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1.  Maternal health-related quality of life after induction of labor or expectant monitoring in pregnancy complicated by intrauterine growth retardation beyond 36 weeks 
Quality of Life Research  2011;20(9):1427-1436.
Objective
Pregnancies complicated by intrauterine growth retardation (IUGR) beyond 36 weeks of gestation are at increased risk of neonatal morbidity and mortality. Optimal treatment in IUGR at term is highly debated. Results from the multicenter DIGITAT (Disproportionate Intrauterine Growth Intervention Trial At Term) trial show that induction of labor and expectant monitoring result in equal neonatal and maternal outcomes for comparable cesarean section rates. We report the maternal health-related quality of life (HR-QoL) that was measured alongside the trial at several points in time.
Methods
Both randomized and non-randomized women were asked to participate in the HR-QoL study. Women were asked to fill out written validated questionnaires, covering background characteristics, condition-specific issues and the Short Form (SF-36), European Quality of Life (EuroQoL 6D3L), Hospital Anxiety and Depression scale (HADS), and Symptom Check List (SCL-90) at baseline, 6 weeks postpartum and 6 months postpartum. We compared the difference scores of all summary measures between the two management strategies by ANOVA. A repeated measures multivariate mixed model was defined to assess the effect of the management strategies on the physical (PCS) and mental (MCS) components of the SF-36. Analysis was by intention to treat.
Results
We analyzed data of 361 randomized and 198 non-randomized patients. There were no clinically relevant differences between the treatments at 6 weeks or 6 months postpartum on any summary measures; e.g., on the SF-36 (PCS: P = .09; MCS: P = .48). The PCS and the MCS were below norm values at inclusion. The PCS improved over time but stayed below norm values at 6 months, while the MCS did not improve.
Conclusion
In pregnancies complicated by IUGR beyond 36 weeks, induction of labor does not affect the long-term maternal quality of life.
doi:10.1007/s11136-011-9891-x
PMCID: PMC3195683  PMID: 21468753
Intrauterine growth retardation; Small for gestational age; Quality of life; Induction of labor; Expectant management
2.  Induction of labour versus expectant monitoring in women with pregnancy induced hypertension or mild preeclampsia at term: the HYPITAT trial 
Background
Hypertensive disorders, i.e. pregnancy induced hypertension and preeclampsia, complicate 10 to15% of all pregnancies at term and are a major cause of maternal and perinatal morbidity and mortality. The only causal treatment is delivery. In case of preterm pregnancies conservative management is advocated if the risks for mother and child remain acceptable. In contrast, there is no consensus on how to manage mild hypertensive disease in pregnancies at term. Induction of labour might prevent maternal and neonatal complications at the expense of increased instrumental vaginal delivery rates and caesarean section rates.
Methods/Design
Women with a pregnancy complicated by pregnancy induced hypertension or mild preeclampsia at a gestational age between 36+0 and 41+0 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant management for spontaneous delivery. The primary outcome of this study is severe maternal morbidity, which can be complicated by maternal mortality in rare cases. Secondary outcome measures are neonatal mortality and morbidity, caesarean and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be by intention to treat. In total, 720 pregnant women have to be randomised to show a reduction in severe maternal complications of hypertensive disease from 12 to 6%.
Discussion
This trial will provide evidence as to whether or not induction of labour in women with pregnancy induced hypertension or mild preeclampsia (nearly) at term is an effective treatment to prevent severe maternal complications.
Trial Registration
The protocol is registered in the clinical trial register number ISRCTN08132825.
doi:10.1186/1471-2393-7-14
PMCID: PMC1950708  PMID: 17662114
3.  Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT) 
Objective To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term.
Design Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)).
Setting Eight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008.
Participants Pregnant women who had a singleton pregnancy beyond 36+0 weeks’ gestation with suspected intrauterine growth restriction.
Interventions Induction of labour or expectant monitoring.
Main outcome measures The primary outcome was a composite measure of adverse neonatal outcome, defined as death before hospital discharge, five minute Apgar score of less than 7, umbilical artery pH of less than 7.05, or admission to the intensive care unit. Operative delivery (vaginal instrumental delivery or caesarean section) was a secondary outcome. Analysis was by intention to treat, with confidence intervals calculated for the differences in percentages or means.
Results 321 pregnant women were randomly allocated to induction and 329 to expectant monitoring. Induction group infants were delivered 10 days earlier (mean difference −9.9 days, 95% CI −11.3 to −8.6) and weighed 130 g less (mean difference −130 g, 95% CI −188 g to −71 g) than babies in the expectant monitoring group. A total of 17 (5.3%) infants in the induction group experienced the composite adverse neonatal outcome, compared with 20 (6.1%) in the expectant monitoring group (difference −0.8%, 95% CI −4.3% to 3.2%). Caesarean sections were performed on 45 (14.0%) mothers in the induction group and 45 (13.7%) in the expectant monitoring group (difference 0.3%, 95% CI −5.0% to 5.6%).
Conclusions In women with suspected intrauterine growth restriction at term, we found no important differences in adverse outcomes between induction of labour and expectant monitoring. Patients who are keen on non-intervention can safely choose expectant management with intensive maternal and fetal monitoring; however, it is rational to choose induction to prevent possible neonatal morbidity and stillbirth.
Trial registration International Standard Randomised Controlled Trial number ISRCTN10363217.
doi:10.1136/bmj.c7087
PMCID: PMC3005565  PMID: 21177352
4.  Induction of labour versus expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks (the PPROMEXIL-trial) 
Background
Preterm prelabour rupture of the membranes (PPROM) is an important clinical problem and a dilemma for the gynaecologist. On the one hand, awaiting spontaneous labour increases the probability of infectious disease for both mother and child, whereas on the other hand induction of labour leads to preterm birth with an increase in neonatal morbidity (e.g., respiratory distress syndrome (RDS)) and a possible rise in the number of instrumental deliveries.
