E; Hurt, R D; Glantz, S A

2006-01-01

Objectives To examine British American Tobacco and other tobacco industry support of the Eliminating Child Labour in Tobacco Growing Foundation. Design Analyses of internal tobacco industry documents and ethnographic data. Results British American Tobacco co‐founded the Eliminating Child Labour in Tobacco Growing Foundation (ECLT) in October 2000 and launched its pilot project in Malawi. ECLT's initial projects were budgeted at US$2.3 million over four years. Labour unions and leaf dealers, through ECLT funds, have undertook modest efforts such as building schools, planting trees, and constructing shallow wells to address the use of child labour in tobacco farming. In stark contrast, the tobacco companies receive nearly US$40 million over four years in economic benefit through the use of unpaid child labour in Malawi during the same time. BAT's efforts to combat child labour in Malawi through ECLT was developed to support the company's “corporate social responsibility agenda” rather than accepting responsibility for taking meaningful steps to eradicate child labour in the Malawi tobacco sector. Conclusion In Malawi, transnational tobacco companies are using child labour projects to enhance corporate reputations and distract public attention from how they profit from low wages and cheap tobacco. PMID:16728754

KLF5 regulates infection- and inflammation-induced pro-labour mediators in human myometrium.

PubMed

Lappas, Martha

2015-05-01

The transcription factor Kruppel-like factor 5 (KLF5) has been shown to associate with nuclear factor kappa B (NFκB) to regulate genes involved in inflammation. However, there are no studies on the expression and regulation of KLF5 in the processes of human labour and delivery. Thus, the aims of this study were to determine the effect of i) human labour on KLF5 expression in both foetal membranes and myometrium; ii) the pro-inflammatory cytokine interleukin 1 beta (IL1β), bacterial product flagellin and the viral dsRNA analogue poly(I:C) on KLF5 expression and iii) KLF5 knockdown by siRNA in human myometrial primary cells on pro-inflammatory and pro-labour mediators. In foetal membranes, there was no effect of term or preterm labour on KLF5 expression. In myometrium, the term labour was associated with an increase in nuclear KLF5 protein expression. Moreover, KLF5 expression was also increased in myometrial cells treated with IL1β, flagellin or poly(IC), likely factors contributing to preterm birth. KLF5 silencing in myometrial cells significantly decreased IL1β-induced cytokine expression (IL6 and IL8 mRNA expression and release), COX2 mRNA expression, and subsequent release of prostaglandins PGE2 and PGF2 α. KLF5 silencing also significantly reduced flagellin- and poly(I:C)-induced IL6 and IL8 mRNA expression. Lastly, IL1β-, flagellin- and poly(I:C)-stimulated NFκB transcriptional activity was significantly suppressed in KLF5-knockout myometrial cells. In conclusion, this study describes novel data in which KLF5 is increased in labouring myometrium, and KLF5 silencing decreased inflammation- and infection-induced pro-labour mediators. © 2015 Society for Reproduction and Fertility.

International migration and New Zealand labour markets.

PubMed

Farmer, R S

1986-06-01

"This paper seeks to assess the value of the overseas-born members of the labour force in ensuring a flexible labour supply in New Zealand since the beginning of the 1970s. Three main issues are considered: first, the role of the labour market in New Zealand's immigration policy; second, international migration trends and the labour market; and third, the evidence on migration and labour market segmentation in New Zealand." Data used are from official external migration statistics, quinquennial censuses, and recent research. The author notes that "in New Zealand immigration measures are currently being taken that emphasize that immigration continues to add to the flexibility of the labour market while uncontrolled emigration is a major cause of labour market instability." (SUMMARY IN FRE AND SPA) excerpt

Amnioinfusion for meconium-stained liquor in labour.

PubMed

Hofmeyr, G Justus; Xu, Hairong; Eke, Ahizechukwu C

2014-01-23

Amnioinfusion is thought to dilute meconium present in the amniotic fluid and so reduce the risk of meconium aspiration. To assess the effects of amnioinfusion for meconium-stained liquor on perinatal outcome. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 December 2013). Randomised trials comparing amnioinfusion with no amnioinfusion for women in labour with moderate or thick meconium staining of the amniotic fluid. Three review authors independently assessed eligibility and trial quality, and extracted data. Fourteen studies of variable quality (4435 women) are included.Subgroup analysis was performed for studies from settings with limited facilities to monitor the baby's condition during labour and intervene effectively, and settings with standard peripartum surveillance.Settings with standard peripartum surveillance: there was considerable heterogeneity for several outcomes. There was no significant reduction in the primary outcomes meconium aspiration syndrome, perinatal death or severe morbidity, and maternal death or severe morbidity. There was a reduction in caesarean sections (CSs) for fetal distress but not overall. Meconium below the vocal cords diagnosed by laryngoscopy was reduced, as was neonatal ventilation or neonatal intensive care unit admission, but there was no significant reduction in perinatal deaths or other morbidity. Planned sensitivity analysis excluding trials with greater risk of bias resulted in an absence of benefits for any of the outcomes studied.Settings with limited peripartum surveillance: three studies were included. In the amnioinfusion group there was a reduction in CS for fetal distress and overall; meconium aspiration syndrome (three studies, 1144 women; risk ratio (RR) 0.17, 95% confidence interval (CI) 0.05 to 0.52); perinatal mortality (three studies, 1151 women; RR 0.24, 95% CI 0.11 to 0.53) and neonatal ventilation or neonatal intensive care unit admission. In one of the studies, meconium

Trade, Labour Markets and Health.

PubMed

McNamara, Courtney; Labonté, Ronald

2017-04-01

Previous analyses indicate that there are a number of potentially serious health risks associated with the Trans-Pacific Partnership (TPP). The objective of this work is to provide further insight into the potential health impacts of the TPP by investigating labour market pathways. The impact of the TPP on employment and working conditions is a major point of contention in broader public debates. In public health literature, these factors are considered fundamental determinants of health, yet they are rarely addressed in analyses of trade and investment agreements. We therefore undertake a prospective policy analysis of the TPP through a content analysis of the agreement's Labour Chapter. Provisions of the Chapter are analyzed with reference to the health policy triangle and four main areas through which labour markets influence health: power relations, social policies, employment conditions and working conditions. Findings indicate that implementation of the TPP can have important impacts on health through labour market pathways. While the Labour Chapter is being presented by proponents of the agreement as a vehicle for improvement in labour standards, we find little evidence to support this view. Instead, we find several ways the TPP may weaken employment relations to the detriment of health.

Improving the knowledge of labour and delivery nurses in India: a randomized controlled trial of mentoring and case sheets in primary care centres.

PubMed

Bradley, Janet; Jayanna, Krishnamurthy; Shaw, Souradet; Cunningham, Troy; Fischer, Elizabeth; Mony, Prem; Ramesh, B M; Moses, Stephen; Avery, Lisa; Crockett, Maryanne; Blanchard, James F

2017-01-07

Birthing in health facilities in India has increased over the last few years, yet maternal and neonatal mortality rates remain high. Clinical mentoring with case sheets or checklists for nurses is viewed as essential for on-going knowledge transfer, particularly where basic training is inadequate. This paper summarizes a study of the effect of such a programme on staff knowledge and skills in a randomized trial of 295 nurses working in 108 Primary Health Centres (PHCs) in Karnataka, India. Stratifying by district, half of the PHCs were randomly assigned to be intervention sites and provided with regular mentoring visits where case sheet/checklists were a central job and teaching aid, and half to be control sites, where no support was provided except provision of case sheets. Nurses' knowledge and skills around normal labour, labour complications and neonate issues were tested before the intervention began and again one year later. Univariate and multivariate analyses were conducted to examine the effect of mentoring and case sheets. Overall, on none of the 3 measures, did case sheet use without mentoring add anything to the basic nursing training when controlling for other factors. Only individuals who used both case-sheets and received mentoring scored significantly higher on the normal labour and neonate indices, scoring almost twice as high as those who only used case-sheets. This group was also associated with significantly higher scores on the complications of labour index, with their scores 2.3 times higher on average than the case sheet only control group. Individuals from facilities with 21 or more deliveries in a month tended to fare worse on all 3 indices. There were no differences in outcomes according to district or years of experience. This study demonstrates that provision of case sheets or checklists alone is insufficient to improve knowledge and practices. However, on-site mentoring in combination with case sheets can have a demonstrable effect on

Amnioinfusion for potential or suspected umbilical cord compression in labour.

PubMed

Hofmeyr, G Justus; Lawrie, Theresa A

2012-01-18

Amnioinfusion aims to prevent or relieve umbilical cord compression during labour by infusing a solution into the uterine cavity. To assess the effects of amnioinfusion for potential or suspected umbilical cord compression on maternal and perinatal outcome . We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2011). Randomised trials of amnioinfusion compared with no amnioinfusion in women with babies at risk of umbilical cord compression in labour. The original review had one author only (Justus Hofmeyr (GJH)). For this update, two authors (GJH and T Lawrie) assessed 13 additional trial reports for eligibility and quality. We extracted data and checked for accuracy. We have included 19 studies, with all but two studies having fewer than 200 participants. Transcervical amnioinfusion for potential or suspected umbilical cord compression was associated with the following reductions: caesarean section overall (13 trials, 1493 participants; average risk ratio (RR) 0.62, 95% confidence interval (CI) 0.46 to 0.83); fetal heart rate (FHR) decelerations (seven trials, 1006 participants; average RR 0.53, 95% CI 0.38 to 0.74); Apgar score less than seven at five minutes (12 trials, 1804 participants; average RR 0.47, 95% CI 0.30 to 0.72); meconium below the vocal cords (three trials, 674 participants, RR 0.53, 95% CI 0.31 to 0.92); postpartum endometritis (six trials, 767 participants; RR 0.45, 95% CI 0.25 to 0.81) and maternal hospital stay greater than three days (four trials, 1051 participants; average RR 0.45, 95% CI 0.25 to 0.78). Transabdominal amnioinfusion showed similar trends, though numbers studied were small.Mean cord umbilical artery pH was higher in the amnioinfusion group (seven trials, 855 participants; average mean difference 0.03, 95% CI 0.00 to 0.06) and there was a trend toward fewer neonates with a low cord arterial pH (less than 7.2 or as defined by trial authors) in the amnioinfusion group (eight trials, 972

Hierarchical cluster analysis of labour market regulations and population health: a taxonomy of low- and middle-income countries

PubMed Central

2012-01-01

Background An important contribution of the social determinants of health perspective has been to inquire about non-medical determinants of population health. Among these, labour market regulations are of vital significance. In this study, we investigate the labour market regulations among low- and middle-income countries (LMICs) and propose a labour market taxonomy to further understand population health in a global context. Methods Using Gross National Product per capita, we classify 113 countries into either low-income (n = 71) or middle-income (n = 42) strata. Principal component analysis of three standardized indicators of labour market inequality and poverty is used to construct 2 factor scores. Factor score reliability is evaluated with Cronbach's alpha. Using these scores, we conduct a hierarchical cluster analysis to produce a labour market taxonomy, conduct zero-order correlations, and create box plots to test their associations with adult mortality, healthy life expectancy, infant mortality, maternal mortality, neonatal mortality, under-5 mortality, and years of life lost to communicable and non-communicable diseases. Labour market and health data are retrieved from the International Labour Organization's Key Indicators of Labour Markets and World Health Organization's Statistical Information System. Results Six labour market clusters emerged: Residual (n = 16), Emerging (n = 16), Informal (n = 10), Post-Communist (n = 18), Less Successful Informal (n = 22), and Insecure (n = 31). Primary findings indicate: (i) labour market poverty and population health is correlated in both LMICs; (ii) association between labour market inequality and health indicators is significant only in low-income countries; (iii) Emerging (e.g., East Asian and Eastern European countries) and Insecure (e.g., sub-Saharan African nations) clusters are the most advantaged and disadvantaged, respectively, with the remaining clusters experiencing levels of population health consistent

Hierarchical cluster analysis of labour market regulations and population health: a taxonomy of low- and middle-income countries.

PubMed

Muntaner, Carles; Chung, Haejoo; Benach, Joan; Ng, Edwin

2012-04-18

An important contribution of the social determinants of health perspective has been to inquire about non-medical determinants of population health. Among these, labour market regulations are of vital significance. In this study, we investigate the labour market regulations among low- and middle-income countries (LMICs) and propose a labour market taxonomy to further understand population health in a global context. Using Gross National Product per capita, we classify 113 countries into either low-income (n = 71) or middle-income (n = 42) strata. Principal component analysis of three standardized indicators of labour market inequality and poverty is used to construct 2 factor scores. Factor score reliability is evaluated with Cronbach's alpha. Using these scores, we conduct a hierarchical cluster analysis to produce a labour market taxonomy, conduct zero-order correlations, and create box plots to test their associations with adult mortality, healthy life expectancy, infant mortality, maternal mortality, neonatal mortality, under-5 mortality, and years of life lost to communicable and non-communicable diseases. Labour market and health data are retrieved from the International Labour Organization's Key Indicators of Labour Markets and World Health Organization's Statistical Information System. Six labour market clusters emerged: Residual (n = 16), Emerging (n = 16), Informal (n = 10), Post-Communist (n = 18), Less Successful Informal (n = 22), and Insecure (n = 31). Primary findings indicate: (i) labour market poverty and population health is correlated in both LMICs; (ii) association between labour market inequality and health indicators is significant only in low-income countries; (iii) Emerging (e.g., East Asian and Eastern European countries) and Insecure (e.g., sub-Saharan African nations) clusters are the most advantaged and disadvantaged, respectively, with the remaining clusters experiencing levels of population health consistent with their labour market

Experiences of early labour management from perspectives of women, labour companions and health professionals: A systematic review of qualitative evidence.

PubMed

Beake Rm Ma Research Associate, Sarah; Chang Ba MPhil PhD Lecturer, Yan-Shing; Cheyne Rm Rgn MSc PhD Professor Of Midwifery, Helen; Spiby MPhil Rn Rm Professor Of Midwifery, Helen; Sandall Rm MSc PhD Professor Of Social Science And Women's Health, Jane; Bick, Debra

2018-02-01

to examine evidence of women's, labour companions' and health professionals' experiences of management of early labour to consider how this could be enhanced to better reflect women's needs. a systematic review of qualitative evidence. women in early labour with term, low risk singleton pregnancies, not booked for a planned caesarean birth or post-dates induction of labour, their labour companions, and health professionals responsible for early labour care (e.g. midwives, nurse-midwives, obstetricians, family doctors). Studies from high and middle income country settings were considered. 21 publications were included from the UK, Ireland, Scandinavia, USA, Italy and New Zealand. Key findings included the impact of communication with health professionals (most usually midwives) on women's decision making; women wanting to be listened to by sympathetic midwives who could reassure that symptoms and signs of early labour were 'normal' and offer clear advice on what to do. Antenatal preparation which included realistic information on what to expect when labour commenced was important and appreciated by women and labour companions. Views of the optimal place for women to remain and allow early labour to progress differed and the perceived benefit of support and help offered by labour companions varied. Some were supportive and helped women to relax, while others were anxious and encouraged women to seek early admission to the planned place of birth. Web-based sources of information are increasingly used by women, with mixed views of the value of information accessed. women, labour companions and health professionals find early labour difficult to manage well, with women unsure of how decisions about admission to their planned place of birth are taken. It is unclear why women are effectively left to manage this aspect of their labour with minimal guidance or support. Tailoring management to meet individual needs, with provision of effective communication could reassure

Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

PubMed

da Cruz, Lyndon; Dorn, Jessy D; Humayun, Mark S; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E; Hafezi, Farhad; Safran, Avinoam B; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V; de Juan, Eugene; Duncan, Jacque L; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C; Ho, Allen C; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V; Arditi, Aries; Greenberg, Robert J

2016-10-01

The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. Thirty participants in 10 centers in the United States and Europe. The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks. Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

An experience with trial of scar in 66 Ethiopian women.

PubMed

Sebhatu, B

1994-10-01

The purpose of this study was to determine the circumstances in which trial of scar is conducted in the obstetric unit of Tikur Anbessa Hospital, Addis Ababa, Ethiopia, and evaluate the safety of the undertaking in terms of maternal and perinatal morbidity and mortality. Between 11 September, 1991 to 10 September, 1992, 66 women with previous caesarean section were given a trial of scar. The main pre-requests to allow a trial of scar were: only one previous lower uterine segment section, a cephalic presentation with no disproportion in the current labour and, the presence of a functional operating theatre. Labour was being monitored by checking the uterine contractions by fundal palpation and counting the Foetal heart rate (FHR) using the Pinnard Stethoscope. Compatible blood was prior prepared in only 7 (10.6%) labours. Forty seven (71.2%) parturients delivered vaginally. In 19 (28.2%) an emergency repeat section was done for failure of progress in labour. In one (1.5%) patient, a uterine scar dehiscence was detected. The 5th minute APGAR score was 7/10 or more in 64 (94.1%) and 6/10 in 3 (4.5%) of 68 neonates. There was one prepartum intra-uterine foetal death and one neonatal death of a preterm baby making the perinatal mortality rate (PNMR) of 29.4 per thousand. There was no maternal death. In conclusion, this study demonstrates that a trial of scar was a safe procedure.

Increased oxidative stress in human fetal membranes overlying the cervix from term non-labouring and post labour deliveries.

PubMed

Chai, M; Barker, G; Menon, R; Lappas, M

2012-08-01

Enzymatic breakdown of the collagen-rich extracellular matrix (ECM) that connects the amnion and chorion layers of the fetal membranes is one of the key events leading to rupture of membranes. Oxidant stress caused by increased formation of reactive oxygen species and/or reduced antioxidant capacity may predispose to membrane rupture, a major cause of preterm birth. The aim of this study was to determine the effect of human labour and supracervical (SC) apposition on antioxidant enzymes and 8-isoprostane (a marker of lipid peroxidation). To determine the effect of human labour on oxidative stress status, fetal membranes from the SC site (SCS) were collected from women at term Caesarean section (no labour), and from the site of membrane rupture (SOR) after spontaneous labour onset and delivery (post labour). To determine the effect of SC apposition on oxidative stress status, amnion was collected from the SCS and a distal site (DS) in women at term Caesarean section in the absence of labour. The release of 8-isoprostane was significantly higher in amnion from the SCS compared to DS, and in fetal membranes from the SOR compared to the SCS. Glutathione peroxidase (GPx) and superoxide dismutase (SOD) activity were lower in amnion from the SC compared to DS. SOD gene expression and enzyme activity were lower in fetal membranes after labour. There was no difference in expression or activity in catalase, GPx and glutathione reductase (GSR) between no labour and post labour fetal membranes. In primary amnion cells, SOD supplementation significantly augmented IL-1β induced MMP-9 expression and activity. In summary, non-labouring SC fetal membranes are characterised by reduced antioxidant enzyme activity when compared to distal membranes, and, as such, may be more susceptible to oxidative damage and thus membrane rupture. Copyright © 2012 Elsevier Ltd. All rights reserved.

Effects of Epidural Labour Analgesia in Mother and Foetus.

PubMed

Deshmukh, Varsha Laxmikant; Ghosh, Shaswatee S; Yelikar, Kanan A; Gadappa, Shreeniwas N

2018-04-01

Aim of study was to determine effect of epidural analgesia on progress of labour and mode of delivery, to find out its complications in labour and puerperium and to evaluate neonatal outcome in terms of APGAR score. The present study was conducted in Department of Obstetrics and Gynaecology at Government Medical College Aurangabad over period of 2 years from June 2014 to June 2016 after taking approval from institutional ethical board. Hundred low-risk primigravidas were included in the study, 50 women received epidural analgesia for relief of labour pain at 3-4 cm and 50 women served as control. The important  outcome  FACTORS studied were the following : (1) duration of active phase of I stage, and II stage, (2) mode of delivery, (3) APGAR scores, (4) untoward reactions and intrapartum complications, (5) overall satisfaction of the mother. The operative delivery rates were not significantly different in both the groups (8% in the control group and 6% in the study group: p value NS, i.e. > 0.05). The duration of first stage (our study showed no significant difference in the duration of first stage in both the study and control groups p value > 0.05) and second stage of labour ( p value NS > 0.05) and the need for oxytocin were comparable in the two groups. The side effects observed were minimal. It has given excellent pain relief and improved neonatal outcome (5 min). EA is associated with rates of vaginal delivery (88 v/s 84%) and LSCS rate (8 v/s 6%) which are comparable with control group. Epidural analgesia is a very promising, safe and effective method of pain relief. No major complications and a good APGAR score make it a good option of care in modern obstetrics.

A cost analysis of inpatient compared with outpatient prostaglandin E2 cervical priming for induction of labour: results from the OPRA trial.

PubMed

Adelson, Pamela L; Wedlock, Garry R; Wilkinson, Chris S; Howard, Kirsten; Bryce, Robert L; Turnbull, Deborah A

2013-09-01

To compare the costs of inpatient (usual care) with outpatient (intervention) care for cervical priming for induction of labour in women with healthy, low-risk pregnancies who are being induced for prolonged pregnancies or for social reasons. Data from a randomised controlled trial at two hospitals in South Australia were matched with hospital financial data. A cost analysis comparing women randomised to inpatient care with those randomised to outpatient care was performed, with an additional analysis focusing on those who received the intervention. Overall, 48% of women randomised into the trial did not receive the intervention. Women randomised to outpatient care had an overall cost saving of $319 per woman (95% CI -$104 to $742) as compared with women randomised to usual care. When restricted to women who actually received the intervention, in-hospital cost savings of $433 (95% CI -$282 to $1148) were demonstrated in the outpatient group. However, these savings were partially offset by the cost of an outpatient priming clinic, reducing the overall cost savings to $156 per woman. Overall cost savings were not statistically significant in women who were randomised to or received the intervention. However, the trend in cost savings favoured outpatient priming.

Immediate delivery compared with expectant management after preterm pre-labour rupture of the membranes close to term (PPROMT trial): a randomised controlled trial.

PubMed

Morris, Jonathan M; Roberts, Christine L; Bowen, Jennifer R; Patterson, Jillian A; Bond, Diana M; Algert, Charles S; Thornton, Jim G; Crowther, Caroline A

2016-01-30

Preterm pre-labour ruptured membranes close to term is associated with increased risk of neonatal infection, but immediate delivery is associated with risks of prematurity. The balance of risks is unclear. We aimed to establish whether immediate birth in singleton pregnancies with ruptured membranes close to term reduces neonatal infection without increasing other morbidity. The PPROMT trial was a multicentre randomised controlled trial done at 65 centres across 11 countries. Women aged over 16 years with singleton pregnancies and ruptured membranes before the onset of labour between 34 weeks and 36 weeks and 6 days weeks who had no signs of infection were included. Women were randomly assigned (1:1) by a computer-generated randomisation schedule with variable block sizes, stratified by centre, to immediate delivery or expectant management. The primary outcome was the incidence of neonatal sepsis. Secondary infant outcomes included a composite neonatal morbidity and mortality indicator (ie, sepsis, mechanical ventilation ≥24 h, stillbirth, or neonatal death); respiratory distress syndrome; any mechanical ventilation; and duration of stay in a neonatal intensive or special care unit. Secondary maternal outcomes included antepartum or intrapartum haemorrhage, intrapartum fever, postpartum treatment with antibiotics, and mode of delivery. Women and caregivers could not be masked, but those adjudicating on the primary outcome were masked to group allocation. Analyses were by intention to treat. This trial is registered with the International Clinical Trials Registry, number ISRCTN44485060. Between May 28, 2004, and June 30, 2013, 1839 women were recruited and randomly assigned: 924 to the immediate birth group and 915 to the expectant management group. One woman in the immediate birth group and three in the expectant group were excluded from the primary analyses. Neonatal sepsis occurred in 23 (2%) of 923 neonates whose mothers were assigned to immediate birth and 29

Arrival in the labour ward in second stage of labour--any prognostic significance?

PubMed

Nkyekyer, K

1998-05-01

A comparative descriptive study was carried out to determine whether, in uncomplicated term pregnancies with the foetus in vertex presentation, there were any differences in maternal or foetal outcome between women who arrived in the labour ward in second stage of labour and those who arrived in early active phase. There were two hundred and seventeen women each in the study and comparison groups. There were no significant differences between the two groups as regards age, parity, marital status and level of education. Women in the comparison group were better antenatal clinic attendants. Those in the study group were more likely to have indicated that they had problems with transportation. They also had considerably shorter labours and all achieved spontaneous vaginal deliveries; a significant proportion (10.6%) of the comparison group had interventional deliveries. The incidence of episiotomies, lower genital tract injuries, manual removal of placenta and postpartum haemorrhage after vaginal delivery were not different between the two groups. Babies born to mothers in the study group were significantly lighter, by about 170 gms, and had a lower incidence of low one-minute Apgar scores. There were no significant differences in the rates of admission to the neonatal intensive care unit or in early neonatal deaths. Arrival in the labour ward in second stage of labour prognosticates non-interventional delivery without any increased risk of adverse outcome to the mother or her baby.

Maternal positioning affects fetal heart rate changes after epidural analgesia for labour.

PubMed

Preston, R; Crosby, E T; Kotarba, D; Dudas, H; Elliott, R D

1993-12-01

Adverse fetal heart rate (FHR) changes suggestive of fetal hypoxia are seen in patients with normal term pregnancies after initiation of epidural block for labour analgesia. It was our hypothesis that, in some parturients, these changes were a consequence of concealed aortocaval compression resulting in decreased uterine blood flow. We expected that the full lateral position compared with the wedged supine position would provide more effective prophylaxis against aortocaval compression. To test our hypothesis we studied the role of maternal positioning on FHR changes during onset of epidural analgesia for labour. Eighty-eight ASA Class I or II term parturients were randomized into two groups: those to be nursed in the wedged supine position and those to be nursed in the full lateral position during induction of an epidural block. External FHR monitoring was employed to assess the fetal response to initiation of labour epidural analgesia. Epidural catheters were sited with the parturients in the sitting position and the patients then assumed the study position. After a negative test dose, a standardized regimen of bupivacaine 0.25% was employed to provide labour analgesia. The quality and efficacy of the block were assessed using VAS pain scores, motor block scores and sensory levels. The results demonstrated that there was no difference in the quality of analgesia provided nor in the incidence of asymmetric blocks. There was no difference in the observed incidence of FHR changes occurring during the initiation of the epidural block.(ABSTRACT TRUNCATED AT 250 WORDS)

Demand and utilisation of labour analgesia service by Nigerian women.

PubMed

Imarengiaye, C O; Ande, A B A

2006-02-01

This study sought to determine the clinical correlates of the demand and utilisation of labour analgesia resources by Nigerian women in labour. All consenting women were interviewed on arrival at the Unit and while in labour. Biodata, options for relief of labour pain, request for analgesia, method of analgesia, VAS score and cervical score at time of request for analgesia were obtained. A total of 288 women in labour were studied. Of these, 108 (37.5%) patients were aware that the pain of labour can be relieved but only 26.0% had prenatal information on labour analgesia. However, 85.1% of the patients would want their pain of labour relieved. A total of 112 (38.9%) did receive analgesia during labour. Cervical dilatation of <4 cm at presentation to the Unit and nulliparity were likely factors for pain treatment during labour (p = 0.001, chi2 test). There is poor utilisation of labour analgesia services. Improved antenatal information on labour analgesia may boost the utilisation of these resources by Nigerian women in labour.

Five-year safety and performance results from the Argus II Retinal Prosthesis System clinical trial

PubMed Central

da Cruz, Lyndon; Dorn, Jessy D.; Humayun, Mark S.; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E.; Hafezi, Farhad; Safran, Avinoam B.; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V.; de Juan, Eugene; Duncan, Jacque L.; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C.; Ho, Allen C.; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V.; Arditi, Aries; Greenberg, Robert J.

2016-01-01

Purpose The Argus® II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) was developed to restore some vision to patients blind from retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception due to end-stage RP. Design The study is a prospective, multicenter, single-arm, clinical trial. Within-patient controls included the non-implanted fellow eye and patients' native residual vision compared to their vision when using the System. Subjects There were 30 subjects in 10 centers in the U.S. and Europe. Methods The worse-seeing eye of blind patients was implanted with the Argus II System. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. Main Outcome Measures The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by three computer-based, objective tests. Secondary measures included functional vision performance on objectively-scored real-world tasks. Results Twenty-four out of 30 patients remained implanted with functioning Argus II Systems at 5 years post-implant. Only one additional serious adverse event was experienced since the 3-year time point. Patients performed significantly better with the System ON than OFF on all visual function tests and functional vision tasks. Conclusions The five-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. PMID:27453256

The home as an appropriate setting for women undertaking cervical ripening before the induction of labour.

PubMed

Reid, Margaret; Lorimer, Karen; Norman, Jane E; Bollapragada, Shrikant S; Norrie, John

2011-02-01

to explore women's experiences of cervical ripening using isosorbide mononitrate (IMN) in the home as part of the main randomised controlled trial. qualitative study with semi-structured interviews carried out at three weeks post partum. Interview transcripts were analysed to identify recurrent themes, focusing on why women became involved in the study, their views about both the self-medication and the home setting, and whether they would repeat the experience. the home. twenty women enrolled in the main randomised controlled trial. the study is part of a double-blind randomised controlled trial with 350 patients investigating whether a nitric oxide donor (IMN) used in cervical ripening improves the process of induction of labour. women liked the opportunity to remain at home during the cervical ripening process. Timing and setting were central issues; women hoped that it would hasten labour, while the home was seen as a setting offering freedom, security and reassurance, as opposed to the hospital, seen as constraining. Two women reported problems with IMN but the remainder reported that they would repeat the experience. women were very positive about the opportunity to undertake cervical ripening at home. It is important to explore this setting further for appropriate interventions. Copyright © 2009 Elsevier Ltd. All rights reserved.

Effect of Oral Voriconazole on Fungal Keratitis in the Mycotic Ulcer Treatment Trial II (MUTT II): A Randomized Clinical Trial.

PubMed

Prajna, N Venkatesh; Krishnan, Tiruvengada; Rajaraman, Revathi; Patel, Sushila; Srinivasan, Muthiah; Das, Manoranjan; Ray, Kathryn J; O'Brien, Kieran S; Oldenburg, Catherine E; McLeod, Stephen D; Zegans, Michael E; Porco, Travis C; Acharya, Nisha R; Lietman, Thomas M; Rose-Nussbaumer, Jennifer

2016-12-01

To compare oral voriconazole with placebo in addition to topical antifungals in the treatment of filamentous fungal keratitis. The Mycotic Ulcer Treatment Trial II (MUTT II), a multicenter, double-masked, placebo-controlled, randomized clinical trial, was conducted in India and Nepal, with 2133 individuals screened for inclusion. Patients with smear-positive filamentous fungal ulcers and visual acuity of 20/400 (logMAR 1.3) or worse were randomized to receive oral voriconazole vs oral placebo; all participants received topical antifungal eyedrops. The study was conducted from May 24, 2010, to November 23, 2015. All trial end points were analyzed on an intent-to-treat basis. Study participants were randomized to receive oral voriconazole vs oral placebo; a voriconazole loading dose of 400 mg was administered twice daily for 24 hours, followed by a maintenance dose of 200 mg twice daily for 20 days, with dosing altered to weight based during the trial. All participants received topical voriconazole, 1%, and natamycin, 5%. The primary outcome of the trial was rate of corneal perforation or the need for therapeutic penetrating keratoplasty (TPK) within 3 months. Secondary outcomes included microbiologic cure at 6 days, rate of re-epithelialization, best-corrected visual acuity and infiltrate and/or scar size at 3 weeks and 3 months, and complication rates associated with voriconazole use. A total of 2133 patients in India and Nepal with smear-positive ulcers were screened; of the 787 who were eligible, 240 (30.5%) were enrolled. Of the 119 patients (49.6%) in the oral voriconazole treatment group, 65 were male (54.6%), and the median age was 54 years (interquartile range, 42-62 years). Overall, no difference in the rate of corneal perforation or the need for TPK was determined for oral voriconazole vs placebo (hazard ratio, 0.82; 95% CI, 0.57-1.18; P = .29). In prespecified subgroup analyses comparing treatment effects among organism subgroups, there was some

Emotional labour underlying caring: an evolutionary concept analysis.

PubMed

Huynh, Truc; Alderson, Marie; Thompson, Mary

2008-10-01

This paper is a report of a concept analysis of emotional labour. Caring is considered as the essence of nursing. Underpinning caring, the internal regulation of emotions or the emotional labour of nurses is invisible. The concept of emotional labour is relatively underdeveloped in nursing. A literature search using keywords 'emotional labour', 'emotional work' and 'emotions' was performed in CINAHL, PsycINFO and REPERE from 1990 to January 2008. We analysed 72 papers whose main focus of inquiry was on emotional labour. We followed Rodgers' evolutionary method of concept analysis. Emotional labour is a process whereby nurses adopt a 'work persona' to express their autonomous, surface or deep emotions during patient encounters. Antecedents to this adoption of a work persona are events occurring during patient-nurse encounters, and which consist of three elements: organization (i.e. social norms, social support), nurse (i.e. role identification, professional commitment, work experience and interpersonal skills) and job (i.e. autonomy, task routine, degree of emotional demand, interaction frequency and work complexity). The attributes of emotional labour have two dimensions: nurses' autonomous response and their work persona strategies (i.e. surface or deep acts). The consequences of emotional labour include organizational (i.e. productivity, 'cheerful environment') and nurse aspects (i.e. negative or positive). The concept of emotional labour should be introduced into preregistration programmes. Nurses also need to have time and a supportive environment to reflect, understand and discuss their emotional labour in caring for 'difficult' patients to deflate the dominant discourse about 'problem' patients.

Interventions to support effective communication between maternity care staff and women in labour: A mixed-methods systematic review.

PubMed

Chang, Yan-Shing; Coxon, Kirstie; Portela, Anayda Gerarda; Furuta, Marie; Bick, Debra

2018-04-01

the objectives of this review were (1) to assess whether interventions to support effective communication between maternity care staff and healthy women in labour with a term pregnancy could improve birth outcomes and experiences of care; and (2) to synthesize information related to the feasibility of implementation and resources required. a mixed-methods systematic review. studies which reported on interventions aimed at improving communication between maternity care staff and healthy women during normal labour and birth, with no apparent medical or obstetric complications, and their family members were included. 'Maternity care staff' included medical doctors (e.g. obstetricians, anaesthetists, physicians, family doctors, paediatricians), midwives, nurses and other skilled birth attendants providing labour, birth and immediate postnatal care. Studies from all birth settings (any country, any facility including home birth, any resource level) were included. two papers met the inclusion criteria. One was a step wedge randomised controlled trial conducted in Syria, and the other a sub-analysis of a randomised controlled trial from the United Kingdom. Both studies aimed to assess effects of communication training for maternity care staff on women's experiences of labour care. The study from Syria reported that a communication skills training intervention for resident doctors was not associated with higher satisfaction reported by women. In the UK study, patient-actors' (experienced midwives) perceptions of safety and communication significantly improved for postpartum haemorrhage scenarios after training with patient-actors in local hospitals, compared with training using manikins in simulation centres, but no differences were identified for other scenarios. Both studies had methodological limitations. the review identified a lack of evidence on impact of interventions to support effective communication between maternity care staff and healthy women during labour and

Use of labour induction and risk of cesarean delivery: a systematic review and meta-analysis

PubMed Central

Mishanina, Ekaterina; Rogozinska, Ewelina; Thatthi, Tej; Uddin-Khan, Rehan; Khan, Khalid S.; Meads, Catherine

2014-01-01

Background: Induction of labour is common, and cesarean delivery is regarded as its major complication. We conducted a systematic review and meta-analysis to investigate whether the risk of cesarean delivery is higher or lower following labour induction compared with expectant management. Methods: We searched 6 electronic databases for relevant articles published through April 2012 to identify randomized controlled trials (RCTs) in which labour induction was compared with placebo or expectant management among women with a viable singleton pregnancy. We assessed risk of bias and obtained data on rates of cesarean delivery. We used regression analysis techniques to explore the effect of patient characteristics, induction methods and study quality on risk of cesarean delivery. Results: We identified 157 eligible RCTs (n = 31 085). Overall, the risk of cesarean delivery was 12% lower with labour induction than with expectant management (pooled relative risk [RR] 0.88, 95% confidence interval [CI] 0.84–0.93; I2 = 0%). The effect was significant in term and post-term gestations but not in preterm gestations. Meta-regression analysis showed that initial cervical score, indication for induction and method of induction did not alter the main result. There was a reduced risk of fetal death (RR 0.50, 95% CI 0.25–0.99; I2 = 0%) and admission to a neonatal intensive care unit (RR 0.86, 95% CI 0.79–0.94), and no impact on maternal death (RR 1.00, 95% CI 0.10–9.57; I2 = 0%) with labour induction. Interpretation: The risk of cesarean delivery was lower among women whose labour was induced than among those managed expectantly in term and post-term gestations. There were benefits for the fetus and no increased risk of maternal death. PMID:24778358

Child Labour and Educational Success in Portugal

ERIC Educational Resources Information Center

Goulart, Pedro; Bedi, Arjun S.

2008-01-01

The current debate on child labour focuses on developing countries. However, Portugal is an example of a relatively developed country where child labour is still a matter of concern as between 8% and 12% of Portuguese children may be classified as workers. This paper studies the patterns of child labour in Portugal and assesses the consequences of…

Failsafe automation of Phase II clinical trial interim monitoring for stopping rules.

PubMed

Day, Roger S

2010-02-01

In Phase II clinical trials in cancer, preventing the treatment of patients on a study when current data demonstrate that the treatment is insufficiently active or too toxic has obvious benefits, both in protecting patients and in reducing sponsor costs. Considerable efforts have gone into experimental designs for Phase II clinical trials with flexible sample size, usually implemented by early stopping rules. The intended benefits will not ensue, however, if the design is not followed. Despite the best intentions, failures can occur for many reasons. The main goal is to develop an automated system for interim monitoring, as a backup system supplementing the protocol team, to ensure that patients are protected. A secondary goal is to stimulate timely recording of patient assessments. We developed key concepts and performance needs, then designed, implemented, and deployed a software solution embedded in the clinical trials database system. The system has been in place since October 2007. One clinical trial tripped the automated monitor, resulting in e-mails that initiated statistician/investigator review in timely fashion. Several essential contributing activities still require human intervention, institutional policy decisions, and institutional commitment of resources. We believe that implementing the concepts presented here will provide greater assurance that interim monitoring plans are followed and that patients are protected from inadequate response or excessive toxicity. This approach may also facilitate wider acceptance and quicker implementation of new interim monitoring algorithms.

