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Treatment with heat-stable carbetocin after vaginal delivery was noninferior to oxytocin for prevention of blood loss of at least 500 ml or use of uterotonics. Noninferiority was not shown for prevention of blood loss of at least 1000 ml, but event rates were low.

Labour is induced in 20–30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone. We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 μg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (≥1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466. Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86–1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69–1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure. In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness. FondsNutsOhra.

Induction of labour is a common obstetric procedure. Both mechanical (eg, Foley catheters) and pharmacological methods (eg, prostaglandins) are used for induction of labour in women with an unfavourable cervix. We aimed to compare the effectiveness and safety of induction of labour with a Foley catheter with induction with vaginal prostaglandin E2 gel. We did an open-label, randomised controlled trial in 12 hospitals in the Netherlands between Feb 10, 2009, and May 17, 2010. We enrolled women with a term singleton pregnancy in cephalic presentation, intact membranes, an unfavourable cervix, an indication for induction of labour, and no prior caesarean section. Participants were randomly allocated by an online randomisation system to induction of labour with a 30 mL Foley catheter or vaginal prostaglandin E2 gel (1:1 ratio). Because of the nature of the intervention this study was not blinded. The primary outcome was caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. All analyses were done on an intention-to-treat basis. We also did a meta-analysis that included our trial. The trial was registered with the Dutch trial registry, number NTR 1646. 824 women were allocated to induction of labour with a Foley catheter (n=412) or vaginal prostaglandin E2 gel (n=412). Caesarean section rates were much the same between the two groups (23% vs 20%, risk ratio [RR] 1·13, 95% CI 0·87–1·47). A meta-analysis including our trial data confirmed that a Foley catheter did not reduce caesarean section rates. We recorded two serious maternal adverse events, both in the prostaglandin group: one uterine perforation and one uterine rupture. In women with an unfavourable cervix at term, induction of labour with a Foley catheter is similar to induction of labour with prostaglandin E2 gel, with fewer maternal and neonatal side-effects. None.

To compare effectiveness and safety of oral misoprostol (50 μg every four hours as needed), low dose vaginal misoprostol (25 to 50 μg every six hours as needed), and our established dinoprostone vaginal gel (one to two mg every six hours as needed) induction. Consenting women with a live term single cephalic fetus for indicated labor induction were randomized (3N = 511). Prior uterine surgery or non-reassuring fetal surveillance were exclusions. Concealed computer generated randomization was stratified and blocked. Newborns were assessed by a team unaware of group assignment. The primary outcome was time from induction at randomization to vaginal birth for initial parametric analysis. Sample size was based on mean difference of 240 minutes with α2 = 0.05 and power 95%. Non-parametric analysis was also pre-specified ranking cesareans as longest vaginal births. Enrollment was from April 1999 to December 2000. Demographics were similar across groups. Analysis was by intent to treat, with no loss to follow up. Mean time (±SD) to vaginal birth was 1356 (±1033) minutes for oral misoprostol, 1530 (±3249) minutes for vaginal misoprostol, and 1208 (±613) minutes for vaginal dinoprostone (P = 0.46, ANOVA). Median times to vaginal birth were 1571, 1339, and 1451 minutes respectively (P = 0.46, Kruskal-Wallis). Vaginal births occurred within 24 hours in 44.9, 53.5 and 47.7% respectively (P = 0.27, χ2). There were no significant differences in Kaplan Meier survival analyses, cesareans, adverse effects, or maternal satisfaction. The newborn who met birth asphyxia criteria received vaginal misoprostol, as did. all three other newborns with cord artery pH<7.0 (P = 0.04, Fisher Exact). There was no significant difference in effectiveness of the three groups. Profound newborn acidemia, though infrequent, occurred only with low dose vaginal misoprostol.