Methods/Design
We aim to determine the effectiveness and cost-effectiveness of immediate delivery after PPROM in near term gestation compared to expectant management. Pregnant women with preterm prelabour rupture of the membranes at a gestational age from 34+0 weeks until 37+0 weeks will be included in a multicentre prospective randomised controlled trial. We will compare early delivery with expectant monitoring.
The primary outcome of this study is neonatal sepsis. Secondary outcome measures are maternal morbidity (chorioamnionitis, puerperal sepsis) and neonatal disease, instrumental delivery rate, maternal quality of life, maternal preferences and costs. We anticipate that a reduction of neonatal infection from 7.5% to 2.5% after induction will outweigh an increase in RDS and additional costs due to admission of the child due to prematurity. Under these assumptions, we aim to randomly allocate 520 women to two groups of 260 women each. Analysis will be by intention to treat. Additionally a cost-effectiveness analysis will be performed to evaluate if the cost related to early delivery will outweigh those of expectant management. Long term outcomes will be evaluated using modelling.
Discussion
This trial will provide evidence as to whether induction of labour after preterm prelabour rupture of membranes is an effective and cost-effective strategy to reduce the risk of neonatal sepsis.
Controlled clinical trial register
ISRCTN29313500
doi:10.1186/1471-2393-7-11
PMCID: PMC1934382  PMID: 17617892
5.  Intrauterine Growth Restriction: Cytokine Profiles of Trophoblast Antigen-Stimulated Maternal Lymphocytes 
Intrauterine growth restriction (IUGR) is an important perinatal syndrome that poses several serious short- and long-term effects. We studied cytokine production by maternal peripheral blood lymphocytes stimulated by trophoblast antigens. 36 women with a diagnosis of IUGR and 22 healthy women with normal fetal growth were inducted. Peripheral blood mononuclear cells were stimulated with trophoblast antigens and levels of the proinflammatory cytokines IL-6, IL-8, IL-12, IL-23, IFNγ, and TNFα and the anti-inflammatory cytokines IL-4, IL-10, and IL-13 were measured in culture supernatants by ELISA. IL-8 was produced at higher levels by blood cells of the IUGR group than normal pregnant women, while IL-13 was produced at lower levels. IL-8, IFNγ, and TNFα were higher in IUGR with placental insufficiency than in normal pregnancy. IL-12 levels were higher and IL-10 levels were lower in IUGR with placental insufficiency than in IUGR without placental insufficiency. We suggest that a stronger pro-inflammatory bias exists in IUGR as compared to normal pregnancy and in IUGR with placental insufficiency when compared to IUGR without placental insufficiency. Several ratios of proinflammatory to anti-inflammatory cytokines also support the existence of an inflammatory bias in IUGR.
doi:10.1155/2012/734865
PMCID: PMC3205724  PMID: 22110537
6.  The Bristol third stage trial: active versus physiological management of third stage of labour. 
BMJ : British Medical Journal  1988;297(6659):1295-1300.
OBJECTIVE--To compare the effects on fetal and maternal morbidity of routine active management of third stage of labour and expectant (physiological) management, in particular to determine whether active management reduced incidence of postpartum haemorrhage. DESIGN--Randomised trial of active versus physiological management. Women entered trial on admission to labour ward with allocation revealed just before vaginal delivery. Five months into trial high rate of postpartum haemorrhage in physiological group (16.5% v 3.8%) prompted modification of protocol to exclude more women and allow those allocated to physiological group who needed some active management to be switched to fully active management. Sample size of 3900 was planned, but even after protocol modification a planned interim analysis after first 1500 deliveries showed continuing high postpartum haemorrhage rate in physiological group and study was stopped. SETTING--Maternity hospital. PARTICIPANTS--Of 4709 women delivered from 1 January 1986 to 31 January 1987, 1695 were admitted to trial and allocated randomly to physiological (849) or active (846) management. Reasons for exclusion were: refusal, antepartum haemorrhage, cardiac disease, breech presentation, multiple pregnancy, intrauterine death, and, after May 1986, ritodrine given two hours before delivery, anticoagulant treatment, and any condition needing a particular management of third stage. INTERVENTIONS--All but six women allocated to active management actually received it, having prophylactic oxytocic, cord clamping before placental delivery, and cord traction; whereas just under half those allocated to physiological management achieved it. A fifth of physiological group received prophylactic oxytocic, two fifths underwent cord traction and just over half clamping of the cord before placental delivery. ENDPOINT--Reduction in incidence of postpartum haemorrhage from 7.5% under physiological management to 5.0% under active management. MEASUREMENTS AND MAIN RESULTS--Incidence of postpartum haemorrhage was 5.9% in active management group and 17.9% in physiological group (odds ratio 3.13; 95% confidence interval 2.3 to 4.2), a contrast reflected in other indices of blood loss. In physiological group third stage was longer (median 15 min v 5 min) and more women needed therapeutic oxytocics (29.7% v 6.4%). Apgar scores at one and five minutes and incidence of neonatal respiratory problems were not significantly different between groups. Babies in physiological group weighed mean of 85 g more than those in active group. When women allocated to and receiving active management (840) were compared with those who actually received physiological management (403) active management still produced lower rate of postpartum haemorrhage (odds ratio 2.4;95% CI1.6 to 3.7). CONCLUSIONS--Policy of active management practised in this trial reduces incidence of postpartum haemorrhage, shortens third stage, and results in reduced neonatal packed cell volume.
PMCID: PMC1834913  PMID: 3144366
7.  Oral misoprostol for induction of labour at term: randomised controlled trial 
BMJ : British Medical Journal  2006;332(7540):509-513.