The Design of Phase II Clinical Trials Testing Cancer Therapeutics: Consensus Recommendations from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee

PubMed Central

Seymour, Lesley; Ivy, S. Percy; Sargent, Daniel; Spriggs, David; Baker, Laurence; Rubinstein, Larry; Ratain, Mark J; Le Blanc, Michael; Stewart, David; Crowley, John; Groshen, Susan; Humphrey, Jeffrey S; West, Pamela; Berry, Donald

2010-01-01

The optimal design of phase II studies continues to be the subject of vigorous debate, especially with regards to studies of newer molecularly targeted agents. The observations that many new therapeutics ‘fail’ in definitive phase III studies, coupled with the numbers of new agents to be tested as well as the increasing costs and complexity of clinical trials further emphasizes the critical importance of robust and efficient phase II design. The Clinical Trial Design Task Force(CTD-TF)of the NCI Investigational Drug Steering Committee (IDSC) has published a series of discussion papers on Phase II trial design in Clinical Cancer Research. The IDSC has developed formal recommendations regarding aspects of phase II trial design which are the subject of frequent debate such as endpoints(response vs. progression free survival), randomization(single arm designs vs. randomization), inclusion of biomarkers, biomarker based patient enrichment strategies, and statistical design(e.g. two stage designs vs. multiple-group adaptive designs). While these recommendations in general encourage the use of progression-free survival as the primary endpoint, the use of randomization, the inclusion of biomarkers and the incorporation of newer designs, we acknowledge that objective response as an endpoint, and single arm designs, remain relevant in certain situations. The design of any clinical trial should always be carefully evaluated and justified based on the characteristic specific to the situation. PMID:20215557

Quest Trial Q348: Evaluation of WaMoS II Data

DTIC Science & Technology

2013-04-01

and slam warning.” Quest Sea Trial Q348 page 7 “In July of 2011, as part of the 11gi project, DRDC acquired and installed a new WaMoS...Fourier series expansion was originally implemented to compare WaMoS II data to reference data of an airborne LIDAR scanner, which yielded very good

Effect of early amniotomy on the outcome of spontaneous labour: a randomized controlled trial of pregnant women in Enugu, South-east Nigeria.

PubMed

Onah, Livinus N; Dim, Cyril C; Nwagha, Uchenna I; Ozumba, Benjamin C

2015-12-01

Early amniotomy is common in obstetric practice but, its effectiveness has not been proven. To determine the effects of early amniotomy on the duration of labour, and other maternal / neonatal outcomes of uncomplicated pregnancies in Enugu, South-east Nigeria. A randomized controlled study of 214 consenting term pregnant women at the University of Nigeria Teaching Hospital Enugu, Nigeria. Intervention group received amniotomy early in active labour while the control group had their membranes conserved. Mean duration of labour for the amniotomy group (279.4 ± 53.7 minutes) was significantly lower than that of control group (354.4 ± 67.5 minutes), (t = -8.988, p <0.001). Three (3.8%) women in amniotomy group needed oxytocin augmentation as against 21 (19.6%) women in the control group RR = 0.14, (CI 95%: 0.04 - 0.46), NNT = 16. The two groups did not vary with respect to cesarean section rate, newborn Apgar scores, and need for new born special care unit admission. Early amniotomy when compared to fetal membrane conservation reduced the duration of labour and need for oxytocin augmentation among term singleton pregnant women in Enugu, Nigeria. Its routine use in well selected cases may reduce prolonged labour and its complications.

Off-Farm Labour Decision of Canadian Farm Operators: Urbanization Effects and Rural Labour Market Linkages

ERIC Educational Resources Information Center

Alasia, Alessandro; Weersink, Alfons; Bollman, Ray D.; Cranfield, John

2009-01-01

Understanding the factors affecting off-farm labour decisions of census-farm operators has significant implications for rural development and farm income support policy. We examine the off-farm labour decisions of Canadian farm operators using micro-level data from the 2001 Census of Agriculture combined with community level data from the 2001…

Accelerated Titration of Oxytocin in Nulliparous Women with Labour Dystocia: Results of the ACTION Pilot Randomized Controlled Trial.

PubMed

Dy, Jessica; Rainey, Jenna; Walker, Mark C; Fraser, William; Smith, Graeme N; White, Ruth Rennicks; Waddell, Patti; Janoudi, Ghayath; Corsi, Daniel J; Wei, Shu Qin

2018-06-01

The primary objective was to determine the feasibility of a large RCT assessing the effectiveness of an accelerated oxytocin titration (AOT) protocol compared with a standard gradual oxytocin titration (GOT) in reducing the risk of CS in nulliparous women diagnosed with dystocia in the first stage of labour. The secondary objective was to obtain preliminary data on the safety and efficacy of the foregoing AOT protocol. This was a multicentre, double-masked, parallel-group pilot RCT. This study was conducted in three Canadian birthing centres. A total of 79 term nulliparous women carrying a singleton pregnancy in spontaneous labour, with a diagnosis of labour dystocia, were randomized to receive either GOT (initial dose 2 mU/min with increments of 2 mU/min) or AOT (initial dose 4 mU/min with increments of 4 mU/min), in a 1:1 ratio. An intention-to-treat analysis was applied. A total of 252 women were screened and approached, 137 (54.4%) consented, and 79 (31.3%) were randomized. Overall protocol adherence was 76 of 79 (96.2%). Of the women randomized, 10 (25.6%) allocated to GOT had a CS compared with six (15.0%) allocated to AOT (Fisher exact test P = 0.27). This pilot study demonstrated that a large, multicentre RCT is not only feasible, but also necessary to assess the effectiveness and safety of an AOT protocol for labour augmentation with regard to CS rate and indicators of maternal and perinatal morbidities. Copyright © 2018 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

Migration in a segmented labour market.

PubMed

Gordon, I

1995-01-01

"Current research in migration is moving on from neo-classical and behavioural perspectives to a more structural approach relating to wider processes, issues of power and the particular role of employers. Within this programme a key issue for investigation is the interaction between spatial mobility and the structuring of labour markets. This paper focuses on the significance of labour market segmentation--in terms both of job stability and gender--for migration, both theoretically and through an empirical analysis of data from the UK Labour Force Survey on sponsored and unsponsored moves." excerpt

A modified varying-stage adaptive phase II/III clinical trial design.

PubMed

Dong, Gaohong; Vandemeulebroecke, Marc

2016-07-01

Conventionally, adaptive phase II/III clinical trials are carried out with a strict two-stage design. Recently, a varying-stage adaptive phase II/III clinical trial design has been developed. In this design, following the first stage, an intermediate stage can be adaptively added to obtain more data, so that a more informative decision can be made. Therefore, the number of further investigational stages is determined based upon data accumulated to the interim analysis. This design considers two plausible study endpoints, with one of them initially designated as the primary endpoint. Based on interim results, another endpoint can be switched as the primary endpoint. However, in many therapeutic areas, the primary study endpoint is well established. Therefore, we modify this design to consider one study endpoint only so that it may be more readily applicable in real clinical trial designs. Our simulations show that, the same as the original design, this modified design controls the Type I error rate, and the design parameters such as the threshold probability for the two-stage setting and the alpha allocation ratio in the two-stage setting versus the three-stage setting have a great impact on the design characteristics. However, this modified design requires a larger sample size for the initial stage, and the probability of futility becomes much higher when the threshold probability for the two-stage setting gets smaller. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Minimizing the Maximum Expected Sample Size in Two-Stage Phase II Clinical Trials with Continuous Outcomes

PubMed Central

Wason, James M. S.; Mander, Adrian P.

2012-01-01

Two-stage designs are commonly used for Phase II trials. Optimal two-stage designs have the lowest expected sample size for a specific treatment effect, for example, the null value, but can perform poorly if the true treatment effect differs. Here we introduce a design for continuous treatment responses that minimizes the maximum expected sample size across all possible treatment effects. The proposed design performs well for a wider range of treatment effects and so is useful for Phase II trials. We compare the design to a previously used optimal design and show it has superior expected sample size properties. PMID:22651118

A prospective pilot study of Dilapan-S compared with Propess for induction of labour at 41+ weeks in nulliparous pregnancy.

PubMed

Crosby, David A; O'Reilly, Claire; McHale, Helen; McAuliffe, Fionnuala M; Mahony, Rhona

2017-12-21

The incidence of labour induction has risen worldwide over the past decade, and this may contribute to the rising caesarean delivery rate. The mechanisms for induction of labour are generally divided into two categories: mechanical and pharmacological. The objective of this study was to determine if mechanical induction with Dilapan-S is an acceptable, safe method of induction of labour in post-dates uncomplicated nulliparous pregnancy. This was a single-centre prospective observational pilot study trial. Fifty-two low-risk nulliparous women with an unfavourable cervix, scheduled for induction of labour for post-dates ≥ 41 weeks gestation, were offered induction of labour with Dilapan-S or Propess from May 2016 until November 2016. The primary outcomes measured were compliance to study protocol and maternal (infection, hyperstimulation) and neonatal outcomes (Apgar score at birth). The secondary outcome measures included change in Bishop's score and caesarean delivery rate. Compliance to study protocol was 25/26 (96%); it was possible to insert Dilapan-S in all but one woman. There were no differences in maternal and neonatal primary outcomes between the groups. There were no cases in either arm of hyperstimulation with either induction method. No difference between the groups was noted in the caesarean delivery rate nor in the mean change in Bishop's score. Dilapan-S is an acceptable, safe form of induction of labour in post-dates uncomplicated nulliparous pregnancy. No cases of hyperstimulation were found, and therefore, Dilapan-S may be a suitable option for outpatient induction of labour in low-risk post-dates nulliparas.

The second stage of labour.

PubMed

Baston, Helen

2004-03-01

This is the third 'midwifery basics' series aimed at student midwives, and focuses on midwifery care during labour. This month, we look at care during the second stage of labour. Students are encouraged to seek further information through a series of activities, and to link theory with practice by considering the issues relating to the care of the woman described in the vignette.

TENS (transcutaneous electrical nerve stimulation) for labour pain.

PubMed

Francis, Richard

2012-05-01

Because TENS is applied inconsistently and not always in line with optimal TENS application theory, this may explain why TENS for labour pain appears to be effective in some individuals and not in others. This article reviews TENS theory, advises upon optimal TENS application for labour pain and discusses some of the limitations of TENS research on labour pain. TENS application for labour pain may include TENS applied to either side of the lower spine, set to 200 mus pulse duration and 100 pulses per second. As pain increases, TENS intensity should be increased and as pain decreases, TENS intensity should be reduced to maintain a strong but pain free intensity of stimulation. This application may particularly reduce back pain during labour.

Step-wise loss of antidepressant effectiveness with repeated antidepressant trials in bipolar II depression.

PubMed

Amsterdam, Jay D; Lorenzo-Luaces, Lorenzo; DeRubeis, Robert J

2016-11-01

This study examined the relationship between the number of prior antidepressant treatment trials and step-wise increase in pharmacodynamic tolerance (or progressive loss of effectiveness) in subjects with bipolar II depression. Subjects ≥18 years old with bipolar II depression (n=129) were randomized to double-blind venlafaxine or lithium carbonate monotherapy for 12 weeks. Responders (n=59) received continuation monotherapy for six additional months. After controlling for baseline covariates of prior medications, there was a 25% reduction in the likelihood of response to treatment with each increase in the number of prior antidepressant trials (odds ratio [OR]=0.75, unstandardized coefficient [B]=-0.29, standard error (SE)=0.12; χ 2 =5.70, P<.02], as well as a 32% reduction in the likelihood of remission with each prior antidepressant trial (OR=0.68, B=-0.39, SE=0.13; χ 2 =9.71, P=.002). This step-wise increase in pharmacodynamic tolerance occurred in both treatment conditions. Prior selective serotonin reuptake inhibitor (SSRI) therapy was specifically associated with a step-wise increase in tolerance, whereas other prior antidepressants or mood stabilizers were not associated with pharmacodynamic tolerance. Neither the number of prior antidepressants, nor the number of prior SSRIs, or mood stabilizers, were associated with an increase in relapse during continuation therapy. The odds of responding or remitting during venlafaxine or lithium monotherapy were reduced by 25% and 32%, respectively, with each increase in the number of prior antidepressant treatment trials. There was no relationship between prior antidepressant exposure and depressive relapse during continuation therapy of bipolar II disorder. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Selecting promising treatments in randomized Phase II cancer trials with an active control.

PubMed

Cheung, Ying Kuen

2009-01-01

The primary objective of Phase II cancer trials is to evaluate the potential efficacy of a new regimen in terms of its antitumor activity in a given type of cancer. Due to advances in oncology therapeutics and heterogeneity in the patient population, such evaluation can be interpreted objectively only in the presence of a prospective control group of an active standard treatment. This paper deals with the design problem of Phase II selection trials in which several experimental regimens are compared to an active control, with an objective to identify an experimental arm that is more effective than the control or to declare futility if no such treatment exists. Conducting a multi-arm randomized selection trial is a useful strategy to prioritize experimental treatments for further testing when many candidates are available, but the sample size required in such a trial with an active control could raise feasibility concerns. In this study, we extend the sequential probability ratio test for normal observations to the multi-arm selection setting. The proposed methods, allowing frequent interim monitoring, offer high likelihood of early trial termination, and as such enhance enrollment feasibility. The termination and selection criteria have closed form solutions and are easy to compute with respect to any given set of error constraints. The proposed methods are applied to design a selection trial in which combinations of sorafenib and erlotinib are compared to a control group in patients with non-small-cell lung cancer using a continuous endpoint of change in tumor size. The operating characteristics of the proposed methods are compared to that of a single-stage design via simulations: The sample size requirement is reduced substantially and is feasible at an early stage of drug development.

Emotional Labour and Governmentality: Productive Power in Childcare

ERIC Educational Resources Information Center

Monrad, Merete

2017-01-01

This article examines the interplay between governance and cost-containment efforts in the public sector and the emotional labour and well-being of childcare workers. Care-work researchers have highlighted the complexities of power in emotional labour, such as the fact that emotional labour may simultaneously benefit the individual worker and…

Participation in two phase II prophylactic HIV vaccine trials in the UK.

PubMed

Gray, Kimberly; Legg, K; Sharp, A; Mackie, N; Olarinde, F; De Souza, C; Weber, J; Peters, B

2008-06-02

There will be a continued imperative to recruit large numbers of healthy volunteers to early phase prophylactic HIV vaccine (PHV) trials. We studied mechanisms associated with participation in two related phase II PHV trials. The most cited reasons for volunteering were altruism and a personal connection to HIV. The most successful recruiting strategies targeted organisations dealing with HIV, health or social issues, or were directed to large audiences through the mass media. However, circulated emails and word of mouth were the most resource-effective approaches. Group discussions and the collection of a pool of potential volunteers were much less effective than one-to-one discussions and immediate screening after recruitment. We utilised our findings to devise key recommendations to assist PHV trial teams who are planning future studies.

Health status and labour force participation: evidence from Australia.

PubMed

Cai, Lixin; Kalb, Guyonne

2006-03-01

This paper examines the effect of health on labour force participation using the Household, Income and Labour Dynamics in Australia (HILDA) Survey. The potential endogeneity of health, especially self-assessed health, in the labour force participation equation is addressed by estimating the health equation and the labour force participation equation simultaneously. Taking into account the correlation between the error terms in the two equations, the estimation is conducted separately for males aged 15-49, males aged 50-64, females aged 15-49 and females aged 50-60. The results indicate that better health increases the probability of labour force participation for all four groups. However, the effect is larger for the older groups and for women. As for the feedback effect, it is found that labour force participation has a significant positive impact on older females' health, and a significant negative effect on younger males' health. For younger females and older males, the impact of labour force participation on health is not significant. The null-hypothesis of exogeneity of health to labour force participation is rejected for all groups. Copyright 2005 John Wiley & Sons, Ltd.

Delivery outcomes after day and night onset of labour.

PubMed

Kanwar, Sandeep; Rabindran, Ranjit; Lindow, Stephen W

2015-11-01

To describe the outcome of night onset of labour as compared with the day onset of labour to investigate if labour that begins at night is more efficient. Retrospective review of labour and delivery data. A large United Kingdom maternity service. Over the period of 10 years, there were 30,022 deliveries, of which 19,842 were studied. A United Kingdom maternity department database was used to identify deliveries over a 10-year period, and the delivery outcomes were retrieved from these records. The 19,842 labours were divided into two categories: night onset (22.00-06.00 h) and day onset (10.00-18.00 h). Rates of operative intervention, augmentation, epidural usage and labour duration. A significant difference in delivery outcome was noted (P=0.004) with the night-onset labours having more normal deliveries (83.6% vs. 82.5%), fewer caesarean sections (8.7% vs. 10.1%), fewer labour augmentations with syntocinon (14.9% vs. 19.5%, P<0.001), fewer artificial rupture of membranes (14.1% vs. 15.6% P<0.001) and a significantly shorter mean first stage duration (4 h 58 min vs. 5 h 7 min, P<0.05). The proportion of women from each group who delivered between 09.00 and 17.00 h was 3660 (31.1%) in the night-onset group and 2414 (30%) in the day-onset group (χ2=1.3, P=NS) Conclusions: Labours that start at night appear to be more efficient than labours that start during the day.

Using Data Augmentation to Facilitate Conduct of Phase I–II Clinical Trials with Delayed Outcomes

PubMed Central

Jin, Ick Hoon; Liu, Suyu; Thall, Peter F.; Yuan, Ying

2014-01-01

A practical impediment in adaptive clinical trials is that outcomes must be observed soon enough to apply decision rules to choose treatments for new patients. For example, if outcomes take up to six weeks to evaluate and the accrual rate is one patient per week, on average three new patients will be accrued while waiting to evaluate the outcomes of the previous three patients. The question is how to treat the new patients. This logistical problem persists throughout the trial. Various ad hoc practical solutions are used, none entirely satisfactory. We focus on this problem in phase I–II clinical trials that use binary toxicity and efficacy, defined in terms of event times, to choose doses adaptively for successive cohorts. We propose a general approach to this problem that treats late-onset outcomes as missing data, uses data augmentation to impute missing outcomes from posterior predictive distributions computed from partial follow-up times and complete outcome data, and applies the design’s decision rules using the completed data. We illustrate the method with two cancer trials conducted using a phase I–II design based on efficacy-toxicity trade-offs, including a computer stimulation study. PMID:25382884

Labour Market Outcomes of Higher Education Undertaken Abroad

ERIC Educational Resources Information Center

Wiers-Jenssen, Jannecke; Try, Sverre

2005-01-01

The aim of this article is to analyse the transferability of higher education undertaken abroad to a domestic labour market. More specifically, how do Norwegians who have undertaken their education abroad cope on the labour market compared to those who have a corresponding education from Norway? To examine this, we analyse short-term labour market…

Optimal dose selection accounting for patient subpopulations in a randomized Phase II trial to maximize the success probability of a subsequent Phase III trial.

PubMed

Takahashi, Fumihiro; Morita, Satoshi

2018-02-08

Phase II clinical trials are conducted to determine the optimal dose of the study drug for use in Phase III clinical trials while also balancing efficacy and safety. In conducting these trials, it may be important to consider subpopulations of patients grouped by background factors such as drug metabolism and kidney and liver function. Determining the optimal dose, as well as maximizing the effectiveness of the study drug by analyzing patient subpopulations, requires a complex decision-making process. In extreme cases, drug development has to be terminated due to inadequate efficacy or severe toxicity. Such a decision may be based on a particular subpopulation. We propose a Bayesian utility approach (BUART) to randomized Phase II clinical trials which uses a first-order bivariate normal dynamic linear model for efficacy and safety in order to determine the optimal dose and study population in a subsequent Phase III clinical trial. We carried out a simulation study under a wide range of clinical scenarios to evaluate the performance of the proposed method in comparison with a conventional method separately analyzing efficacy and safety in each patient population. The proposed method showed more favorable operating characteristics in determining the optimal population and dose.

What influences midwives in estimating labour pain?

PubMed

Williams, A C de C; Morris, J; Stevens, K; Gessler, S; Cella, M; Baxter, J

2013-01-01

Clinicians' estimates of patients' pain are frequently used as a basis for delivering care, and the characteristics of the clinician and of the patient influence this estimate. We studied pain estimation by midwives attending women in uncomplicated labour. Sixty-six practising midwives of varied age, ethnicity and professional experience were asked to complete a trait empathy measure and then to estimate the maximum pain and anxiety experienced by six women whose filmed labour contractions they viewed. Additionally, they rated similarity to the labouring women in ethnicity, and described their beliefs about pain expression according to ethnicity. Midwife estimates of pain and anxiety were highly correlated. Longer professional experience was associated with lower pain estimates, while more births to the midwife herself was associated with higher pain estimates. A multiple regression model identified number of births to the midwife herself, and two components of empathy (perspective taking and identification), to be important in predicting midwife pain estimates for women in labour. Midwives expressed clear beliefs about women's expression of pain during labour according to ethnicity, but these beliefs were not consistent across midwives, even between midwives of similar ethnicity. Midwives' personal characteristics can bias the estimation of pain in woman in labour and therefore influence treatment. © 2012 European Federation of International Association for the Study of Pain Chapters.

[Emotional labour of nursing care: an evolutionary concept analysis].

PubMed

Truc, Huynh; Alderson, Marie; Thompson, Mary

2009-06-01

Caring is considered as the essence of nursing. Underpinning caring, the internal regulation of emotions or the emotional labour of nurses is invisible. The concept of emotional labour is relatively underdeveloped in nursing. A literature search using keywords 'emotional labour', 'emotional work' and 'emotions' was performed in CINAHL, psycINFO and REPERE from 1990 to January 2008. We analysed 72 papers whose main focus of inquiry was on emotional labour. We followed Rodgers' evolutionary method of concept analysis. Emotional labour is a process whereby nurse adopt a 'work persona' to express their autonomous, surface or deep emotions during patient encounters. Antecedents to this adoption of a work persona are events occurring during patient-nurse encounters, and which consist of three elements : organization (i.e.social norms, social support), nurse (i.e.role identification, professional commitment, work experience and interpersonal skills) and job (i.e.autonomy, task routine, degree of emotional demand, interaction frequency and work complexity). The attributes of emotional labour have two dimensions : nurses' autonomous response and their work persona strategies (i.e. surface or deep acts). The consequences of emotional labour include organizational (i.e.productivity, 'cheerful environment') and nurse aspects (i.e. negative or positive) the concept of emotional labour should be introduced into preregistration programmes. Nurses also need to have time and a supportive environment to reflect, understand and discuss their emotional labour in caring for 'difficult' patients to deflate the dominant discourse about 'problem' patients.

Amnioinfusion for umbilical cord compression in labour.

PubMed

Hofmeyr, G J

2000-01-01

Amnioinfusion aims to prevent or relieve umbilical cord compression during labour by infusing a solution into the uterine cavity. The objective of this review was to assess the effects of amnioinfusion on maternal and perinatal outcome for potential or suspected umbilical cord compression or potential amnionitis. The Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register were searched. Randomised trials of amnioinfusion compared with no amnioinfusion in women with babies at risk of umbilical cord compression; and women at risk of intrauterine infection. Eligibility and trial quality were assessed by the reviewer. Twelve studies were included. Transcervical amnioinfusion for potential or suspected umbilical cord compression was associated with the following reductions: fetal heart rate decelerations (relative risk 0.54, 95% confidence interval 0.43 to 0.68); caesarean section for suspected fetal distress (relative risk 0.35, 95% confidence interval 0.24 to 0.52); neonatal hospital stay greater than 3 days (relative risk 0.40, 95% confidence interval 0. 26 to 0.62); maternal hospital stay greater than 3 days (relative risk 0.46, 95% 0.29 to 0.74). Transabdominal amnioinfusion showed similar results. Transcervical amnioinfusion to prevent infection in women with membranes ruptured for more than 6 hours was associated with a reduction in puerperal infection (relative risk 0.50, 95% confidence interval 0.26 to 0.97). Amnioinfusion appears to reduce the occurrence of variable heart rate decelerations and lower the use of caesarean section. However the studies were done in settings where fetal distress was not confirmed by fetal blood sampling. The results may therefore only be relevant where caesarean sections are commonly done for abnormal fetal heart rate alone. The trials reviewed are too small to address the possibility of rare but serious maternal adverse effects of amnioinfusion.

Narratives of neoliberalism: 'clinical labour' in context.

PubMed

Parry, Bronwyn

2015-06-01

Cross-border reproductive care has been thrust under the international spotlight by a series of recent scandals. These have prompted calls to develop more robust means of assessing the exploitative potential of such practices and the need for overarching and normative forms of national and international regulation. Allied theorisations of the emergence of forms of clinical labour have cast the outsourcing of reproductive services such as gamete donation and gestational surrogacy as artefacts of a wider neoliberalisation of service provision. These accounts share with many other narratives of neoliberalism a number of key assertions that relate to the presumed organisation of labour relations within this paradigm. This article critically engages with four assumptions implicit in these accounts: that clinical labourers constitute a largely homogeneous underclass of workers; that reproductive labour has been contractualised in ways that disembed it from wider social and communal relations; that contractualisation can provide protection for clinical labour lessening the need for formal regulatory oversight; and that the transnationalisation of reproductive service labour is largely unidirectional and characterised by a dynamic of provision in which 'the rest' services 'the West'. Drawing on the first findings of a large-scale ethnographic research project into assisted reproduction in India I provide evidence to refute these assertions. In so doing the article demonstrates that while the outsourcing and contractualisation of reproductive labour may be embedded in a wider neoliberal paradigm these practices cannot be understood nor their impacts be fully assessed in isolation from their social and cultural contexts. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Evaluation of the quality of the reporting of phase II clinical trials in oncology: A systematic review.

PubMed

Rivoirard, Romain; Langrand-Escure, Julien; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Rancoule, Chloé; Magné, Nicolas; Bourmaud, Aurélie

2018-05-01

To describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation. databases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed. Thirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analysed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analysed articles. The quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies. Copyright © 2018 Elsevier B.V. All rights reserved.

Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review.

PubMed

Cabarrou, B; Mourey, L; Dalenc, F; Balardy, L; Kanoun, D; Roché, H; Boher, J M; Rougé-Bugat, M E; Filleron, Thomas

2017-08-01

As the incidence of invasive breast cancer will increase with age, the number of elderly patients with a diagnosis metastatic breast cancer will also rise. But the use of cytotoxic drugs in elderly metastatic breast cancer patients is not systematic and is dreaded by medical oncologists. The need for prospective oncologic data from this population seems increasingly obvious. The main objective of this review is to investigate design and characteristics of phase II trials that assess activity and feasibility of chemotherapies in elderly advanced/metastatic breast cancer patients. An electronic search in PUBMED allowed us to retrieve articles published in English language on phase II trials in elderly metastatic breast cancer between January 2002 and May 2016. Sixteen publications were finally included in this review. The primary endpoint was a simple, a composite, and a co-primary endpoints in 11, three, and two studies, respectively. Efficacy was the primary objective in 15 studies: simple (n = 10), composite (n = 3), co-primary endpoints (n = 2). Composite or co-primary endpoints combined efficacy and toxicity. Thirteen studies used multistage designs. Only five studies evaluated the feasibility, i.e., to jointly assess efficacy and tolerance to treatment (toxicity, quality of life, etc) as primary endpoint. Development of elderly specific phase III clinical trials might be challenging, it therefore seems essential to conduct phase II clinical trials evaluating jointly efficacy and toxicity in a well-defined geriatric population. Use of multistage designs that take into account heterogeneity would allow to identify a subpopulation at interim analysis and to reduce the number of patients exposed to an inefficient or a toxic treatment regimen. It is crucial to evaluate new therapies (targeted therapies, immunotherapies) using adequate methodologies (Study design, endpoint).

A multicentre randomized controlled trial of gentle assisted pushing in the upright posture (GAP) or upright posture alone compared with routine practice to reduce prolonged second stage of labour (the Gentle Assisted Pushing study): study protocol.

PubMed

Hofmeyr, G Justus; Singata, Mandisa; Lawrie, Theresa; Vogel, Joshua P; Landoulsi, Sihem; Seuc, Armando H; Gülmezoglu, A Metin

2015-12-16

Fundal pressure (pushing on the upper part of the uterus in the direction of the birth canal) is often performed in routine practice, however the benefit and indications for its use are unclear and vigorous pressure is potentially harmful. There is some evidence that it may be applied routinely or to expedite delivery in some situations (e.g. fetal distress or maternal exhaustion), particularly in settings where other methods of achieving delivery (forceps, vacuum) are not available. Gentle assisted pushing (GAP) is an innovative method of applying gentle but steady pressure to the uterine fundus with the woman in an upright posture. This trial aims to evaluate the use of GAP in an upright posture, or upright posture alone, on reducing the mean time of delivery and the associated maternal and neonatal complications in women not having delivered following 15-30 min in the second stage of labour. We will conduct a multicentre, randomized, unblinded, controlled trial with three parallel arms (1:1:1). 1,145 women will be randomized at three hospitals in South Africa. Women will be eligible for inclusion if they are ≥18 years old, nulliparous, gestational age ≥ 35 weeks, have a singleton pregnancy in cephalic presentation and vaginal delivery anticipated. Women with chronic medical conditions or obstetric complications are not eligible. If eligible women are undelivered following 15-30 min in the second stage of labour, they will be randomly assigned to: 1) GAP in the upright posture, 2) upright posture only and 3) routine practice (recumbent/supine posture). The primary outcome is the mean time from randomization to complete delivery. Secondary outcomes include operative delivery, adverse neonatal outcomes, maternal adverse events and discomfort. This trial will establish whether upright posture and/or a controlled method of applying fundal pressure (GAP) can improve labour outcomes for women and their babies. If fundal pressure is found to have a measurable

The development of a Simplified, Effective, Labour Monitoring-to-Action (SELMA) tool for Better Outcomes in Labour Difficulty (BOLD): study protocol.

PubMed

Souza, João Paulo; Oladapo, Olufemi T; Bohren, Meghan A; Mugerwa, Kidza; Fawole, Bukola; Moscovici, Leonardo; Alves, Domingos; Perdona, Gleici; Oliveira-Ciabati, Livia; Vogel, Joshua P; Tunçalp, Özge; Zhang, Jim; Hofmeyr, Justus; Bahl, Rajiv; Gülmezoglu, A Metin

2015-05-26

The partograph is currently the main tool available to support decision-making of health professionals during labour. However, the rate of appropriate use of the partograph is disappointingly low. Apart from limitations that are associated with partograph use, evidence of positive impact on labour-related health outcomes is lacking. The main goal of this study is to develop a Simplified, Effective, Labour Monitoring-to-Action (SELMA) tool. The primary objectives are: to identify the essential elements of intrapartum monitoring that trigger the decision to use interventions aimed at preventing poor labour outcomes; to develop a simplified, monitoring-to-action algorithm for labour management; and to compare the diagnostic performance of SELMA and partograph algorithms as tools to identify women who are likely to develop poor labour-related outcomes. A prospective cohort study will be conducted in eight health facilities in Nigeria and Uganda (four facilities from each country). All women admitted for vaginal birth will comprise the study population (estimated sample size: 7,812 women). Data will be collected on maternal characteristics on admission, labour events and pregnancy outcomes by trained research assistants at the participating health facilities. Prediction models will be developed to identify women at risk of intrapartum-related perinatal death or morbidity (primary outcomes) throughout the course of labour. These predictions models will be used to assemble a decision-support tool that will be able to suggest the best course of action to avert adverse outcomes during the course of labour. To develop this set of prediction models, we will use up-to-date techniques of prognostic research, including identification of important predictors, assigning of relative weights to each predictor, estimation of the predictive performance of the model through calibration and discrimination, and determination of its potential for application using internal validation

Head-to-cervix force: an important physiological variable in labour. 1. The temporal relation between head-to-cervix force and intrauterine pressure during labour.

PubMed

Allman, A C; Genevier, E S; Johnson, M R; Steer, P J

1996-08-01

To investigate the relation between the rise in intrauterine pressure and rise in fetal head to cervix force in normal, slow and induced labour. Prospective observational study. The labour ward of a London teaching hospital. Forty patients were recruited from the antenatal clinic and labour ward of a West London Hospital. Five had normal onset and progression of labour, 14 had slow progression of labour and 21 had induced onset of labour. Intrauterine pressure and head-to-cervix force was measured simultaneously using an intrauterine pressure catheter and a specially designed four sensor head-to-cervix force probe. For each contraction of each labour, scattergrams of force by pressure were plotted. Three patterns were observed. When the rise in pressure preceded the rise in force, a positive 'loop' was generated. When the rise in pressure and force occurred simultaneously a linear pattern was generated (a neutral 'loop'). When the rise in pressure lags the rise in force, a negative 'loop' was generated. In normally progressive labour the distribution of loops was 29.1%, 22.6% and 48.3%, respectively, in slow labour the distribution was 26.1%, 14.1% and 59.8% and in induced labour the distribution was 33.8%, 14.4% and 51.8%. These distributions were not statistically different. However, a higher proportion of negative loops was observed in labours augmented with oxytocin compared to those receiving no oxytocin (MW-U = 87, P = 0.036). No differences were observed comparing parity, use of PGE2, epidural analgesia, or mode of delivery. Contraction frequency (number/10 minutes) was inversely correlated to the percentage of negative loops (rs = -0.34, P = 0.033) and positively correlated with percentage of positive loops (rs = 0.36, P = 0.027). This is the first report of the temporal relation between intrauterine pressure and head-to-cervix force in labour. The most common pattern is that the rise in pressure lags the rise in force, suggesting that a seal has to be

Generalized optimal design for two-arm, randomized phase II clinical trials with endpoints from the exponential dispersion family.

PubMed

Jiang, Wei; Mahnken, Jonathan D; He, Jianghua; Mayo, Matthew S

2016-11-01

For two-arm randomized phase II clinical trials, previous literature proposed an optimal design that minimizes the total sample sizes subject to multiple constraints on the standard errors of the estimated event rates and their difference. The original design is limited to trials with dichotomous endpoints. This paper extends the original approach to be applicable to phase II clinical trials with endpoints from the exponential dispersion family distributions. The proposed optimal design minimizes the total sample sizes needed to provide estimates of population means of both arms and their difference with pre-specified precision. Its applications on data from specific distribution families are discussed under multiple design considerations. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour.

PubMed

Alfirevic, Zarko; Devane, Declan; Gyte, Gillian Ml; Cuthbert, Anna

2017-02-03

Cardiotocography (CTG) records changes in the fetal heart rate and their temporal relationship to uterine contractions. The aim is to identify babies who may be short of oxygen (hypoxic) to guide additional assessments of fetal wellbeing, or determine if the baby needs to be delivered by caesarean section or instrumental vaginal birth. This is an update of a review previously published in 2013, 2006 and 2001. To evaluate the effectiveness and safety of continuous cardiotocography when used as a method to monitor fetal wellbeing during labour. We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 November 2016) and reference lists of retrieved studies. Randomised and quasi-randomised controlled trials involving a comparison of continuous cardiotocography (with and without fetal blood sampling) with no fetal monitoring, intermittent auscultation intermittent cardiotocography. Two review authors independently assessed study eligibility, quality and extracted data from included studies. Data were checked for accuracy. We included 13 trials involving over 37,000 women. No new studies were included in this update.One trial (4044 women) compared continuous CTG with intermittent CTG, all other trials compared continuous CTG with intermittent auscultation. No data were found comparing no fetal monitoring with continuous CTG. Overall, methodological quality was mixed. All included studies were at high risk of performance bias, unclear or high risk of detection bias, and unclear risk of reporting bias. Only two trials were assessed at high methodological quality.Compared with intermittent auscultation, continuous cardiotocography showed no significant improvement in overall perinatal death rate (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.59 to 1.23, N = 33,513, 11 trials, low quality evidence), but was associated with halving neonatal seizure rates (RR 0.50, 95% CI 0.31 to 0.80, N = 32,386, 9 trials, moderate quality evidence). There was no

Multicenter Phase II Trial of Temsirolimus and Bevacizumab in Pancreatic Neuroendocrine Tumors

PubMed Central

Hobday, Timothy J.; Qin, Rui; Reidy-Lagunes, Diane; Moore, Malcolm J.; Strosberg, Jonathan; Kaubisch, Andreas; Shah, Manisha; Kindler, Hedy Lee; Lenz, Heinz-Josef; Chen, Helen; Erlichman, Charles

2015-01-01

Purpose There are few effective therapies for pancreatic neuroendocrine tumors (PNETs). Recent placebo-controlled phase III trials of the mammalian target of rapamycin (mTOR) inhibitor everolimus and the vascular endothelial growth factor (VEGF)/platelet-derived growth factor receptor inhibitor sunitinib have noted improved progression-free survival (PFS). Preclinical studies have suggested enhanced antitumor effects with combined mTOR and VEGF pathway–targeted therapy. We conducted a clinical trial to evaluate combination therapy against these targets in PNETs. Patients and Methods We conducted a two-stage single-arm phase II trial of the mTOR inhibitor temsirolimus 25 mg intravenously (IV) once per week and the VEGF-A monoclonal antibody bevacizumab 10 mg/kg IV once every 2 weeks in patients with well or moderately differentiated PNETs and progressive disease by RECIST within 7 months of study entry. Coprimary end points were tumor response rate and 6-month PFS. Results A total of 58 patients were enrolled, and 56 patients were eligible for response assessment. Confirmed response rate (RR) was 41% (23 of 56 patients). PFS at 6 months was 79% (44 of 56). Median PFS was 13.2 months (95% CI, 11.2 to 16.6). Median overall survival was 34 months (95% CI, 27.1 to not reached). For evaluable patients, the most common grade 3 to 4 adverse events attributed to therapy were hypertension (21%), fatigue (16%), lymphopenia (14%), and hyperglycemia (14%). Conclusion The combination of temsirolimus and bevacizumab had substantial activity and reasonable tolerability in a multicenter phase II trial, with RR of 41%, well in excess of single targeted agents in patients with progressive PNETs. Six-month PFS was a notable 79% in a population of patients with disease progression by RECIST criteria within 7 months of study entry. On the basis of this trial, continued evaluation of combination mTOR and VEGF pathway inhibitors is warranted. PMID:25488966

Vaginal delivery of breech presentation.