AbstractObjectiveTo determine whether discontinuing oxytocin stimulation in the active phase of induced labour is associated with lower caesarean section rates.DesignInternational multicentre, double blind, randomised controlled trial.SettingNine hospitals in Denmark and one in the Netherlands between 8 April 2016 and 30 June 2020.Participants1200 women stimulated with intravenous oxytocin infusion during the latent phase of induced labour.InterventionWomen were randomly assigned to have their oxytocin stimulation discontinued or continued in the active phase of labour.Main outcome measureDelivery by caesarean section.ResultsA total of 607 women were assigned to discontinuation and 593 to continuation of the oxytocin infusion. The rates of caesarean section were 16.6% (n=101) in the discontinued group and 14.2% (n=84) in the continued group (relative risk 1.17, 95% confidence interval 0.90 to 1.53). In 94 parous women with no previous caesarean section, the caesarean section rate was 7.5% (11/147) in the discontinued group and 0.6% (1/155)in the continued group (relative risk 11.6, 1.15 to 88.7). Discontinuation was associated with longer duration of labour (median from randomisation to delivery 282 v 201 min; P<0.001), a reduced risk of hyperstimulation (20/546 (3.7%) v 70/541 (12.9%); P<0.001), and a reduced risk of fetal heart rate abnormalities (153/548 (27.9%) v 219/537 (40.8%); P<0.001) but rates of other adverse maternal and neonatal outcomes were similar between groups.ConclusionsIn a setting where monitoring of the fetal condition and the uterine contractions can be guaranteed, routine discontinuation of oxytocin stimulation may lead to a small increase in caesarean section rate but a significantly reduced risk of uterine hyperstimulation and abnormal fetal heart rate patterns.Trial registrationClinicalTrials.gov NCT02553226.

Oxytocin is effective in reducing labour duration but can be associated with fetal and maternal complications that could potentially be reduced by discontinuing the treatment during labour. We aimed to assess the impact of discontinuing oxytocin during active labour on neonatal morbidity. STOPOXY was a multicentre, randomised, open-label, controlled, superiority trial conducted in 21 maternity units in France. Participants who received oxytocin before 4 cm dilation were randomly assigned 1:1 to either discontinuous oxytocin (oxytocin infusion stopped beyond a cervical dilation equal to or greater than 6 cm) or continuous oxytocin (administration of oxytocin continued until delivery). Randomisation was stratified by centre and parity. The primary outcome, neonatal morbidity, was assessed at birth using a composite variable defined by an umbilical arterial pH at birth less than 7·10, a base excess greater than 10 mmol/L, umbilical arterial lactates greater than 7 mmol/L, a 5-min Apgar score less than 7, or admission to the neonatal intensive care unit. Efficacy and safety was assessed in participants who were randomly assigned (excluding those who withdrew consent or were deemed ineligible after randomisation) and had reached a cervical dilation of at least 6 cm. This trial is registered with ClinicalTrials.gov, NCT03991091. Of 2459 participants randomly assigned between Jan 13, 2020, and Jan 24, 2022, 2170 were eligible to receive the intervention and were included in the final modified intention-to-treat analysis. The primary outcome occurred for 102 (9·6%) of 1067 participants (95% CI 7·9 to 11·5) in the discontinuous oxytocin group and for 101 (9·2%) of 1103 participants (7·6 to 11·0) in the continuous oxytocin group; absolute difference 0·4% (95% CI –2·1 to 2·9); relative risk 1·0 (95% CI 0·8 to 1·4). There were no clinically significant differences in adverse events between the two groups of the safety population. Among participants receiving oxytocin in early labour, discontinuing oxytocin when the active phase is reached does not clinically or statistically significantly reduce neonatal morbidity compared with continuous oxytocin. French Ministry of Health and the Département de la Recherche Clinique et du Développement de l'Assistance Publique–Hôpitaux de Paris.

Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist—such as the uterotonic drug oxytocin—most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting. In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as ≥500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database ( http://www. clinicaltrials.gov) as number NCT00097123. Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12·0% to 6·4%, p<0·0001; relative risk 0·53 [95% CI 0·39–0·74]) and acute severe postpartum haemorrhage (1·2% to 0·2%, p<0·0001; 0·20 [0·04–0·91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262·3 mL to 214·3 mL, p<0·0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control. Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.