Objective To compare oral misoprostol solution with vaginal prostaglandin gel (dinoprostone) for induction of labour at term to determine whether misoprostol is superior.
Design Randomised double blind placebo controlled trial.
Setting Maternity departments in three hospitals in Australia.
Population Pregnant women with a singleton cephalic presentation at ≥ 36+6 weeks' gestation, with an indication for prostaglandin induction of labour.
Interventions 20 μg oral misoprostol solution at ourly intervals and placebo vaginal gel or vaginal dinoprostone gel at six hourly intervals and placebo oral solution.
Main outcome measures Vaginal birth within 24 hours; uterine hyperstimulation with associated changes in fetal heart rate; caesarean section (all); and caesarean section for fetal distress.
Results 741 women were randomised, 365 to the misoprostol group and 376 to the vaginal dinoprostone group. There were no significant differences between the two treatment groups in the primary outcomes: vaginal birth not achieved in 24 hours (misoprostol 168/365 (46.0%) v dinoprostone 155/376 (41.2%); relative risk 1.12, 95% confidence interval 0.95 to 1.32; P = 0.134), caesarean section (83/365 (22.7%) v 100/376 (26.6%); 0.82, 0.64 to 1.06; P = 0.127), caesarean section for fetal distress (32/365 (8.8%) v 35/376 (9.3%); 0.91, 0.57 to 1.44; P = 0.679), or uterine hyperstimulation with changes in fetal heart rate (3/365 (0.8%) v 6/376 (1.6%); 0.55, 0.14 to 2.21; P = 0.401). Although there were differences in the process of labour induction, there were no significant differences in adverse maternal or neonatal outcomes.
Conclusions This trial shows no evidence that oral misoprostol is superior to vaginal dinoprostone for induction of labour. However, it does not lead to poorer health outcomes for women or their infants, and oral treatment is preferred by women.
Trial registration National Health and Medical Research Council, Perinatal Trials, PT0361.
doi:10.1136/bmj.38729.513819.63
PMCID: PMC1388124  PMID: 16455695
8.  Maternal positioning to correct occipito-posterior fetal position in labour: a randomised controlled trial 
Background
The occipito-posterior (OP) fetal head position during the first stage of labour occurs in 10-34% of cephalic presentations. Most will spontaneous rotate in anterior position before delivery, but 5-8% of all births will persist in OP position for the third stage of labour. Previous observations have shown that this can lead to an increase of complications, such as an abnormally long labour, maternal and fetal exhaustion, instrumental delivery, severe perineal tears, and emergency caesarean section. Usual care in the case of diagnosis of OP position is an expectant management. However, maternal postural techniques have been reported to promote the anterior position of the fetal head for delivery. A Cochrane review reported that these maternal positions are well accepted by women and reduce back pain. However, the low sample size of included studies did not allow concluding on their efficacy on delivery outcomes, particularly those related to persistent OP position. Our objective is to evaluate the efficacy of maternal position in the management of OP position during the first stage of labour.
Methods/design
A randomised clinical trial is ongoing in the maternity unit of the Geneva University Hospitals, Geneva, Switzerland. The unit is the largest in Switzerland with 4,000 births/year. The trial will involve 438 women with a fetus in OP position, confirmed by sonography, during the first stage of the labour. The main outcome measure is the position of the fetal head, diagnosed by ultrasound one hour after randomisation.
Discussion
It is important to evaluate the efficacy of maternal position to correct fetal OP position during the first stage of the labour. Although these positions seem to be well accepted by women and appear easy to implement in the delivery room, the sample size of the last randomised clinical trial published in 2005 to evaluate this intervention had insufficient power to demonstrate clear evidence of effectiveness. If the technique demonstrates efficacy, it would reduce the physical and psychological consequences of complications at birth related to persistent OP position.
Trial registration
ClinicalTrials.gov, http://www.clinicaltrials.gov: (no. NCT01291355).
doi:10.1186/1471-2393-14-83
PMCID: PMC3942064  PMID: 24564746
Fetal head position; Occipito-posterior; Maternal position; Randomised controlled trial; Second stage of labour
9.  Effect of routine controlled cord traction as part of the active management of the third stage of labour on postpartum haemorrhage: multicentre randomised controlled trial (TRACOR) 
Objective To assess the impact of controlled cord traction on the incidence of postpartum haemorrhage and other characteristics of the third stage of labour in a high resource setting.
Design Randomised controlled trial.
Setting Five university hospital maternity units in France.
Participants Women aged 18 or more with a singleton fetus at 35 or more weeks’ gestation and planned vaginal delivery.
Interventions Women were randomly assigned to management of the third stage of labour by controlled cord traction or standard placenta expulsion (awaiting spontaneous placental separation before facilitating expulsion). Women in both arms received prophylactic oxytocin just after birth.
Main outcome measure Incidence of postpartum haemorrhage ≥500 mL as measured in a collector bag.
Results The incidence of postpartum haemorrhage did not differ between the controlled cord traction arm (9.8%, 196/2005) and standard placenta expulsion arm (10.3%, 206/2008): relative risk 0.95 (95% confidence interval 0.79 to 1.15). The need for manual removal of the placenta was significantly less frequent in the controlled cord traction arm (4.2%, 85/2033) compared with the standard placenta expulsion arm (6.1%, 123/2024): relative risk 0.69, 0.53 to 0.90); as was third stage of labour of more than 15 minutes (4.5%, 91/2030 and 14.3%, 289/2020, respectively): relative risk 0.31, 0.25 to 0.39. Women in the controlled cord traction arm reported a significantly lower intensity of pain and discomfort during the third stage than those in the standard placenta expulsion arm. No uterine inversion occurred in either arm.
Conclusions In a high resource setting, the use of controlled cord traction for the management of placenta expulsion had no significant effect on the incidence of postpartum haemorrhage and other markers of postpartum blood loss. Evidence to recommend routine controlled cord traction for the management of placenta expulsion to prevent postpartum haemorrhage is therefore lacking.