PubMed

Kotaska, Andrew; Menticoglou, Savas; Gagnon, Robert

2009-06-01

elective Caesarean section. (I) 2. Careful case selection and labour management in a modern obstetrical setting may achieve a level of safety similar to elective Caesarean section. (II-1) 3. Planned vaginal delivery is reasonable in selected women with a term singleton breech fetus. (I) 4. With careful case selection and labour management, perinatal mortality occurs in approximately 2 per 1000 births and serious short-term neonatal morbidity in approximately 2% of breech infants. Many recent retrospective and prospective reports of vaginal breech delivery that follow specific protocols have noted excellent neonatal outcomes. (II-1) 5. Long-term neurological infant outcomes do not differ by planned mode of delivery even in the presence of serious short-term neonatal morbidity. (I) RECOMMENDATIONS: LABOUR SELECTION CRITERIA: 1. For a woman with suspected breech presentation, pre- or early labour ultrasound should be performed to assess type of breech presentation, fetal growth and estimated weight, and attitude of fetal head. If ultrasound is not available, Caesarean section is recommended. (II-1A) 2. Contraindications to labour include a. Cord presentation (II-3A) b. Fetal growth restriction or macrosomia (I-A) c. Any presentation other than a frank or complete breech with a flexed or neutral head attitude (III-B) d. Clinically inadequate maternal pelvis (III-B) e. Fetal anomaly incompatible with vaginal delivery (III-B) 3. Vaginal breech delivery can be offered when the estimated fetal weight is between 2500 g and 4000 g. (II-2B) LABOUR MANAGEMENT: 4. Clinical pelvic examination should be performed to rule out pathological pelvic contraction. Radiologic pelvimetry is not necessary for a safe trial of labour; good progress in labour is the best indicator of adequate fetal-pelvic proportions. (III-B) 5. Continuous electronic fetal heart monitoring is preferable in the first stage and mandatory in the second stage of labour. (I-A) When membranes rupture, immediate vaginal

Division of labour in the yeast: Saccharomyces cerevisiae.

PubMed

Wloch-Salamon, Dominika M; Fisher, Roberta M; Regenberg, Birgitte

2017-10-01

Division of labour between different specialized cell types is a central part of how we describe complexity in multicellular organisms. However, it is increasingly being recognized that division of labour also plays an important role in the lives of predominantly unicellular organisms. Saccharomyces cerevisiae displays several phenotypes that could be considered a division of labour, including quiescence, apoptosis and biofilm formation, but they have not been explicitly treated as such. We discuss each of these examples, using a definition of division of labour that involves phenotypic variation between cells within a population, cooperation between cells performing different tasks and maximization of the inclusive fitness of all cells involved. We then propose future research directions and possible experimental tests using S. cerevisiae as a model organism for understanding the genetic mechanisms and selective pressures that can lead to the evolution of the very first stages of a division of labour. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Altered gene expression in human placenta after suspected preterm labour.

PubMed

Oros, D; Strunk, M; Breton, P; Paules, C; Benito, R; Moreno, E; Garcés, M; Godino, J; Schoorlemmer, J

2017-07-01

Suspected preterm labour occurs in around 9% of pregnancies. However, almost two-thirds of women admitted for threatened preterm labour ultimately deliver at term and are considered risk-free for fetal development. We examined placental and umbilical cord blood samples from preterm or term deliveries after threatened preterm labour as well as term deliveries without threatened preterm labour. We quantitatively analysed the mRNA expression of inflammatory markers (IL6, IFNγ, and TNFα) and modulators of angiogenesis (FGF2, PGF, VEGFA, VEGFB, and VEGFR1). A total of 132 deliveries were analysed. Preterm delivery and term delivery after suspected preterm labour groups showed similar increases in TNFα expression compared with the term delivery control group in umbilical cord blood samples. Placental samples from preterm and term deliveries after suspected preterm labour exhibited significantly increased expression of TNFα and IL6 and decreased expression of IFNγ. Suspected preterm labour was also associated with altered expression of angiogenic factors, although not all differences reached statistical significance. We found gene expression patterns indicative of inflammation in human placentas after suspected preterm labour regardless of whether the deliveries occurred preterm or at term. Similarly, a trend towards altered expression of angiogeneic factors was not limited to preterm birth. These findings suggest that the biological mechanisms underlying threatened preterm labour affect pregnancies independently of gestational age at birth. Copyright © 2017 Elsevier Ltd. All rights reserved.

A meta-ethnographic synthesis of midwives' and nurses' experiences of adverse labour and birth events.

PubMed

Elmir, Rakime; Pangas, Jackie; Dahlen, Hannah; Schmied, Virginia

2017-12-01

Health professionals are frequently exposed to traumatic events due to the nature of their work. While traumatic and adverse labour and birth events experienced by women are well researched, less attention has been given to midwives' and nurses' experiences of these events and the impact it has on their lives. To undertake a meta-ethnographic study of midwives' and nurses' experiences of adverse labour and birth events. Scopus, CINHAL PLUS, MEDLINE and PUBMED databases were searched using subject headings and keywords. The search was limited to papers published in peer-reviewed journals from 2004-October 2016. Quality appraisal was undertaken using the Critical Appraisal Skills Programme tool. Papers had to be qualitative or have a substantial qualitative component. Studies were included if they primarily focused on midwives' or nurses' perspectives or experiences of complicated, traumatic or adverse labour and birth events. A meta-ethnographic approach was used incorporating methods of reciprocal translation guided by the work of Noblit and Hare (1988, Meta-Ethnography: Synthesizing qualitative studies (Vol. 11). Newbury Park: Sage publications). Eleven qualitative studies were included in the final sample. Four major themes were (i) feeling the chaos; (ii) powerless, responsible and a failure; (iii) "It adds another scar to my soul"; and (iv) finding a way to deal with it. Midwives and nurses feel relatively unprepared when faced with a real-life labour and birth emergency event. While many of the midwives and nurses were traumatised by the experience, some were able to view their encounter as an opportunity to develop their emergency response skills. Witnessing and being involved in a complicated or adverse labour and birth event can be traumatic for nurses and midwives. Organisational and collegial support needs to be available to enable these health professionals to talk about their feelings and concerns. © 2017 John Wiley & Sons Ltd.

Strategies to retain participants in a long-term HIV prevention randomized controlled trial: Lessons from the MINTS-II study

PubMed Central

Horvath, Keith J.; Nygaard, Kate; Danilenko, Gene P.; Goknur, Sinan; Oakes, J. Michael; Rosser, B.R. Simon

2012-01-01

Achieving satisfactory retention in online HIV prevention trials typically have proved difficult, particularly over extended timeframes. The overall aim of this study was to assess factors associated with retention in the Men’s INTernet Study II (MINTS-II), a randomized controlled trial of a sexual risk reduction intervention for men who have sex with men. Participants were recruited via e-mails and banner advertisements in December, 2007 to participate in the MINTS-II Sexpulse intervention and followed over a 12-month period. Retention across the treatment and control arms was 85.2% at 12 months. Factors associated with higher retention included: randomization to the control arm, previous participation in a study by the research team, e-mail and telephone reminders to complete a survey once it was available to take, and fewer e-mail contacts between surveys. The results provide evidence that achieving satisfactory retention is possible in online HIV prevention trials, and suggest best practices for maximizing retention. PMID:21538084

Labour epidural analgesia in Poland in 2009 - a survey.

PubMed

Furmanik, Jacek

2013-01-01

Labour analgesia in most developed countries is funded by the state, available to every woman in labour, and plays an important role in the everyday activities of most anaesthetists. This paper presents the second part of an Obstetric Anaesthesia Survey which was conducted in 2009. The first part of the Survey, relating to anaesthesia for caesarean sections, was published in 2010. The author sent out 432 questionnaires containing questions about hospital size and location, staffing levels and numbers of deliveries per year. There were also questions regarding regional and other pain relief methods used in labour, ways of administration, drugs used and monitoring of patients. The response rate was 24%. Around 45% of responding hospitals had only 1-3 deliveries per year, which makes it difficult to provide separate obstetric anaesthetic cover. Only ten hospitals (11%) employed an anaesthetist for the labour ward. Epidural analgesia was used in 55% of hospitals but only 20% provided the service for 24 hours per day and free of charge. Entonox was used very occasionally, but the most common means of pain relief was pethidine injection. There were marked differences in the medication used for labour epidurals, with 18% of units using high concentrations of local anaesthetics which could result in motor block. Despite a lack of regulations in Polish law and a lack of proper training in 50% of units, midwives were looking after the patients with established labour epidural which could create medico-legal consequences. There was also a marked variation in the parameters monitored during labour analgesia. Epidural labour analgesia was offered for 24 hours per day and free of charge in only 20% of hospitals. Without public pressure it will be difficult to get more funding from the National Health Fund (NFZ) to enable other hospitals, especially those with small obstetric units, to introduce regional labour analgesia. Although the 2009 guidelines addressed most of the issues

SPIRIT: A seamless phase I/II randomized design for immunotherapy trials.

PubMed

Guo, Beibei; Li, Daniel; Yuan, Ying

2018-06-07

Immunotherapy-treatments that enlist the immune system to battle tumors-has received widespread attention in cancer research. Due to its unique features and mechanisms for treating cancer, immunotherapy requires novel clinical trial designs. We propose a Bayesian seamless phase I/II randomized design for immunotherapy trials (SPIRIT) to find the optimal biological dose (OBD) defined in terms of the restricted mean survival time. We jointly model progression-free survival and the immune response. Progression-free survival is used as the primary endpoint to determine the OBD, and the immune response is used as an ancillary endpoint to quickly screen out futile doses. Toxicity is monitored throughout the trial. The design consists of two seamlessly connected stages. The first stage identifies a set of safe doses. The second stage adaptively randomizes patients to the safe doses identified and uses their progression-free survival and immune response to find the OBD. The simulation study shows that the SPIRIT has desirable operating characteristics and outperforms the conventional design. Copyright © 2018 John Wiley & Sons, Ltd.

Perioperative antibiotic prophylaxis in the treatment of acute cholecystitis (PEANUTS II trial): study protocol for a randomized controlled trial.

PubMed

Loozen, Charlotte S; van Santvoort, Hjalmar C; van Geloven, Antoinette A W; Nieuwenhuijzen, Grard A P; de Reuver, Philip R; Besselink, Mark H G; Vlaminckx, Bart; Kelder, Johannes C; Knibbe, Catherijne A J; Boerma, Djamila

2017-08-23

The additional value of perioperative antibiotic prophylaxis in preventing infectious complications after emergency cholecystectomy for acute cholecystitis is a much-debated subject in the surgical community. Evidence-based guidelines are lacking, and consequently the use of antibiotic prophylaxis varies greatly among surgeons and hospitals. Recently, high-level evidence became available demonstrating that postoperative antibiotic prophylaxis in patients with acute cholecystitis does not reduce the risk of infectious complications. Preoperative antibiotic prophylaxis in relation to the risk of infectious complications, however, has never been studied. The PEANUTS II trial is a randomized, controlled, multicenter, open-label noninferiority trial whose aim is to determine the utility of preoperative antibiotic prophylaxis in patients undergoing emergency cholecystectomy for acute calculous cholecystitis. Patients with mild or moderate acute cholecystitis, as defined according the Tokyo Guidelines, will be randomly assigned to a single preoperative dose of antibiotic prophylaxis (2000 mg of first-generation cephalosporin delivered intravenously) or no antibiotic prophylaxis before emergency cholecystectomy. The primary endpoint is a composite endpoint consisting of all postoperative infectious complications occurring during the first 30 days after surgery. Secondary endpoints include all the individual components of the primary endpoint, all other complications, duration of hospital stay, and total costs. The hypothesis is that the absence of antibiotic prophylaxis is noninferior to the presence of antibiotic prophylaxis. A noninferiority margin of 10% is assumed. With a 1-sided risk of 2.5% and a power of 80%, a total of 454 subjects will have to be included. Analysis will be performed according to the intention-to-treat principle. The PEANUTS II trial will provide evidence-based advice concerning the utility of antibiotic prophylaxis in patients undergoing

Effect of child labour on growth of children.

PubMed

Ambadekar, N N; Wahab, S N; Zodpey, S P; Khandait, D W

1999-11-01

This community based group comparison study was undertaken to assess the effect of child labour on the growth of children. The study subjects were 223 child labourers aged between 8-15 y who were matched by age to an equal number of controls and pair matched for gender. The mean weight of the male child labourers and the controls increased from 23.8 (+/-5.9) to 41.2 (+/-9.7) kg and 23.9 (+/-4.8) to 44.4 (+/-10.3) kg respectively, while mean height increased from 121.5 (+/-12.6) to 151.9 (+/-10.6) cm and 122.0 (+/-8.4) to 154.8 (+/-10.8) cm respectively from 8-15 y. At older ages (12 y and above for weight and 14 y and above for height) the difference was statistically significant. The same was not observed for the female study subjects. Similarly standard deviation (s.d.) scores for weight for age and height for age of male comparison subjects was significantly (P<0.01) nearer to National Centre for Health Statistics (NCHS) standard than that of the child labourers. Body mass index (BMI) below normal value, that is, 18.5 was observed in significantly (P=0.0261) more child labourers 180 (80.7%) than controls 160 (71.1%). With increasing duration of employment BMI decreased from 18.1 (+/-3.5) to 17.3 (+/-2.2). Genital development was observed to be delayed significantly in male child labourers. Therefore, it can be concluded that labouring at a young age has a deleterious effect on the growth of the child.

Whole Brain Radiotherapy and RRx-001: Two Partial Responses in Radioresistant Melanoma Brain Metastases from a Phase I/II Clinical Trial: A TITE-CRM Phase I/II Clinical Trial.

PubMed

Kim, Michelle M; Parmar, Hemant; Cao, Yue; Pramanik, Priyanka; Schipper, Matthew; Hayman, James; Junck, Larry; Mammoser, Aaron; Heth, Jason; Carter, Corey A; Oronsky, Arnold; Knox, Susan J; Caroen, Scott; Oronsky, Bryan; Scicinski, Jan; Lawrence, Theodore S; Lao, Christopher D

2016-04-01

Kim et al. report two patients with melanoma metastases to the brain that responded to treatment with RRx-001 and whole brain radiotherapy (WBRT) without neurologic or systemic toxicity in the context of a phase I/II clinical trial. RRx-001 is an reactive oxygen and reactive nitrogen species (ROS/RNS)-dependent systemically nontoxic hypoxic cell radiosensitizer with vascular normalizing properties under investigation in patients with various solid tumors including those with brain metastases. Metastatic melanoma to the brain is historically associated with poor outcomes and a median survival of 4 to 5 months. WBRT is a mainstay of treatment for patients with multiple brain metastases, but no significant therapeutic advances for these patients have been described in the literature. To date, candidate radiosensitizing agents have failed to demonstrate a survival benefit in patients with brain metastases, and in particular, no agent has demonstrated improved outcome in patients with metastatic melanoma. Kim et al. report two patients with melanoma metastases to the brain that responded to treatment with novel radiosensitizing agent RRx-001 and WBRT without neurologic or systemic toxicity in the context of a phase I/II clinical trial. Published by Elsevier Inc.

Physiotherapy rehabilitation for whiplash associated disorder II: a systematic review and meta-analysis of randomised controlled trials

PubMed Central

Wright, Chris; Heneghan, Nicola; Eveleigh, Gillian; Calvert, Melanie; Freemantle, Nick

2011-01-01

Objective To evaluate effectiveness of physiotherapy management in patients experiencing whiplash associated disorder II, on clinically relevant outcomes in the short and longer term. Design Systematic review and meta-analysis. Two reviewers independently searched information sources, assessed studies for inclusion, evaluated risk of bias and extracted data. A third reviewer mediated disagreement. Assessment of risk of bias was tabulated across included trials. Quantitative synthesis was conducted on comparable outcomes across trials with similar interventions. Meta-analyses compared effect sizes, with random effects as primary analyses. Data sources Predefined terms were employed to search electronic databases. Additional studies were identified from key journals, reference lists, authors and experts. Eligibility criteria for selecting studies Randomised controlled trials (RCTs) published in English before 31 December 2010 evaluating physiotherapy management of patients (>16 years), experiencing whiplash associated disorder II. Any physiotherapy intervention was included, when compared with other types of management, placebo/sham, or no intervention. Measurements reported on ≥1 outcome from the domains within the international classification of function, disability and health, were included. Results 21 RCTs (2126 participants, 9 countries) were included. Interventions were categorised as active physiotherapy or a specific physiotherapy intervention. 20/21 trials were evaluated as high risk of bias and one as unclear. 1395 participants were incorporated in the meta-analyses on 12 trials. In evaluating short term outcome in the acute/sub-acute stage, there was some evidence that active physiotherapy intervention reduces pain and improves range of movement, and that a specific physiotherapy intervention may reduce pain. However, moderate/considerable heterogeneity suggested that treatments may differ in nature or effect in different trial patients. Differences

Medulloblastoma in children and adolescents: a systematic review of contemporary phase I and II clinical trials and biology update.

PubMed

Bautista, Francisco; Fioravantti, Victoria; de Rojas, Teresa; Carceller, Fernando; Madero, Luis; Lassaletta, Alvaro; Moreno, Lucas

2017-11-01

Survival rates for patients with medulloblastoma have improved in the last decades but for those who relapse outcome is dismal and new approaches are needed. Emerging drugs have been tested in the last two decades within the context of phase I/II trials. In parallel, advances in genetic profiling have permitted to identify key molecular alterations for which new strategies are being developed. We performed a systematic review focused on the design and outcome of early-phase trials evaluating new agents in patients with relapsed medulloblastoma. PubMed, clinicaltrials.gov, and references from selected studies were screened to identify phase I/II studies with reported results between 2000 and 2015 including patients with medulloblastoma aged <18 years. A total of 718 studies were reviewed and 78 satisfied eligibility criteria. Of those, 69% were phase I; 31% phase II. Half evaluated conventional chemotherapeutics and 35% targeted agents. Overall, 662 patients with medulloblastoma/primitive neuroectodermal tumors were included. The study designs and the response assessments were heterogeneous, limiting the comparisons among trials and the correct identification of active drugs. Median (range) objective response rate (ORR) for patients with medulloblastoma in phase I/II studies was 0% (0-100) and 6.5% (0-50), respectively. Temozolomide containing regimens had a median ORR of 16.5% (0-100). Smoothened inhibitors trials had a median ORR of 8% (3-8). Novel drugs have shown limited activity against relapsed medulloblastoma. Temozolomide might serve as backbone for new combinations. Novel and more homogenous trial designs might facilitate the development of new drugs. © 2017 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Knowledge and decision-making for labour analgesia of Australian primiparous women.

PubMed

Raynes-Greenow, Camille H; Roberts, Christine L; McCaffery, Kirsten; Clarke, Judith

2007-06-01

to assess and investigate knowledge of labour pain management options and decision-making among primiparous women. a semi-structured guide was used in focus groups to gather pregnant women's knowledge concerning labour analgesia. Attitudes to labour and pain relief, knowledge of pain relief, trustworthiness of knowledge sources, and plans and expectations for labour pain relief were investigated. a major tertiary obstetric hospital in metropolitan Sydney, Australia. twenty five primiparous women, who were 25 weeks or more gestation, and planning a vaginal birth. although women considered themselves knowledgeable, they were unable to describe labour analgesic risks or benefits. There was a large discrepancy between perception and actual knowledge. The main source of knowledge was anecdotal information. Late in pregnancy was considered the ideal time to be given information about labour analgesia. Women described their labour pain relief plans as flexible in relation to their labour circumstances; however, most women wanted to take an active role in decision-making. the large discrepancy between perceived knowledge and actual knowledge of the likely consequences of labour analgesia suggests that women rely too heavily on anecdotal information. clinicians should be aware that some women overestimate their knowledge and understanding of analgesic options, which is often based on anecdotal information. Standardised labour analgesia information at an appropriate time in their pregnancy may benefit some women and assist health-care providers and women to practice shared decision-making.

Increased xanthine oxidase during labour--implications for oxidative stress.

PubMed

Many, A; Roberts, J M

1997-11-01

Xanthine dehydrogenase/oxidase (XDH/XO) produces uric acid. When in the oxidase form, this production is coupled with the generation of free radicals. Hypoxia-reperfusion enhances conversion of XDH to XO. Since the placenta is exposed to short periods of hypoxia reperfusion during labour, 17 placentae of pregnancy terminated by elective caesarean section and five placentae of pregnancies terminated by caesarean section during labour were examined for XDH/XO activity. It was found that XO activity was higher in the placentae of labouring women (P = 0.003), which suggests that labour enhances conversion of XDH to XO, facilitating free radical production.

Phase II clinical trial of combination chemotherapy with dexamethasone for lymphoma in dogs.

PubMed

Greenberg, Chelsea B; Boria, Pedro A; Borgatti-Jeffreys, Antonella; Raskin, Rose E; Lucroy, Michael D

2007-01-01

Dogs with histologically confirmed lymphoma were treated with a 14-week induction chemotherapy protocol that included dexamethasone. A phase II clinical trial was done using a standard two-stage design. Complete remission occurred in 21 (88%) dogs, with a median initial progression-free interval of 186 days. Toxicity was mild and self-limiting in the majority of dogs.

Field Trial of Methoxyflurane, Nitrous Oxide, and Trichloroethylene as Obstetric Analgesics

PubMed Central

Rosen, M.; Mushin, W. W.; Jones, P. L.; Jones, E. V.

1969-01-01

In a field trial of 1,257 patients receiving methoxyflurane, trichloroethylene, and nitrous-oxide/oxygen for the relief of pain in labour methoxyflurane has been shown to have certain advantages which support its use in midwifery practice. The trial confirms our objective method for screening an inhalational agent as an obstetric analgesic. PMID:4895340

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.

Webcam Delivery of the Camperdown Program for Adolescents Who Stutter: A Phase II Trial

ERIC Educational Resources Information Center

Carey, Brenda; O'Brian, Sue; Lowe, Robyn; Onslow, Mark

2014-01-01

Purpose: This Phase II clinical trial examined stuttering adolescents' responsiveness to the Webcam-delivered Camperdown Program. Method: Sixteen adolescents were treated by Webcam with no clinic attendance. Primary outcome was percentage of syllables stuttered (%SS). Secondary outcomes were number of sessions, weeks and hours to maintenance,…

Unexpected consequences: women's experiences of a self-hypnosis intervention to help with pain relief during labour.

PubMed

Finlayson, Kenneth; Downe, Soo; Hinder, Susan; Carr, Helen; Spiby, Helen; Whorwell, Peter

2015-09-25

Self-hypnosis is becoming increasingly popular as a means of labour pain management. Previous studies have produced mixed results. There are very few data on women's views and experiences of using hypnosis in this context. As part of a randomized controlled trial of self-hypnosis for intra-partum pain relief (the SHIP Trial) we conducted qualitative interviews with women randomized to the intervention arm to explore their views and experiences of using self-hypnosis during labour and birth. Participants were randomly selected from the intervention arm of the study, which consisted of two antenatal self-hypnosis training sessions and a supporting CD that women were encouraged to listen to daily from 32 weeks gestation until the birth of their baby. Those who consented were interviewed in their own homes 8-12 weeks after birth. Following transcription, the interviews were analysed iteratively and emerging concepts were discussed amongst the authors to generate organizing themes. These were then used to develop a principal organizing metaphor or global theme, in a process known as thematic networks analysis. Of the 343 women in the intervention group, 48 were invited to interview, and 16 were interviewed over a 12 month period from February 2012 to January 2013. Coding of the data and subsequent analysis revealed a global theme of 'unexpected consequences', supported by 5 organising themes, 'calmness in a climate of fear', 'from sceptic to believer', 'finding my space', 'delays and disappointments' and 'personal preferences'. Most respondents reported positive experiences of self-hypnosis and highlighted feelings of calmness, confidence and empowerment. They found the intervention to be beneficial and used a range of novel strategies to personalize their self-hypnosis practice. Occasionally women reported feeling frustrated or disappointed when their relaxed state was misinterpreted by midwives on admission or when their labour and birth experiences did not match

Pain relief in labour: a qualitative study to determine how to support women to make decisions about pain relief in labour

PubMed Central

2014-01-01

Background Engagement in decision making is a key priority of modern healthcare. Women are encouraged to make decisions about pain relief in labour in the ante-natal period based upon their expectations of what labour pain will be like. Many women find this planning difficult. The aim of this qualitative study was to explore how women can be better supported in preparing for, and making, decisions during pregnancy and labour regarding pain management. Methods Semi-structured interviews were conducted with 13 primiparous and 10 multiparous women at 36 weeks of pregnancy and again within six weeks postnatally. Data collection and analysis occurred concurrently to identify key themes. Results Three main themes emerged from the data. Firstly, during pregnancy women expressed a degree of uncertainty about the level of pain they would experience in labour and the effect of different methods of pain relief. Secondly, women reflected on how decisions had been made regarding pain management in labour and the degree to which they had felt comfortable making these decisions. Finally, women discussed their perceived levels of control, both desired and experienced, over both their bodies and the decisions they were making. Conclusion This study suggests that the current approach of antenatal preparation in the NHS, of asking women to make decisions antenatally for pain relief in labour, needs reviewing. It would be more beneficial to concentrate efforts on better informing women and on engaging them in discussions around their values, expectations and preferences and how these affect each specific choice rather than expecting them to make to make firm decisions in advance of such an unpredictable event as labour. PMID:24397421

Development of a multidimensional labour satisfaction questionnaire: dimensions, validity, and internal reliability

PubMed Central

Smith, L

2001-01-01

Background—No published quantitative instrument exists to measure maternal satisfaction with the quality of different models of labour care in the UK. Methods—A quantitative psychometric multidimensional maternal satisfaction questionnaire, the Women's Views of Birth Labour Satisfaction Questionnaire (WOMBLSQ), was developed using principal components analysis with varimax rotation of successive versions. Internal reliability and content and construct validity were assessed. Results—Of 300 women sent the first version (WOMBLSQ1), 120 (40%) replied; of 300 sent WOMBLSQ2, 188 (62.7%) replied; of 500 women sent WOMBLSQ3, 319 (63.8%) replied; and of 2400 women sent WOMBLSQ4, 1683 (70.1%) replied. The latter two versions consisted of 10 dimensions in addition to general satisfaction. These were (Cronbach's alpha): professional support in labour (0.91), expectations of labour (0.90), home assessment in early labour (0.90), holding the baby (0.87), support from husband/partner (0.83), pain relief in labour (0.83), pain relief immediately after labour (0.65), knowing labour carers (0.82), labour environment (0.80), and control in labour (0.62). There were moderate correlations (range 0.16–0.73) between individual dimensions and the general satisfaction scale (0.75). Scores on individual dimensions were significantly related to a range of clinical and demographic variables. Conclusion—This multidimensional labour satisfaction instrument has good validity and internal reliability. It could be used to assess care in labour across different models of maternity care, or as a prelude to in depth exploration of specific areas of concern. Its external reliability and transferability to care outside the South West region needs further evaluation, particularly in terms of ethnicity and social class. Key Words: Women's Views of Birth Labour Satisfaction Questionnaire (WOMBLSQ); labour; questionnaire PMID:11239139

Factors Associated with Trial of Labour and Mode of Delivery in Robson Group 5: A Select Group of Women With Previous Caesarean Section.

PubMed

Smithies, Mila; Woolcott, Christy G; Brock, Jo-Ann K; Maguire, Bryan; Allen, Victoria M

2018-06-01

To determine the proportion of women in Robson group 5 (RG5) who were eligible for a trial of labour after Caesarean (TOLAC) and, among eligible candidates, identify determinants of having a TOLAC and subsequent vaginal delivery (VD). This population-based cohort study used data derived from the Nova Scotia Atlee Perinatal Database. Deliveries from 1998-2014 to women in RG5 (≥1 previous CS with a singleton term cephalic fetus) were included. Eligibility for a TOLAC was based on SOGC criteria. Multivariable logistic regression was used to identify characteristics independently associated with TOLAC and VD. The characteristics associated with VD were used in a logistic model to predict the theoretical probability of VD in women who did not have a TOLAC. Of the 15 111 deliveries in RG5, 75.3% were by CS. Of the 14 763 eligible women, 5488 (37.2%) had a TOLAC, of which 3739 (68.1%) resulted in VD. Predictors of VD included high area-level income and either a CS without labour or a spontaneous VD in the preceding pregnancy. While mode of previous delivery also predicted TOLAC among eligible women, high area-level income was associated with reduced odds of TOLAC. The probability of VD in women who did not undergo TOLAC was estimated to be 47.1%, and the lowest CS rate attainable in RG5 was estimated at 46.3%. Sociodemographic factors such as income and previous mode of delivery were associated with the rates of TOLAC and subsequent VD in eligible women, and suggest that the Caesarean section rate in RG5 could be safely reduced. Copyright © 2018 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

N-acetyl cysteine add-on treatment for bipolar II disorder: a subgroup analysis of a randomized placebo-controlled trial.

PubMed

Magalhães, P V; Dean, O M; Bush, A I; Copolov, D L; Malhi, G S; Kohlmann, K; Jeavons, S; Schapkaitz, I; Anderson-Hunt, M; Berk, M

2011-03-01

The evidence base for the pharmacological treatment of bipolar II disorder is limited. In bipolar disorder, there is evidence for glutathione depletion and increased oxidative stress, as well as dysregulation of glutamate; N-acetyl cysteine (NAC) has effects on both of these systems. Add-on NAC has been shown to have a significant benefit on depressive symptoms in a randomized placebo-controlled trial. In this report, we explore the effects of this compound in a subset of patients with bipolar II disorder from that trial. Individuals were randomized to NAC or placebo in addition to treatment as usual, in a double-blind fashion. Mood and functional outcomes were assessed up to 24 weeks of treatment. Fourteen individuals were available for this report, seven in each group. Six people achieved full remission of both depressive and manic symptoms in the NAC group; this was true for only two people in the placebo group (χ(2)=4.67, p=0.031). Subgroup analyses in a small subsample of patients. Not all participants had elevated depression scores at baseline. Notwithstanding all the limitations that subgroup analysis of trials carry, this data could serve as a hypothesis-generating stimulus for further clinical trials of pharmacologic treatment for bipolar II depression. Copyright © 2010 Elsevier B.V. All rights reserved.

Intracutaneous sterile water for back pain in labour.

PubMed Central

Reynolds, J. L.

1994-01-01

Intracutaneous sterile water appears to be a simple, effective, and harmless technique for relieving back pain. This technique has been used to relieve pain of renal colic, whiplash, and back pain in labour. Family doctors often practise obstetrics in small or isolated units that have limited options for pain relief in labour. This technique is simple, is easy to learn, and appears effective for relieving back pain, which complicates about one third of all labours. Images Figures 1-2 Figures 3-4 PMID:7950471

The Impact of Training-Intensive Labour Market Policies on Labour and Educational Prospects of NEETS: Evidence from Catalonia (Spain)

ERIC Educational Resources Information Center

Alegre, Miquel Àngel; Casado, David; Sanz, Jordi; Todeschini, Federico A.

2015-01-01

Background: The literature has shown that the way active labour market policies (ALMP) aimed at youth are designed and implemented can influence the labour and educational prospects of youngsters. The evaluation of the Catalan PQPIs (initial vocational qualification programmes) presented here seeks to provide new evidence on the effectiveness of…

Reverse breech extraction versus the standard approach of pushing the impacted fetal head up through the vagina in caesarean section for obstructed labour: A randomised controlled trial.

PubMed

Nooh, Ahmed Mohamed; Abdeldayem, Hussein Mohammed; Ben-Affan, Othman

2017-05-01

The objective of this study was to assess effectiveness and safety of the reverse breech extraction approach in Caesarean section for obstructed labour, and compare it with the standard approach of pushing the fetal head up through the vagina. This randomised controlled trial included 192 women. In 96, the baby was delivered by the 'reverse breech extraction approach', and in the remaining 96, by the 'standard approach'. Extension of uterine incision occurred in 18 participants (18.8%) in the reverse breech extraction approach group, and 46 (47.9%) in the standard approach group (p = .0003). Two women (2.1%) in the reverse breech extraction approach group needed blood transfusion and 11 (11.5%) in the standard approach group (p = .012). Pyrexia developed in 3 participants (3.1%) in the reverse breech extraction approach group, and 19 (19.8%) in the standard approach group (p = .0006). Wound infection occurred in 2 women (2.1%) in the reverse breech extraction approach group, and 12 (12.5%) in the standard approach group (p = .007). Apgar score <7 at 5 minutes was noted in 8 babies (8.3%) in the reverse breech extraction approach group, and 21 (21.9%) in the standard approach group (p = .015). In conclusion, reverse breech extraction in Caesarean section for obstructed labour is an effective and safe alternative to the standard approach of pushing the fetal head up through the vagina.

[Effectiveness and safety of atosiban vs. pulsatile administration of fenoterol in the treatment of preterm labour].

PubMed

Nonnenmacher, A; Hopp, H; Dudenhausen, J

2009-10-01

The aim of this study was to compare the efficacy and side effects of atosiban with those of fenoterol (pulsatile administration) for acute tocolysis. A prospective, open-label, randomised controlled trial was performed. Patients in preterm labour at 24+0 to 33+6 weeks of gestation were randomised to receive atosiban (A) or fenoterol (F) pulsatile administration. Primary outcome was the arrest of preterm labour. The proportion of woman remaining undelivered at 48 hours (86.3% atosiban group and 79.6% fenoterol group) and at 7 days (78.4% vs. 66.7%) was comparable. The incidence of maternal cardiovascular side effects was lower in the atosiban group (4% vs. 78%, p=0.0). Tocolysis was terminated as a result of maternal adverse effects in the fenoterol group (9%). Fetal tachycardia was lower in the atosiban group (2% vs. 22%). The mean duration of tocolytic administration was lower in the atosiban group (19 h vs. 24.5 h, p<0.05). The adverse effects in the pulsatile administration of fenoterol for short duration were only dependent on the initial dosage for the arrest of preterm labour. Neonatal outcome were similar between the treatment groups and were rather related to the gestational age not to the tocolytic agent. Atosiban was comparable in clinical effectiveness and was associated with fewer maternal and fetal adverse effects, so that fenoterol cannot be recommended. Completion of tocolytic therapy 12 hours after arrest of preterm labour is effective and associated with a short mean duration. Georg Thieme Verlag KG Stuttgart-New York.

Ethnic variation between white European women in labour outcomes in a setting in which the management of labour is standardised-a healthy migrant effect?

PubMed

Walsh, J; Mahony, R; Armstrong, F; Ryan, G; O'Herlihy, C; Foley, M

2011-05-01

To test the hypothesis that women from Eastern European countries have lower caesarean delivery rates and higher spontaneous labour rates relative to Irish women in a setting in which the management of labour is standardised. A retrospective review of prospectively collected data. Tertiary referral centre, Dublin, Ireland. All Irish and Eastern European term nulliparous women who laboured and delivered in 2008. A comparison of labour outcomes between women from Ireland and women from Eastern European countries. The principal outcomes measured were the gestational age at onset of labour, whether labour was spontaneous or induced, the need for oxytocin augmentation, duration of labour, mode of delivery, epidural use and birthweight. Of 2556 Irish (n = 2041) and Eastern European (n = 511) term cephalic singleton labours in the calendar year 2008, women from Eastern Europe were significantly more likely to labour spontaneously (74.6% versus 65.9%, P < 0.001), required less epidural analgesia (68.4% versus 59.7%) and were significantly less likely to require delivery by caesarean section (8.6% versus 15.7%, P < 0.001) than Irish women. This is despite no significant difference between the two groups with regard to mean birthweight (3581 g versus 3569 g, P = 0.6) or macrosomia (birthweight over 4000 g) (18% versus 16%, P = 0.4). There were significant differences in maternal age at delivery (27.2 years versus 29.2 years, P < 0.001) and body mass index (BMI) (24.1 kg/m² versus 25.4 kg/m², P < 0.001) between the two groups. These findings confirm our hypothesis that economic migrants from Eastern European countries exhibit a so-called 'healthy migrant effect' in terms of obstetric outcomes. © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.

The prevention of early-onset neonatal group B streptococcal disease.

PubMed

Money, Deborah; Allen, Victoria M

2013-10-01

To review the evidence in the literature and to provide recommendations on the management of pregnant women in labour for the prevention of early-onset neonatal group B streptococcal disease. The key revisions in this updated guideline include changed recommendations for regimens for antibiotic prophylaxis, susceptibility testing, and management of women with pre-labour rupture of membranes. Maternal outcomes evaluated included exposure to antibiotics in pregnancy and labour and complications related to antibiotic use. Neonatal outcomes of rates of early-onset group B streptococcal infections are evaluated. Published literature was retrieved through searches of MEDLINE, CINAHL, and The Cochrane Library from January 1980 to July 2012 using appropriate controlled vocabulary and key words (group B streptococcus, antibiotic therapy, infection, prevention). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to May 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). The recommendations in this guideline are designed to help clinicians identify and manage pregnancies at risk for neonatal group B streptococcal disease to optimize maternal and perinatal outcomes. No cost-benefit analysis is provided. There is good evidence based on randomized control trial data that in women with pre-labour rupture of membranes at term who are colonized with group B streptococcus, rates of neonatal infection are

Emotional labour and stress within mental health nursing.

PubMed

Mann, S; Cowburn, J

2005-04-01

For many within the nursing profession, the work role involves a great deal of emotional work or 'emotional labour'. Such emotional work can be performed through 'surface acting' in which the individual simply feigns an appropriate emotion, or through 'deep acting' in which they actually try to feel the required emotion. The current study aims to aid understanding of the complex relationship between components of emotional labour and stress within the mental health nursing sector. Thirty-five mental health nurses completed questionnaires relating to a total of 122 nurse-patient interactions. Data were collected in relation to: (1) the duration and intensity of the interaction; (2) the variety of emotions expressed; (3) the degree of surface or deep acting the nurse performed; and (4) the perceived level of stress the interaction involved. Nurses also completed Daily Stress Indicators. Results suggest that: (1) emotional labour is positively correlated with both 'interaction stress' and daily stress levels; (2) the deeper the intensity of interactions and the more variety of emotions experienced, the more emotional labour was reported; and (3) surface acting was a more important predictor of emotional labour than deep acting. Implications for mental health nurses are outlined.

