Induction of labour with a viable infant: a randomised clinical trial comparing intravaginal misoprostol and intravaginal dinoprostone

Patrick Rozenberg , Sylvie Chevret , François Goffinet , Isabelle Durand-Zaleski , Y Ville , Christophe Vayssière , Aline Roberto , Zouhair Lahna , Israel Nisand , Caroline Fisch , Philippe Chaumet-Riffaud , Claude Chastang
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Abstract

Objective To compare the efficacy and safety of vaginal misoprostol (50μg) with vaginal dinoprostone.

Design Double-blind randomised trial.

Setting Obstetrics Department, Poissy Hospital, France.

Participants 370 patients with medical indications for induction of labour.

Outcome measures Vaginal deliveries within 24 hours, as well as time to vaginal deliveries, caesarean rates, costs, and fetal, neonatal and maternal condition.

Results Compared with vaginal dinoprostone, vaginal misoprostol resulted in greater efficacy in several areas: vaginal delivery within 24 hours; time to vaginal delivery; and vaginal delivery within 12 hours. There was a non-significant increase in the caesarean section rate for fetal distress in the misoprostol group, but fewer caesarean sections for failed induction. Fetal tolerance was similar in the two groups, although significantly more neonates had a cord pH <7.20 and (non-significantly) none had meconium stained amniotic fluid in the misoprostol group. The incidence of poor neonatal outcome was similar in both groups. Subgroup analysis by indication for induction showed that the higher rates of arterial cord pH <7.20 and of meconium-stained amniotic fluid with misoprostol persisted only in possible fetal compromise. Poor neonatal outcome was less frequent in the misoprostol group in cases of induction for non-fetal indications.

Conclusions Vaginal misoprostol resulted in successful and earlier induction of labour more often than dinoprostone, but the safety of misoprostol raises some concern in potentially compromised infants. Misoprostol should be preferred to dinoprostone in cases of induction for non-fetal indications.

可存活婴儿引产:一项比较阴道内米索前列醇和阴道内迪诺前列酮的随机临床试验
目的比较50μg阴道米索前列醇与阴道迪诺前列酮的疗效和安全性。设计双盲随机试验。背景:法国泊西医院产科。参与者370名有引产医学指征的病人。结果测量24小时内阴道分娩、阴道分娩时间、剖宫产率、成本以及胎儿、新生儿和产妇状况。结果阴道米索前列醇与阴道迪诺前列醇相比,在以下几个方面具有更大的疗效:24小时内阴道分娩;阴道分娩时间;12小时内阴道分娩。米索前列醇组胎儿窘迫的剖宫产率无显著增加,但引产失败的剖宫产率较少。两组胎儿耐受性相似,但米索前列醇组新生儿脐带pH值明显高于7.20,羊水无胎粪染色(不显著)。两组新生儿预后不良的发生率相似。根据诱导指征进行的亚组分析显示,只有在可能的胎儿损害中,动脉脐带pH <7.20和米索前列醇粪染色羊水的较高发生率才会持续存在。在非胎儿适应症诱导的情况下,米索前列醇组新生儿预后较差。结论阴道米索前列醇比迪诺前列酮更容易成功和更早引产,但米索前列醇的安全性引起了一些对潜在受损婴儿的关注。在非胎儿适应症诱导的情况下,米索前列醇应优先于迪诺前列酮。
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