Trial registration ClinicalTrials.gov NCT01044082.
doi:10.1136/bmj.f1541
PMCID: PMC3610557  PMID: 23538918
10.  Induction of labour versus expectant management for prelabour rupture of the membranes at term: an economic evaluation 
BACKGROUND: As the interval between rupture of the fetal membranes at term and delivery increases, so may the risk of fetal and maternal infection. Recently the TERMPROM (Term Prelabor Rupture of the Membranes) Study Group reported the results of a randomized controlled trial comparing 4 management strategies: induction with oxytocin (IwO), induction with prostaglandin (IwP), and expectant management and induction with either oxytocin (EM-O) or prostaglandin (EM-P) if complications developed. The study found no statistically significant differences in neonatal infection and cesarean section rates between any of the 4 groups. OBJECTIVE: To conduct an economic evaluation comparing the cost of (a) IwO and EM-O, (b) IwP and EM-P and (c) IwO and IwP. DESIGN: An economic analysis, conducted alongside the clinical trial, using a third-party payer perspective. Analysis included all treatment costs incurred for both the mother and the baby. Information on health care utilization and outcomes was collected for all study participants. Three countries (Canada, the United Kingdom and Australia), corresponding to the largest study recruitment, were chosen for calculation of unit costs. For each country, the base, low and high estimates of unit cost for each service item were generated. Intention-to-treat analysis. Extensive statistical and sensitivity analyses were performed. RESULTS: The median cost of IwO per patient was significantly lower statistically than that of EM-O and IwP. This result held in all 3 countries compared -$114 and -$46 in Canada, -113 Pounds and -63 Pounds in the UK, and -A$30 and -A$49 in Australia) and after an extensive sensitivity analysis. There was no statistically significant difference in median cost per patient between IwP and EM-P. CONCLUSION: Although the clinical results of the TERMPROM study did not find IwO to be preferable to the other treatment alternatives, the economic evaluation found it to be less costly. However, these cost differences, even though statistically significant, are not likely to be important in many countries. When this is the case, the authors recommend that women be offered a choice between management strategies.
PMCID: PMC1228562  PMID: 9400406
11.  Should cervical favourability play a role in the decision for labour induction in gestational hypertension or mild pre-eclampsia at term? An exploratory analysis of the HYPITAT trial 
Bjog  2012;119(9):1123-1130.
Objective
To examine whether cervical favourability (measured by cervical length and the Bishop score) should inform obstetricians’ decision regarding labour induction for women with gestational hypertension or mild pre-eclampsia at term.
Design
A post hoc analysis of the Hypertension and Pre-eclampsia Intervention Trial At Term (HYPITAT).
Setting
Obstetric departments of six university and 32 teaching and district hospitals in the Netherlands.
Population
A total of 756 women diagnosed with gestational hypertension or pre-eclampsia between 36 + 0 and 41 + 0 weeks of gestation randomly allocated to induction of labour or expectant management.
Methods
Data were analysed using logistic regression modelling.
Main outcome measures
The occurrence of a high-risk maternal situation defined as either maternal complications or progression to severe disease. Secondary outcomes were caesarean delivery and adverse neonatal outcomes.
Results
The superiority of labour induction in preventing high-risk situations in women with gestational hypertension or mild pre-eclampsia at term varied significantly according to cervical favourability. In women who were managed expectantly, the longer the cervix the higher the risk of developing maternal high-risk situations, whereas in women in whom labour was induced, cervical length was not associated with a higher probability of maternal high-risk situations (test of interaction P = 0.03). Similarly, the beneficial effect of labour induction on reducing the caesarean section rate was stronger in women with an unfavourable cervix.
Conclusion
Against widely held opinion, our exploratory analysis showed that women with gestational hypertension or mild pre-eclampsia at term who have an unfavourable cervix benefited more from labour induction than other women.
Trial registration
The trial has been registered in the clinical trial register as ISRCTN08132825.
doi:10.1111/j.1471-0528.2012.03405.x
PMCID: PMC3440582  PMID: 22703475
Bishop score; cervical length; expectant management; gestational hypertension; induction of labour; pre-eclampsia
12.  "GINEXMAL RCT: Induction of labour versus expectant management in gestational diabetes pregnancies" 
Background
Gestational Diabetes (GDM) is one of the most common complications of pregnancies affecting around 7% of women. This clinical condition is associated with an increased risk of developing fetal macrosomia and is related to a higher incidence of caesarean section in comparison to the general population. Strong evidence indicating the best management between induction of labour at term and expectant monitoring are missing.
Methods/Design
Pregnant women with singleton pregnancy in vertex presentation previously diagnosed with gestational diabetes will be asked to participate in a multicenter open-label randomized controlled trial between 38+0 and 39+0 gestational weeks. Women will be recruited in the third trimester in the Outpatient clinic or in the Day Assessment Unit according to local protocols. Women who opt to take part will be randomized according to induction of labour or expectant management for spontaneous delivery. Patients allocated to the induction group will be admitted to the obstetric ward and offered induction of labour via use of prostaglandins, Foley catheter or oxytocin (depending on clinical conditions). Women assigned to the expectant arm will be sent to their domicile where they will be followed up until delivery, through maternal and fetal wellbeing monitoring twice weekly. The primary study outcome is the Caesarean section (C-section) rate, whilst secondary measurement4s are maternal and neonatal outcomes. A total sample of 1760 women (880 each arm) will be recruited to identify a relative difference between the two arms equal to 20% in favour of induction, with concerns to C-section rate. Data will be collected until mothers and newborns discharge from the hospital. Analysis of the outcome measures will be carried out by intention to treat.