The Emotional Labour of Caring in Teaching

ERIC Educational Resources Information Center

Isenbarger, Lynn; Zembylas, Michalinos

2006-01-01

This article is based on a collaborative action research study between one teacher and a teacher educator and provides an account of the emotional labour in enacting caring teaching in an inclusive classroom. The emotional labour demanded in caring relationships is an area of research that has not received much attention. Results from this case…

Uterine activity monitoring during labour--a multi-centre, blinded two-way trial of external tocodynamometry against electrohysterography.

PubMed

Reinhard, J; Hayes-Gill, B R; Schiermeier, S; Löser, H; Niedballa, L M; Haarmann, E; Sonnwald, A; Hatzmann, W; Heinrich, T M; Louwen, F

2011-10-01

The aim of this study was to determine the quality of intrapartum uterine activity (UA) monitoring in daily practice during the first and second stages of labour. The total duration of inadequate UA monitoring is quantified in relation to the technique applied, namely, external tocodynamometry (TOCO) or electrohysterography (EHG). 144 UA recordings, collected from 1st September 2008 until 15th October 2009 from deliveries at the Marien-Hospital Witten, Germany, were analysed by obstetricians based at different centres. The included recordings were from singleton and simultaneously with external TOCO and EHG monitored pregnancies. External TOCO and EHG UA recordings were blinded. The percentages of "adequate" UA recordings in the first and second stages of labour were much higher for the external EHG than the external TOCO mode (p<0.001). All doctors evaluated the UA assessment as "easier" (p <0.001) using the EHG compared with TOCO. Intrapartum UA monitoring in -daily practice via the EHG mode provides a more recognisable UA trace than the TOCO. © Georg Thieme Verlag KG Stuttgart · New York.

Contribution of migrant coffee labourers infected with Onchocerca volvulus to the maintenance of the microfilarial reservoir in an ivermectin-treated area of Mexico

PubMed Central

Rodríguez-Pérez, Mario A; Cabrera, Aldo Segura; Ortega, Cristian Lizarazo; Basáñez, María-Gloria; Davies, John B

2007-01-01

Background Since 1991, in Mexico, ivermectin has been administered twice a year to all residents in the onchocerciasis endemic foci which are mainly located in the coffee growing areas. However, the presence of a potentially infected itinerant seasonal labour force which is not treated regularly could jeopardise the attainment of the 85% coverage which is the present target for elimination of the disease. Methods The prevalence and intensity of Onchocerca volvulus microfilariae (mf), as well as their transmission from humans to vectors, were assessed during the coffee planting-clearing and harvesting seasons of 1997–1998, and 1998–1999 in two localities (I and II) of Southern Chiapas, Mexico, which regularly receive an influx of untreated migrant coffee labourers. Results Localities I and II had, respectively, an average of 391 (± 32) and 358 (± 14) resident inhabitants, and 70 (± 52) and 498 (± 289) temporary labourers. The ratio of migrants to residents ranged from 0.1:1 in locality I to 2.4:1 in locality II. The proportion of infected Simulium ochraceum s.l. parous flies was significantly lower in locality I than in locality II, and significantly higher during the stay of the migrants than before their arrival or after their departure. Parity and infection were higher in May-July than in November-February (in contrast with the latter being typically considered as the peak onchocerciasis transmission season by S. ochraceum s.l.). Conclusion The presence of significant numbers of untreated and potentially infected migrants may contribute to ongoing transmission, and their incorporation into ivermectin programmes should be beneficial for the attainment of the elimination goals of the regional initiative. However, the possibility that the results also reflect transmission patterns for the area cannot be excluded and these should be analyzed further. PMID:18088423

Evolving understanding and treatment of labour dystocia.

PubMed

Karaçam, Zekiye; Walsh, Denis; Bugg, George John

2014-11-01

The objective of the review is to critically review the diagnosis and management of dystocia in the first stage of labour. We conducted a narrative review of research since 1998. Eight studies were identified, four about the onset and duration of active phase of the first stage of labour, one on the diagnosis of dystocia, and three focused on the treatment of dystocia. The review demonstrates that current understandings of dystocia rest on outdated definitions of active first stage of labour, its progress and on treatments with an equivocal evidence base. These include the cervical dilatation threshold for active first stage, uncertainty over whether a reduced rate of dilatation and reduced strength of uterine contractions always represent pathology and the effectiveness of amniotomy/oxytocin for treating dystocia. Prospective studies should evaluate the impact of defining the active phase of the first stage of labour as commencing at 6 cm dilated and should test this definition in combination with Zhang's revised partogram. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Targeting radioimmunotherapy of hepatocellular carcinoma with iodine ({sup 131}I) metuximab injection: Clinical Phase I/II trials

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

Chen Zhinan; Mi Li; Xu Jing

2006-06-01

Purpose: HAb18G/CD147 is a hepatocellular carcinoma (HCC)-associated antigen. We developed iodine ({sup 131}I) metuximab injection (Licartin), a novel {sup 131}I-labeled HAb18G/CD147-specific monoclonal antibody F(ab'){sub 2} fragment, and evaluated its safety, pharmacokinetics, and clinical efficacy on HCC in Phase I/II trials. Methods and Materials: In a Phase I trial, 28 patients were randomly assigned to receive the injection in 9.25-, 18.5-, 27.75-, or 37-MBq/kg doses by hepatic artery infusion. In a multicenter Phase II trial, 106 patients received the injection (27.75 MBq/kg) on Day 1 of a 28-day cycle. Response rate and survival rate were the endpoints. Results: No life-threatening toxicmore » effects were found. The safe dosage was 27.75 MBq/kg. The blood clearance fitted a biphasic model, and its half-life was 90.56-63.93 h. In the Phase II trial, the injection was found to be targeted and concentrated to tumor tissues. Of the 73 patients completing two cycles, 6 (8.22%) had a partial response, 14 (19.18%) minor response, and 43 (58.90%) stable disease. The 21-month survival rate was 44.54%. The survival rate of progression-free patients was significantly higher than that of patients with progressive disease after either one or two cycles (p < 0.0001 or p 0.0019). Conclusion: Iodine ({sup 131}I) metuximab injection is safe and active for HCC patients.« less

The ethics of surrogacy: women's reproductive labour.

PubMed Central

van Niekerk, A; van Zyl, L

1995-01-01

The aim of this article is to establish whether there is anything intrinsically immoral about surrogacy arrangements from the perspective of the surrogate mother herself. Specific attention is paid to the claim that surrogacy is similar to prostitution in that it reduces women's reproductive labour to a form of alienated and/or dehumanized labour. PMID:8778458

Nuclear Factor Kappa B Activation Occurs in the Amnion Prior to Labour Onset and Modulates the Expression of Numerous Labour Associated Genes

PubMed Central

Lim, Sheri; MacIntyre, David A.; Lee, Yun S.; Khanjani, Shirin; Terzidou, Vasso; Teoh, T. G.; Bennett, Phillip R.

2012-01-01

Background Prior to the onset of human labour there is an increase in the synthesis of prostaglandins, cytokines and chemokines in the fetal membranes, particular the amnion. This is associated with activation of the transcription factor nuclear factor kappa B (NFκB). In this study we characterised the level of NFκB activity in amnion epithelial cells as a measure of amnion activation in samples collected from women undergoing caesarean section at 39 weeks gestation prior to the onset of labour. Methodology/Principal Findings We found that a proportion of women exhibit low or moderate NFκB activity while other women exhibit high levels of NFκB activity (n = 12). This activation process does not appear to involve classical pathways of NFκB activation but rather is correlated with an increase in nuclear p65-Rel-B dimers. To identify the full range of genes upregulated in association with amnion activation, microarray analysis was performed on carefully characterised non-activated amnion (n = 3) samples and compared to activated samples (n = 3). A total of 919 genes were upregulated in response to amnion activation including numerous inflammatory genes such cyclooxygenase-2 (COX-2, 44-fold), interleukin 8 (IL-8, 6-fold), IL-1 receptor accessory protein (IL-1RAP, 4.5-fold), thrombospondin 1 (TSP-1, 3-fold) and, unexpectedly, oxytocin receptor (OTR, 24-fold). Ingenuity Pathway Analysis of the microarray data reveal the two main gene networks activated concurrently with amnion activation are i) cell death, cancer and morphology and ii) cell cycle, embryonic development and tissue development. Conclusions/Significance Our results indicate that assessment of amnion NFκB activation is critical for accurate sample classification and subsequent interpretation of data. Collectively, our data suggest amnion activation is largely an inflammatory event that occurs in the amnion epithelial layer as a prelude to the onset of labour. PMID:22485186

Care of the perineum in the second stage of labour: a study of views and practices of Australian midwives.

PubMed

Stamp, G E

1997-06-01

to seek the views of midwives on the practices related to the perineum in the second stage of labour; to identify predictors of their practices and to identify their actual practices in the second stage of labour, prior to a randomised trial of second stage perineal massage. independent midwives in South Australia and 194 midwives working in the delivery suites and birth centres of seven public hospitals in four states of Australia. midwives were surveyed using a questionnaire which sought their views on, and practices relating to, second stage perineal massage, delivery of the head and reasons for cutting an episiotomy. one third of the respondents 'never' practised perineal massage in the second stage of labour, 43% were 'undecided' as to its value and 19% disagreed with the practice. Over half agreed that its use should be decided by the woman and her partner. When invited to select the five statements they most agreed with, and the five they most disagreed with, out of a possible 24, equal numbers (26%) were for and against the statement referring to such massage as helping to stretch the perineum and prevent tearing. More than half (55%) disagreed with the statement which predicted they would find the practice distasteful, while only 1.6% agreed with this statement. During delivery of the head, 71% of respondents attempted some form of flexion. There was 100% agreement that fetal distress almost always or frequently was an indication for cutting an episiotomy. there is little evidence from randomised trials to support many of the second stage practices, and further research will clarify those which are most effective. This sample of midwives demonstrated considerable variation in their views on, and practices in, the second stage of labour. Although one-fifth disagreed with the practice of second stage perineal massage, and 40% agreed that the midwife should decide, more than half (57%) believed it was a matter of choice for the woman and her partner. All were

Effectiveness of a physical activity programme based on the Pilates method in pregnancy and labour.

PubMed

Rodríguez-Díaz, Luciano; Ruiz-Frutos, Carlos; Vázquez-Lara, Juana María; Ramírez-Rodrigo, Jesús; Villaverde-Gutiérrez, Carmen; Torres-Luque, Gema

To assess the effectiveness and safety of a physical activity programme based on use of the Pilates method, over eight weeks in pregnant women, on functional parameters, such as weight, blood pressure, strength, flexibility and spinal curvature, and on labour parameters, such as, type of delivery, episiotomy, analgesia and newborn weight. A randomized clinical trial was carried out on pregnant women, applying a programme of physical activity using the Pilates method, designed specifically for this population. A sample consisting of a total of 105 pregnant women was divided into two groups: intervention group (n=50) (32.87±4.46 years old) and control group (n=55) (31.52±4.95 years old). The intervention group followed a physical activity programme based on the Pilates method, for 2 weekly sessions, whereas the control group did not follow the program. Significant improvements (p<0.05) in blood pressure, hand grip strength, hamstring flexibility and spinal curvature, in addition to improvements during labour, decreasing the number of Caesareans and obstructed labour, episiotomies, analgesia and the weight of the newborns were found at the end of the intervention. A physical activity programme of 8 weeks based on the Pilates method improves functional parameters in pregnant women and benefits delivery. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

[The role of emotional labour in oncology].

PubMed

Szluha, Kornélia; Lazányi, Kornélia; Molnár, Péter

2007-01-01

Oncologists and related health care professionals (HCPs) do not only have to follow professional protocols in their everyday work, but also have to communicate proper attitudes towards patients suffering from malignant diseases. This task is often a heavier load than the implementation of professional activities themselves. The present article is based on a survey on HCP work motivation, employment parameters and correlations with emotional labour. Fifty oncology HCPs at Debrecen University Medical Health Sciences Centre volunteered to participate in this survey containing 20 simple-choice questions. More than 90 percent of HCPs make an effort to hide their emotional state, giving way to possible negative side effects. The survey showed significant differences between the level of emotional labour of those working in the field of oncology longer or shorter than ten years. Surface and deep emotional labour is more frequent among professionals already working in oncology for a longer period of time. This can serve us with explanation to the burn-out syndrome so frequent in this profession. To diminish the load of emotional labour, healthcare institutes have to aim at hiring employees that spontaneously fit the emotional and behavioural norms facing them, and do not need officially prescribed behavioural norms for everyday work. Their constant need for respect and appreciation of their values must be kept in mind, because the capability of genuine emotional labour diminishes parallel to the number of years spent in work.

Immunophenotyping and activation status of maternal peripheral blood leukocytes during pregnancy and labour, both term and preterm.

PubMed

Zhang, Jianhong; Shynlova, Oksana; Sabra, Sally; Bang, Annie; Briollais, Laurent; Lye, Stephen J

2017-10-01

The onset of labour in rodents and in humans is associated with physiological inflammation which is manifested by infiltration of activated maternal peripheral leukocytes (mPLs) into uterine tissues. Here, we used flow cytometry to immunophenotype mPLs throughout gestation and labour, both term and preterm. Peripheral blood was collected from non-pregnant women and pregnant women in the 1st, 2nd and 3rd trimesters. Samples were also collected from women in active labour at term (TL) or preterm (PTL) and compared with women term not-in-labour (TNIL) and preterm not-in-labour (PTNIL). Different leukocyte populations were identified by surface markers such as CD45, CD14, CD15, CD3, CD4, CD8, CD19 and CD56. Their activation status was measured by the expression levels of CD11b, CD44, CD55, CD181 and CD192 proteins. Of all circulating CD45+ leukocytes, we detected significant increases in CD15+ granulocytes (i) in pregnant women versus non-pregnant; (ii) in TL women versus TNIL and versus pregnant women in the 1st/2nd/3rd trimester; (iii) in PTL women versus PTNIL. TL was characterized by (iv) increased expressions of CD11b, CD55 and CD192 on granulocytes; (v) increased mean fluorescent intensity (MFI) of CD55 and CD192 on monocytes; (vi) increased CD44 MFI on CD3+ lymphocytes as compared to late gestation. In summary, we have identified sub-populations of mPLs that are specifically activated in association with gestation (granulocytes) or with the onset of labour (granulocytes, monocytes and lymphocytes). Additionally, beta regression analysis created a set of reference values to rank this association between immune markers of pregnancy and to identify activation status with potential prognostic and diagnostic capability. © 2017 The Authors. Journal of Cellular and Molecular Medicine published by John Wiley & Sons Ltd and Foundation for Cellular and Molecular Medicine.

Women's perceptions, expectations and satisfaction with induced labour--a questionnaire-based study.

PubMed

Shetty, Ashalatha; Burt, Rhona; Rice, Pat; Templeton, Allan

2005-11-01

To evaluate the understanding and expectations of women undergoing labour induction, to assess their actual experience of the process and to compare their satisfaction with labour to those labouring spontaneously. Four hundred and fifty women at term undergoing induction of labour and cervical ripening with prostaglandinE2 vaginal tablets and 450 women labouring spontaneously were recruited into the study. The induction group were requested to complete a questionnaire prior to the start of their induction process and another questionnaire post-delivery. The post-delivery questionnaire contained two sections, one pertaining to issues to do with the induction and the second with the actual labour process. The spontaneously labouring group was requested to complete a questionnaire post-delivery, which only contained the section pertaining to the actual labour process. The main outcome measures were satisfaction with labour, perception of pain and length of labour between the induced and spontaneous labour groups, and issues that the women might wish changed about their induction. In the induction group, 34.7% were not satisfied with the information they received about the induction prior to the procedure and 27.2% expected to deliver within 12h of the administration of the inducing agent. Post-induction, 40% of the women felt the most important aspect they would like to change about their induction were they to have another one, would be the speed of the induction, 13.6% felt they might wish to take the inducing agent orally, 7% to have fewer vaginal examinations and 9% to have fewer complications. Among the women who returned questionnaires, 26.3% had a caesarean delivery in the induction group and 21.4% in the spontaneous labour group. Significantly more women were satisfied with their labour in the spontaneous labour group 79.5% versus 70.4%, RR 0.89, 95% CI 0.8-0.96, P=0.006). Labour that is artificially induced does result in lower satisfaction rates as compared

Type of Labour in the First Pregnancy and Cumulative Maternal Morbidity.

PubMed

Allen, Victoria M; Baskett, Thomas F; O'Connell, Colleen M

2015-08-01

To estimate cumulative maternal morbidity among women who delivered at term in their first pregnancy on the basis of type of labour in the first pregnancy. Using a 25-year population-based cohort (1988 to 2012) derived from the Nova Scotia Atlee Perinatal Database, we determined the type of labour in successive pregnancies in low-risk, nulliparous women at term in their first pregnancy (who had at least one subsequent pregnancy), and the maternal outcomes in subsequent deliveries based on the type of labour in the first pregnancy. A total of 36 871 pregnancies satisfied inclusion and exclusion criteria, 1346 of which were delivered by Caesarean section without labour in the first pregnancy. Rates of most adverse maternal outcomes were low (≤1%). The type of labour in the first pregnancy influenced the subsequent risk of postpartum hemorrhage and blood transfusion, and the risks increased with successive deliveries when labours were spontaneous in onset or were induced. The risks for abnormal placentation were low with subsequent deliveries, including following CS without labour in the first pregnancy, and risks for overall severe maternal morbidity were less than 10% for all subsequent deliveries. The absolute risks for severe maternal morbidity outcomes in a population of women without a high number of subsequent pregnancies were small (regardless of type of labour in the first pregnancy); this provides important information for women, families, and caregivers when considering pregnancy outcomes related to type of labour.

Relation between induced labour indications and neonatal morbidity.

PubMed

Hernández-Martínez, Antonio; Pascual-Pedreño, Ana Isabel; Baño-Garnés, Ana Belén; Del Rocío Melero-Jiménez, Maria; Molina-Alarcón, Milagros

2014-12-01

To assess the main neonatal morbidity results in relation to induced labour indications. Historical groups from a total of 3,817 deliveries over a three year period (2009, 2010 and 2011) in "Mancha-Centro" Hospital (Alcázar de San Juan) formed the study group. All programmed and non-avoidable caesarean sections and pregnancies under 35 weeks were excluded. The main variable result was a neonatal morbidity variable made up of the Apgar score after 5 min, pH of umbilical artery <7.10 and the neonatal need for resuscitation type III-V. Multivariate analysis was used to control confounding variables. The incidence of induced labour was 22.6 % (862). The highest indication was premature rupture of membranes for more than 12 h 22.8 % (190), poorly controlled diabetes 22.6 % (189) and oligoamnios 16.2 % (135). The rate of pH lower than 7.10 was 2.8 % (22), the rate of the Apgar score lower than 7 after 5 min was 0.2 % (2) and the neonatal need for resuscitation type III-IV was 5.7 % (48) for induced labour. The relation between induced labour and neonatal morbidity indicators were not statistically significant. 10.1 % (4) of induced labour for suspected intrauterine growth restriction and 8.6 % (10) of postterm pregnancies required neonatal resuscitation type III-IV. No relation was found between induced labour and the neonatal morbidity indicators. The highest neonatal risk indicator is when a intrauterine growth restriction, hypertensión/preeclampsia or a postterm pregnancy is suspected.

Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial—the EOLE study protocol

PubMed Central

Barasinski, Chloé; Vendittelli, Françoise

2016-01-01

Introduction The scientific data currently available do not allow any definitive conclusion to be reached about what type of pushing should be recommended to women during the second stage of labour. The objective of this trial is to assess and compare the effectiveness of directed open-glottis pushing versus directed closed-glottis pushing. Secondary objectives are to assess, according to the type of pushing: immediate maternal and neonatal morbidity, intermediate-term maternal pelvic floor morbidity, uncomplicated birth, and women's satisfaction at 4 weeks post partum. Methods and analysis This multicentre randomised clinical trial compares directed closed-glottis pushing (Valsalva) versus directed open-glottis pushing during the second stage of labour in 4 hospitals of France. The study population includes pregnant women who received instruction in both types of pushing, have no previous caesarean delivery, are at term and have a vaginal delivery planned. Randomisation takes place during labour once cervical dilation ≥7 cm. The principal end point is assessed by a composite criterion: spontaneous delivery without perineal lesion (no episiotomy or spontaneous second-degree, third-degree or fourth-degree lacerations). We will need to recruit 125 women per group. The primary analysis will be by intention-to-treat analysis, with the principal results reported as crude relative risks (RRs) with their 95% CIs. A multivariate analysis will be performed to take prognostic and confounding factors into account to obtain adjusted RRs. Ethics and dissemination This study was approved by a French Institutional Review Board (Comité de Protection des Personnes Sud Est 6:N°AU1168). Results will be reported in peer-reviewed journals and at scientific meetings. This study will make it possible to assess the effectiveness of 2 types of directed pushing used in French practice and to assess their potential maternal, fetal and neonatal effects. Findings from the study will be

International labour migration in the Asian-Pacific region: patterns, policies and economic implications.

PubMed

Athukorala, P

1993-11-01

"This paper reviews the literature on international labour migration from and within the Asian-Pacific region. It deals with patterns and characteristics of migration flows, government policies towards labour migration, and economic implications of labour migration for both labour-exporting and importing countries in the region. The indications are that, despite gradual slowing down of labour flows to the western industrial countries and the Middle East, labour migration will continue to be a major economic influence on surplus-labour countries in the region. As an integral part of the growth dynamism in the region, labour migration has now begun to take on a regional dimension, with immense implications for the process of industrial restructuring in high growth economies and the changing pattern of economic interdependence among countries." excerpt

A phase II trial for the efficacy of physiotherapy intervention for early-onset hip osteoarthritis: study protocol for a randomised controlled trial.

PubMed

Kemp, Joanne L; Moore, Kate; Fransen, Marlene; Russell, Trevor G; Crossley, Kay M

2015-01-27

Early-onset hip osteoarthritis is commonly seen in people undergoing hip arthroscopy and is associated with increased pain, reduced ability to participate in physical activity, reduced quality of life and reduced range of motion and muscle strength. Despite this, the efficacy of non-surgical interventions such as exercise therapies remains unknown. The primary aim is to establish the feasibility of a phase III randomised controlled trial investigating a targeted physiotherapy intervention for people with early-onset hip osteoarthritis. The secondary aims are to determine the size of treatment effects of a physiotherapy intervention, targeted to improve hip joint range and hip-related symptoms in early-onset hip osteoarthritis following hip arthroscopy, compared to a health-education control. This protocol describes a randomised, assessor- and participant-blind, controlled clinical trial. We will include 20 participants who are (i) aged between 18 and 50 years; (ii) have undergone hip arthroscopy during the past six to 12 months; (iii) have early-onset hip osteoarthritis (defined as chondrolabral pathology) at the time of hip arthroscopy; and (iv) experience hip-related pain during activities. Primary outcome will be the feasibility of a phase III clinical trial. Secondary outcomes will be (i) perceived global change score; (ii) hip-related symptoms (measured using the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale, activity subscale, and sport and recreation subscale); (iii) hip quality of life (measured using the HOOS quality of life subscale and International Hip Outcome tool; (iv) hip muscle strength and (v) hip range of motion. The physiotherapy intervention is semi-standardised, including joint and soft tissue mobilisation and stretching, hip and trunk muscle retraining and functional and activity-specific retraining and education. The control intervention encompasses individualised health education, with the same frequency and duration

Diverse definitions of prolonged labour and its consequences with sometimes subsequent inappropriate treatment.

PubMed

Nystedt, Astrid; Hildingsson, Ingegerd

2014-07-16

Prolonged labour very often causes suffering from difficulties that may have lifelong implications. This study aimed to explore the prevalence and treatment of prolonged labour and to compare birth outcome and women's experiences of prolonged and normal labour. Women with spontaneous onset of labour, living in a Swedish county, were recruited two months after birth, to a cross-sectional study. Women (n = 829) completed a questionnaire that investigated socio-demographic and obstetric background, birth outcome and women's feelings and experiences of birth. The prevalence of prolonged labour, as defined by a documented ICD-code and inspection of partogram was calculated. Four groups were identified; women with prolonged labour as identified by documented ICD-codes or by partogram inspection but no ICD-code; women with normal labour augmented with oxytocin or not. Every fifth woman experienced a prolonged labour. The prevalence with the documented ICD-code was (13%) and without ICD-code but positive partogram was (8%). Seven percent of women with prolonged labour were not treated with oxytocin. Approximately one in three women (28%) received oxytocin augmentation despite having no evidence of prolonged labour. The length of labour differed between the four groups of women, from 7 to 23 hours.Women with a prolonged labour had a negative birth experience more often (13%) than did women who had a normal labour (3%) (P <0.00). The factors that contributed most strongly to a negative birth experience in women with prolonged labour were emergency Caesarean section (OR 9.0, 95% CI 1.2-3.0) and to strongly agree with the following statement 'My birth experience made me decide not to have any more children' (OR 41.3, 95% CI 4.9-349.6). The factors that contributed most strongly to a negative birth experience in women with normal labour were less agreement with the statement 'It was exiting to give birth' (OR 0.13, 95% CI 0.34-0.5). There is need for increased clinical skill in

Diverse definitions of prolonged labour and its consequences with sometimes subsequent inappropriate treatment

PubMed Central

2014-01-01

Background Prolonged labour very often causes suffering from difficulties that may have lifelong implications. This study aimed to explore the prevalence and treatment of prolonged labour and to compare birth outcome and women’s experiences of prolonged and normal labour. Method Women with spontaneous onset of labour, living in a Swedish county, were recruited two months after birth, to a cross-sectional study. Women (n = 829) completed a questionnaire that investigated socio-demographic and obstetric background, birth outcome and women’s feelings and experiences of birth. The prevalence of prolonged labour, as defined by a documented ICD-code and inspection of partogram was calculated. Four groups were identified; women with prolonged labour as identified by documented ICD-codes or by partogram inspection but no ICD-code; women with normal labour augmented with oxytocin or not. Results Every fifth woman experienced a prolonged labour. The prevalence with the documented ICD-code was (13%) and without ICD-code but positive partogram was (8%). Seven percent of women with prolonged labour were not treated with oxytocin. Approximately one in three women (28%) received oxytocin augmentation despite having no evidence of prolonged labour. The length of labour differed between the four groups of women, from 7 to 23 hours. Women with a prolonged labour had a negative birth experience more often (13%) than did women who had a normal labour (3%) (P <0.00). The factors that contributed most strongly to a negative birth experience in women with prolonged labour were emergency Caesarean section (OR 9.0, 95% CI 1.2-3.0) and to strongly agree with the following statement ‘My birth experience made me decide not to have any more children’ (OR 41.3, 95% CI 4.9-349.6). The factors that contributed most strongly to a negative birth experience in women with normal labour were less agreement with the statement ‘It was exiting to give birth’ (OR 0.13, 95% CI 0

New Round of Studies Begin in Phase 0/I/II Cancer Prevention Clinical Trials Program | Division of Cancer Prevention

Cancer.gov

The NCI Division of Cancer Prevention’s Phase 0/I/II Cancer Prevention Clinical Trials Program, also known as the Consortia for Early Phase Prevention Trials, is beginning a new round of studies in the effort toward systematic early clinical development of promising preventive agents for people at increased risk of developing cancer. |

Effect-site concentration of remifentanil during patient-controlled analgesia in labour.

PubMed

Jost, A; Blagus, R; Ban, B; Kamenik, M

2015-08-01

Intravenous remifentanil has been described for patient-controlled analgesia in labour. Recently, the application of target-controlled infusion pumps with Minto's pharmacokinetic/pharmacodynamic model has been reported. Hypothetical effect-site remifentanil concentration during patient-controlled analgesia for labour has yet to be examined. The aim of this concept study was to explore characteristics of this parameter. We performed a historical cohort study based on our previous randomised cross-over clinical trial and analysed hypothetical effect-site remifentanil concentration. Values at spontaneous vaginal delivery and Apgar scores were tested for correlation. The association between pain score and the corresponding effect-site remifentanil concentration before and after bolus administration, and their relative difference, was examined with a linear mixed-effects model, adjusted for other variables. A series of 23 parturients with uncomplicated singleton pregnancies were included. On average, effect-site remifentanil concentration was highest during the third quarter throughout our recordings (5.5ng/mL; maximum 15.8ng/mL). The mean (median) {IQR} [range] at spontaneous vaginal delivery (n=14) was 2.52 (1.32) {0.95-4.28} [0.65-6.88] ng/mL, all Apgar scores were >7, and no correlation was confirmed. A negative association between effect-site remifentanil concentration before bolus administration and pain score (scale 0-100) was observed (-3.9, 95% CI -5.16 to -2.61, P <0.01). The residual value of hypothetical effect-site remifentanil concentration before uterine contraction, at the beginning of bolus administration, predicted lower pain scores. Monitoring effect-site remifentanil concentration may be potentially useful when remifentanil is administered for labour analgesia. However, our results need to be confirmed with a pharmacokinetic model optimized for pregnant patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

Division of labour and the evolution of extreme specialization.

PubMed

Cooper, Guy A; West, Stuart A

2018-05-28

Division of labour is a common feature of social groups, from biofilms to complex animal societies. However, we lack a theoretical framework that can explain why division of labour has evolved on certain branches of the tree of life but not others. Here, we model the division of labour over a cooperative behaviour, considering both when it should evolve and the extent to which the different types should become specialized. We found that: (1) division of labour is usually-but not always-favoured by high efficiency benefits to specialization and low within-group conflict; and (2) natural selection favours extreme specialization, where some individuals are completely dependent on the helping behaviour of others. We make a number of predictions, several of which are supported by the existing empirical data, from microbes and animals, while others suggest novel directions for empirical work. More generally, we show how division of labour can lead to mutual dependence between different individuals and hence drive major evolutionary transitions, such as those to multicellularity and eusociality.

Motivation, recruitment, and screening of volunteers for a phase I/II HIV preventive vaccine trial in Thailand.

PubMed

Jenkins, R A; Chinaworapong, S; Morgan, P A; Ruangyuttikarn, C; Sontirat, A; Chiu, J; Michael, R A; Nitayaphan, S; Khamboonruang, C

1998-06-01

Data from recruitment and screening for a phase I/II preventive HIV-1 vaccine trial in Thailand were evaluated with respect to correlates of participation at each phase. Correlates included demographic variables, motivation for interest in the trial, and factors related to communication and contact. Participants were recruited at two sites through varied methods. The majority of prescreenees reported altruistic motives for interest in the trial and blood donors emerged as a group that may have been particularly altruistic. Findings indicated site differences in attrition during recruitment and screening, but not in enrollment into the vaccine trial. Blood donation and willingness to be contacted by phone at home were significantly related to making and keeping screening appointments.

Emotional labour: learning from the past, understanding the present.

PubMed

Elliott, Chris

2017-10-26

The number of nurses considering leaving the profession has continued to rise, and in many areas there is a nursing shortfall. For many of those leaving the profession, the decision results from workplace stress. This article examines the concept of emotional labour, which has been linked to compassion fatigue and subsequent burnout. Emotional labour is the term used to describe the process of displaying outward emotion that may not match our internal emotion; this dissonance can lead to highly stressful situations. The concept is explored from a genealogical perspective, specifically focusing on how gender, socio-political and health cultures have influenced the evolution of the discourse that defines how emotional labour is perceived, understood and valued. This article will identify what has shaped the discourse and how the historical influences have influenced perceptions. The article identifies that emotional labour has traditionally been viewed as women's work and has been undervalued. The influence of male nurses and the gradual decline of heavy industry has served to improve the understanding and value of the concept. Lessons from the past can inform the management of the stresses of emotional labour. Emotional labour is a recognised component of workplace stress and this article makes a number of recommendations for further research or management strategies, which may assist in the recognition and management of the stresses nurses face when delivering emotionally demanding care.

Early labour services: changes, triggers, monitoring and evaluation.

PubMed

Spiby, Helen; Green, Josephine M; Richardson-Foster, Helen; Hucknall, Clare

2013-04-01

to identify the changes to early labour services, their triggers and monitoring. a mixed methods approach in two stages, firstly a postal questionnaire survey of Heads of Midwifery (HoM) services in NHS Trusts in England (cover sheet to each HoM and questionnaire for each unit in their jurisdiction) and, secondly, semi-structured telephone interviews with a purposive sample of senior midwives. The interviews sought further information about reasons for change; the impact of changes and explored the unit's particular innovations. PARTICIPANTS AND RESPONSE RATE: 145 (89%) NHS Trusts provided data (cover sheet and/or questionnaire); responses were received from all areas and types of unit. Seventeen HoMs or designated senior midwives were interviewed. 83 of 170 units (49%) had made changes to early labour service provision during the past 5 years, including home assessment; the introduction of triage units and telephone assessment tools. Changes were more likely in high volume units and in consultant units with midwifery-led care areas. Further changes were planned by 93/178 (25%) units. Triggers for changes to early labour services comprised local or unit-based factors, including Category X (non-labour) admissions, response to service users and research evidence. The impact of Category X admissions on workload contributed to the triggers for change. Fifty-six (31%) could provide a confirmed figure or estimate for category X admissions. Experiences of introducing change included issues related to engagement of the workforce and the contribution of clinical leadership. Thirty-eight (48%) units did not routinely monitor use of early labour services. Overall monitoring of services was not significantly more likely in units that had made changes. Audit activity was reported more frequently in units that had made changes to their early labour services. early labour services had undergone significant changes following a range of triggers but the extent of change was not

Unbiased estimation in seamless phase II/III trials with unequal treatment effect variances and hypothesis-driven selection rules.

PubMed

Robertson, David S; Prevost, A Toby; Bowden, Jack

2016-09-30

Seamless phase II/III clinical trials offer an efficient way to select an experimental treatment and perform confirmatory analysis within a single trial. However, combining the data from both stages in the final analysis can induce bias into the estimates of treatment effects. Methods for bias adjustment developed thus far have made restrictive assumptions about the design and selection rules followed. In order to address these shortcomings, we apply recent methodological advances to derive the uniformly minimum variance conditionally unbiased estimator for two-stage seamless phase II/III trials. Our framework allows for the precision of the treatment arm estimates to take arbitrary values, can be utilised for all treatments that are taken forward to phase III and is applicable when the decision to select or drop treatment arms is driven by a multiplicity-adjusted hypothesis testing procedure. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

The nature of labour pain: An updated review of the literature.

PubMed

Whitburn, Laura Y; Jones, Lester E; Davey, Mary-Ann; McDonald, Susan

2018-04-20

The pain experience associated with labour is complex. Literature indicates psychosocial and environmental determinants of labour pain, and yet methods to support women usually target physiological attributes via pharmacological interventions. To provide an update of our understanding of labour pain based on modern pain science. The review aims to help explain why women can experience labour pain so differently - why some cope well, whilst others experience great suffering. This understanding is pertinent to providing optimal support to women in labour. A literature search was conducted in databases Medline, Cumulative Index to Nursing and Allied Health Literature and PsycINFO, using search terms labor/labour, childbirth, pain, experience and perception. Thirty-one papers were selected for inclusion. Labour pain is a highly individual experience. It is a challenging, emotional and meaningful pain and is very different from other types of pain. Key determinants and influences of labour pain were identified and grouped into cognitive, social and environmental factors. If a woman can sustain the belief that her pain is purposeful (i.e. her body working to birth her baby), if she interprets her pain as productive (i.e. taking her through a process to a desired goal) and the birthing environment is safe and supportive, it would be expected she would experience the pain as a non-threatening, transformative life event. Changing the conceptualisation of labour pain to a purposeful and productive pain may be one step to improving women's experiences of it, and reducing their need for pain interventions. Copyright © 2018 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

Why do health labour market forces matter?

PubMed Central

McPake, Barbara; Araújo, Edson Correia; Lemiere, Christophe; El Maghraby, Atef; Cometto, Giorgio

2013-01-01

Abstract Human resources for health have been recognized as essential to the development of responsive and effective health systems. Low- and middle-income countries seeking to achieve universal health coverage face human resource constraints – whether in the form of health worker shortages, maldistribution of workers or poor worker performance – that seriously undermine their ability to achieve well-functioning health systems. Although much has been written about the human resource crisis in the health sector, labour economic frameworks have seldom been applied to analyse the situation and little is known or understood about the operation of labour markets in low- and middle-income countries. Traditional approaches to addressing human resource constraints have focused on workforce planning: estimating health workforce requirements based on a country’s epidemiological and demographic profile and scaling up education and training capacities to narrow the gap between the “needed” number of health workers and the existing number. However, this approach neglects other important factors that influence human resource capacity, including labour market dynamics and the behavioural responses and preferences of the health workers themselves. This paper describes how labour market analysis can contribute to a better understanding of the factors behind human resource constraints in the health sector and to a more effective design of policies and interventions to address them. The premise is that a better understanding of the impact of health policies on health labour markets, and subsequently on the employment conditions of health workers, would be helpful in identifying an effective strategy towards the progressive attainment of universal health coverage. PMID:24347708

Outcome of misoprostol and oxytocin in induction of labour

PubMed Central

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

2017-01-01

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

New Labour's Policies for Schools: Raising the Standard?

ERIC Educational Resources Information Center

Docking, Jim, Ed.