Background The approach to induction of labour differs internationally, with timing of amniotomy being controversial. Some institutions favour performing artificial rupture of membranes prior to commencement of oxytocin infusion, with the belief that the labour will progress more efficiently. In other institutions, the approach recommended is for oxytocin infusion with intact amniotic membranes until the person has reached the active phase of labour, citing risk of infection with early amniotomy. Current evidence is inconclusive. We are performing a randomised controlled trial assessing whether delaying amniotomy until the active phase of labour can decrease the rate of chorioamnionitis. Methods This is a randomised controlled trial at a single centre in New Zealand. Pregnant people undergoing induction of labour at ≥ 37 weeks gestational age with intact membranes and a singleton gestation are eligible for the trial. Participants are randomised to ‘Early’ amniotomy, at the commencement of oxytocin infusion, or to ‘Late’ amniotomy, when they have reached a cervical dilation of 6 or more centimetres or when they have been receiving oxytocin infusion for 12 h. The primary outcome of the trial is chorioamnionitis. To detect a decrease in chorioamnionitis from 9 to 3% with a power of 80% and a 95% CI, we will require 488 participants in total, randomised in a 1:1 ratio. Discussion If delaying amniotomy reduces the rate of chorioamnionitis, this is important to inform future practice. Chorioamnionitis entails risk to both the pregnant person and the fetus and is an important contributor to neonatal sepsis, neonatal intensive care unit admission, maternal sepsis, caesarean, wound infection and postoperative infective complications. Conversely, if the rate of chorioamnionitis is not affected by timing of amniotomy, this will allow for safe individualization of care. Trial registration The trial is registered on the Australian and New Zealand Clinical Trials Registry, anzctr.org.au. Full registry title is ‘Impact of early versus late artificial rupture of membranes during oxytocin induction of labour on the incidence of chorioamnionitis: A randomised controlled trial’. Trial ID: ACTRN12621000405819. Date registered 14 April 2021.

Background Despite growing interest in the (therapeutic) use of intranasal oxytocin administration in children, the potential side-effects of intranasal oxytocin have remained largely unclear to date. The current study is the first double-blind randomized controlled trial to examine side-effects following single administration of oxytocin nasal spray in elementary school-aged children. Methods One hundred children (8–12 years old) were randomly assigned to receive oxytocin or placebo nasal spray. We assessed side-effects by means of a standardized, drug-specific questionnaire and an open-ended question at two time points: 90 min after nasal spray administration and 24 h after administration. Results There were no significant associations between nasal spray condition and total frequency of reported side-effects or reports of specific side-effects. Children and their mothers were unable to correctly guess nasal spray allocation, further supporting that the subjective experience of oxytocin versus placebo nasal spray effects was similar. Moreover, the majority of reported side-effects were classified as mild and ceased within 24 h after the procedure, indicating that the nasal sprays were well tolerated. Conclusion In all, this study is the first randomized controlled trial to provide information on the safety of intranasal oxytocin administration in middle childhood. The current study suggests that single administration of intranasal oxytocin is likely safe in elementary school-aged children.

Background Postpartum hemorrhage (PPH) remains a leading cause of maternal morbidity and mortality worldwide. It is therefore important to improve our understanding of the risk factors for PPH according to parity, in particular, those linked to modifiable obstetric practices. The aim of this study was to assess the risk of PPH by the duration of the second and third stages of labor, stratified by parity. Methods This study was based on secondary analysis of data from participants in a randomized controlled trial. A sample of women from three university hospitals in France aged at least 18 years, with a singleton pregnancy, in the first stage of labor, at 36–42 weeks of gestation, with epidural anesthesia and a vaginal delivery were included. The main outcome was PPH rates, defined by blood loss > 500 mL within 2 h after delivery. Characteristics of mothers, newborns, labor, and delivery, and their relation to PPH were explored with multivariable regression models. Results Of 1598 women included, 864 were nulliparous and 680 parous; their respective PPH rates were 9.1% (79/864) and 7.4% (54/680) ( P  = 0.2), and the overall rate 8.3% (133/1598). The multivariable analysis found that PPH was associated with the durations of both oxytocin exposure (aOR 1.10, 95%CI 1.01–1.20) and the third stage of labour (aOR 1.80, 95%CI 1.37–2.38) among nulliparous women, and the PPH risk increased with both duration of the third stage (aOR 2.10, 95%CI 1.56–2.83) and history of PPH (aOR 3.02, 95%CI 1.38–6.59) among parous women. Conclusions The duration of oxytocin exposure was found to be a risk factor for PPH among nulliparous women as was a history of PPH among parous women. Future studies should focus on duration of third stage of labor, especially when active management of the third stage of labor (AMTSL) is routinely used. Trial registration The trial was registered at ClinicalTrials.gov NCT01113229.