Discussion
The present trial will provide evidence as to whether or not, in women affected by gestational diabetes, induction of labour between 38+0 and 39+0 weeks is an effective management to ameliorate maternal and neonatal outcomes. The primary objective is to determine whether caesarean section rate could be reduced among women undergoing induction of labour, in comparison to patients allocated to expectant monitoring. The secondary objective consists of the assessment and comparison of maternal and neonatal outcomes in the two study arms.
Trial Registration
The study protocol has been registered in the ClinicalTrials.gov Protocol Registration System, identification number NCT01058772.
doi:10.1186/1471-2393-11-31
PMCID: PMC3108319  PMID: 21507262
13.  Outcomes of Induction of Labour in Women with Previous Caesarean Delivery: A Retrospective Cohort Study Using a Population Database 
PLoS ONE  2013;8(4):e60404.
Background
There is evidence that induction of labour (IOL) around term reduces perinatal mortality and caesarean delivery rates when compared to expectant management of pregnancy (allowing the pregnancy to continue to await spontaneous labour or definitive indication for delivery). However, it is not clear whether IOL in women with a previous caesarean section confers the same benefits. The aim of this study was to describe outcomes of IOL at 39–41 weeks in women with one previous caesarean delivery and to compare outcomes of IOL or planned caesarean delivery to those of expectant management.
Methods and Findings
We performed a population-based retrospective cohort study of singleton births greater than 39 weeks gestation, in women with one previous caesarean delivery, in Scotland, UK 1981–2007 (n = 46,176). Outcomes included mode of delivery, perinatal mortality, neonatal unit admission, postpartum hemorrhage and uterine rupture. 40.1% (2,969/7,401) of women who underwent IOL 39–41 weeks were ultimately delivered by caesarean. When compared to expectant management IOL was associated with lower odds of caesarean delivery (adjusted odds ratio [AOR] after IOL at 39 weeks of 0.81 [95% CI 0.71–0.91]). There was no significant effect on the odds of perinatal mortality but greater odds of neonatal unit admission (AOR after IOL at 39 weeks of 1.29 [95% CI 1.08–1.55]). In contrast, when compared with expectant management, elective repeat caesarean delivery was associated with lower perinatal mortality (AOR after planned caesarean at 39 weeks of 0.23 [95% CI 0.07–0.75]) and, depending on gestation, the same or lower neonatal unit admission (AOR after planned caesarean at 39 weeks of 0.98 [0.90–1.07] at 40 weeks of 1.08 [0.94–1.23] and at 41 weeks of 0.77 [0.60–1.00]).
Conclusions
A more liberal policy of IOL in women with previous caesarean delivery may reduce repeat caesarean delivery, but increases the risks of neonatal complications.
doi:10.1371/journal.pone.0060404
PMCID: PMC3615029  PMID: 23565242
14.  Nifedipine versus atosiban in the treatment of threatened preterm labour (Assessment of Perinatal Outcome after Specific Tocolysis in Early Labour: APOSTEL III-Trial) 
Background
Preterm birth is the most common cause of neonatal morbidity and mortality. Postponing delivery for 48 hours with tocolytics to allow for maternal steroid administration and antenatal transportation to a centre with neonatal intensive care unit facilities is the standard treatment for women with threatening preterm delivery in most centres. However, there is controversy as to which tocolytic agent is the drug of first choice. Previous trials have focused on tocolytic efficacy and side effects, and are probably underpowered to detect clinically meaningfull differences in neonatal outcome. Thus, the current evidence is inconclusive to support a balanced recommendation for clinical practice. This multicenter randomised clinical trial aims to compare nifedipine and atosiban in terms of neonatal outcome, duration of pregnancy and maternal side effects.
Methods/Design
The Apostel III trial is a nationwide multicenter randomised controlled study. Women with threatened preterm labour (gestational age 25 – 34 weeks) defined as at least 3 contractions per 30 minutes, and 1) a cervical length of ≤ 10 mm or 2) a cervical length of 11-30 mm and a positive Fibronectin test or 3) ruptured membranes will be randomly allocated to treatment with nifedipine or atosiban. Primary outcome is a composite measure of severe neonatal morbidity and mortality. Secondary outcomes will be time to delivery, gestational age at delivery, days on ventilation support, neonatal intensive care (NICU) admittance, length admission in neonatal intensive care, total days in hospital until 3 months corrected age, convulsions, apnoea, asphyxia, proven meningitis, pneumothorax, maternal side effects and costs. Furthermore, an economic evaluation of the treatment will be performed. Analysis will be by intention to treat principle. The power calculation is based on an expected 10% difference in the prevalence of adverse neonatal outcome. This implies that 500 women have to be randomised (two sided test, β 0.2 at alpha 0.05).
Discussion
This trial will provide evidence on the optimal drug of choice in acute tocolysis in threatening preterm labour.
Trial registration
Clinical trial registration: NTR2947, date of registration: June 20th 2011.
doi:10.1186/1471-2393-14-93
PMCID: PMC3944539  PMID: 24589124
Preterm birth; Tocolytics; Nifedipine; Atosiban; Outcome; Drug safety
15.  Induction of labour for improving birth outcomes for women at or beyond term 
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 a policy of induction at 41 completed weeks (287 days) or more.
Fewer babies in the labour induction group had meconium aspiration syndrome (RR 0.50, 95% CI 0.34 to 0.73; eight trials, 2371 infants) compared with a policy of expectant management. There was no statistically significant difference between the rates of neonatal intensive care unit (NICU) admission for induction compared with expectant management (RR 0.90, 95% CI 0.78 to 1.04; 10 trials, 6161 infants). For women in the policy of induction arms of trials, there were significantly fewer caesarean sections compared with expectant management in 21 trials of 8749 women (RR 0.89, 95% CI 0.81 to 0.97).