This book, which is designed primarily for undergraduate and graduate students of education, contains 12 papers devoted the New Labour's policies for schools in the United Kingdom. "Introduction" (Jim Docking) presents an overview of the book's contents and lists questions to help evaluate the effectiveness of New Labour's educational…

Protocol for the ProCare Trial: a phase II randomised controlled trial of shared care for follow-up of men with prostate cancer

PubMed Central

Emery, Jon; Doorey, Juanita; Jefford, Michael; King, Madeleine; Pirotta, Marie; Hayne, Dickon; Martin, Andrew; Trevena, Lyndal; Lim, Tee; Constable, Roger; Hawks, Cynthia; Hyatt, Amelia; Hamid, Akhlil; Violet, John; Gill, Suki; Frydenberg, Mark; Schofield, Penelope

2014-01-01

Introduction Men with prostate cancer require long-term follow-up to monitor disease progression and manage common adverse physical and psychosocial consequences of treatment. There is growing recognition of the potential role of primary care in cancer follow-up. This paper describes the protocol for a phase II multisite randomised controlled trial of a novel model of shared care for the follow-up of men after completing treatment for low-moderate risk prostate cancer. Methods and analysis The intervention is a shared care model of follow-up visits in the first 12 months after completing treatment for prostate cancer with the following specific components: a survivorship care plan, general practitioner (GP) management guidelines, register and recall systems, screening for distress and unmet needs and patient information resources. Eligible men will have completed surgery and/or radiotherapy for low-moderate risk prostate cancer within the previous 8 weeks and have a GP who consents to participate. Ninety men will be randomised to the intervention or current hospital follow-up care. Study outcome measures will be collected at baseline, 3, 6 and 12 months and include anxiety, depression, unmet needs, prostate cancer-specific quality of life and satisfaction with care. Clinical processes and healthcare resource usage will also be measured. The principal emphasis of the analysis will be on obtaining estimates of the treatment effect size and assessing feasibility in order to inform the design of a subsequent phase III trial. Ethics and dissemination Ethics approval has been granted by the University of Western Australia and from all hospital recruitment sites in Western Australia and Victoria. Results of this phase II trial will be reported in peer-reviewed publications and in conference presentations. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12610000938000 PMID:24604487

Perception of labour pain among the Yoruba ethnic group in Nigeria.

PubMed

Kuti, O; Faponle, A F

2006-05-01

In Nigeria, it is generally assumed that labour is well tolerated and pain relief is not usually considered an important part of intra-partum care. This prospective study was carried out to assess mothers' perception of labour pain and determine any factor that may influence it. During the period of study, 281 women who delivered at Wesley Guild Hospital Ilesa, Nigeria were interviewed within 2 h of delivery to assess the severity of labour pain and desire for analgesia. Perception of labour pain was assessed using a 3-point verbal rating. The majority (68.3%) of women described labour pain as severe with only 5.3% describing it as mild. More than 86% of the women would want the pain relieved. Perception of pain was not influenced by age, parity and educational level. Management of pain in labour should form an important part of intra-partum care as is the case in developed countries.

Motion analysis and trials of the deep sea hybrid underwater glider Petrel-II

NASA Astrophysics Data System (ADS)

Liu, Fang; Wang, Yan-hui; Wu, Zhi-liang; Wang, Shu-xin

2017-03-01

A hybrid underwater glider Petrel-II has been developed and field tested. It is equipped with an active buoyancy unit and a compact propeller unit. Its working modes have been expanded to buoyancy driven gliding and propeller driven level-flight, which can make the glider work in strong currents, as well as many other complicated ocean environments. Its maximal gliding speed reaches 1 knot and the propelling speed is up to 3 knots. In this paper, a 3D dynamic model of Petrel-II is derived using linear momentum and angular momentum equations. According to the dynamic model, the spiral motion in the underwater space is simulated for the gliding mode. Similarly the cycle motion on water surface and the depth-keeping motion underwater are simulated for the level-flight mode. These simulations are important to the performance analysis and parameter optimization for the Petrel-II underwater glider. The simulation results show a good agreement with field trials.

The emotional labour of nursing -- Defining and managing emotions in nursing work.

PubMed

Gray, Benjamin

2009-02-01

Emotions in health organisations tend to remain tacit and in need of clarification. Often, emotions are made invisible in nursing and reduced to part and parcel of 'women's work' in the domestic sphere. Smith (1992) applied the notion of emotional labour to the study of student nursing, concluding that further research was required. This means investigating what is often seen as a tacit and uncodified skill. A follow-up qualitative study was conducted over a period of twelve months to re-examine the role of the emotional labour of nursing. Data were collected primarily from 16 in-depth and semi-structured interviews with nurses. Key themes elicited at interviews touch upon diverse topics in the emotional labour of nursing. In particular, this article will address nurse definitions of emotional labour; the routine aspects of emotional labour in nursing; traditional and modern images of nursing; and gender and professional barriers that involve emotional labour in health work. This is important in improving nurse training and best practice; investigating clinical settings of nurses' emotional labour; looking at changing techniques of patient consultation; and beginning to explore the potential therapeutic value of emotional labour.

Victorian paramedics' encounters and management of women in labour: an epidemiological study.

PubMed

McLelland, Gayle; Morgans, Amee; McKenna, Lisa

2015-02-05

Although it is generally accepted that paramedics attend unexpected births, there is a paucity of literature about their management of women in labour. This study aimed to investigate the caseload of women in labour attended by a statewide ambulance service in Australia during one year and the management provided by paramedics. Retrospective clinical data collected on-scene by paramedics via in-field electronic patient care records were provided by Ambulance Victoria. Patient case reports were electronically extracted from the Ambulance Victoria's Clinical Data Warehouse via comprehensive filtering followed by manual sorting. Descriptive statistics were analysed using Statistical Package for Social Sciences (SPSS v.19). Over a 12-month period, paramedics were called to 1517 labouring women. Two thirds of women were at full-term gestation, and 40% of pre-term pregnancies were less than 32 weeks gestation. Paramedics documented 630 case reports of women in early labour and a further 767 in established labour. There were 204 women thought to be second stage labour, including 134 who progressed to childbirth under paramedic care. When paramedics assisted with births, the on-scene time was significantly greater than those patients transported in labour. Pain relief was provided significantly more often to women in established labour than in early labour. Oxygen was given to significantly more women in preterm labour. While paramedics performed a range of procedures including intravenous cannulation, administration of analgesia and oxygen, most women required minimal intervention. Paramedics needed to manage numerous obstetric and medical complications during their management. Paramedics provide emergency care and transportation for women in labour. Most of the women were documented to be at term gestation with minimal complications. To enable appropriate decision making about management and transportation, paramedics require a range of clinical assessment skills

Gove's Offensive and the Failure of Labour's Response

ERIC Educational Resources Information Center

Hatcher, Richard

2012-01-01

In this article the author examines the response of the Labour leadership to the Conservative-led Government's policies for restructuring and re-agenting the school system. His focus is on the role of local authorities and local democracy. He identifies two contradictory dynamics in Labour's current thinking. One promises to enhance local…

Women's experiences of becoming a mother after prolonged labour.

PubMed

Nystedt, Astrid; Högberg, Ulf; Lundman, Berit

2008-08-01

This paper is a report of a study to explore women's experiences of becoming a mother after prolonged labour. The negativity associated with a complicated labour such as prolonged labour can lead to a struggle to become a healthy mother and could restrict the process of becoming a mother. Interviews were conducted in 2004 with 10 mothers who had been through a prolonged labour with assisted vaginal or caesarean delivery 1-3 months previously. Thematic content analysis was used. Three themes were formulated, describing women's experiences as fumbling in the dark, struggling for motherhood and achieving confidence in being a mother. The difficulties and suffering involved in becoming a mother after a prolonged labour were interpreted to be like 'fumbling in the dark'. Women experienced bodily fatigue, accompanied by feelings of illness and detachment from the child. Having the child when in this condition entailed a struggle to become a mother. In spite of these experiences and the desire to achieve confidence in being a mother, the reassurance of these women regarding their capacity for motherhood was crucial: it was central to their happiness as mothers, encouraged interaction and relationship with the child, and contributed to their adaptation to motherhood. Women experiencing prolonged labour may be comparable with the experience of and recovery from illness, which could contribute to difficulties transitioning to motherhood and limit a woman's ability to be emotionally available for the child.

Operating theatre nurses: emotional labour and the hostess role.

PubMed

Timmons, Stephen; Tanner, Judith

2005-04-01

Emotional labour has been established as a significant factor in nursing work, although no studies have been done looking at emotional labour specifically in an operating theatre nursing context. Theatre staff (17 nurses and three Operating Department Practitioners (technicians) were observed in practice over a period of nine months by one of the authors. Each of the staff was subsequently interviewed. The transcriptions of the observation fieldwork notes and the semistructured interviews were analysed for themes and content. The (predominantly female) nurses perceived that one of their responsibilities was 'looking after the surgeons'. We have described this as the 'hostess' role. This role consisted of two major areas of activity: 'keeping the surgeons happy' and 'not upsetting the surgeons'. Examples are given of how this was accomplished through talk and actions. The (predominantly male) operating department practitioners did not see this as part of their work. This 'hostess' role is a kind of emotional labour, but performed with coworkers rather than patients. Like other forms of emotional labour, it is strongly gendered. The emotional labour performed by the theatre nurses was necessary to maintain what has been called elsewhere the 'sentimental order'.

Do health-related labour costs weaken the competitiveness of the economy?

PubMed

Häussler, Bertram; Ecker, Thomas; Schneider, Markus

2006-12-01

At least in Germany, it is widely assumed that healthcare-related labour costs weaken the competitiveness of national industries. However, there is a lack of knowledge about the amount of employers' financial burden in Germany and in other competing countries, as well as the impact on market prices of German goods. To quantify the health-related labour costs for employers in seven countries and different industries, and identify the effects of current reforms in Germany on the financial burden of employers. We calculated the spending on health in Germany and the burden on German employers (by branch of production). We then compared the total burden with that of six other countries. A univariate analysis was then conducted to examine the connection between health-related labour costs and employment. In 2000, employers paid 41.2% of the total of 283.3 billion spent on health matters in Germany. These total costs account for 3.2% of the gross output (UK: 1.8%, Switzerland: 1.9%, Poland: 2.1%, US: 3.2%, France: 3.6%, The Netherlands: 3.7%). Health-related labour costs account for 10.6% of the total labour costs. The health-related labour costs per employee are on average 3013 (from 2752 to 4793 in healthcare and the chemical industry, respectively). In the UK and the US there are corresponding labour costs of 1836 and 4256 per employee, respectively. The current health reform (2003) would reduce the labour costs by only 0.7% after 4 years (based on 2000, with all factors remaining constant). Employment increased by 3.7% from 1995 to 2000 (textile industry: -26.8%, vehicle manufacture: +18.3%). There is no empirical connection between employment and health-related labour costs. Labour costs increased by a higher amount than the health-related labour costs. The burden on German employers is moderate when compared internationally. The current reform of the German health system is not expected to improve companies' financial situation or

Text4Heart II - improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial.

PubMed

Maddison, Ralph; Stewart, Ralph; Doughty, Rob; Scott, Tony; Kerr, Andrew; Benatar, Jocelyne; Whittaker, Robyn; Rawstorn, Jonathan C; Rolleston, Anna; Jiang, Yannan; Estabrooks, Paul; Sullivan, Rachel Karen; Bartley, Hannah; Pfaeffli Dale, Leila

2018-01-25

Cardiac rehabilitation (CR) is an essential component of contemporary management for patients with coronary heart disease, including following an acute coronary syndrome (ACS). CR typically involves education and support to assist people following an ACS to make lifestyle changes and prevent subsequent events. Despite its benefits, uptake and participation in tradition CR programs is low. The use of mobile technologies (mHealth) offers the potential to improve reach, access, and delivery of CR support. We aim to determine the effectiveness and cost-effectiveness of a text-messaging intervention (Text4Heart II) to improve adherence to medication and lifestyle change in addition to usual care in people following an ACS. A second aim is to use the RE-AIM framework to inform the potential implementation of Text4Heart II within health services in New Zealand. Text4Heart II is a two-arm, parallel, superiority randomized controlled trial conducted in two large metropolitan hospitals in Auckland, New Zealand. Three hundred and thirty participants will be randomized to either a 24-week theory- and evidence-based personalized text message program to support self-management in addition to usual CR, or usual CR alone (control). Outcomes are assessed at 6 and 12 months. The primary outcome is the proportion of participants adhering to medication at 6 months as measured by dispensed records. Secondary outcomes include medication adherence at 12 months, the proportion of participants adhering to self-reported healthy behaviors (physical activity, fruit and vegetable consumption, moderating alcohol intake and smoking status) measured using a composite health behavior score, self-reported medication adherence, cardiovascular risk factors (lipids, blood pressure), readmissions and related hospital events at 6 and 12 months. A cost-effectiveness analysis will also be conducted. Using the RE-AIM framework, we will determine uptake and sustainability of the intervention. The

Zombie tapeworms in late capitalism: accelerating clinical and reproductive labour in Mira Grant's Parasitology Trilogy.

PubMed

Attebery, Stina

2016-12-01

Biomedicine is increasingly shaped by the speculative economical values of neoliberal capitalism. A key feature of this new bioeconomical regime is the patenting and circulation of organisms and tissue samples, allowing rapid commercialisation of bacterial, animal and human biomedical materials. When thinking about this trend towards commercialisation, we must consider the ways by which biomedicine has been shaped by economics to better address these exploitative relationships between medical researchers and subjects. These fraught questions of agency and exploitation can be addressed through the concept of clinical labour, a term Melinda Cooper and Catherine Waldby coined to discuss embodied forms of labour, including surrogacy, clinical trials and tissue economies, that dominate the post-Fordist biomedical economy. As a genre that extrapolates from contemporary technoscientific practices, science fiction is uniquely positioned to explore the ethics of biomedical research in this neoliberal speculative economy. Science fiction can give human-like agency and affect to microbial, animal and alien life, allowing modified organisms to speak and interact with their creators. Creating these dialogues between commercialised organisms and biomedical researchers makes clear the connections between contemporary clinical practice and exploitative labour relations, illuminating the more troubling aspects of the new bioeconomy and imagining alternatives to this system. 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/.

Re-thinking skilled international labour migration: world cities and banking organisations.

PubMed

Beaverstock, J V

1994-08-01

"Highly skilled professional and managerial labour migration has become an important facet of the contemporary world economy. The operations of transnational corporations have created more opportunities for skilled migrants to work abroad.... There is a growing interest amongst economic geographers to examine this form of migration through an appreciation of global economic restructuring, labour market change and world cities. Consequently, this paper introduces a new conceptual framework...[which] is based on the rationale that world cities, and the patterns of labour market demand that exist within them, are of paramount importance in influencing highly skilled professional and managerial labour migration within the world economy. The author uses an example of highly skilled labour migration within the transnational banking sector [in London] to illustrate this new conceptual framework." excerpt

Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review

PubMed Central

Antoniou, Miranta; Jorgensen, Andrea L; Kolamunnage-Dona, Ruwanthi

2016-01-01

Background Personalized medicine is a growing area of research which aims to tailor the treatment given to a patient according to one or more personal characteristics. These characteristics can be demographic such as age or gender, or biological such as a genetic or other biomarker. Prior to utilizing a patient’s biomarker information in clinical practice, robust testing in terms of analytical validity, clinical validity and clinical utility is necessary. A number of clinical trial designs have been proposed for testing a biomarker’s clinical utility, including Phase II and Phase III clinical trials which aim to test the effectiveness of a biomarker-guided approach to treatment; these designs can be broadly classified into adaptive and non-adaptive. While adaptive designs allow planned modifications based on accumulating information during a trial, non-adaptive designs are typically simpler but less flexible. Methods and Findings We have undertaken a comprehensive review of biomarker-guided adaptive trial designs proposed in the past decade. We have identified eight distinct biomarker-guided adaptive designs and nine variations from 107 studies. Substantial variability has been observed in terms of how trial designs are described and particularly in the terminology used by different authors. We have graphically displayed the current biomarker-guided adaptive trial designs and summarised the characteristics of each design. Conclusions Our in-depth overview provides future researchers with clarity in definition, methodology and terminology for biomarker-guided adaptive trial designs. PMID:26910238

New Labour and Education: An Evidence-Based Analysis

ERIC Educational Resources Information Center

Galton, Maurice

2007-01-01

This article looks at the evidence concerning performance and progress in the primary school over the lifetime of New Labour's tenure in government since 1997. It examines the claims made by New Labour that the Literacy and Numeracy Strategies have been an outstanding success and have changed the ways that teachers teach. On the evidence of the…

A comparative analysis of the results from 4 trials of beta-blocker therapy for heart failure: BEST, CIBIS-II, MERIT-HF, and COPERNICUS.

PubMed

Domanski, Michael J; Krause-Steinrauf, Heidi; Massie, Barry M; Deedwania, Prakash; Follmann, Dean; Kovar, David; Murray, David; Oren, Ron; Rosenberg, Yves; Young, James; Zile, Michael; Eichhorn, Eric

2003-10-01

Recent large randomized, controlled trials (BEST [Beta-blocker Evaluation of Survival Trial], CIBIS-II [Cardiac Insufficiency Bisoprolol Trial II], COPERNICUS [Carvedilol Prospective Randomized Cumulative Survival Study], and MERIT-HF [Metoprolol Randomized Intervention Trial in Congestive Heart Failure]) have addressed the usefulness of beta-blockade in the treatment of advanced heart failure. CIBIS-II, COPERNICUS, and MERIT-HF have shown that beta-blocker treatment with bisoprolol, carvedilol, and metoprolol XL, respectively, reduce mortality in advanced heart failure patients, whereas BEST found a statistically nonsignificant trend toward reduced mortality with bucindolol. We conducted a post hoc analysis to determine whether the response to beta-blockade in BEST could be related to differences in the clinical and demographic characteristics of the study populations. We generated a sample from BEST to resemble the patient cohorts studied in CIBIS-II and MERIT-HF to find out whether the response to beta-blocker therapy was similar to that reported in the other trials. These findings are further compared with COPERNICUS, which entered patients with more severe heart failure. To achieve conformity with the entry criteria for CIBIS-II and MERIT-HF, the BEST study population was adjusted to exclude patients with systolic blood pressure <100 mm Hg, heart rate <60 bpm, and age >80 years (exclusion criteria employed in those trials). The BEST comparison subgroup (BCG) was further modified to more closely reflect the racial demographics reported for patients enrolled in CIBIS-II and MERIT-HF. The association of beta-blocker therapy with overall survival and survival free of cardiac death, sudden cardiac death, and progressive pump failure in the BCG was assessed. In the BCG subgroup, bucindolol treatment was associated with significantly lower risk of death from all causes (hazard ratio (HR)=0.77 [95% CI=0.65, 0.92]), cardiovascular death (HR=0.71 [0.58, 0.86]), sudden

Impact on caesarean section rates following injections of sterile water (ICARIS): a multicentre randomised controlled trial.

PubMed

Lee, Nigel; Mårtensson, Lena B; Homer, Caroline; Webster, Joan; Gibbons, Kristen; Stapleton, Helen; Dos Santos, Natalie; Beckmann, Michael; Gao, Yu; Kildea, Sue

2013-05-03

Sterile water injections have been used as an effective intervention for the management of back pain during labour. The objective of the current research is to determine if sterile water injections, as an intervention for back pain in labour, will reduce the intrapartum caesarean section rate. A double blind randomised placebo controlled trialSetting: Maternity hospitals in AustraliaParticipants: 1866 women in labour, ≥18 years of age who have a singleton pregnancy with a fetus in a cephalic presentation at term (between 37 + 0 and 41 + 6 weeks gestation), who assess their back pain as equal to or greater than seven on a visual analogue scale when requesting analgesia and able to provide informed consent. Participants will be randomised to receive either 0.1 to 0.3 millilitres of sterile water or a normal saline placebo via four intradermal injections into four anatomical points surrounding the Michaelis' rhomboid over the sacral area. Two injections will be administered over the posterior superior iliac spine (PSIS) and the remaining two at two centimetres posterior, and one centimetre medial to the PSIS respectively. Proportion of women who have a caesarean section in labour.Randomisation: Permuted blocks stratified by research site.Blinding (masking):Double-blind trial in which participants, clinicians and research staff blinded to group assignment. Funded by the National Health and Medical Research CouncilTrial registration:Australian New Zealand Clinical Trials Registry (No ACTRN12611000221954). Sterile water injections, which may have a positive effect on reducing the CS rate, have been shown to be a safe and simple analgesic suitable for most maternity settings. A procedure that could reduce intervention rates without adversely affecting safety for mother and baby would benefit Australian families and taxpayers and would reduce requirements for maternal operating theatre time. Results will have external validity, as the technique may be easily applied to

PROM and Labour Effects on Urinary Metabolome: A Pilot Study

PubMed Central

Meloni, Alessandra; Palmas, Francesco; Mereu, Rossella; Deiana, Sara Francesca; Fais, Maria Francesca; Mussap, Michele; Ragusa, Antonio; Pintus, Roberta; Fanos, Vassilios; Melis, Gian Benedetto

2018-01-01

Since pathologies and complications occurring during pregnancy and/or during labour may cause adverse outcomes for both newborns and mothers, there is a growing interest in metabolomic applications on pregnancy investigation. In fact, metabolomics has proved to be an efficient strategy for the description of several perinatal conditions. In particular, this study focuses on premature rupture of membranes (PROM) in pregnancy at term. For this project, urine samples were collected at three different clinical conditions: out of labour before PROM occurrence (Ph1), out of labour with PROM (Ph2), and during labour with PROM (Ph3). GC-MS analysis, followed by univariate and multivariate statistical analysis, was able to discriminate among the different classes, highlighting the metabolites most involved in the discrimination. PMID:29511388

Castor oil for induction of labour: a retrospective study.

PubMed

Neri, Isabella; Dante, Giulia; Pignatti, Lucrezia; Salvioli, Chiara; Facchinetti, Fabio

2018-08-01

The aim of this study is to investigate the safety and efficacy of castor oil to induce labour. A retrospective observational case control study was conducted over five years. Castor oil was proposed to women referred to the Birth Centre (Castor Oil group (COG)). They were compared to women who chose to be followed by the traditional doctor-led unit (control group (CG)). Castor oil was administered in a 60 ml single dose in 200 ml of warm water. Inclusion criteria were gestational age between 40 and 41 weeks plus premature rupture of membranes between 12 and 18 hours or amniotic fluid index ≤4 or Bishop Score of ≤4 or absence of spontaneous labour over 41 + 4 weeks. Pharmacological induction of labour was required for 18 women in the COG (45%) and 36 in the CG (90%) (p < .001). The mode of delivery differed significantly between groups: women assuming castor oil showed a higher incidence of vaginal delivery, whereas the incidence of caesarean section was lower in the COG, but no statistical significance was reached. The use of castor oil is related to a higher probability of labour initiation within 24 hours. Castor oil can be considered a safe non-pharmacological method for labour induction.

Gender, family status and physician labour supply.

PubMed

Wang, Chao; Sweetman, Arthur

2013-10-01

With the increasing participation of women in the physician workforce, it is important to understand the sources of differences between male and female physicians' market labour supply for developing effective human resource policies in the health care sector. Gendered associations between family status and physician labour supply are explored in the Canadian labour market, where physicians are paid according to a common fee schedule and have substantial discretion in setting their hours of work. Canadian 1991, 1996, 2001 and 2006 twenty percent census files with 22,407 physician observations are used for the analysis. Although both male and female physicians have statistically indistinguishable hours of market work when never married and without children, married male physicians have higher market hours, and their hours are unchanged or increased with parenthood. In contrast, female physicians have lower market hours when married, and much lower hours when a parent. Little change over time in these patterns is observed for males, but for females two offsetting trends are observed: the magnitude of the marriage-hours effect declined, whereas that for motherhood increased. Preferences and/or social norms induce substantially different labour market outcomes. In terms of work at home, the presence of children is associated with higher hours for male physicians, but for females the hours increase is at least twice as large. A male physician's spouse is much less likely to be employed, and if employed, has lower market hours in the presence of children. In contrast, a female physician's spouse is more likely to be employed if there are three or more children. Both male and female physicians have lower hours of work when married to another physician. Overall, there is no gender difference in physician market labour supply after controlling for family status and demographics. Copyright © 2013 Elsevier Ltd. All rights reserved.

Usefulness of elastography in predicting the outcome of Foley catheter labour induction.

PubMed

Wozniak, Slawomir; Czuczwar, Piotr; Szkodziak, Piotr; Paszkowski, Tomasz

2015-06-01

Incorrect selection of women for labour induction may increase the risk of caesarean section and other postpartum and neonatal complications. It has been recently shown that elastography of the uterine cervix holds the potential to predict the outcome of pharmacological labour induction. There are no data on the usefulness of elastography in predicting the outcome of mechanical induction of labour. To assess the usefulness of elastographic cervical assessment in predicting the success of Foley catheter labour induction. This prospective observational study included 39 pregnant women at term with an unfavourable cervix (Bishop score ≤ 6) suitable for Foley catheter labour induction. Before labour induction the following data were recorded: Bishop score, cervical length (measured by ultrasound) and the stiffness of cervical internal os, canal and external os assessed by elastography (elastography index - EI). Statistical relationships between pre-interventional assessment of the cervix and outcome of Foley catheter labour induction (successful induction, time to delivery and route of delivery) were analysed. EI's of internal cervical os and cervical canal were significantly lower (softer) in women with successful labour induction and vaginal delivery, while EI's of the external cervical os, Bishop score and cervix length were not significantly different. Time to vaginal delivery was significantly correlated with the EI's of internal cervical os, cervical canal and Bishop score, but not with EI's of the external cervical os and cervix length. Elastography has the potential to predict the outcome of Foley catheter labour induction. © 2015 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Labour Market Driven Learning Analytics

ERIC Educational Resources Information Center

Kobayashi, Vladimer; Mol, Stefan T.; Kismihók, Gábor

2014-01-01

This paper briefly outlines a project about integrating labour market information in a learning analytics goal-setting application that provides guidance to students in their transition from education to employment.

The future population and the future labour force.

PubMed

Young, C

1994-01-01

"The combination of two recent publications by the Australian Bureau of Statistics (ABS) provides a useful insight into feasible future trends in the population, the labour force and dependency ratios. In addition, earlier ABS census data and its regular publications from the Labour Force Surveys clarify the historical trends in the relative number of dependants and nondependants. These various sources of data are brought together in this paper.... Official population projections...highlight the fact that the combination of annual zero net migration and 10 per cent below replacement fertility would not produce an immediate decline in Australia's population.... The conventional labour-force dependency ratio suggests that the dependency situation in Australia in 2041 will be no worse than it was in the early 1980s." excerpt

[Child labour].

PubMed

Marsella, L T; Savastano, L; Saracino, V; Del Vecchio, R

2005-01-01

The authors emphasize the violation of children's and adolescents' rights as a result of the exploitation of child labour. Besides the legal aspect, they pointed out the medical features related to the delicate growing process of the child in the phases of development and adaptation of the main organs to hard work. Currently the problem is being supervised by those states that recognize the right for minors to be protected against any kind of physical, mental, spiritual and moral risk.

MRC ORACLE Children Study. Long term outcomes following prescription of antibiotics to pregnant women with either spontaneous preterm labour or preterm rupture of the membranes

PubMed Central

Kenyon, Sara; Brocklehurst, Peter; Jones, David; Marlow, Neil; Salt, Alison; Taylor, David

2008-01-01

Background The Medical Research Council (MRC) ORACLE trial evaluated the use of co-amoxiclav 375 mg and/or erythromycin 250 mg in women presenting with preterm rupture of membranes (PROM) ORACLE I or in spontaneous preterm labour (SPL) ORACLE II using a factorial design. The results showed that for women with a singleton baby with PROM the prescription of erythromycin is associated with improvements in short term neonatal outcomes, although co-amoxiclav is associated with prolongation of pregnancy, a significantly higher rate of neonatal necrotising enterocolitis was found in these babies. Prescription of erythromycin is now established practice for women with PROM. For women with SPL antibiotics demonstrated no improvements in short term neonatal outcomes and are not recommended treatment. There is evidence that both these conditions are associated with subclinical infection so perinatal antibiotic administration may reduce the risk of later disabilities, including cerebral palsy, although the risk may be increased through exposure to inflammatory cytokines, so assessment of longer term functional and educational outcomes is appropriate. Methods The MRC ORACLE Children's Study will follow up UK children at age 7 years born to 4809 women with PROM and the 4266 women with SPL enrolled in the earlier ORACLE trials. We will use a parental questionnaire including validated tools to assess disability and behaviour. We will collect the frequency of specific medical conditions: cerebral palsy, epilepsy, respiratory illness including asthma, diabetes, admission to hospital in last year and other diseases, as reported by parents. National standard test results will be collected to assess educational attainment at Key Stage 1 for children in England. Discussion This study is designed to investigate whether or not peripartum antibiotics improve health and disability for children at 7 years of age. Trial registration The ORACLE Trial and Children Study is registered in the

Use of Non-invasive Uterine Electromyography in the Diagnosis of Preterm Labour

PubMed Central

Lucovnik, M.; Novak-Antolic, Z.; Garfield, R.E.

2012-01-01

Predictive values of methods currently used in the clinics to diagnose preterm labour are low. This leads to missed opportunities to improve neonatal outcomes and, on the other hand, to unnecessary hospitalizations and treatments. In addition, research of new and potentially more effective preterm labour treatments is hindered by the inability to include only patients in true preterm labour into studies. Uterine electromyography (EMG) detects changes in cell excitability and coupling required for labour and has higher predictive values for preterm delivery than currently available methods. This methodology could also provide a better means to evaluate various therapeutic interventions for preterm labour. Our manuscript presents a review of uterine EMG studies examining the potential clinical value that this technology possesses over what is available to physicians currently. We also evaluated the impact that uterine EMG could have on investigation of preterm labour treatments by calculating sample sizes for studies using EMG vs. current methods to enrol women. Besides helping clinicians to make safer and more cost-effective decisions when managing patients with preterm contractions, implementation of uterine EMG for diagnosis of preterm labour would also greatly reduce sample sizes required for studies of treatments. PMID:24753891

75 Years of the International Labour Review: A Retrospective.

ERIC Educational Resources Information Center

Thomas, Albert; And Others

1996-01-01

Contains 18 articles published in International Labour Review from 1921-1975 that discuss the International Labour Organisation, international labor movement and law, economics and the labor market, family security, full employment, population growth, industrial welfare, trade policy and employment growth, and income expectations and rural-urban…

Gender and migration on the labour market: Additive or interacting disadvantages in Germany?

PubMed

Fleischmann, Fenella; Höhne, Jutta

2013-09-01

Despite substantial differences in labour market attainment according to gender and migration status, gender and ethnic differences in labour market behaviour are most often studied separately. In contrast, this study describes and analyses interactions between gender, ethnic background and immigrant generation with regard to labour market participation, part-time work, and occupational status. The double comparison aims to reveal whether gender gaps in these labour market outcomes among the majority population generalise to ethnic minorities. Moreover, we ask whether variation in gender gaps in labour market behaviour follows the patterns in migrants' origin countries, and whether gender gaps show signs of intergenerational assimilation. Our heterogeneous choice and OLS regressions of 2009 German Microcensus data reveal considerable variation in gender gaps in labour market behaviour between East and West Germany, across ethnic groups and across generations. Intergenerational comparisons show that most ethnic minorities assimilate towards German patterns of gendered labour market attainment. Copyright © 2013 Elsevier Inc. All rights reserved.

[Phase II clinical trial of nedaplatin in advanced non-small cell lung cancer].

PubMed

Xu, Rui-hua; Guan, Zhong-zhen; Jiang, Wen-qi; Huang, He; Hu, Xiao-hua; Xie, Wei-min; Li, Xing-gen; Liu, Ya-li; Pan, Liang-xi; Dai, Ai-di; Zhuang, Wu; Zhang, Chun; Ma, Zhi-yong; Wang, Jian-hua

2002-12-01

The aim of this study was to observe the efficacy and the side effects of nedaplatin in treatment of non-small cell lung cancer (NSCLC). This is a multi-center phase II clinical trial. The previously chemotherapy treated patients with NSCLC were administrated nedaplatin alone. Nedaplatin was given at 100 mg/m2, i.v., repeated every 3 weeks. The chemonaive patients with NSCLC were randomized to two groups. The combination trial group was given with nedaplatin + vindesine regimen, and the combination control group with cisplatin + vindesine. Of 138 patients, 16 were in the nedaplatin single drug group; 60 were in the combination trial group; and 62 were in the combination control group. All of the 16 cases in the single drug group, which were treated with platinum previously, achieved 12.5% of response rate. And the combination trial group and control group had a very similar response rate, which were 26.7% versus 25.8%, respectively. The incidence rates of neutropenia and anemia were similar in the two groups. But the incidence rate of thrombocytopenia was higher in the trial group than that in the control group. Nedaplatin has a possibility to result in mild nausea/vomiting. Nedaplatin is an effective platinum drug in the treatment of NSCLC, not only for no previously chemotherapy patients, but also for those patients resistant to cisplatin/carboplatin. Nedaplatin has a good clinical tolerance. And the main adverse reaction was myelosuppression, especially thrombocytopenia.

Preterm labour: an overview of current and emerging therapeutics.

PubMed

Schwarz, Matthias K; Page, Patrick

2003-08-01

Preterm labour is a major cause of perinatal mortality and morbidity. However, during the past 40 years of clinical studies and despite the use of multiple therapeutic agents, the rate of preterm birth has not drastically declined. In 1991, it was estimated that in the US approximately 116,000 women admitted with acute episodes of preterm labour were treated each year with ritodrine, which is the first drug approved by the US FDA and still remains the standard therapy for treating preterm labour. Ritodrine (Yutopar( trade mark )) stimulates the beta(2)-adrenergic receptor throughout the body, causing an inhibitory action in different tissues that, among other side effects, also leads to an attenuation of uterine contractility. More recently, a new therapeutic agent, atosiban (Tractocile( trade mark )), a peptidic oxytocin receptor antagonist, has been introduced to the market. However, the use of the various pharmacological agents to treat preterm labour remains restricted, due to lack of uterine selectivity, low efficacy and potentially serious side effects for the mother or the foetus. Therefore, there is an urgent need to develop drugs with myometrial selectivity that would allow long-lasting inhibition of labour and prolong pregnancy up to a stage when good foetal maturation raises the chances of survival. One of the major obstacles hampering the development of new therapeutic agents is the marked inter-species difference in terms of preterm labour physiology, which complicates the preclinical evaluation of new candidate molecules in animal models of disease. In this review, the authors will provide a comprehensive update of past, current and new approaches for the management of preterm labour, including beta(2)-adrenergic agonists, calcium channel blockers, oxytocin antagonists, prostaglandin antagonists and other potential therapeutics. For each of the therapies used today, the review will cover the mechanism of action, benefit and adverse effects, and

Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design.

PubMed

Richert, Laura; Doussau, Adélaïde; Lelièvre, Jean-Daniel; Arnold, Vincent; Rieux, Véronique; Bouakane, Amel; Lévy, Yves; Chêne, Geneviève; Thiébaut, Rodolphe

2014-02-26

Many candidate vaccine strategies against human immunodeficiency virus (HIV) infection are under study, but their clinical development is lengthy and iterative. To accelerate HIV vaccine development optimised trial designs are needed. We propose a randomised multi-arm phase I/II design for early stage development of several vaccine strategies, aiming at rapidly discarding those that are unsafe or non-immunogenic. We explored early stage designs to evaluate both the safety and the immunogenicity of four heterologous prime-boost HIV vaccine strategies in parallel. One of the vaccines used as a prime and boost in the different strategies (vaccine 1) has yet to be tested in humans, thus requiring a phase I safety evaluation. However, its toxicity risk is considered minimal based on data from similar vaccines. We newly adapted a randomised phase II trial by integrating an early safety decision rule, emulating that of a phase I study. We evaluated the operating characteristics of the proposed design in simulation studies with either a fixed-sample frequentist or a continuous Bayesian safety decision rule and projected timelines for the trial. We propose a randomised four-arm phase I/II design with two independent binary endpoints for safety and immunogenicity. Immunogenicity evaluation at trial end is based on a single-stage Fleming design per arm, comparing the observed proportion of responders in an immunogenicity screening assay to an unacceptably low proportion, without direct comparisons between arms. Randomisation limits heterogeneity in volunteer characteristics between arms. To avoid exposure of additional participants to an unsafe vaccine during the vaccine boost phase, an early safety decision rule is imposed on the arm starting with vaccine 1 injections. In simulations of the design with either decision rule, the risks of erroneous conclusions were controlled <15%. Flexibility in trial conduct is greater with the continuous Bayesian rule. A 12-month gain in

Social Security Contribution to Productivity and Wages in Labour Organization Perspective

NASA Astrophysics Data System (ADS)

Supriadi, Y. N.

2017-03-01

This research is investigating the discrepancy fulfilment of the right to social security and decent wages to increase labour productivity in the perspective of labour organizations, in which the company provides social security, and wages have not been able to meet the needs of workers, on the other hand, the workers are always required to increase productivity. Therefore, this study aims to identify the social security and wages that affect labour productivity. So this research will provide input to the company to undertake effective measures and efficient for the company’s sustainability. This research was conducted using a survey method approach and quantitative data analysis techniques that are causal comparative sample of 223 respondents from 504 study population includes all labour organization’s District and municipal in Banten Province. The results showed the significant influence of social security and wages to increase labour productivity. Therefore, companies are required to act strategically in maintaining prohibitionists labour through re-design of the work environment, increase workers’ participation, intervention, and satisfy the needs of workers whose impact will be realized understanding between workers and companies in maintaining the company’s business.

The Interaction between Higher Education and Labour Market in Changing Economic Environment

ERIC Educational Resources Information Center

Gravite, Aija

2015-01-01

This paper explores challenges higher education institutions face while ensuring one of the quality assurance criteria--meeting the demands of labour market. The relationship between labour market and higher education institutions becomes even more complicated during the periods of rapid changes in labour market caused by economic collisions. In…

Sociodemographic differences in women's experience of early labour care: a mixed methods study.

PubMed

Henderson, Jane; Redshaw, Maggie

2017-07-13

To explore women's experiences of early labour care focusing on sociodemographic differences, and to examine the effect of antenatal education, using mixed methods. England, 2014. Women who completed postal questionnaires about their experience of maternity care, including questions about antenatal education, early labour and sociodemographic factors, included space for free-text comments. Worries about labour, contact with midwives in early labour and subsequent care. This study was based on secondary analysis of a national maternity survey carried out in England in 2014. Quantitative data were analysed using descriptive statistics and binary logistic regression; qualitative data were analysed using a thematic content analytic approach. Completed questionnaires were received from 4578 women (47% response rate). There were significant differences by sociodemographic factors, particularly ethnicity, in women's worries about early labour. Compared with white women, women from black or minority ethnic groups had an adjusted OR of 1.93 (95% CI 1.56 to 2.39) of feeling worried about not knowing when labour would start. Among women who contacted a midwife at the start of labour, 84% perceived their advice as appropriate, more in older and multiparous women. Overall, 64% of women were asked to come to the hospital at this time, more in multiparous women (adjusted OR 1.63, 95% CI 1.35 to 1.96). Those who did not have access to antenatal education experienced greater worry about early labour. Five themes emerged from the qualitative analysis: 'Differentiating between early and active labour', 'Staff attitudes', 'Not being allowed…', 'Previous labours' and 'Perceived consequences for women'. These findings reinforce the importance of providing reassurance to women in early labour, taking care that women do not feel neglected or dismissed. In particular, primiparous and ethnic minority women reported greater worry about early labour and require additional reassurance. �

Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. analysis and examples.

PubMed Central

Peto, R.; Pike, M. C.; Armitage, P.; Breslow, N. E.; Cox, D. R.; Howard, S. V.; Mantel, N.; McPherson, K.; Peto, J.; Smith, P. G.

1977-01-01

Part I of this report appeared in the previous issue (Br. J. Cancer (1976) 34,585), and discussed the design of randomized clinical trials. Part II now describes efficient methods of analysis of randomized clinical trials in which we wish to compare the duration of survival (or the time until some other untoward event first occurs) among different groups of patients. It is intended to enable physicians without statistical training either to analyse such data themselves using life tables, the logrank test and retrospective stratification, or, when such analyses are presented, to appreciate them more critically, but the discussion may also be of interest to statisticians who have not yet specialized in clinical trial analyses. PMID:831755

Prospective randomised multicentre trial with the birth trainer EPI-NO for the prevention of perineal trauma.

PubMed

Ruckhäberle, Eugen; Jundt, Katharina; Bäuerle, Martin; Brisch, Karl-Heinz; Ulm, Kurt; Dannecker, Christian; Schneider, Karl Theo Mario

2009-10-01

In several non-randomised trials training with EPI-NO increased the rate of intact perineum and decreased episiotomy rates, shortened the second stage of labour and lowered use of pain killers. To verify the preliminary results with EPI-NO in a prospective randomised trial. Randomised, single-blind multicentre trial in four university hospitals in Germany including 276 primigravidae. After training with EPI-NO we observed a significant increase in the incidence of intact perineum (37.4% vs 25.7%; P = 0.05) and a tendency towards lower episiotomy rates (41.9% vs 50.5%; P = 0.11). We found no significant differences between the two groups regarding incidence of perineal tears, duration of second stage of labour, use of pain relief and rate of vaginal infection. Training with EPI-NO increases significantly the likelihood of having an intact perineum and reduces the episiotomy rate.

First-time mothers' experiences of early labour in Italian maternity care services.

PubMed

Cappelletti, Giulia; Nespoli, Antonella; Fumagalli, Simona; Borrelli, Sara E

2016-03-01

The aim of this study is to explore first-time mothers' experiences of early labour in Italian maternity care services when admitted to hospital or advised to return home after maternity triage assessment. The study was conducted in a second-level maternity hospital in northern Italy with an obstetric unit for both low- and high-risk women. The participants included 15 first-time mothers in good general health with spontaneous labour at term of a low-risk pregnancy who accessed maternity triage during early labour, and were either admitted to hospital or advised to return home. A qualitative interpretive phenomenological study was conducted. A face-to-face recorded semi-structured interview was conducted with each participant 48-72h after birth. Four key themes emerged from the interviews: (a) recognising signs of early labour; (b) coping with pain at home; (c) seeking reassurance from healthcare professionals; and (d) being admitted to hospital versus returning home. Uncertainty about the progression of labour and the need for reassurance were cited by women as the main reasons for hospital visit in early labour. An ambivalent feeling was reported by the participants when admitted to hospital in early labour. In fact, while the women felt reassured in the first instance, some women subsequently felt dissatisfied due to the absence of one-to-one dedicated care during early labour. When advised to return home, a number of women reported feelings of disappointment, anger, fear, discouragement and anxiety about not being admitted to hospital; however, some of these women reported a subsequent feeling of comfort due to being at home and putting in place the suggestions made by the midwives during the maternity triage assessment. The guidance provided by midwives during triage assessment seemed to be the key factor influencing women׳s satisfaction when advised either to return home or to stay at the hospital during early labour. During antenatal classes and clinics

Exploiting Patient Labour at Kew Cottages, Australia, 1887-1950

ERIC Educational Resources Information Center

Monk, Lee-Ann

2010-01-01

This article examines the exploitation of patient labour at Kew Cottages, Australia's first purpose-built state institution for people with learning disabilities. Analysing historical evidence for the period 1887-1950 shows that unpaid patient labour contributed significantly to the economy of the Cottages and so to the government department of…

Workers with Disabilities and the Challenges of Emotional Labour

ERIC Educational Resources Information Center

Wilton, Robert D.

2008-01-01

This paper explores the implications of emotional labour for workers with disabilities, drawing on qualitative data from interviews with 59 respondents who had disabilities and who worked in service sector occupations. The analysis illustrates that employer demands for emotional labour may prove difficult for workers with a range of disabilities,…

Delivery mode and neonatal outcome after a trial of external cephalic version (ECV): a prospective trial of vaginal breech versus cephalic delivery.

PubMed

Reinhard, Joscha; Sänger, Nicole; Hanker, Lars; Reichenbach, Lena; Yuan, Juping; Herrmann, Eva; Louwen, Frank

2013-04-01

To examine the delivery mode and neonatal outcome after a trial of external cephalic version (ECV) procedures. This is an interim analysis of an ongoing larger prospective off-centre randomised trial, which compares a clinical hypnosis intervention against neuro-linguistic programming (NLP) of women with a singleton breech foetus at or after 37(0/7) (259 days) weeks of gestation and normal amniotic fluid index. Main outcome measures were delivery mode and neonatal outcome. On the same day after the ECV procedure two patients (2 %), who had unsuccessful ECVs, had Caesarean sections (one due to vaginal bleeding and one due to pathological CTG). After the ECV procedure 40.4 % of women had cephalic presentation (n = 38) and 58.5 % (n = 55) remained breech presentation. One patient remained transverse presentation (n = 1; 1.1 %). Vaginal delivery was observed by 73.7 % of cephalic presentation (n = 28), whereas 26.3 % (n = 10) had in-labour Caesarean sections. Of those, who selected a trial of vaginal breech delivery, 42.4 % (n = 14) delivered vaginally and 57.6 % (n = 19) delivered via Caesarean section. There is a statistically significant difference between the rate of vaginal birth between cephalic presentation and trial of vaginal breech delivery (p = 0.009), however, no difference in neonatal outcome was observed. ECV is a safe procedure and can reduce not only the rate of elective Caesarean sections due to breech presentation but also the rate of in-labour Caesarean sections even if a trial of vaginal breech delivery is attempted.

International labour migration statistics in Asia: an appraisal.

PubMed

Athukorala, P C; Wickramasekara, P

1996-01-01

"The present paper attempts a critical review of the data systems of seven major labour-exporting countries--Bangladesh, India, Indonesia, Pakistan, Philippines, Sri Lanka and Thailand--which account for over 90 per cent of labour outflows from Asia....Data...are discussed under separate sections focusing on limitations as well as potential for further exploitation.... For all countries reviewed here, these data significantly understate total labour outflows, and the magnitude of the error seems to vary between countries and reflect both differences relating to the coverage and efficiency of the approval and monitoring procedure. This throws serious doubts on the appropriateness of official outmigration series for cross country comparison. Frequent changes in reporting procedures also make for discrete changes and spurious shifts in data which render trend analysis quite hazardous." (SUMMARY IN FRE AND SPA) excerpt

Chronic disease and labour force participation among older Australians.

PubMed

Schofield, Deborah J; Shrestha, Rupendra N; Passey, Megan E; Earnest, Arul; Fletcher, Susan L

2008-10-20

To examine the association between long-term health conditions and being out of the labour force among older Australians. Retrospective analysis of cross-sectional data from the Australian Bureau of Statistics 2003 Survey of Disability, Ageing and Carers for people aged 45-64 years. Rates of premature retirement associated with ill health; odds ratios of being out of the labour force associated with each long-term health condition and number of conditions; weighted population estimates; estimates of gross domestic product lost as a result. 9198 people surveyed were aged 45-64 years, 3010 of whom were not in the labour force. Of these, 1373 (45.6%) had retired because of a chronic health condition, most commonly a back problem (10.4%), or arthritis and related disorders (8.6%). When adjusted for age and sex, all conditions studied except diseases of the ear and mastoid process, other endocrine/nutritional and metabolic disorders, noise-induced deafness or hearing loss, and high cholesterol were significantly associated with being out of the labour force. Extrapolating from these results, an estimated 663 235 older Australians were not working because of ill health, reducing Australia's gross domestic product by around $14.7 billion per annum. Prevention of long-term health conditions may help older Australians remain in the labour force longer, thereby increasing revenue to fund health care for the ageing population.

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

PubMed

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

2016-08-01

More than 150,000 pregnant women in England and Wales have their labour induced each year. Multiple pharmacological, mechanical and complementary methods are available to induce labour. To assess the relative effectiveness, safety and cost-effectiveness of labour induction methods and, data permitting, effects in different clinical subgroups. We carried out a systematic review using Cochrane methods. The Cochrane Pregnancy and Childbirth Group's Trials Register was searched (March 2014). This contains over 22,000 reports of controlled trials (published from 1923 onwards) retrieved from weekly searches of OVID MEDLINE (1966 to current); Cochrane Central Register of Controlled Trials (The Cochrane Library); EMBASE (1982 to current); Cumulative Index to Nursing and Allied Health Literature (1984 to current); ClinicalTrials.gov; the World Health Organization International Clinical Trials Registry Portal; and hand-searching of relevant conference proceedings and journals. We included randomised controlled trials examining interventions to induce labour compared with placebo, no treatment or other interventions in women eligible for third-trimester induction. We included outcomes relating to efficacy, safety and acceptability to women. In addition, for the economic analysis we searched the Database of Abstracts of Reviews of Effects, and Economic Evaluations Databases, NHS Economic Evaluation Database and the Health Technology Assessment database. We carried out a network meta-analysis (NMA) using all of the available evidence, both direct and indirect, to produce estimates of the relative effects of each treatment compared with others in a network. We developed a de novo decision tree model to estimate the cost-effectiveness of various methods. The costs included were the intervention and other hospital costs incurred (price year 2012-13). We reviewed the literature to identify preference-based utilities for the health-related outcomes in the model. We calculated

Effects of preventive versus "on-demand" nutritional support on paid labour productivity, physical exercise and performance status during PEG-interferon-containing treatment for hepatitis C.

PubMed

Huisman, Ellen J; van Meer, Suzanne; van Hoek, Bart; van Soest, Hanneke; van Nieuwkerk, Karin M J; Arends, Joop E; Siersema, Peter D; van Erpecum, Karel J

2016-04-01

Deterioration of nutritional status during PEG-interferon containing therapy for chronic hepatitis C can be ameliorated by preventive nutritional support. We aimed to explore whether such support also affects paid labour productivity, physical exercise and performance status. In this prospective randomized controlled trial (J Hepatol 2012;57:1069-75), 53 patients with chronic hepatitis C had been allocated to "on demand" support (n=26: nutritional intervention if weight loss>5%) or preventive support (n=27: regular dietary advice plus energy- and protein-rich evening snack) during PEG-interferon-containing therapy. Paid labour productivity, physical exercise and performance status were evaluated at baseline, after 24 and (if applicable) after 48 weeks of treatment. At baseline, 46% of patients performed paid labour and 62% performed some kind of physical exercise. Furthermore, most patients were able to carry out normal activity with only minor symptoms of disease (mean Karnofsky performance score: 94). Decreases of paid labour productivity (-21% vs. -70%, P=0.003), physical exercise activity (-43% vs. -87%, P=0.005) and Karnofsky performance scores (-12% vs. -24%, P<0.001) were less in the preventive than in "on demand" group after 24 weeks of treatment. Effects of preventive nutritional support were even more pronounced after 48 weeks. Preventive nutritional support markedly ameliorates decreases of paid labour productivity, physical exercise and performance status during PEG-interferon-containing treatment for chronic hepatitis C. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

China: surplus labour and migration.

PubMed

Banister, J; Taylor, J R

1989-12-01

Surplus labor force and migration trends in China are examined, with emphasis on the impact of underemployment in rural areas. "Government policy encourages surplus labourers to transfer out of crop farming into agricultural sidelines or non-agricultural work. Peasants are urged to stay where they are, shifting jobs without shifting location; however, many rural areas are poorly endowed for providing alternative employment, so their surplus workers must also leave the village to find work. Many do not formally migrate, but rather move on a seasonal basis or set up 'temporary' residence in an urban place. This 'floating' population has been escalating rapidly in recent years....[The authors argue] that China's cities and towns can absorb millions of surplus labourers from rural areas each year, to the mutual benefit of sending and receiving areas." excerpt

Optimal cost-effective designs of Phase II proof of concept trials and associated go-no go decisions.

PubMed

Chen, Cong; Beckman, Robert A

2009-01-01

This manuscript discusses optimal cost-effective designs for Phase II proof of concept (PoC) trials. Unlike a confirmatory registration trial, a PoC trial is exploratory in nature, and sponsors of such trials have the liberty to choose the type I error rate and the power. The decision is largely driven by the perceived probability of having a truly active treatment per patient exposure (a surrogate measure to development cost), which is naturally captured in an efficiency score to be defined in this manuscript. Optimization of the score function leads to type I error rate and power (and therefore sample size) for the trial that is most cost-effective. This in turn leads to cost-effective go-no go criteria for development decisions. The idea is applied to derive optimal trial-level, program-level, and franchise-level design strategies. The study is not meant to provide any general conclusion because the settings used are largely simplified for illustrative purposes. However, through the examples provided herein, a reader should be able to gain useful insight into these design problems and apply them to the design of their own PoC trials.

Neoadjuvant FOLFOX 4 versus FOLFOX 4 with Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a multicentre randomised controlled phase II trial--the PRODIGE 22--ECKINOXE trial.

PubMed

Karoui, Mehdi; Rullier, Anne; Luciani, Alain; Bonnetain, Franck; Auriault, Marie-Luce; Sarran, Antony; Monges, Geneviève; Trillaud, Hervé; Le Malicot, Karine; Leroy, Karen; Sobhani, Iradj; Bardier, Armelle; Moreau, Marie; Brindel, Isabelle; Seitz, Jean François; Taieb, Julien

2015-07-10

In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However, for 20 to 30% of these patients, the current curative treatment strategy of surgical excision followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an attractive concept for these CCs and has the potential to impact upon both of these causes of failure. Optimum systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Added to this, shrinking the primary tumor before surgery may reduce the risk of incomplete surgical excision, and the risk of tumor cell shedding during surgery. PRODIGE 22--ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy and feasibility of two chemotherapy regimens (FOLFOX-4 alone and FOLFOX-4 + Cetuximab) in a peri-operative strategy in patients with bulky CCs. Patients with CC deemed as high risk T3, T4 and/or N2 on initial abdominopelvic CT scan are randomized to either colectomy and adjuvant chemotherapy (control arm), or 4 cycles of neoadjuvant chemotherapy with FOLFOX-4 (for RAS mutated patients). In RAS wild-type patients a third arm testing FOLFOX+ cetuximab has been added prior to colectomy. Patients in the neoadjuvant chemotherapy arms will receive postoperative treatment for 4 months (8 cycles) to complete their therapeutic schedule. The primary endpoint of the study is the histological Tumor Regression Grade (TRG) as defined by Ryan. The secondary endpoints are: treatment strategy safety (toxicity, primary tumor related complications under chemotherapy, peri-operative morbidity), disease-free and recurrence free survivals at 3 years, quality of life, carcinologic quality and

The Impact of Learning on Women's Labour Market Transitions

ERIC Educational Resources Information Center

Haasler, Simone R.

2014-01-01

Women play an increasingly important role in the labour market and as wage earners. Moreover, in many countries, young women have outperformed men in terms of educational attainment and qualification. Still, women's human capital investment does not pay off as it does for men as they are still significantly disadvantaged on the labour market.…

Labour market income inequality and mortality in North American metropolitan areas.

PubMed

Sanmartin, C; Ross, N A; Tremblay, S; Wolfson, M; Dunn, J R; Lynch, J

2003-10-01

To investigate relations between labour market income inequality and mortality in North American metropolitan areas. An ecological cross sectional study of relations between income inequality and working age (25-64 years) mortality in 53 Canadian (1991) and 282 US (1990) metropolitan areas using four measures of income inequality. Two labour market income concepts were used: labour market income for households with non-trivial attachment to the labour market and labour market income for all households, including those with zero and negative incomes. Relations were assessed with weighted and unweighted bivariate and multiple regression analyses. US metropolitan areas were more unequal than their Canadian counterparts, across inequality measures and income concepts. The association between labour market income inequality and working age mortality was robust in the US to both the inequality measure and income concept, but the association was inconsistent in Canada. Three of four inequality measures were significantly related to mortality in Canada when households with zero and negative incomes were included. In North American models, increases in earnings inequality were associated with hypothetical increases in working age mortality rates of between 23 and 33 deaths per 100 000, even after adjustment for median metropolitan incomes. This analysis of labour market inequality provides more evidence regarding the robust nature of the relation between income inequality and mortality in the US. It also provides a more refined understanding of the nature of the relation in Canada, pointing to the role of unemployment in generating Canadian metropolitan level health inequalities.

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.

Emotional Labour of Caregivers Confronted With Aggressive Brain-injured Patients.

PubMed

Huet, Magali; Dany, Lionel; Apostolidis, Thémistoklis

2018-06-01

Aggressive behaviours are common with people who have suffered brain injuries and induce difficult emotions among certified nursing assistants and medical-psychological assistants who take care of them. These caregivers carry out emotional labour whose content and strategies are little known. The study explores the emotional labour of certified nursing assistants and medical-psychological assistants faced with the aggressive behaviours of brain-injured patients. Semi-structured interviews were conducted with 37 caregivers. Interviews were analysed via a thematic content analysis. The analysis shows that the emotional labour of caregivers varies in accordance with the state of "consciousness" or "non-consciousness" that they attribute to the brain-injured patient with regard to this aggressive behaviour. This is a deep acting strategy. Moreover, caregivers shut off their emotions in order not to transmit them to the patient. This surface acting has the first objective for the caregiver of maintaining control of the situation and a second objective of protecting the patient emotionally and therefore of being perceived as a "good" caregiver. Emotional labour also meets a need to preserve the professional self-image and professional status negatively affected in the interaction with the aggressive brain-injured patient. Our study specifies the different strategies of the emotional labour of caregivers and their circumstances of use when they are confronted with aggressive behaviour by brain-injured patients. Targeted support for this emotional labour, such as training and practical analysis, is essential for the development of care practices promoting a caring relationship. Copyright © 2017 Elsevier Inc. All rights reserved.

Labour induction with gestational hypertension: A great obstetric challenge.

PubMed

Khaskheli, Meharun-Nissa; Baloch, Shahla; Sheeba, Aneela; Baloch, Sarmad; Khan, Fahad

2017-01-01

To observe the fetomaternal morbidity and mortality with induction of labour in pregnant women with gestational hypertension. The subjected study population included was 138 pregnant women with gestational hypertension. These pregnant women were between 34-40 weeks of gestational period in whom labour was induced, while the pregnant women who had labour induction for other reasons were excluded. These women were registered on the predesigned proforma. The data was collected and analyzed on SPSS version 21. Out of the 138 cases, mean age of the women was 25.93±5.037, prim gravid women were 78(56.5%), gestational period in majority of these women 71(51.4%) varied between 35-38 weeks. The common presenting symptoms were oedema 119(86.23%), headache 90(65.21%). Labour induction in majority of the cases 81(58.7%) was carried with prosten pessary. The Caesarean section was needed in 39(28.3%) women in emergency due to maternal and fetal reasons or due to failed induction. Maternal complications were uncontrolled hypertension 23(16.7%), intensive care unit admission 21(15.2%), fits 15(10.9%), post partum haemorrhage 13(9.4%). Fetal complications were birth asphyxia 49(35.5%), neonatal intensive care unit admission 17(12.3%), neonatal death 14(10.1%). The emergency Caesarean section rate was quite high with induction of labour in pregnant women with gestational diabetes. The maternal morbidity as well as fetal morbidity and mortality rate was also high.

Incoherence in the South African Labour Market for Intermediate Skills

ERIC Educational Resources Information Center

Kraak, Andre

2008-01-01

This article is concerned with the production and employment of technically skilled labour at the intermediate level in South Africa. Three differing labour market pathways to intermediate skilling are identified. These are: the traditional apprenticeship route, the new "Learnerships" pathway (similar to the "modern…

Reductions in labour capacity from heat stress under climate warming

NASA Astrophysics Data System (ADS)

Dunne, John P.; Stouffer, Ronald J.; John, Jasmin G.

2013-06-01

A fundamental aspect of greenhouse-gas-induced warming is a global-scale increase in absolute humidity. Under continued warming, this response has been shown to pose increasingly severe limitations on human activity in tropical and mid-latitudes during peak months of heat stress. One heat-stress metric with broad occupational health applications is wet-bulb globe temperature. We combine wet-bulb globe temperatures from global climate historical reanalysis and Earth System Model (ESM2M) projections with industrial and military guidelines for an acclimated individual's occupational capacity to safely perform sustained labour under environmental heat stress (labour capacity)--here defined as a global population-weighted metric temporally fixed at the 2010 distribution. We estimate that environmental heat stress has reduced labour capacity to 90% in peak months over the past few decades. ESM2M projects labour capacity reduction to 80% in peak months by 2050. Under the highest scenario considered (Representative Concentration Pathway 8.5), ESM2M projects labour capacity reduction to less than 40% by 2200 in peak months, with most tropical and mid-latitudes experiencing extreme climatological heat stress. Uncertainties and caveats associated with these projections include climate sensitivity, climate warming patterns, CO2 emissions, future population distributions, and technological and societal change.

The Right to Education for Children in Domestic Labour: Empirical Evidence from Kenya

NASA Astrophysics Data System (ADS)

Munene, Ishmael I.; Ruto, Sara J.

2010-02-01

Since 1948, various UN conventions have recognised basic education as a human right. Yet this right continues to be denied to many child labourers across the world. This articles draws on the results of a study examining how children in domestic labour in Kenya access and participate in education. Three issues were explored: (1) the correlates of child domestic labourers; (2) their working conditions and contexts; and (3) the right to education. Interviews and group discussions held in one city and two rural districts elicited data from 91 child domestic labourers and 84 adults. The results indicated that child labour was both poverty-induced and adult-initiated, and that children worked in hazardous environments characterised by economic exploitation. Most did not attend school; those who did had to contend with a rigid school structure and an authoritarian class environment. Children in domestic labour often skipped school, and their participation in classes was low.

Sequence analysis to assess labour market participation following vocational rehabilitation: an observational study among patients sick-listed with low back pain from a randomised clinical trial in Denmark

PubMed Central

Lindholdt, Louise; Labriola, Merete; Nielsen, Claus Vinther; Horsbøl, Trine Allerslev; Lund, Thomas

2017-01-01

Introduction The return-to-work (RTW) process after long-term sickness absence is often complex and long and implies multiple shifts between different labour market states for the absentee. Standard methods for examining RTW research typically rely on the analysis of one outcome measure at a time, which will not capture the many possible states and transitions the absentee can go through. The purpose of this study was to explore the potential added value of sequence analysis in supplement to standard regression analysis of a multidisciplinary RTW intervention among patients with low back pain (LBP). Methods The study population consisted of 160 patients randomly allocated to either a hospital-based brief or a multidisciplinary intervention. Data on labour market participation following intervention were obtained from a national register and analysed in two ways: as a binary outcome expressed as active or passive relief at a 1-year follow-up and as four different categories for labour market participation. Logistic regression and sequence analysis were performed. Results The logistic regression analysis showed no difference in labour market participation for patients in the two groups after 1 year. Applying sequence analysis showed differences in subsequent labour market participation after 2 years after baseline in favour of the brief intervention group versus the multidisciplinary intervention group. Conclusion The study indicated that sequence analysis could provide added analytical value as a supplement to traditional regression analysis in prospective studies of RTW among patients with LBP. PMID:28729315

From Labour Market to Labour Process: Finding a Basis for Curriculum in TVET

ERIC Educational Resources Information Center

Gamble, Jeanne

2016-01-01

In the sociology of education the relation between education and work is analysed in many ways and, since the rise of neoliberalism, increasingly in market terms. Skills are the dominant labour market currency, described in terms of competence profiles that seek to link educational qualifications directly to work. Contrary to the widespread appeal…

Maintaining power: women's experiences from labour onset before admittance to maternity ward.

PubMed

Carlsson, Ing-Marie; Ziegert, Kristina; Sahlberg-Blom, Eva; Nissen, Eva

2012-02-01

In Sweden pregnant women are encouraged to remain at home until the active phase of labour. Recommendation is based on evidence, that women who seek care and are admitted in the latent phase of labour are subjected to more obstetric interventions and suffer more complications than women who remain at home until the active phase of labour. The aim of this study was to obtain a deeper understanding of how women, who remain at home until the active phase of labour, experience the period from labour onset until admission to labour ward. Interviews were conducted with 19 women after they had given birth to their first child. A Constructivist Grounded theory method was used. 'Maintaining power' was identified as the core category, explaining the women's experience of having enough power, when the labour started. Four related categories: 'to share the experience with another', 'to listen to the rhythm of the body', 'to distract oneself' and 'to be encased in a glass vessel', explained how the women coped and thereby maintained power. The first time mothers in this study, who managed to stay at home during the latent phase of labour, had a sense of power that was expressed as a driving force towards the birth, a bodily and mental strength and the right to decide over their own bodies. This implies that women who maintain power have the ability to make choices during the birth process. The professionals need to be sensitive, supportive and respectful to women's own preferences in the health-care encounter, to promote the existing power throughout the birthing process. Copyright © 2010 Elsevier Ltd. All rights reserved.

Pushing/bearing down methods for the second stage of labour.

PubMed

Lemos, Andrea; Amorim, Melania Mr; Dornelas de Andrade, Armele; de Souza, Ariani I; Cabral Filho, José Eulálio; Correia, Jailson B

2017-03-26

Maternal pushing during the second stage of labour is an important and indispensable contributor to the involuntary expulsive force developed by uterine contraction. There is no consensus on an ideal strategy to facilitate these expulsive efforts and there are contradictory results about the influence on the mother and fetus. To evaluate the benefits and possible disadvantages of different kinds of techniques regarding maternal pushing/breathing during the expulsive stage of labour on maternal and fetal outcomes. We searched Cochrane Pregnancy and Childbirth's Trials Register (19 September 2016) and reference lists of retrieved studies. Randomised controlled trials (RCTs) and quasi-RCTs assessing the effects of pushing/bearing down techniques (type and/or timing) performed during the second stage of labour on maternal and neonatal outcomes. Cluster-RCTs were eligible for inclusion, but none were identified. Studies using a cross-over design and those published in abstract form only were not eligible for inclusion in this review. Two review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. Data were checked for accuracy. In this updated review, we included 21 studies in total, eight (884 women) comparing spontaneous pushing versus directed pushing, with or without epidural analgesia and 13 (2879 women) comparing delayed pushing versus immediate pushing with epidural analgesia. Our GRADE assessments of evidence ranged from moderate to very low quality; the main reasons for downgrading were study design limitations and imprecision of effect estimates. Overall, the included studies varied in their risk of bias; most were judged to be at unclear risk of bias. Comparison 1: types of pushing: spontaneous pushing versus directed pushingThere was no clear difference in the duration of the second stage of labour (mean difference (MD) 10.26 minutes; 95% confidence interval (CI) -1.12 to 21.64 minutes, six studies, 667 women, random

Phase II Trials for Heterogeneous Patient Populations with a Time-to-Event Endpoint.

PubMed

Jung, Sin-Ho

2017-07-01

In this paper, we consider a single-arm phase II trial with a time-to-event end-point. We assume that the study population has multiple subpopulations with different prognosis, but the study treatment is expected to be similarly efficacious across the subpopulations. We review a stratified one-sample log-rank test and present its sample size calculation method under some practical design settings. Our sample size method requires specification of the prevalence of subpopulations. We observe that the power of the resulting sample size is not very sensitive to misspecification of the prevalence.

An accelerated dose escalation with a grass pollen allergoid is safe and well-tolerated: a randomized open label phase II trial.

PubMed

Chaker, A M; Al-Kadah, B; Luther, U; Neumann, U; Wagenmann, M

2015-01-01

The number of injections in the dose escalation of subcutaneous immunotherapy (SCIT) is small for some currently used hypoallergenic allergoids, but can still be inconvenient to patients and can impair compliance. The aim of this trial was to compare safety and tolerability of an accelerated to the conventional dose escalation scheme of a grass pollen allergoid. In an open label phase II trial, 122 patients were 1:1 randomized for SCIT using a grass pollen allergoid with an accelerated dose escalation comprising only 4 weekly injections (Group I) or a conventional dose escalation including 7 weekly injections (Group II). Safety determination included the occurrence of local and systemic adverse events. Tolerability was assessed by patients and physicians. Treatment-related adverse events were observed in 22 (36.1 %) patients in Group I and 15 (24.6 %) in Group II. Local reactions were reported by 18 patients in Group I and 11 in Group II. Five Grade 1 systemic reactions (WAO classification) were observed in Group I and 2 in Group II. Grade 2 reactions occurred 3 times in Group I and 2 times in Group II. Tolerability was rated as "good" or "very good" by 53 (86.9 %) patients in Group I and 59 (100 %) in Group II by investigators. Forty-eight patients in Group I (80.0 %) and 54 in Group II (91.5 %) rated tolerability as "good" or "very good". The dose escalation of a grass pollen allergoid can be accelerated with safety and tolerability profiles comparable to the conventional dose escalation.

Outcomes of elective induction of labour compared with expectant management: population based study

PubMed Central

Ferguson, Evelyn; Duffy, Andrew; Ford, Ian; Chalmers, James; Norman, Jane E

2012-01-01

Objective To determine neonatal outcomes (perinatal mortality and special care unit admission) and maternal outcomes (mode of delivery, delivery complications) of elective induction of labour compared with expectant management. Design Retrospective cohort study using an unselected population database. Setting Consultant and midwife led obstetric units in Scotland 1981-2007. Participants 1 271 549 women with singleton pregnancies of 37 weeks or more gestation. Interventions Outcomes of elective induction of labour (induction of labour with no recognised medical indication) at 37, 38, 39, 40, and 41 weeks’ gestation compared with those of expectant management (continuation of pregnancy to either spontaneous labour, induction of labour or caesarean section at a later gestation). Main outcome measures Extended perinatal mortality, mode of delivery, postpartum haemorrhage, obstetric anal sphincter injury, and admission to a neonatal or special care baby unit. Outcomes were adjusted for age at delivery, parity, year of birth, birth weight, deprivation category, and, where appropriate, mode of delivery. Results At each gestation between 37 and 41 completed weeks, elective induction of labour was associated with a decreased odds of perinatal mortality compared with expectant management (at 40 weeks’ gestation 0.08% (37/44 764) in the induction of labour group versus 0.18% (627/350 643) in the expectant management group; adjusted odds ratio 0.39, 99% confidence interval 0.24 to 0.63), without a reduction in the odds of spontaneous vertex delivery (at 40 weeks’ gestation 79.9% (35 775/44 778) in the induction of labour group versus 73.7% (258 665/350 791) in the expectant management group; adjusted odds ratio 1.26, 1.22 to 1.31). Admission to a neonatal unit was, however, increased in association with elective induction of labour at all gestations before 41 weeks (at 40 weeks’ gestation 8.0% (3605/44 778) in the induction of labour group compared

Labour analgesia with intrathecal fentanyl decreases maternal stress.

PubMed

Cascio, M; Pygon, B; Bernett, C; Ramanathan, S

1997-06-01

Lumbar epidural analgesia (LEA) decreases maternal stress as measured by maternal circulating plasma catecholamine concentrations. Intrathecal fentanyl (ITF) provides effective labour analgesia but its effect on maternal epinephrine (Epi) and norepinephrine (NE) concentrations is not known. This study assesses whether ITF reduces maternal stress in the same manner as conventional LEA. Twenty-four healthy women in active labour received either 25 micrograms ITF (n = 12) or epidural lidocaine 1.5% (n = 12) for analgesia. Venous blood samples were collected before anaesthesia and at five minute intervals for 30 min following anaesthesia for the measurement of plasma Epi and NE by high performance liquid chromatography. Maternal blood pressure (BP), heart rate (HR), visual analog scores (VAS) to pain and pruritus were recorded at the same time. Both ITF and LEA decreased pain VAS scores, maternal BP, and plasma Epi concentrations with only minimal effects on plasma NE concentrations. Intrathecal fentanyl (ITF) and LEA reduced plasma epi to a similar extent, with ITF reducing the levels slightly faster than LEA. Intrathecal fentanyl(ITF) and LEA reduced plasma Epi concentrations by 52% and 51%, respectively (P value < 0.01). We conclude that ITF is as effective as LEA in producing pain relief in the labouring patient. Intrathecal Fentanyl (ITF) is also capable of reducing maternal plasma epinephrine concentration, thus avoiding the possibly deleterious side effects of excess amounts of this catecholamine during labour.

MRC ORACLE Children Study. Long term outcomes following prescription of antibiotics to pregnant women with either spontaneous preterm labour or preterm rupture of the membranes.

PubMed

Kenyon, Sara; Brocklehurst, Peter; Jones, David; Marlow, Neil; Salt, Alison; Taylor, David

2008-04-24

The Medical Research Council (MRC) ORACLE trial evaluated the use of co-amoxiclav 375 mg and/or erythromycin 250 mg in women presenting with preterm rupture of membranes (PROM) ORACLE I or in spontaneous preterm labour (SPL) ORACLE II using a factorial design. The results showed that for women with a singleton baby with PROM the prescription of erythromycin is associated with improvements in short term neonatal outcomes, although co-amoxiclav is associated with prolongation of pregnancy, a significantly higher rate of neonatal necrotising enterocolitis was found in these babies. Prescription of erythromycin is now established practice for women with PROM. For women with SPL antibiotics demonstrated no improvements in short term neonatal outcomes and are not recommended treatment. There is evidence that both these conditions are associated with subclinical infection so perinatal antibiotic administration may reduce the risk of later disabilities, including cerebral palsy, although the risk may be increased through exposure to inflammatory cytokines, so assessment of longer term functional and educational outcomes is appropriate. The MRC ORACLE Children's Study will follow up UK children at age 7 years born to 4809 women with PROM and the 4266 women with SPL enrolled in the earlier ORACLE trials. We will use a parental questionnaire including validated tools to assess disability and behaviour. We will collect the frequency of specific medical conditions: cerebral palsy, epilepsy, respiratory illness including asthma, diabetes, admission to hospital in last year and other diseases, as reported by parents. National standard test results will be collected to assess educational attainment at Key Stage 1 for children in England. This study is designed to investigate whether or not peripartum antibiotics improve health and disability for children at 7 years of age. The ORACLE Trial and Children Study is registered in the Current Controlled Trials registry. ISCRTN 52995660.

Phase II trial suggests new drug can shrink tumors in advanced ovarian cancer | Center for Cancer Research

Cancer.gov

In an ongoing phase II trial led by Jung-Min Lee, M.D., an Investigator in CCR’s Women’s Malignancies Branch, using the drug prexasertib led to decreases in tumor size in patients with advanced ovarian cancer, known as high-grade serious ovarian carcinoma, who currently have limited treatment options. Read more…

Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial.

PubMed

Lee, Michael; Généreux, Philippe; Shlofmitz, Richard; Phillipson, Daniel; Anose, Bynthia M; Martinsen, Brad J; Himmelstein, Stevan I; Chambers, Jeff W

2017-06-01

The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.). ORBIT II was a single-arm trial that enrolled 443 patients at 49U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of <50% without the occurrence of in-hospital MACE.The present analysis reports the final, 3-year follow-up results from ORBIT II. The majority of subjects (88.2%) underwent PCI with drug-eluting stents after orbital atherectomy. There were 360 (81.3%) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%). The 3-year target lesion revascularization rate was 7.8%. In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions. The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely

Labour migration and the single European market: a synthetic and prospective note.

PubMed

Ardittis, S

1990-12-01

"The present paper is an attempt to analyse and forecast the following major issues relating to migration in Europe after 1992: (i) the evolution and structure of intra-European flows in the forthcoming single European market; (ii) the integration, after 1992, of established immigrant communities, including ethnic minorities and second generation groups; (iii) future immigration from non-EC member states.... The article explains that, in addition to policy-related mutations inherent in the completion of the internal market, other factors (demographic changes and insufficient enrolment of national graduate students in key disciplines) and issues (emergence of atypical groups such as second generation and Eastern European migrants), are due to generate new patterns and modified interests in European labour migration after 1992." excerpt

A phase I/II clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced cervical cancer.

PubMed

Murakami, Naoya; Kato, Shingo; Nakano, Takashi; Uno, Takashi; Yamanaka, Takeharu; Sakurai, Hideyuki; Yoshimura, Ryoichi; Hiratsuka, Junichi; Kuroda, Yuki; Yoshio, Kotaro; Itami, Jun

2016-08-17

This paper describes about a study protocol of phase I/II multicenter prospective clinical trial evaluating the feasibility and efficacy of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced uterine cervical cancer patients. Patients with histologically confirmed FIGO stage IB2, IIA2, IIB, and IIIB uterine cervical carcinoma width of which is larger than 5 cm assessed by MRI will be entered to this clinical trial. Protocol therapy is 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP (40 mg/m(2)), followed by 24 Gy in 4 fractions of HBT and central shield EBRT up to 50-50.4 Gy in 25-28 fractions. Tumor width is assessed again within one week before the first HBT and if the tumor width is larger than 4 cm, patients proceed to the secondary registration. In phase I section, feasibility of this will be investigated. If less than 10 % out of 20 patients experienced greater than grade 3 acute non-hematologic adverse effects, the study proceeds to phase II part. In phase II part a total of 55 patients will be accrued and the efficacy of the HBT will be investigated comparing with historical control data. If the lower margin of 90 % confidence interval of the 2-year pelvic progression-free survival of the HBT trial is higher than 64 %, the HBT is considered to be more effective than conventional ICBT. The aim of this study is to demonstrate the feasibility and efficacy of the HBT for locally advanced cervical cancer. This trial will clarify the indication, feasibility, and efficacy of this new technique. UMIN000019081 ; Registration date: 2015/9/30.