Authors’ conclusions
A policy of labour induction compared with expectant management is associated with fewer perinatal deaths and fewer caesarean sections. Some infant morbidities such as meconium aspiration syndrome were also reduced with a policy of post-term labour induction although no significant differences in the rate of NICU admission were seen.
However, the absolute risk of perinatal death is small. Women should be appropriately counselled in order to make an informed choice between scheduled induction for a post-term pregnancy or monitoring without induction (or delayed induction).
doi:10.1002/14651858.CD004945.pub3
PMCID: PMC4065650  PMID: 22696345
* Pregnancy, Prolonged; *Watchful Waiting; Cesarean Section [utilization]; Infant Mortality; Infant, Newborn; Labor, Induced [*adverse effects]; Randomized Controlled Trials as Topic; Risk; Female; Humans; Pregnancy
16.  Active versus expectant management for women in the third stage of labour 
Background
Active management of the third stage of labour involves giving a prophylactic uterotonic, early cord clamping and controlled cord traction to deliver the placenta. With expectant management, signs of placental separation are awaited and the placenta is delivered spontaneously. Active management was introduced to try to reduce haemorrhage, a major contributor to maternal mortality in low-income countries.
Objectives
To compare the effectiveness of active versus expectant management of the third stage of labour.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group Trials Register (15 February 2011).
Selection criteria
Randomised and quasi-randomised controlled trials comparing active versus expectant management of the third stage of labour.
Data collection and analysis
Two review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction.
Main results
We included seven studies (involving 8247 women), all undertaken in hospitals, six in high-income countries and one in a low-income country. Four studies compared active versus expectant management, and three compared active versus a mixture of managements. We used random-effects in the analyses because of clinical heterogeneity. There was an absence of high quality evidence for our primary outcomes. The evidence suggested that for women at mixed levels of risk of bleeding, active management showed a reduction in the average risk of maternal primary haemorrhage at time of birth (more than 1000 mL) (average risk ratio (RR) 0.34, 95% confidence interval (CI) 0.14 to 0.87, three studies, 4636 women) and of maternal haemoglobin (Hb) less than 9 g/dL following birth (average RR 0.50, 95% CI 0.30 to 0.83, two studies, 1572 women). We also found no difference in the incidence in admission of infants to neonatal units (average RR 0.81, 95% CI 0.60 to 1.11, two studies, 3207 women) nor in the incidence of infant jaundice requiring treatment (0.96, 95% CI 0.55 to 1.68, two studies, 3142 women). There were no data on our other primary outcomes of very severe postpartum haemorrhage (PPH) at the time of birth (more than 2500 mL), maternal mortality, or neonatal polycythaemia needing treatment.
Active management also showed a significant decrease in primary blood loss greater than 500 mL, and mean maternal blood loss at birth, maternal blood transfusion and therapeutic uterotonics during the third stage or within the first 24 hours, or both and significant increases in maternal diastolic blood pressure, vomiting after birth, after-pains, use of analgesia from birth up to discharge from the labour ward and more women returning to hospital with bleeding (outcome not pre-specified). There was also a decrease in the baby’s birthweight with active management, reflecting the lower blood volume from interference with placental transfusion.
In the subgroup of women at low risk of excessive bleeding, there were similar findings, except there was no significant difference identified between groups for severe haemorrhage or maternal Hb less than 9 g/dL (at 24 to 72 hours).
Hypertension and interference with placental transfusion might be avoided by using modifications to the active management package, e.g. omitting ergot and deferring cord clamping, but we have no direct evidence of this here.
Authors’ conclusions
Although there is a lack of high quality evidence, active management of the third stage reduced the risk of haemorrhage greater than 1000 mL at the time of birth in a population of women at mixed risk of excessive bleeding, but adverse effects were identified. Women should be given information on the benefits and harms of both methods to support informed choice. Given the concerns about early cord clamping and the potential adverse effects of some uterotonics, it is critical now to look at the individual components of third-stage management. Data are also required from low-income countries.
doi:10.1002/14651858.CD007412.pub3
PMCID: PMC4026059  PMID: 22071837
17.  Immersion in water in labour and birth 
Background
Enthusiasts suggest that labouring in water and waterbirth increase maternal relaxation, reduce analgesia requirements and promote a midwifery model of care. Critics cite the risk of neonatal water inhalation and maternal/neonatal infection.
Objectives
To assess the evidence from randomised controlled trials about immersion in water during labour and waterbirth on maternal, fetal, neonatal and caregiver outcomes.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 June 2011) and reference lists of retrieved studies.
Selection criteria
Randomised controlled trials comparing immersion in any bath tub/pool with no immersion, or other non-pharmacological forms of pain management during labour and/or birth, in women during labour who were considered to be at low risk of complications, as defined by the researchers.
Data collection and analysis
We assessed trial eligibility and quality and extracted data independently. One review author entered data and the other checked for accuracy.
Main results
This review includes 12 trials (3243 women): eight related to just the first stage of labour: one to early versus late immersion in the first stage of labour; two to the first and second stages; and another to the second stage only. We identified no trials evaluating different baths/pools, or the management of third stage of labour.
Results for the first stage of labour showed there was a significant reduction in the epidural/spinal/paracervical analgesia/anaesthesia rate amongst women allocated to water immersion compared to controls (478/1254 versus 529/1245; risk ratio (RR) 0.90; 95% confidence interval (CI) 0.82 to 0.99, six trials). There was also a reduction in duration of the first stage of labour (mean difference −32.4 minutes; 95% CI −58.7 to −6.13). There was no difference in assisted vaginal deliveries (RR 0.86; 95% CI 0.71 to 1.05, seven trials), caesarean sections (RR 1.21; 95% CI 0.87 to 1.68, eight trials), use of oxytocin infusion (RR 0.64; 95%CI 0.32 to 1.28,five trials), perineal trauma or maternal infection. There were no differences for Apgar score less than seven at five minutes (RR 1.58; 95% CI 0.63 to 3.93, five trials), neonatal unit admissions (RR 1.06; 95% CI 0.71 to 1.57, three trials), or neonatal infection rates (RR 2.00; 95% CI 0.50 to 7.94, five trials).