Performing Labour in Look Left Look Right's "Above and Beyond"

ERIC Educational Resources Information Center

Alston, Adam

2015-01-01

This article looks at the theme of "performing labour" in Look Left Look Right's "Above and Beyond" (2013). In this performance, individual audience members participate as a generic staff member in a fully functioning five star hotel in London. I consider three modes of performing labour in "Above and Beyond":…

BOP2: Bayesian optimal design for phase II clinical trials with simple and complex endpoints.

PubMed

Zhou, Heng; Lee, J Jack; Yuan, Ying

2017-09-20

We propose a flexible Bayesian optimal phase II (BOP2) design that is capable of handling simple (e.g., binary) and complicated (e.g., ordinal, nested, and co-primary) endpoints under a unified framework. We use a Dirichlet-multinomial model to accommodate different types of endpoints. At each interim, the go/no-go decision is made by evaluating a set of posterior probabilities of the events of interest, which is optimized to maximize power or minimize the number of patients under the null hypothesis. Unlike other existing Bayesian designs, the BOP2 design explicitly controls the type I error rate, thereby bridging the gap between Bayesian designs and frequentist designs. In addition, the stopping boundary of the BOP2 design can be enumerated prior to the onset of the trial. These features make the BOP2 design accessible to a wide range of users and regulatory agencies and particularly easy to implement in practice. Simulation studies show that the BOP2 design has favorable operating characteristics with higher power and lower risk of incorrectly terminating the trial than some existing Bayesian phase II designs. The software to implement the BOP2 design is freely available at www.trialdesign.org. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Phase II trial of CoQ10 for ALS finds insufficient evidence to justify Phase III

PubMed Central

Kaufmann, Petra; Thompson, John L.P.; Levy, Gilberto; Buchsbaum, Richard; Shefner, Jeremy; Krivickas, Lisa S.; Katz, Jonathan; Rollins, Yvonne; Barohn, Richard J.; Jackson, Carlayne E.; Tiryaki, Ezgi; Lomen-Hoerth, Catherine; Armon, Carmel; Tandan, Rup; Rudnicki, Stacy A.; Rezania, Kourosh; Sufit, Robert; Pestronk, Alan; Novella, Steven P.; Heiman-Patterson, Terry; Kasarskis, Edward J.; Pioro, Erik P.; Montes, Jacqueline; Arbing, Rachel; Vecchio, Darleen; Barsdorf, Alexandra; Mitsumoto, Hiroshi; Levin, Bruce

2010-01-01

Objective Amyotrophic lateral sclerosis (ALS) is a devastating, and currently incurable, neuromuscular disease in which oxidative stress and mitochondrial impairment are contributing to neuronal loss. Coenzyme Q10 (CoQ10), an antioxidant and mitochondrial cofactor, has shown promise in ALS transgenic mice, and in clinical trials for neurodegenerative diseases other than ALS. Our aims were to choose between two high doses of CoQ10 for ALS, and to determine if it merits testing in a Phase III clinical trial. Methods We designed and implemented a multi-center trial with an adaptive, two-stage, bias-adjusted, randomized, placebo-controlled, double-blind, Phase II design (n=185). The primary outcome in both stages was decline in the ALS Functional Rating Scale-revised (ALSFRSr) score over 9 months. Stage 1 (dose selection, 35 participants per group) compared CoQ10 doses of 1,800 and 2,700 mg/day. Stage 2 (futility test, 75 patients per group) compared the dose selected in Stage 1 against placebo. Results Stage 1 selected the 2,700 mg dose. In Stage 2, the pre-specified primary null hypothesis that this dose is superior to placebo was not rejected. It was rejected, however, in an accompanying pre-specified sensitivity test, and further supplementary analyses. Pre-specified secondary analyses showed no significant differences between CoQ10 at 2,700 mg/day and placebo. There were no safety concerns. Interpretation CoQ10 at 2,700 mg daily for 9 months shows insufficient promise to warrant Phase III testing. Given this outcome, the adaptive Phase II design incorporating a dose selection and a futility test avoided the need for a much larger conventional Phase III trial. PMID:19743457

The influence of labour on the pharmacokinetics of intravenously administered amoxicillin in pregnant women

PubMed Central

Muller, Anouk E; Dörr, P Joep; Mouton, Johan W; De Jongh, Joost; Oostvogel, Paul M; Steegers, Eric A P; Voskuyl, Rob A; Danhof, Meindert

2008-01-01

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECTExamples exist that pharmacokinetics of drugs in pregnant women can differ from that in non-pregnant individuals.In pregnant women before the onset of labour, the pharmacokinetics of amoxicillin is similar to that in non-pregnant individuals, but for women during labour this is unknown. WHAT THIS STUDY ADDSLabour influences the pharmacokinetics of amoxicillin.During labour and even more in the immediate postpartum period, the peripheral volume of distribution was decreased compared with pregnant women before the onset of labour.The volume of distribution increases with an increasing amount of oedema. AIMS Many physiological changes take place during pregnancy and labour. These might change the pharmacokinetics of amoxicillin, necessitating adjustment of the dose for prevention of neonatal infections. We investigated the influence of labour on the pharmacokinetics of amoxicillin. METHODS Pregnant women before and during labour were recruited and treated with amoxicillin intravenously. A postpartum dose was offered. Blood samples were obtained and amoxicillin concentrations were determined using high-pressure liquid chromatography. The pharmacokinetics were characterized by nonlinear mixed-effects modelling using NONMEM. RESULTS The pharmacokinetics of amoxicillin in 34 patients was best described by a three-compartment model. Moderate interindividual variability was identified in CL, central and peripheral volumes of distribution. The volume of distribution (V) increased with an increasing amount of oedema. Labour influenced the parameter estimate of peripheral volume of distribution (V2). V2 was decreased during labour, and even more in the immediate postpartum period. For all patients the population estimates (mean ± SE) for CL and V were 21.1 ± 4.1 l h−1 (CL), 8.7 ± 6.6 l (V1), 11.8 ± 7.7 l (V2) and 20.5 ± 15.4 l (V3) respectively. CONCLUSIONS The peripheral distribution volume of amoxicillin in pregnant women during

Computing Careers and Irish Higher Education: A Labour Market Anomaly

ERIC Educational Resources Information Center

Stephens, Simon; O'Donnell, David; McCusker, Paul

2007-01-01

This paper explores the impact of developments in the Irish economy and labour market on computing course development in the higher education (HE) sector. Extant computing courses change, or new courses are introduced, in attempts to match labour market demands. The conclusion reached here, however, is that Irish HE is producing insufficient…

Stress, pre-term labour and birth outcomes.

PubMed

MacKey, M C; Williams, C A; Tiller, C M

2000-09-01

Stress, pre-term labour and birth outcomes Preliminary studies have suggested that stress may be associated with the onset, treatment and outcomes of pre-term labour; however, a systematic comparison of the stress of women with and without pre-term labour has not been reported. Therefore, the purpose of this exploratory study was to compare the stress (daily hassles and mood states) and birth outcomes of black and white women who experienced pre-term labour (PTL) during pregnancy with those who did not. The convenience sample consisted of 35 pregnant women hospitalized in 1996-1997 for the treatment of PTL (24-35 weeks gestation) and 35 controls matched on age, race, parity, gestational age and method of hospital payment. Women in the PTL group had significantly higher tension-anxiety and depression-dejection on the Profile of Mood States (POMS), lower mean birthweight and mean gestational age, and a higher percentage of babies born <37 weeks and weighing 2500 g or less. Black women in the PTL group and white women in the control group had significantly higher scores on the fatigue sub-scale of the POMS and the work and future security sub-scales of the Daily Hassles Scale. Women in the PTL group whose babies weighed 2500 g or less had significantly higher scores on the health, inner concern and financial responsibility sub-scales of the Daily Hassles Scale. The findings from this study indicate the need for further exploration of the interaction of race and stress in understanding and preventing PTL and low birthweight and the need to examine the role of social support in preventing pre-term birth after an episode of PTL.

South Carolina Shipyards: Labour, Logistics, Lumber and Ladies

NASA Astrophysics Data System (ADS)

Harris, Lynn

2010-10-01

Southern shipyards, like Hobcaw and Mars Bluff, were established at locations chosen primarily for convenient access to transportation networks, building materials, clientele and labour. The historical record reveals a home front role played by local plantation owners and slaves as shipyard labour. Women served as project fundraisers, shipyard dilettantes, shipwright’s wives and possibly slave mistresses with a paucity of material culture to confirm their presence in the archaeological record. Archaeological investigations on land and underwater yield evidence of artefacts associated with diet, shipbuilding, warfare and ethnicity.

Emotional Labour in University Lecturers: Considerations for Higher Education Institutions

ERIC Educational Resources Information Center

Berry, Karen; Cassidy, Simon

2013-01-01

Emotional labour is a state that exists when there is a discrepancy between the emotional demeanour that an individual displays and the genuinely felt emotions that would be inappropriate to display (Mann 1999b).The study examined levels of emotional labour in university lecturers and compared these data to other occupations. Employing a mixed…

Human Capital Linkages to Labour Productivity: Implications from Thai Manufacturers

ERIC Educational Resources Information Center

Rukumnuaykit, Pungpond; Pholphirul, Piriya

2016-01-01

Human capital investment is a necessary condition for improving labour market outcomes in most countries. Empirical studies to investigate human capital and its linkages on the labour demand side are, however, relatively scarce due to limitations of firm-level data-sets. Using firm-level data from the Thai manufacturing sector, this paper aims to…

Janus kinase inhibitors for the treatment of inflammatory bowel diseases: developments from phase I and phase II clinical trials.

PubMed

D'Amico, Ferdinando; Fiorino, Gionata; Furfaro, Federica; Allocca, Mariangela; Danese, Silvio

2018-06-23

A new pharmacological class, janus kinases (JAK) inhibitors, has been shown to be effective and safe for the treatment of inflammatory bowel diseases (IBD). The aim of this review is to provide an overview of the JAK inhibitors currently under investigation in phase I and II clinical trials for patients with Crohn's disease (CD) and ulcerative colitis (UC), and the possible future perspectives for the treatment of IBD patients with this class of drugs. Areas covered: This review describes the JAK-STAT pathway and analyzes the efficacy and safety of new small molecules such as filgotinib, upadacitinib, TD-1473, peficitinib and Pf-06651600/Pf-06700841, showing data from phase I and II trials. Expert Opinion: JAK inhibitors, if approved by the regulatory authorities, could represent a novel and intriguing drug class. In the next years the approach to patients with IBD will become increasingly personalized.

Epidural therapy for the treatment of severe pre-eclampsia in non labouring women.

PubMed

Ray, Amita; Ray, Sujoy

2017-11-28

Pre-eclampsia is a pregnancy-specific multi-organ disorder, which is characterised by hypertension and multisystem organ involvement and which has significant maternal and fetal morbidity and mortality. Failure of the placental vascular remodelling and reduced uteroplacental flow form the etiopathological basis of pre-eclampsia. There are several established therapies for pre-eclampsia including antihypertensives and anticonvulsants. Most of these therapies aim at controlling the blood pressure or preventing complications of elevated blood pressure, or both. Epidural therapy aims at blocking the vasomotor tone of the arteries, thereby increasing uteroplacental blood flow. This review was aimed at evaluating the available evidence about the possible benefits and risks of epidural therapy in the management of severe pre-eclampsia, to define the current evidence level of this therapy, and to determine what (if any) further evidence is required. To assess the effectiveness, safety and cost of the extended use of epidural therapy for treating severe pre-eclampsia in non-labouring women. This review aims to compare the use of extended epidural therapy with other methods, which include intravenous magnesium sulphate, anticonvulsants other than magnesium sulphate, with or without use of the antihypertensive drugs and adjuncts in the treatment of severe pre-eclampsia.This review only considered the use of epidural anaesthesia in the management of severe pre-eclampsia in the antepartum period and not as pain relief in labour. We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (13 July 2017) and reference lists of retrieved studies. Randomised controlled trials (RCTs) or quasi-RCTs comparing epidural therapy versus traditional therapy for pre-eclampsia in the form of antihypertensives, anticonvulsants, magnesium sulphate, low-dose dopamine, corticosteroids or a combination of

Availability of Skilled Labour in Selected Occupations in Western Australia

ERIC Educational Resources Information Center

Shah, Chandra; Cooney, Richard; Long, Michael; Burke, Gerald

2005-01-01

This report investigates the future supply of and demand for certain types of skilled labour at the trades and sub-trades levels that will be required for these projects up to 2010. In particular, it focuses on skilled labour in the mechanical, fabrication and electrical trades and mobile plant operators and construction workers in the sub-trades.…

Dentist education and labour market in Mexico: elements for policy definition

PubMed Central

2012-01-01

Background Here, the educational and labour market characteristics of Mexican dentists are revised. Dentistry is a health profession that has been scarcely studied in developing countries. This analysis attempts to understand the relationships and gaps between the supply and demand of dentists in the country. Around 5000 new dentists graduate every year looking for a place in the labour market. Methods A cross-sectional study with exploratory, descriptive and correlational scope was carried out between 2006 and 2008. Analyses of quantitative data on dentists from national surveys and occupational statistics were complemented with qualitative information provided by 43 key informants in five Mexican states. Results The 2008 dentist labour market can be characterized as follows: 75% worked in the private sector, most of them independently; more than two-thirds were women; the proportion of specialists was low (slightly more than 10%); unemployment was more than 20% and labour wastage was nearly 40%, with most wastage corresponding with female dentists. The increase in the number of dentists entering the labour market during the last two decades is more related to the educational market than to the population’s health needs and the number of dentists actually required to meet them. Conclusions The problems identified in the Mexican dentist labour market necessitate urgent intervention on behalf of regulatory bodies in order to balance the tendencies of supply and demand in the number of trained professionals as well as in their incorporation into different market areas. Adequate policies are required to increase the likelihood of achieving this objective. PMID:22974344

Dentist education and labour market in Mexico: elements for policy definition.

PubMed

González-Robledo, Luz María; González-Robledo, María Cecilia; Nigenda, Gustavo

2012-09-13

Here, the educational and labour market characteristics of Mexican dentists are revised. Dentistry is a health profession that has been scarcely studied in developing countries. This analysis attempts to understand the relationships and gaps between the supply and demand of dentists in the country. Around 5000 new dentists graduate every year looking for a place in the labour market. A cross-sectional study with exploratory, descriptive and correlational scope was carried out between 2006 and 2008. Analyses of quantitative data on dentists from national surveys and occupational statistics were complemented with qualitative information provided by 43 key informants in five Mexican states. The 2008 dentist labour market can be characterized as follows: 75% worked in the private sector, most of them independently; more than two-thirds were women; the proportion of specialists was low (slightly more than 10%); unemployment was more than 20% and labour wastage was nearly 40%, with most wastage corresponding with female dentists. The increase in the number of dentists entering the labour market during the last two decades is more related to the educational market than to the population's health needs and the number of dentists actually required to meet them. The problems identified in the Mexican dentist labour market necessitate urgent intervention on behalf of regulatory bodies in order to balance the tendencies of supply and demand in the number of trained professionals as well as in their incorporation into different market areas. Adequate policies are required to increase the likelihood of achieving this objective.

Sequence analysis to assess labour market participation following vocational rehabilitation: an observational study among patients sick-listed with low back pain from a randomised clinical trial in Denmark.

PubMed

Lindholdt, Louise; Labriola, Merete; Nielsen, Claus Vinther; Horsbøl, Trine Allerslev; Lund, Thomas

2017-07-20

The return-to-work (RTW) process after long-term sickness absence is often complex and long and implies multiple shifts between different labour market states for the absentee. Standard methods for examining RTW research typically rely on the analysis of one outcome measure at a time, which will not capture the many possible states and transitions the absentee can go through. The purpose of this study was to explore the potential added value of sequence analysis in supplement to standard regression analysis of a multidisciplinary RTW intervention among patients with low back pain (LBP). The study population consisted of 160 patients randomly allocated to either a hospital-based brief or a multidisciplinary intervention. Data on labour market participation following intervention were obtained from a national register and analysed in two ways: as a binary outcome expressed as active or passive relief at a 1-year follow-up and as four different categories for labour market participation. Logistic regression and sequence analysis were performed. The logistic regression analysis showed no difference in labour market participation for patients in the two groups after 1 year. Applying sequence analysis showed differences in subsequent labour market participation after 2 years after baseline in favour of the brief intervention group versus the multidisciplinary intervention group. The study indicated that sequence analysis could provide added analytical value as a supplement to traditional regression analysis in prospective studies of RTW among patients with LBP. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Primiparous women's preferences for care during a prolonged latent phase of labour.

PubMed

Ängeby, Karin; Wilde-Larsson, Bodil; Hildingsson, Ingegerd; Sandin-Bojö, Ann-Kristin

2015-10-01

To investigate primiparous women's preferences for care during a prolonged latent phase of labour. A qualitative study based on focus groups and individual interviews and analysed with inductive content analysis. Sixteen primiparous women with a prolonged latent phase of labour >18 hours were interviewed in five focus groups (n = 11) or individually (n = 5). One main category emerged "Beyond normality - a need of individual adapted guidance in order to understand and manage an extended latent phase of labour" which covers the women's preferences during the prolonged latent phase. Five categories were generated from the data: "A welcoming manner and not being rejected", "Individually adapted care", "Important information which prepares for reality and coping", "Participation and need for feedback" and "Staying nearby the labour ward or being admitted for midwifery support". Women with a prolonged latent phase of labour sought to use their own resources, but their needs for professional support increased as time passed. A welcoming attitude from an available midwife during the latent phase created a feeling of security, and personally adapted care was perceived positively. Women with a prolonged latent phase of labour preferred woman-centred care. Midwives play an important role in supporting these women. Women's need for midwifery-support increases as the time spent in latent phase increases. Copyright © 2015 Elsevier B.V. All rights reserved.

Hypothermia for Traumatic Brain Injury in Children-A Phase II Randomized Controlled Trial.

PubMed

Beca, John; McSharry, Brent; Erickson, Simon; Yung, Michael; Schibler, Andreas; Slater, Anthony; Wilkins, Barry; Singhal, Ash; Williams, Gary; Sherring, Claire; Butt, Warwick

2015-07-01

To perform a pilot study to assess the feasibility of performing a phase III trial of therapeutic hypothermia started early and continued for at least 72 hours in children with severe traumatic brain injury. Multicenter prospective randomized controlled phase II trial. All eight of the PICUs in Australia and New Zealand and one in Canada. Children 1-15 years old with severe traumatic brain injury and who could be randomized within 6 hours of injury. The control group had strict normothermia to a temperature of 36-37°C for 72 hours. The intervention group had therapeutic hypothermia to a temperature of 32-33°C for 72 hours followed by slow rewarming at a rate compatible with maintaining intracranial pressure and cerebral perfusion pressure. Of 764 children admitted to PICU with traumatic brain injury, 92 (12%) were eligible and 55 (7.2%) were recruited. There were five major protocol violations (9%): three related to recruitment and consent processes and two to incorrect temperature management. Rewarming took a median of 21.5 hours (16-35 hr) and was performed without compromise in the cerebral perfusion pressure. There was no increase in any complications, including infections, bleeding, and arrhythmias. There was no difference in outcomes 12 months after injury; in the therapeutic hypothermia group, four (17%) had a bad outcome (pediatric cerebral performance category, 4-6) and three (13%) died, whereas in the normothermia group, three (12%) had a bad outcome and one (4%) died. Early therapeutic hypothermia in children with severe traumatic brain injury does not improve outcome and should not be used outside a clinical trial. Recruitment rates were lower and outcomes were better than expected. Conventional randomized controlled trials in children with severe traumatic brain injury are unlikely to be feasible. A large international trials group and alternative approaches to trial design will be required to further inform practice.

A robust two-stage design identifying the optimal biological dose for phase I/II clinical trials.

PubMed

Zang, Yong; Lee, J Jack

2017-01-15

We propose a robust two-stage design to identify the optimal biological dose for phase I/II clinical trials evaluating both toxicity and efficacy outcomes. In the first stage of dose finding, we use the Bayesian model averaging continual reassessment method to monitor the toxicity outcomes and adopt an isotonic regression method based on the efficacy outcomes to guide dose escalation. When the first stage ends, we use the Dirichlet-multinomial distribution to jointly model the toxicity and efficacy outcomes and pick the candidate doses based on a three-dimensional volume ratio. The selected candidate doses are then seamlessly advanced to the second stage for dose validation. Both toxicity and efficacy outcomes are continuously monitored so that any overly toxic and/or less efficacious dose can be dropped from the study as the trial continues. When the phase I/II trial ends, we select the optimal biological dose as the dose obtaining the minimal value of the volume ratio within the candidate set. An advantage of the proposed design is that it does not impose a monotonically increasing assumption on the shape of the dose-efficacy curve. We conduct extensive simulation studies to examine the operating characteristics of the proposed design. The simulation results show that the proposed design has desirable operating characteristics across different shapes of the underlying true dose-toxicity and dose-efficacy curves. The software to implement the proposed design is available upon request. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Educational Aspirations, Child Labour Imperatives and Structural Inequality in the South African Agricultural Sector

ERIC Educational Resources Information Center

Duncan, Norman; Bowman, Brett

2008-01-01

Despite the widespread condemnation of the practice of child labour, it remains a pervasive phenomenon in developing countries. In such contexts, labour and education often represent competing activities for children. Drawing on a study of child labour located within the critical social science tradition, this article explores insider accounts of…

Landlordism, Rent Regulation and the Labour Party in mid-twentieth century Britain, 1950-64.

PubMed

Child, Phil

2018-03-01

This article examines the politics of private renting in 1950s and early 1960s Britain, through the radical approach taken by Labour Party towards private landlords. Through setting the radical aims of Labour in a mid-twentieth-century context of decrepit housing, rising rents and sluggish public housing programmes, Labour's rationale in arguing for the 'abolition' of the private landlord is more transparent. This article takes a chronological approach, investigating what actions Labour actors took, at local and national level, and what effect this had on the wider housing market. Part one takes a long view of Labour attitudes to the private rented sector. Part two explores the policy of 'municipalization'-the attempt to place rented homes under local authority control. Part three discusses the post-1962 policy shift to state-sponsored 'improvement' of private rented housing, prior to Labour's victory at the 1964 general election. Three key arguments are made: that Labour's radicalism hastened the collapse of the post-war private rented sector; that rental market weaknesses indicated the confused place of renting in the 'tenurial pattern'; and that the proposed 'abolition' of private landlords had a direct effect on slum clearance and the composition of British cities. The conclusion suggests that Labour's pursuit of the private landlord can shed light on the vast urban transformations of the post-war period. It invites greater attention to be paid to the effects that political ideas had on the composition of the twentieth-century British housing market.

Refuting the "Nimble Fingers" Argument [and] Working Together against Child Labour.

ERIC Educational Resources Information Center

World of Work, 1996

1996-01-01

An International Labour Organization study refutes one of the most common arguments of apologists for child labor in the hand-woven carpet industry--the so-called nimble fingers argument. Excerpts from presentations at an International Labour Organization meeting highlight the commitment to eradicating child labor. (JOW)

Domestic labour, paid employment and women's health: analysis of life course data.

PubMed

Blane, D; Berney, L; Montgomery, S M

2001-03-01

The relationship between the amount of domestic labour performed by a woman during her lifetime and a variety of self-reported and objective measures of her health in early old age was examined in the female members (n = 155) of a data set containing considerable life course information, including full household, residential and occupational histories. Domestic labour, on its own, proved a weak predictor of health. The relationship strengthened when domestic labour was combined with the hazards of the formal paid employment which the woman had performed. This suggests that it is the combination of domestic labour plus paid employment which influences women's health. The robustness of this conclusion is indicated by its agreement with other studies which reached the same conclusion through an analysis of data with markedly different characteristics.

Who cares? Offering emotion work as a 'gift' in the nursing labour process.

PubMed

Bolton, S C

2000-09-01

Who cares? Offering emotion work as a 'gift' in the nursing labour process The emotional elements of the nursing labour process are being recognized increasingly. Many commentators stress that nurses' 'emotional labour' is hard and productive work and should be valued in the same way as physical or technical labour. However, the term 'emotional labour' fails to conceptualize the many occasions when nurses not only work hard on their emotions in order to present the detached face of a professional carer, but also to offer authentic caring behaviour to patients in their care. Using qualitative data collected from a group of gynaecology nurses in an English National Health Service (NHS) Trust hospital, this paper argues that nursing work is emotionally complex and may be better understood by utilizing a combination of Hochschild's concepts: emotion work as a 'gift' in addition to 'emotional labour'. The gynaecology nurses in this study describe their work as 'emotionful' and therefore it could be said that this particular group of nurses represent a distinct example. Nevertheless, though it is impossible to generalize from limited data, the research presented in this paper does highlight the emotional complexity of the nursing labour process, expands the current conceptual analysis, and offers a path for future research. The examination further emphasizes the need to understand and value the motivations behind nurses' emotion work and their wish to maintain caring as a central value in professional nursing.

The Mismeasure of Academic Labour

ERIC Educational Resources Information Center

Papadopoulos, Angelika

2017-01-01

In quantifying and qualifying the scope of academic labour, workload models serve multiple ends. They are intended to facilitate equitable and transparent divisions of academic work, to provide academics with a sense of whether their workload is reasonable relative to their colleagues, and universities with a mechanism for rationalising the…

Labour market entries and exits of women from different origin countries in the UK.

PubMed

Khoudja, Yassine; Platt, Lucinda

2018-01-01

Labour force participation rates of women differ strongly by ethnic origin. Even though existing research using cross-sectional studies has demonstrated that part of these differences can be attributed to compositional differences in human capital, household conditions and gender attitudes, residual 'ethnic effects' typically remain. To further our understanding of women's labour market behaviour across ethnic groups, we use a large-scale longitudinal study and apply a dynamic perspective to examine how far relevant life-course events in addition to individual characteristics, gender attitudes and religiosity contribute to the explanation of ethnic differences in women's labour force entries and exits in the UK. Our findings show that, adjusting for all these factors, Indian and Caribbean women do not differ from White majority women in their labour force entry and exit probabilities but that Pakistani and Bangladeshi women are less likely to enter and more likely to exit the labour market, whereas Black African women have higher entry rates. We also find that relations between life-course events and labour market transitions differ by ethnic group. Most notably, Pakistani and Bangladeshi women's labour market transitions are less sensitive to child-bearing and Caribbean women's transitions less sensitive to partnership changes than other women's. Copyright © 2017 Elsevier Inc. All rights reserved.

Sociodemographic differences in women’s experience of early labour care: a mixed methods study

PubMed Central

Henderson, Jane; Redshaw, Maggie

2017-01-01

Objectives To explore women’s experiences of early labour care focusing on sociodemographic differences, and to examine the effect of antenatal education, using mixed methods. Setting England, 2014. Participants Women who completed postal questionnaires about their experience of maternity care, including questions about antenatal education, early labour and sociodemographic factors, included space for free-text comments. Outcome measures Worries about labour, contact with midwives in early labour and subsequent care. Methods This study was based on secondary analysis of a national maternity survey carried out in England in 2014. Quantitative data were analysed using descriptive statistics and binary logistic regression; qualitative data were analysed using a thematic content analytic approach. Results Completed questionnaires were received from 4578 women (47% response rate). There were significant differences by sociodemographic factors, particularly ethnicity, in women’s worries about early labour. Compared with white women, women from black or minority ethnic groups had an adjusted OR of 1.93 (95% CI 1.56 to 2.39) of feeling worried about not knowing when labour would start. Among women who contacted a midwife at the start of labour, 84% perceived their advice as appropriate, more in older and multiparous women. Overall, 64% of women were asked to come to the hospital at this time, more in multiparous women (adjusted OR 1.63, 95% CI 1.35 to 1.96). Those who did not have access to antenatal education experienced greater worry about early labour. Five themes emerged from the qualitative analysis: ‘Differentiating between early and active labour’, ‘Staff attitudes’, ‘Not being allowed…’, ‘Previous labours’ and ‘Perceived consequences for women’. Conclusion These findings reinforce the importance of providing reassurance to women in early labour, taking care that women do not feel neglected or dismissed. In particular, primiparous and

Debate: Race, Labour and the Archbishop, or the Currency of Race.

ERIC Educational Resources Information Center

Stanford, Jacqui

2001-01-01

Explores how race is exploited to serve political agendas in Britain, examining the Labour Government's orientation to race. Argues that the Labour Government manipulates issues to suggest concern while actually removing race from the policy agenda in education. Reflects on the Archbishop of Canterbury's "Jesus 2000" to support the…

Progression of the first stage of spontaneous labour: A prospective cohort study in two sub-Saharan African countries

PubMed Central

Fawole, Bukola; Mugerwa, Kidza; Alves, Domingos; Souza, Hayala; Reis, Rodrigo; Oliveira-Ciabati, Livia; Maiorano, Alexandre; Akintan, Adesina; Alu, Francis E.; Oyeneyin, Lawal; Adebayo, Amos; Byamugisha, Josaphat; Idris, Hadiza A.; Okike, Ola; Althabe, Fernando; Hundley, Vanora; Pattinson, Robert; Sanghvi, Harshadkumar C.; Tunçalp, Özge; Vogel, Joshua P.; Stanton, Mary Ellen; Liljestrand, Jerker; ten Hoope-Bender, Petra; Mathai, Matthews; Bahl, Rajiv

2018-01-01

Background Escalation in the global rates of labour interventions, particularly cesarean section and oxytocin augmentation, has renewed interest in a better understanding of natural labour progression. Methodological advancements in statistical and computational techniques addressing the limitations of pioneer studies have led to novel findings and triggered a re-evaluation of current labour practices. As part of the World Health Organization's Better Outcomes in Labour Difficulty (BOLD) project, which aimed to develop a new labour monitoring-to-action tool, we examined the patterns of labour progression as depicted by cervical dilatation over time in a cohort of women in Nigeria and Uganda who gave birth vaginally following a spontaneous labour onset. Methods and findings This was a prospective, multicentre, cohort study of 5,606 women with singleton, vertex, term gestation who presented at ≤ 6 cm of cervical dilatation following a spontaneous labour onset that resulted in a vaginal birth with no adverse birth outcomes in 13 hospitals across Nigeria and Uganda. We independently applied survival analysis and multistate Markov models to estimate the duration of labour centimetre by centimetre until 10 cm and the cumulative duration of labour from the cervical dilatation at admission through 10 cm. Multistate Markov and nonlinear mixed models were separately used to construct average labour curves. All analyses were conducted according to three parity groups: parity = 0 (n = 2,166), parity = 1 (n = 1,488), and parity = 2+ (n = 1,952). We performed sensitivity analyses to assess the impact of oxytocin augmentation on labour progression by re-examining the progression patterns after excluding women with augmented labours. Labour was augmented with oxytocin in 40% of nulliparous and 28% of multiparous women. The median time to advance by 1 cm exceeded 1 hour until 5 cm was reached in both nulliparous and multiparous women. Based on a 95th percentile threshold

A phase II trial of tideglusib in Alzheimer's disease.

PubMed

Lovestone, Simon; Boada, Mercè; Dubois, Bruno; Hüll, Michael; Rinne, Juha O; Huppertz, Hans-Jürgen; Calero, Miguel; Andrés, María V; Gómez-Carrillo, Belén; León, Teresa; del Ser, Teodoro

2015-01-01

The ARGO study was a phase II, double-blind, placebo controlled, four parallel arm trial of tideglusib in Alzheimer's disease (AD). To prove the clinical efficacy of an inhibitor of glycogen synthase kinase-3 (GSK-3), in AD. Mild to moderate (Mini-Mental State Examination (MMSE) score, 14-26) AD patients on cholinesterase inhibitor and/or memantine treatment were administered tideglusib or placebo for 26 weeks. The ADAS-cog15 was the primary efficacy measure; function, cognition, behavior, and quality of life were assessed as secondary measures; cerebral atrophy in MRI and the levels of tau, amyloid-β, and BACE1 in cerebrospinal fluid (CSF) were exploratory endpoints. 306 AD patients were randomized to active (1000 mg QD: n = 86, 1000 mg QOD: n = 90, and 500 mg QD: n = 50) or placebo (n = 85) in 55 sites in four European countries. There were no statistically significant differences between either active and placebo arms in the efficacy variables. However, BACE1 in CSF significantly decreased with treatment in a small subgroup of patients. Participants with mild AD in the 500 mg QD group showed significant responses on ADAS-cog15, MMSE, and word fluency. Diarrhea (14-18% in active, 11% placebo) and dose-dependent, mild to moderate, and fully reversible transaminase increase (9-16% in active, 3.5% placebo) were the most frequent adverse events. Short term (26 weeks) tideglusib was acceptably safe but produced no clinical benefit in this trial. However, given the non-linear dose response, especially in mildly affected patients, further dose finding studies in early disease stages and for longer duration are warranted to examine GSK-3 inhibition in AD patients.

Effect of Carbon Ion Radiotherapy for Sacral Chordoma: Results of Phase I-II and Phase II Clinical Trials

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

Imai, Reiko, E-mail: r_imai@nirs.go.j; Kamada, Tadashi; Tsuji, Hiroshi

2010-08-01

Purpose: To summarize the results of treatment for sacral chordoma in Phase I-II and Phase II carbon ion radiotherapy trials for bone and soft-tissue sarcomas. Patients and Methods: We performed a retrospective analysis of 38 patients with medically unresectable sacral chordomas treated with the Heavy Ion Medical Accelerator in Chiba, Japan between 1996 and 2003. Of the 38 patients, 30 had not received previous treatment and 8 had locally recurrent tumor after previous resection. The applied carbon ion dose was 52.8-73.6 Gray equivalents (median, 70.4) in a total of 16 fixed fractions within 4 weeks. Results: The median patient agemore » was 66 years. The cranial tumor extension was S2 or greater in 31 patients. The median clinical target volume was 523 cm{sup 3}. The median follow-up period was 80 months. The 5-year overall survival rate was 86%, and the 5-year local control rate was 89%. After treatment, 27 of 30 patients with primary tumor remained ambulatory with or without supportive devices. Two patients experienced severe skin or soft-tissue complications requiring skin grafts. Conclusion: Carbon ion radiotherapy appears effective and safe in the treatment of patients with sacral chordoma and offers a promising alternative to surgery.« less

Previous anxiety and depression as risk factors for early labour force exit.

PubMed

Rudolph, Kara E; Eaton, William W

2016-04-01

Individuals with a history of mental illness have lower earnings than individuals without. A possible reason is that those with prior anxiety or depression may be more likely to exit the labour force prior to retirement age, but evidence has been mixed and limited. Our objective was to compare risk of early labour force exit between employed adults with a history of depression or anxiety versus those without, separately for men and women. We used data from the Baltimore Epidemiological Catchment Area Follow-up Cohort, which collected baseline data in 1981 and follow-up data 1993-1996 and 2004-2005. Cox proportional hazards models estimated the relative risk of labour force exit comparing those with versus without prior history of anxiety or depressive disorders. Women with prior anxiety or depression are at 37% increased risk of dropping out of the labour force as compared to women without, controlling for age, socioeconomic status, race and marital status (HR: 1.37, 95% CI 1.04 to 1.79). Men with prior anxiety or depression are 18% more likely to subsequently drop out of the labour force as compared to men without, controlling for the above confounders as well as veteran status, but this association is not statistically significant (HR: 1.18, 95% CI 0.72 to 1.27). Prior anxiety or depression increases risk of early labour force exit for women. These findings may help explain previously reported lower earnings among female individuals with a history of mental illness and highlight the importance of considering anxiety and depressive disorders in policies supporting labour force participation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The effect of colour and design in labour and delivery: A scientific approach

NASA Astrophysics Data System (ADS)

Duncan, Jane

2011-03-01

This study was part of a broader three year research project at London's Chelsea and Westminster Hospital, "A Study of the Effect of the Visual and Performing Arts in Healthcare", exploring whether visual and performing arts have any measurable effect on physiological, psychological and biological outcomes of clinical significance on patient recovery, and providing a potential cost saving benefit to the NHS. In this specific study of women in labour, two measurements were identified as having clinical significance for achieving optimal outcomes during labour and delivery: length of labour and frequency of requirement for analgesia. A screen was designed to hide emergency equipment with the joint aim of reducing women's anxieties and (through visual art) acting as a focal point of attention and distraction during labour, thus diminishing requirements for analgesia. Results demonstrated, in the presence of the screen, a statistically significant shortening of the duration of labour by 2.1h with frequency of requests for epidural analgesia 7% lower in the study group than in the control group. The significant clinical outcomes of this research provide the evidence of the value of integrating visual art into the environment of a labour and delivery room, improving the quality of the maternity service and potentially delivering real cost savings benefits to Hospitals.

Effectiveness of triclosan-coated PDS Plus versus uncoated PDS II sutures for prevention of surgical site infection after abdominal wall closure: the randomised controlled PROUD trial.

PubMed

Diener, Markus K; Knebel, Phillip; Kieser, Meinhard; Schüler, Philipp; Schiergens, Tobias S; Atanassov, Vladimir; Neudecker, Jens; Stein, Erwin; Thielemann, Henryk; Kunz, Reiner; von Frankenberg, Moritz; Schernikau, Utz; Bunse, Jörg; Jansen-Winkeln, Boris; Partecke, Lars I; Prechtl, Gerald; Pochhammer, Julius; Bouchard, Ralf; Hodina, René; Beckurts, K Tobias E; Leißner, Lothar; Lemmens, Hans-Peter; Kallinowski, Friedrich; Thomusch, Oliver; Seehofer, Daniel; Simon, Thomas; Hyhlik-Dürr, Alexander; Seiler, Christoph M; Hackert, Thilo; Reissfelder, Christoph; Hennig, René; Doerr-Harim, Colette; Klose, Christina; Ulrich, Alexis; Büchler, Markus W

2014-07-12

Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery, and triclosan-coated sutures were developed to reduce their occurrence. The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure, compared with non-coated PDS II sutures, in the prevention of surgical site infections. This multicentre, randomised controlled group-sequential superiority trial was done in 24 German hospitals. Adult patients (aged ≥18 years) who underwent elective midline abdominal laparotomy for any reason were eligible for inclusion. Exclusion criteria were impaired mental state, language problems, and participation in another intervention trial that interfered with the intervention or outcome of this trial. A central web-based randomisation tool was used to randomly assign eligible participants by permuted block randomisation with a 1:1 allocation ratio and block size 4 before mass closure to either triclosan-coated sutures (PDS Plus) or uncoated sutures (PDS II) for abdominal fascia closure. The primary endpoint was the occurrence of superficial or deep surgical site infection according to the Centers for Disease Control and Prevention criteria within 30 days after the operation. Patients, surgeons, and the outcome assessors were masked to group assignment. Interim and final analyses were by modified intention to treat. This trial is registered with the German Clinical Trials Register, number DRKS00000390. Between April 7, 2010, and Oct 19, 2012, 1224 patients were randomly assigned to intervention groups (607 to PDS Plus, and 617 to PDS II), of whom 1185 (587 PDS Plus and 598 PDS II) were analysed by intention to treat. The study groups were well balanced in terms of patient and procedure characteristics. The occurrence of surgical site infections did not differ between the PDS Plus group (87 [14·8%] of 587) and the PDS II group (96 [16·1%] of 598

Conception, complicated pregnancy, and labour of gods and heroes in Greek mythology.

PubMed

Iavazzo, Christos; Trompoukis, Constantinos; Sardi, Thalia; Falagas, Matthew E

2008-01-01

Pregnancy and labour are holy moments in a woman's life. Even in Greek mythology we can find descriptions of them. We searched in the Greek myths to find descriptions of labours of ancient heroes and gods. We identified descriptions of extracorporeal fertilization, superfecundation, ectopic pregnancy, preterm labour, prolonged pregnancy and Caesarean section. The use of imagination could help the reader to find similarities in present or future developments in the field of obstetrics. It could be concluded that various aspects of modern obstetrical practice are described in Greek mythology.

Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma: North Central Cancer Treatment Group trial N0745 (Alliance)

PubMed Central

Hubbard, Joleen M.; Mahoney, Michelle R.; Loui, William S.; Roberts, Lewis R.; Smyrk, Thomas C.; Gatalica, Zoran; Borad, Mitesh; Kumar, Shaji; Alberts, Steven R.

2017-01-01

Background Angiogenesis has been a major target of novel drug development in hepatocellular carcinoma (HCC). It is hypothesized that the combination of two antiangiogenic agents, sorafenib and bevacizumab, will provide greater blockade of angiogenesis. Objective To determine the optimal dose, safety, and effectiveness of dual anti-angiogenic therapy with sorafenib and bevacizumab in patients with advanced HCC. Patients and Methods Patients with locally advanced or metastatic HCC not amenable for surgery or liver transplant were eligible. The phase I starting dose level was bevacizumab 1.25 mg/kg day 1 and 15 plus sorafenib 400 mg twice daily (BID) days 1–28. In the phase II portion, patients were randomized to receive bevacizumab and sorafenib at the maximum tolerated dose (MTD) or sorafenib 400 mg BID. Results 17 patients were enrolled in the phase I component. Dose-limiting toxicities included grade 3 hand/foot skin reaction, fatigue, hypertension, alanine/aspartate aminotransferase increase, dehydration, hypophosphatemia, creatinine increase, hypoglycemia, nausea/vomiting, and grade 4 hyponatremia. 7 patients were enrolled onto the phase II component at the MTD: sorafenib 200 mg BID days 1–28 and bevacizumab 2.5 mg/kg every other week. 57% (4/7) had grade 3 AEs at least possibly related to treatment,. No responses were observed in the phase II portion. Estimated median time to progression and survival were 8.6 months (95% CI: 0.4–16.3) and 13.3 months (95% CI 4.4 – not estimable), respectively. Conclusions The MTD of the combination is sorafenib 200 mg twice daily on days 1–28 plus bevacizumab 2.5 mg/kg on days 1 and 15 of a 28-day cycle. In the phase II portion of the trial, concerns regarding excessive toxicity, low efficacy, and slow enrollment led to discontinuation of the trial. (Clinical Trials ID: NCT00867321.) PMID:27943153

[Attitude of pregnant women towards labour--study of forms of preparation and preferences].

PubMed

Kosińska, Katarzyna; Krychowska, Alina; Wielgoś, Mirosław; Myszewska, Aleksandra; Przyboś, Andrzej

2005-12-01

The aim of this study was to assess the knowledge of alternative delivery techniques among pregnant women and their preferences concerning the course of labour. 275 woman hospitalizated in obstetric wards in Puck and Ist Clinic in Warsaw were questionnaired in the period of July 2003 - February 2004. The mean age of women was 26 +/- 4.9. 55.7% of them were nulliparous, 44.3% multiparous. T-Student test was used for statistical analysis. The majority of questionnaired women knew alternative positions during delivery and possible analgetic techniques. 25.1% of women attended labour school. 81.2% wanted to give birth in the hospital, 10% at home and 8.8% in the delivery room. 51.1% preferred waterbirth and 22.5% obstetric chair--most of them came from the big cities, were better educated and attended labour school. Almost half of all women are in favour of epidural anaesthesia of delivery. Caesarean section on request was supported by 13.8%. For 67.4% the presence of intimates during labour was important. Labour school has a significant influence on women's knowledge and their preferences. Waterbirth and other modern delivery techniques are very popular among better educated women from big cities, while those with lower education from small cities and villages prefer "classic" labour. Therefore promotion of modern delivery methods and active participation in labour should be concentrated on these groups of women. Nowadays obstetric departments should ensure not only safety of giving birth but also complete personal comfort for pregnant women.

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial).

PubMed

Généreux, Philippe; Lee, Arthur C; Kim, Christopher Y; Lee, Michael; Shlofmitz, Richard; Moses, Jeffrey W; Stone, Gregg W; Chambers, Jeff W

2015-06-15

Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients

Screened selection design for randomised phase II oncology trials: an example in chronic lymphocytic leukaemia

PubMed Central

2013-01-01

Background As there are limited patients for chronic lymphocytic leukaemia trials, it is important that statistical methodologies in Phase II efficiently select regimens for subsequent evaluation in larger-scale Phase III trials. Methods We propose the screened selection design (SSD), which is a practical multi-stage, randomised Phase II design for two experimental arms. Activity is first evaluated by applying Simon’s two-stage design (1989) on each arm. If both are active, the play-the-winner selection strategy proposed by Simon, Wittes and Ellenberg (SWE) (1985) is applied to select the superior arm. A variant of the design, Modified SSD, also allows the arm with the higher response rates to be recommended only if its activity rate is greater by a clinically-relevant value. The operating characteristics are explored via a simulation study and compared to a Bayesian Selection approach. Results Simulations showed that with the proposed SSD, it is possible to retain the sample size as required in SWE and obtain similar probabilities of selecting the correct superior arm of at least 90%; with the additional attractive benefit of reducing the probability of selecting ineffective arms. This approach is comparable to a Bayesian Selection Strategy. The Modified SSD performs substantially better than the other designs in selecting neither arm if the underlying rates for both arms are desirable but equivalent, allowing for other factors to be considered in the decision making process. Though its probability of correctly selecting a superior arm might be reduced, it still performs reasonably well. It also reduces the probability of selecting an inferior arm. Conclusions SSD provides an easy to implement randomised Phase II design that selects the most promising treatment that has shown sufficient evidence of activity, with available R codes to evaluate its operating characteristics. PMID:23819695

Screened selection design for randomised phase II oncology trials: an example in chronic lymphocytic leukaemia.

PubMed

Yap, Christina; Pettitt, Andrew; Billingham, Lucinda

2013-07-03

As there are limited patients for chronic lymphocytic leukaemia trials, it is important that statistical methodologies in Phase II efficiently select regimens for subsequent evaluation in larger-scale Phase III trials. We propose the screened selection design (SSD), which is a practical multi-stage, randomised Phase II design for two experimental arms. Activity is first evaluated by applying Simon's two-stage design (1989) on each arm. If both are active, the play-the-winner selection strategy proposed by Simon, Wittes and Ellenberg (SWE) (1985) is applied to select the superior arm. A variant of the design, Modified SSD, also allows the arm with the higher response rates to be recommended only if its activity rate is greater by a clinically-relevant value. The operating characteristics are explored via a simulation study and compared to a Bayesian Selection approach. Simulations showed that with the proposed SSD, it is possible to retain the sample size as required in SWE and obtain similar probabilities of selecting the correct superior arm of at least 90%; with the additional attractive benefit of reducing the probability of selecting ineffective arms. This approach is comparable to a Bayesian Selection Strategy. The Modified SSD performs substantially better than the other designs in selecting neither arm if the underlying rates for both arms are desirable but equivalent, allowing for other factors to be considered in the decision making process. Though its probability of correctly selecting a superior arm might be reduced, it still performs reasonably well. It also reduces the probability of selecting an inferior arm. SSD provides an easy to implement randomised Phase II design that selects the most promising treatment that has shown sufficient evidence of activity, with available R codes to evaluate its operating characteristics.

University and Vocational Education, and Youth Labour Market Outcomes in Australia

ERIC Educational Resources Information Center

Marks, Gary N.

2017-01-01

The purpose of this study is to examine the effects of university and vocational education, and other influences on a variety of labour market outcomes for Australian youths aged between 16 and 25. The six labour market outcomes investigated are: occupational status, hourly and weekly earnings, employment, unemployment and full-time work. The…

Impact of social factors on labour discrimination of disabled women.

PubMed

Mondéjar-Jiménez, José; Vargas-Vargas, Manuel; Meseguer-Santamaría, María-Leticia; Mondéjar-Jiménez, Juan-Antonio

2009-01-01

Disabled women suffer from a double labour discrimination due to their gender and their disability. In rural areas, in addition, they also suffer from a lack of specific services, the isolation of the disabled associations, problems with public transport, the dispersion of population centres, and a limited access to information that could improve their chances of entering the labour market. The current work adopts a constructivist perspective on disability and offers a preliminary examination of the influence of social factors, such as the rural or urban nature of the disabled women's place of residence, the assistance they receive from their family or outside the family, the quantity of information they receive about the labour market, and their educational level, on the activity and employment status of this group of people.

Marginalisation, discrimination and the health of Latino immigrant day labourers in a central North Carolina community.

PubMed

Fleming, Paul J; Villa-Torres, Laura; Taboada, Arianna; Richards, Chelly; Barrington, Clare

2017-03-01

The morbidity and mortality of Latino immigrants in the United States (US) stem from a complex mix of policy, culture, discrimination and economics. Immigrants working as day labourers may be particularly vulnerable to the negative influences of these social factors due to limited access to social, financial and legal resources. We aimed to understand how the health of male Latino day labourers in North Carolina, US is influenced by their experiences interacting with their community and perceptions of their social environment. To respond to our research questions, we conducted three focus groups (n = 9, n = 10, n = 10) and a photovoice project (n = 5) with Latino male immigrants between October 2013 and March 2014. We conducted a thematic analysis of transcripts from the discussions in the focus groups and the group discussions with Photovoice participants. We found that men's health and well-being were primarily shaped by their experiences and feelings of discrimination and marginalisation. We identified three main links between discrimination/marginalisation and poor health: (i) dangerous work resulted in workplace injuries or illnesses; (ii) unsteady employment caused stress, anxiety and insufficient funds for healthcare; and (iii) exclusionary policies and treatment resulted in limited healthcare accessibility. Health promotion with Latino immigrant men in new settlement areas could benefit from community-building activities, addressing discrimination, augmenting the reach of formal healthcare and building upon the informal mechanisms that immigrants rely on to meet their health needs. Reforms to immigration and labour policies are also essential to addressing these structural barriers to health for these men. © 2016 John Wiley & Sons Ltd.

Placental heat shock proteins: no immunohistochemical evidence for a differential stress response in preterm labour.

PubMed

Divers, M J; Bulmer, J N; Miller, D; Lilford, R J

1995-01-01

The aetiology of idiopathic preterm labour remains obscure. The hypothesis that a stress response induced by low-grade bacterial infection in utero-placental tissues was investigated. Distribution of cognate and inducible isoforms of heat shock proteins (HSP) 70 kD, HSP 60 kD and HSP 90 kD were investigated in an immunohistochemical study of placental and decidual tissues before and after labour at varying gestations. Subjects were pregnant women undergoing singleton delivery after idiopathic preterm labour at less than 34 weeks' gestation (n = 23); spontaneous term labour at 37-42 weeks' gestation (n =24); preterm caesarean sections at less than 34 weeks' gestation for preeclampsia or intrauterine growth retardation (n=14); elective caesarean section at 37-42 weeks' gestation for cephalopelvic disproportion (n = 6). HSP expression was constant throughout the third trimester of pregnancy and did not change following the onset of labour, regardless of gestational age. A stress response in decidual tissues as determined by immunohistochemical analysis is apparently not associated with preterm labour.

Phase II trial of pirfenidone in children and young adults with neurofibromatosis type 1 and progressive plexiform neurofibromas.

PubMed

Widemann, Brigitte C; Babovic-Vuksanovic, Dusica; Dombi, Eva; Wolters, Pamela L; Goldman, Stewart; Martin, Staci; Goodwin, Anne; Goodspeed, Wendy; Kieran, Mark W; Cohen, Bruce; Blaney, Susan M; King, Allison; Solomon, Jeffrey; Patronas, Nicholas; Balis, Frank M; Fox, Elizabeth; Steinberg, Seth M; Packer, Roger J

2014-09-01

Pirfenidone, an oral anti-inflammatory, antifibrotic agent with activity in idiopathic pulmonary fibrosis, may mediate anti-tumor activity in neurofibromatosis type 1 (NF1) and plexiform neurofibromas (PN) by inhibition of fibroblast proliferation and collagen synthesis. The primary objective of this open label, single arm phase II trial was to evaluate the activity of pirfenidone in children and young adults with inoperable PN. Patients (3-21 years) with NF1-related progressive PN received pirfenidone at the previously determined optimal dose (500 mg/m(2) orally, q8h) on a continuous dosing schedule (one cycle = 28 days). Volumetric MRI analysis was used to assess response. Progression was defined as ≥ 20% PN volume increase compared to baseline. Pirfenidone would be considered active if it doubled the median time to progression (TTP) compared to the TTP on the placebo arm of a phase II trial with the farnesyltransferase inhibitor tipifarnib, which used near identical eligibility criteria. Toxicities, objective response rate, and quality of life (QOL) also were evaluated. Thirty-six patients were enrolled and tolerated pirfenidone well with intermittent nausea and vomiting as the most frequent toxicities. A dose reduction was required in only three patients. The median TTP for pirfenidone was 13.2 months compared to 10.6 months for the placebo control group from the tipifarnib trial (two-tailed P = 0.92; one-tailed P = 0.46). No objective responses were observed. Pirfenidone was well tolerated, but did not demonstrate activity as defined in this trial and does not warrant further evaluation in children with NF1 and progressive PN. © 2014 Wiley Periodicals, Inc.

Gemcitabine plus sorafenib in patients with advanced pancreatic cancer: a phase II trial of the University of Chicago Phase II Consortium

PubMed Central

Wroblewski, Kristen; Wallace, James A.; Hall, Michael J.; Locker, Gershon; Nattam, Sreenivasa; Agamah, Edem; Stadler, Walter M.; Vokes, Everett E.

2015-01-01

Summary Background Sorafenib, an inhibitor of B-raf, VEGFR2, and PDGFR-β, has activity against pancreatic cancer in preclinical models. In a phase I trial of gemcitabine plus sorafenib, 57% of pancreatic cancer patients achieved stable disease. Patients and methods We conducted a multi-center phase II trial of sorafenib plus gemcitabine in chemo-naïve patients with histologicallyconfirmed, advanced pancreatic cancer. Patients received sorafenib 400 mg twice daily and gemcitabine 1,000 mg/m2 on days 1, 8 and 15 of a 28 day cycle. Results Seventeen patients enrolled at 4 centers; 13 were evaluable for response. There were no objective responses; 18% had stable disease. Median overall survival was 4.0 months (95% CI: 3.4, 5.9); median progression-free survival was 3.2 months (95% CI: 1.6, 3.6). Grade 3/4 toxicities included thrombosis in 18% of patients, dehydration or hand-foot syndrome in 12%, and hypertension or gastrointestinal bleeding in 6%. Conclusion Gemcitabine plus sorafenib is inactive in advanced pancreatic cancer. PMID:20803052

Inter-institutional Variation in Use of Caesarean Delivery for Labour Dystocia.

PubMed

Riddell, Corinne A; Hutcheon, Jennifer A; Strumpf, Erin C; Abenhaim, Haim A; Kaufman, Jay S

2017-11-01

To establish the degree of variation across hospitals in the use of Caesarean delivery for the indication of labour dystocia before and after accounting for maternal, fetal, and hospital characteristics. This study was a retrospective, population-based cohort study of nulliparous women delivering term singletons in cephalic position following labour. Delivery visits were extracted from three provincial perinatal registries in the Canadian provinces of Ontario, Alberta, and British Columbia, from 2008-2012. Crude hospital-specific rates of Caesarean delivery for labour dystocia were reported, and these rates were then stabilized to account for hospitals with low delivery volumes. Rates were then adjusted for maternal, fetal, and hospital characteristics using hierarchical logistic regression. Among 403 205 women delivering at 170 hospitals, the overall Caesarean delivery rate was 21.0%, and the rate of Caesarean delivery for labour dystocia was 12.7%, indicating that 60% of all Caesarean deliveries were performed in part for this indication. The middle 95% of hospitals had Caesarean delivery rates for labour dystocia ranging from 4.5% to 24.7%. Differences in maternal case mix and hospital characteristics explained only a small proportion of this variation (95% central range 6.3%-21.7%). Considerable inter-hospital variation in rates of Caesarean delivery for labour dystocia remained after accounting for differences in maternal and hospital factors. Reporting systems that monitor variation in inter-institutional rates should incorporate stabilization and adjustment for case-mix differences and consider indication-specific rates of Caesarean delivery to more fairly compare hospital performance and better target interventions to reduce Caesarean delivery for specific indications. Copyright © 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

Continuous Flow in Labour-Intensive Manufacturing Process

NASA Astrophysics Data System (ADS)

Pacheco Eng., Jhonny; Carbajal MSc., Eduardo; Stoll-Ing., Cesar, Dr.

2017-06-01

A continuous-flow manufacturing represents the peak of standard production, and usually it means high production in a strict line production. Furthermore, low-tech industry demands high labour-intensive, in this context the efficient of the line production is tied at the job shop organization. Labour-intensive manufacturing processes are a common characteristic for developing countries. This research aims to propose a methodology for production planning in order to fulfilment a variable monthly production quota. The main idea is to use a clock as orchestra director in order to synchronize the rate time (takt time) of customer demand with the manufacturing time. In this way, the study is able to propose a stark reduction of stock in process, over-processing, and unnecessary variability.

Learning to Adapt: Does Returning to Education Improve Labour Market Outcomes?

ERIC Educational Resources Information Center

Chesters, Jenny

2014-01-01

The transition into a post-industrial economy changed the nature of the Australian labour market extinguishing jobs in traditional industries and creating jobs in new industries. Workers displaced from the manufacturing sector and women seeking to re-enter the labour market after taking time out for family reasons need to retrain in order to…

Intravitreal sirolimus for the treatment of geographic atrophy: results of a phase I/II clinical trial.

PubMed

Petrou, Philip A; Cunningham, Denise; Shimel, Katherine; Harrington, Molly; Hammel, Keri; Cukras, Catherine A; Ferris, Frederick L; Chew, Emily Y; Wong, Wai T

2014-12-18

To investigate the safety and effects of intravitreal sirolimus for the potential treatment of geographic atrophy (GA). The study was a single-center, open-label, phase I/II trial enrolling six participants with bilateral GA treated with intravitreal sirolimus in only one randomly assigned eye, with the fellow eye as control. The primary efficacy outcome measure was the change in total GA area from baseline on color fundus photography (CFP); secondary outcomes included changes in GA area on fundus autofluorescence (FAF), visual acuity, central retinal thickness (CRT), and macular sensitivity from baseline. Although no systemic adverse events were attributed to treatment, two of six participants had ocular adverse events that were possibly associated. The treated eye of one participant developed abnormal paralesional changes on FAF that were associated with accelerated retinal thinning. This accelerated retinal thinning was also seen in the treated eye of a second participant. Because of concern that these events were associated with treatment, treatment was suspended. Comparisons of treated and fellow eyes for change in visual acuity, change in GA area, and change in CRT showed no evidence of treatment benefit and generally favored the untreated fellow eye. While paralesional FAF changes and rapid retinal thinning observed are potentially part of the natural course of GA, they may possibly be related to treatment. No general evidence of anatomical or functional benefit was detected in treated eyes. Further data on intravitreal sirolimus for GA treatment will be available from a larger phase II trial. (ClinicalTrials.gov number, NCT01445548.). Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.

Obstetric and psychological characteristics of women choosing epidural analgesia during labour: A cohort study.

PubMed

Sitras, Vasilis; Šaltytė Benth, Jūratė; Eberhard-Gran, Malin

2017-01-01

To investigate the obstetric and psychological characteristics of women who opt to use epidural analgesia (EDA) during labour and the impact of participating in labour preparation courses on women's decisions to use EDA. Longitudinal cohort study. Akershus University Hospital, Norway. 2596 women with singleton pregnancies and intended vaginal delivery. Data were collected using two self-completed questionnaires at pregnancy weeks 17 and 32. Fear of childbirth was assessed by the Wijma Delivery Expectancy Questionnaire (W-DEQ). Symptoms of anxiety were measured by the Hopkins Symptom Check List (SCL-25) and depression by the Edinburgh Postnatal Depression Scale (EPDS). Obstetric and socio-demographic information was retrieved from birth records at the maternity ward. Preference for EDA was indicated by the questionnaire item "I would prefer an epidural regardless" on a 4-point scale (1 = highly agree, 4 = highly disagree) at pregnancy week 32. Twenty-one percent of the women (540/2596) answered that they would choose EDA as the only alternative method of analgesia during labour. Counselling for fear of childbirth [OR 3.23 (95%CI 2.12; 4.92)] and W-DEQ sum score ≥ 85 [OR 2.95 (95%CI 2.06; 4.23)] were significantly (p<0.001) associated with choice of EDA. Participation in labour preparation courses was significantly (p = 0.008) associated with a reduction of intended use of EDA during labour [OR 0.67 (95%CI 0.49; 0.90)]. Fear of childbirth is significantly associated with women's choice of EDA during labour. On the other hand, women that participate in labour preparation courses would rather consider other methods of analgesia during labour.

Social Cohesion and the Labour Market: Societal Regimes of Civic Attitudes and Labour Market Regimes

ERIC Educational Resources Information Center

Dimeglio, Isabelle; Janmaat, Jan Germen; Mehaut, Philippe

2013-01-01

The aim of this paper is to test the connections between the indicators used in the literature on social cohesion, which usually reflect "general" values or behaviours, and indicators specific to a particular space, namely the labour market. A key question is the stability of the social cohesion's indicators when moving from a societal…

Endoplasmic reticulum stress is induced in the human placenta during labour

PubMed Central

Veerbeek, J.H.W.; Tissot Van Patot, M.C.; Burton, G.J.; Yung, H.W.

2015-01-01

Placental endoplasmic reticulum (ER) stress has been postulated in the pathophysiology of pre-eclampsia (PE) and intrauterine growth restriction (IUGR), but its activation remains elusive. Oxidative stress induced by ischaemia/hypoxia-reoxygenation activates ER stress in vitro. Here, we explored whether exposure to labour represents an in vivo model for the study of acute placental ER stress. ER stress markers, GRP78, P-eIF2α and XBP-1, were significantly higher in laboured placentas than in Caesarean-delivered controls localised mainly in the syncytiotrophoblast. The similarities to changes observed in PE/IUGR placentas suggest exposure to labour can be used to investigate induction of ER stress in pathological placentas. PMID:25434970

Combination of three-dimensional ultrasound measurement of foetal adrenal gland enlargement and placental alpha microglobulin-1 for the prediction of the timing of delivery within seven days in women with threatened preterm labour and preterm labour.

PubMed

Santipap, Monchai; Phupong, Vorapong

2018-03-23

The aim of this study was to predict the timing of delivery within seven days in singleton pregnant women with threatened preterm labour and preterm labour by using a three-dimensional (3D) ultrasound measurement of foetal adrenal gland volume enlargement, a foetal zone enlargement and cervicovaginal placental alpha microglobulin-1 (PAMG-1) test. This prospective cohort study included singleton pregnant women at 22-36 +6  weeks of gestation who presented with threatened preterm labour and with preterm labour. Transabdominal 3D ultrasound measurement of the whole foetal adrenal gland and of the foetal adrenal zone were performed. Qualitative cervicovaginal PAMG-1 detection was performed at the same time. One hundred and fifty-four pregnant women were included into the study. Eighty-four pregnant women had threatened preterm labour and seventy pregnant women had preterm labour. Twenty-nine pregnant women (18%) delivered within seven days. Use of foetal adrenal gland volume enlargement, foetal zone enlargement and the PAMG-1 test in combination increased sensitivity; if one parameter was positive, the sensitivity, specificity, positive predictive value and negative predictive value were 82.8%, 27.2%, 20.9% and 87.2%, respectively, in the prediction of the timing of delivery within seven days. The combination of foetal adrenal gland enlargement and PAMG-1 increased sensitivity for the prediction of the timing of delivery within seven days in pregnant women presenting with threatened preterm labour and preterm labour. Impact Statement What is already known on this subject? An increased foetal adrenal gland volume is significantly correlated with the risk of preterm birth. What do the results of this study add? The combination of a foetal adrenal gland enlargement and a placental alpha microglobulin-1 increased sensitivity for the prediction of the timing of delivery within seven days in pregnant women presenting with threatened preterm labour and preterm labour

What makes clinical labour different? The case of human guinea pigging.

PubMed

Różyńska, Joanna

2018-05-24

Each year thousands of individuals enrol in clinical trials as healthy volunteers to earn money. Some of them pursue research participation as a full-time or at least a part-time job. They call themselves professional or semiprofessional guinea pigs. The practice of paying healthy volunteers raises numerous ethical concerns. Different payment models have been discussed in literature. Dickert and Grady argue for a wage-payment model. This model gives research subjects a standardised hourly wage, and it is based on an assumption that research participation is morally indistinguishable from other forms of unskilled labour. In this paper, I will challenge this assumption. I will argue that human guinea pigging has particular characteristics which taken together make it significantly different from other forms of labour. (1) Participation in research is skill-independent. Healthy volunteers are valuable not because they are skilful persons, but because they are human bodies. (2) The role of research volunteers is mainly passive. They are not asked to produce goods or deliver services. They are paid for enduring unpleasant, painful and risky interventions performed by investigators. (3) Research volunteering involves inherent risks and uncertainties, and subjects have little or no control over their minimisation and materialisation. I conclude that participation in clinical research is a specific kind of activity. It is more like renting out one's body to strangers, than working. Thus, research participation should not be treated on par with other forms of employment. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Labour force participation and the influence of having arthritis on financial status.

PubMed

Schofield, Deborah J; Callander, Emily J; Shrestha, Rupendra N; Percival, Richard; Kelly, Simon J; Passey, Megan E

2015-07-01

The objective of this study was to quantify the impact that having arthritis has on income poverty status and accumulated wealth in Australia. Cross-sectional analysis of Health&WealthMOD, a microsimulation model built on data from the Australian Bureau of Statistics' Survey of Disability, Ageing and Carers and STINMOD, an income and savings microsimulation model. Across all categories of labour force participation status (employed full time, part time or not in the labour force at all), those with arthritis were significantly more likely to be in poverty. Those employed full time with no health condition had 0.82 times the odds of being in income poverty (95 % CI 0.80-0.84) compared with those employed full time with arthritis. Those not in the labour force with no chronic health conditions had 0.36 times the odds of being in income poverty compared with those not in the labour force due to arthritis (95 % CI 0.36-0.37). For people not in the labour force with no long-term health condition, the total value of their wealth was 211 % higher (95 % CI 38-618 %) than the amount of wealth accumulated by those not in the labour force due to arthritis. Similarly, those employed part time with no chronic health condition had 50 % more wealth than those employed part time with arthritis (95 % CI 3-116 %). Arthritis has a profound impact upon the economic circumstances of individuals, which adds a further dimension to the detrimental living standards of older individuals suffering from the condition.

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.

Labour Market Intermediaries: A Corrective to the Human Capital Paradigm (Mis)matching Skills and Jobs?

ERIC Educational Resources Information Center

Dobbins, Tony; Plows, Alexandra

2017-01-01

The orthodox supply-side human capital theory (HCT) paradigm is inadequate for understanding and adjusting to labour market volatility in UK regional economies like Wales. This article explores the role of regional labour market intermediaries (LMIs) in matching supply (skills) and demand (job opportunities) in regional labour markets. Some LMIs…

A multi-center, randomized, clinical trial comparing adhesive polyurethane foam dressing and adhesive hydrocolloid dressing in patients with grade II pressure ulcers in primary care and nursing homes

PubMed Central

2013-01-01

Background Pressure ulcers (PrUs) are ischemic wounds in the skin and underlying tissues caused by long-standing pressure force over an external bone or cartilaginous surface. PrUs are an important challenge for the overall health system because can prolong patient hospitalization and reduce quality of life. Moreover, 95% of PrUs are avoidable, suggesting they are caused by poor quality care assistance. PrUs are also costly, increasing national costs. For example, they represent about 5% of overall annual health expenses in Spain. Stages I and II PrUs have a combined prevalence of 65%. According main clinical guidelines, stage II PrUs (PrU-IIs) are usually treated by applying special dressings (polyurethane or hydrocolloid). However, little scientific evidence regarding their efficacy has been identified in scientific literature. Our aim is to assess the comparative efficacy of adhesive polyurethane foam and hydrocolloid dressings in the treatment of PrU-IIs in terms of healed ulcer after 8 weeks of follow-up. Methods/design This paper describes the development and evaluation protocol of a randomized clinical trial of two parallel treatment arms. A total of 820 patients with at least 1 PrU-II will be recruited from primary health care and home care centers. All patients will receive standardized healing procedures and preventive measures (e.g. positional changes and pressure-relieving support surfaces), following standardized procedures. The main outcome will be the percentage of wounds healed after 8 weeks. Secondary outcomes will include cost-effectiveness, as evaluated by cost per healed ulcer and cost per treated patient and safety evaluated by adverse events. Discussion This trial will address the hypothesis that hydrocolloid dressings will heal at least 10% more stage II PrUs and be more cost-effective than polyurethane foam dressings after 8 weeks. Trial registration This trial has been registered with controlled-trials number ISCRCTN57842461 and Eudra

Labour management guidelines for a Tanzanian referral hospital: The participatory development process and birth attendants' perceptions.

PubMed

Maaløe, Nanna; Housseine, Natasha; van Roosmalen, Jos; Bygbjerg, Ib Christian; Tersbøl, Britt Pinkowski; Khamis, Rashid Saleh; Nielsen, Birgitte Bruun; Meguid, Tarek

2017-06-07

While international guidelines for intrapartum care appear to have increased rapidly since 2000, literature suggests that it has only in few instances been matched with reviews of local modifications, use, and impact at the targeted low resource facilities. At a Tanzanian referral hospital, this paper describes the development process of locally achievable, partograph-associated, and peer-reviewed labour management guidelines, and it presents an assessment of professional birth attendants' perceptions. Part 1: Modification of evidence-based international guidelines through repeated evaluation cycles by local staff and seven external specialists in midwifery/obstetrics. Part 2: Questionnaire evaluation 12 months post-implementation of perceptions and use among professional birth attendants. Part 1: After the development process, including three rounds of evaluation by staff and two external peer-review cycles, there were no major concerns with the guidelines internally nor externally. Thereby, international recommendations were condensed to the eight-paged 'PartoMa guidelines ©'. This pocket booklet includes routine assessments, supportive care, and management of common abnormalities in foetal heart rate, labour progress, and maternal condition. It uses colour codes indicating urgency. Compared to international guidelines, reductions were made in frequency of assessments, information load, and ambiguity. Part 2: Response rate of 84% (n = 84). The majority of staff (93%) agreed that the guidelines helped to improve care. They found the guidelines achievable (89%), and the graphics worked well (90%). Doctors more often than nurse-midwives (89% versus 74%) responded to use the guidelines daily. The PartoMa guidelines ensure readily available, locally achievable, and acceptable support for intrapartum surveillance, triage, and management. This is a crucial example of adapting evidence-based international recommendations to local reality. This paper describes the

Panamanian women׳s experience of vaginal examination in labour: A questionnaire validation.

PubMed

Bonilla-Escobar, Francisco J; Ortega-Lenis, Delia; Rojas-Mirquez, Johanna C; Ortega-Loubon, Christian

2016-05-01

to validate a tool that allows healthcare providers to obtain accurate information regarding Panamanian women׳s thoughts and feelings about vaginal examination during labour that can be used in other Latin-American countries. validation study based on a database from a cross-sectional study carried out in two tertiary care hospitals in Panama City, Panama. Women in the immediate postpartum period who had spontaneous labour onset and uncomplicated deliveries were included in the study from April to August 2008. Researchers used a survey designed by Lewin et al. that included 20 questions related to a patient׳s experience during a vaginal examination. five constructs (factors) related to a patient׳s experience of vaginal examination during labour were identified: Approval (Alpha Cronbach׳s 0.72), Perception (0.67), Rejection (0.40), Consent (0.51), and Stress (0.20). it was demonstrated the validity of the scale and its constructs used to obtain information related to vaginal examination during labour, including patients' experiences with examination and healthcare staff performance. utilisation of the scale will allow institutions to identify items that need improvement and address these areas in order to promote the best care for patients in labour. Copyright © 2016 Elsevier Ltd. All rights reserved.

Short and long-term labour market consequences of coronary heart disease: a register-based follow-up study.

PubMed

Kruse, Marie; Sørensen, Jan; Davidsen, Michael; Gyrd-Hansen, Dorte

2009-06-01

The aim of this study was to analyse to what extent individuals with coronary heart disease (CHD) leave the labour market earlier than individuals without CHD and to discuss the implications for rehabilitation. Individuals with CHD were identified from the Danish National Cohort study and were followed from the year of their first hospital admission for CHD and onwards for up to 23 years. Individuals with CHD were individually matched with individuals without CHD. We analysed their short-term labour market participation and compared the long-term withdrawal risk for the two groups through Cox regression. In the year after the first CHD-related admission, 79% of individuals with CHD maintained their labour force participation compared with 93% of individuals without CHD. Individuals with CHD had a hazard ratio of 1.32 for withdrawal compared with their matched counterparts. This means that the individuals with CHD were on the labour market, on average, for 0.8 years less than the individuals without CHD. Stratified analyses showed that, in particular, individuals with CHD aged below 60 years and individuals employed as manual labour may benefit from cardiac rehabilitation, which aims to maintain labour market participation. Individuals with CHD have a significantly increased risk of withdrawing from the labour market. Especially younger individuals and those employed as manual labour seem to have greater problems in maintaining labour market participation. This suggests that greater focus in cardiac rehabilitation on returning these individuals to the labour market might be worthwhile.

Digital labour and development: impacts of global digital labour platforms and the gig economy on worker livelihoods.

PubMed

Graham, Mark; Hjorth, Isis; Lehdonvirta, Vili

2017-05-01

As ever more policy-makers, governments and organisations turn to the gig economy and digital labour as an economic development strategy to bring jobs to places that need them, it becomes important to understand better how this might influence the livelihoods of workers. Drawing on a multi-year study with digital workers in Sub-Saharan Africa and South-east Asia, this article highlights four key concerns for workers: bargaining power, economic inclusion, intermediated value chains, and upgrading. The article shows that although there are important and tangible benefits for a range of workers, there are also a range of risks and costs that unduly affect the livelihoods of digital workers. Building on those concerns, it then concludes with a reflection on four broad strategies - certification schemes, organising digital workers, regulatory strategies and democratic control of online labour platforms - that could be employed to improve conditions and livelihoods for digital workers.

Labour management and Obstetric outcomes among pregnant women admitted in latent phase compared to active phase of labour at Bugando Medical Centre in Tanzania.

PubMed

Chuma, Clotrida; Kihunrwa, Albert; Matovelo, Dismas; Mahendeka, Marietha

2014-02-12

Interventions given to women admitted in latent or active phase of labor may influence the outcomes of labor and ameliorate complications which can affect the mother and fetus. Labour management, maternal and fetal outcomes among low risk women presenting both in latent phase and active phase of labour in Tanzania have not recently been explored. This was a descriptive cross-sectional study. It was done from February to April 2013. Case notes were collected serially until the sample size was reached. A structured checklist was used to extract data. Data was analyzed using SPSS version 17. A p < 0.05 was considered significant at 95% confidence interval. Five hundred case notes of low risk pregnant women were collected, half of each presented in latent phase and active phase of labour. Key interventions including augmentation with oxytocin, artificial rupture of membranes and caesarean section were significantly higher in the latent phase group than the active phase group 84(33.6%) versus 52(20.8%) p < 0.05; 96(38.6%) versus 56(22.4%) p < 0.05 and 87(34.8%) versus 60(24.0%) p < 0.05 respectively. Spontaneous vertex delivery was higher among pregnant women admitted initially in active phase than in latent phase groups 180(72.0%), versus 153(61.2%) p > 0.01). There were more women in the active phase group who sustained genital tract tear and postpartum haemorrhage than in the latent phase group 101(18.6%), versus 38(15.6%) p < 0.01 and 46(18.4%), versus 17(6.6%) p < 0.05 respectively. Pregnant women admitted at BMC in latent phase of labour are subjected to more obstetric interventions than those admitted in the active phase. There is need to produce guidelines on management of women admitted in latent phase of labour at BMC to reduce the risk of unnecessary interventions.

Temporary agency work, migration and the crisis in Greece: labour market segmentation intensified.

PubMed

Maroukis, Thanos

2016-05-01