Of the three trials that compared water immersion during the second stage with no immersion, one trial showed a significantly higher level of satisfaction with the birth experience (RR 0.24; 95% CI 0.07 to 0.80).
A lack of data for some comparisons prevented robust conclusions. Further research is needed.
Authors’ conclusions
Evidence suggests that water immersion during the first stage of labour reduces the use of epidural/spinal analgesia and duration of the first stage of labour. There is limited information for other outcomes related to water use during the first and second stages of labour, due to intervention and outcome variability. There is no evidence of increased adverse effects to the fetus/neonate or woman from labouring in water or waterbirth. However, the studies are very variable and considerable heterogeneity was detected for some outcomes. Further research is needed.
doi:10.1002/14651858.CD000111.pub3
PMCID: PMC3982045  PMID: 19370552
18.  Effects of algorithm for diagnosis of active labour: cluster randomised trial 
Objective To compare the effectiveness of an algorithm for diagnosis of active labour in primiparous women with standard care in terms of maternal and neonatal outcomes.
Design Cluster randomised trial.
Setting Maternity units in Scotland with at least 800 annual births.
Participants 4503 women giving birth for the first time, in 14 maternity units. Seven experimental clusters collected data from a baseline sample of 1029 women and a post-implementation sample of 896 women. The seven control clusters had a baseline sample of 1291 women and a post-implementation sample of 1287 women.
Intervention Use of an algorithm by midwives to assist their diagnosis of active labour, compared with standard care.
Main outcomes Primary outcome: use of oxytocin for augmentation of labour. Secondary outcomes: medical interventions in labour, admission management, and birth outcome.
Results No significant difference was found between groups in percentage use of oxytocin for augmentation of labour (experimental minus control, difference=0.3, 95% confidence interval −9.2 to 9.8; P=0.9) or in the use of medical interventions in labour. Women in the algorithm group were more likely to be discharged from the labour suite after their first labour assessment (difference=−19.2, −29.9 to −8.6; P=0.002) and to have more pre-labour admissions (0.29, 0.04 to 0.55; P=0.03).
Conclusions Use of an algorithm to assist midwives with the diagnosis of active labour in primiparous women did not result in a reduction in oxytocin use or in medical intervention in spontaneous labour. Significantly more women in the experimental group were discharged home after their first labour ward assessment.
Trial registration Current Controlled Trials ISRCTN00522952.
doi:10.1136/bmj.a2396
PMCID: PMC2601030  PMID: 19064606
19.  Labour management and Obstetric outcomes among pregnant women admitted in latent phase compared to active phase of labour at Bugando Medical Centre in Tanzania 
Background
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.
Methods
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.
Results
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.
Conclusions
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.
doi:10.1186/1471-2393-14-68
PMCID: PMC3925356  PMID: 24521301
Latent phase of labour; Active phase of labour; Interventions; Low risk pregnancy
20.  Impending macrosomia: will induction of labour modify the risk of caesarean delivery? 
Objective
To compare the annual incidence rates of caesarean delivery between induction of labour and expectant management in the setting of macrosomia.
Design
This is a retrospective cohort study.
Setting
Deliveries in the USA in 2003.
Population
Singleton births of macrosomic neonates to low-risk nulliparous women at 39 weeks of gestation and beyond.
Methods
Women who had induction of labour at 39 weeks of gestation with a neonatal birthweight of 4000 ± 125 g (3875–4125 g) were compared with women who delivered (either induced or spontaneous labour) at 40, 41 or 42 weeks (i.e. expectant management), assuming an intrauterine fetal weight gain of 200 g per additional week of gestation. Similar comparisons were made at 40 and 41 weeks of gestation. Chi-square test and multivariable logistic regression analysis were used for statistical comparison.
Main outcome measures
Method of delivery, 5-minute Apgar scores, neonatal injury.
Results
There were 132 112 women meeting the study criteria. In women whose labours were induced at 39 weeks and who delivered a neonate with a birthweight of 4000 ± 125 g, the frequency of caesarean was lower compared with women who delivered at a later gestational age (35.2% versus 40.9%; adjusted OR 1.25, 95% CI 1.17–1.33). This trend was maintained at both 40 weeks (36.1% versus 42.6%; adjusted OR 1.31, 95% CI 1.23–1.40) and 41 weeks (38.9% versus 41.8%; adjusted OR 1.16, 95% CI 1.06–1.28) of gestation.
Conclusions
In the setting of known birthweight, it appears that induction of labour may reduce the risk of caesarean delivery. Future research should concentrate on clinical and radiological methods to better estimate birthweight to facilitate improved clinical care. These findings deserve examination in a large, prospective, randomised trial.
doi:10.1111/j.1471-0528.2011.03248.x
PMCID: PMC3428793  PMID: 22251443
Induction of labour; macrosomia; mode of delivery
21.  Cost-effectiveness of induction of labour versus serial antenatal monitoring in the Canadian Multicentre Postterm Pregnancy Trial. 
OBJECTIVE: To determine the cost-effectiveness of induction of labour versus serial fetal monitoring while awaiting spontaneous labour in postterm pregnancies. DESIGN: Cost-effectiveness and cost-minimization analyses conducted as part of a Canadian multicentre randomized clinical trial. SETTING: Twenty-two Canadian hospitals, of which 19 were teaching hospitals and 3 were community hospitals. PATIENTS: Women with uncomplicated pregnancies of 41 or more weeks' gestation were randomly assigned to induction of labour or serial antenatal monitoring. Of the 3418 women enrolled, no data were received on 11. Therefore, results were based on data from 1701 women in the induction arm of the study and 1706 women in the monitoring arm. MAIN OUTCOME MEASURES: Perinatal mortality and neonatal morbidity, rates of cesarean section and health care costs. Hospital costing models were developed specifically for the study. Data on use of major resources (e.g., length of hospital stay, surgical procedures, major diagnostic tests and procedures, and medications) for all trial participants were collected and combined with data on minor tests and procedures (e.g., laboratory tests) abstracted from a detailed review of medical records of a sample of patients. RESULTS: Because the results of the clinical trial showed a nonsignificant difference in perinatal mortality and neonatal morbidity between the induction and monitoring arms, the authors conducted a cost-minimization rather than a cost-effectiveness analysis. The mean cost per patient with a postterm pregnancy managed through monitoring was $3132 (95% confidence interval [CI] $3090 to $3174) and per patient who underwent induction of labour was $2939 (95% CI $2898 to $2981), for a difference of $193. The significantly higher (p < 0.0001) mean cost per patient in the monitoring arm was due mainly to the costs of additional monitoring and the significantly higher rates of cesarean section among these patients. Estimated conservatively, the savings resulting from a universal policy of managing postterm pregnancies by induction of labour in Canada may be as high as $8 million a year. CONCLUSIONS: A policy of managing postterm pregnancy through induction of labour not only results in more favourable outcomes than a monitoring strategy but does so at a lower cost.
PMCID: PMC1337908  PMID: 7728693
22.  Outcomes of elective induction of labour compared with expectant management: population based study 
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 with 7.3% (25 572/350 791) in the expectant management group; adjusted odds ratio 1.14, 1.09 to 1.20).
Conclusion Although residual confounding may remain, our findings indicate that elective induction of labour at term gestation can reduce perinatal mortality in developed countries without increasing the risk of operative delivery.
doi:10.1136/bmj.e2838
PMCID: PMC3349781  PMID: 22577197
23.  Randomised comparison of early versus late induction of labour in post-term pregnancy. 
In a prospective randomised study of mothers referred for prolonged pregnancy (around the 42nd week) 214 (group 1) were submitted to attempted induction of labour and 195 (group 2) assigned to continue for a further week without intervention. Strict selection criteria were used for the certainty of term. Mothers in group 2 were given regular non-stress tests to ensure fetal wellbeing, as were those in group 1 in whom induction failed. In group 1, 48 (23%) out of 210 first attempted inductions failed. In group 2, 135 (69%) of the births started spontaneously as compared with 38 (18%) in group 1. The mean duration of labour was 7.5 hours in each group. There was no significant difference in incidence of operative delivery, use of analgesics, or signs of perinatal asphyxia. Significantly more children in group 1 needed phototherapy for hyperbilirubinaemia. There was a clustering of births in the late afternoon and evening, which was most pronounced in group 1. A policy of vigilant non-intervention up to the 44th completed week of pregnancy does not appear to jeopardize mother or fetus.
PMCID: PMC1246355  PMID: 3109575
24.  Induction of labour versus expectant management for nulliparous women over 35 years of age: a multi-centre prospective, randomised controlled trial 
Background
British women are increasingly delaying childbirth. The proportion giving birth over the age of 35 rose from 12% in 1996 to 20% in 2006. Women over this age are at a higher risk of perinatal death, and antepartum stillbirth accounts for 61% of all such deaths. Women over 40 years old have a similar stillbirth risk at 39 weeks as women who are between 25 and 29 years old have at 41 weeks.
Many obstetricians respond to this by suggesting labour induction at term to forestall some of the risk. In a national survey of obstetricians 37% already induce women aged 40–44 years. A substantial minority of parents support such a policy, but others do not on the grounds that it might increase the risk of Caesarean section. However trials of induction in other high-risk scenarios have not shown any increase in Caesarean sections, rather the reverse. If induction for women over 35 did not increase Caesareans, or even reduced them, it would plausibly improve perinatal outcome and be an acceptable intervention. We therefore plan to perform a trial to test the effect of such an induction policy on Caesarean section rates.
This trial is funded by the NHS Research for Patient Benefit (RfPB) Programme.
Design
The 35/39 trial is a multi-centre, prospective, randomised controlled trial. It is being run in twenty UK centres and we aim to recruit 630 nulliparous women (315 per group) aged over 35 years of age, over two years. Women will be randomly allocated to one of two groups:
Induction of labour between 390/7 and 396/7 weeks gestation.
Expectant management i.e. awaiting spontaneous onset of labour unless a situation develops necessitating either induction of labour or Caesarean Section.
The primary purpose of this trial is to establish what effect a policy of induction of labour at 39 weeks for nulliparous women of advanced maternal age has on the rate of Caesarean section deliveries. The secondary aim is to act as a pilot study for a trial to answer the question, does induction of labour in this group of women improve perinatal outcomes? Randomisation will occur at 360/7 – 396/7 weeks gestation via a computerised randomisation programme at the Clinical Trials Unit, University of Nottingham. There will be no blinding to treatment allocation.
Discussion
The 35/39 trial is powered to detect an effect of induction of labour on the risk of caesarean section, it is underpowered to determine whether it improves perinatal outcome. The current study will also act as a pilot for a larger study to address this question.
Trial registration
ISRCTN11517275
doi:10.1186/1471-2393-12-145
PMCID: PMC3560256  PMID: 23231750
Induction of labour; Advanced maternal age; Perinatal outcome; Caesarean delivery
25.  Randomised controlled trial of oxytocin alone versus oxytocin and ergometrine in active management of third stage of labour. 
BMJ : British Medical Journal  1993;307(6913):1167-1171.
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.
PMCID: PMC1679299  PMID: 8251842

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