Alfirevic Zarko, Aflaifel Nasreen, Weeks Andrew
Department of Women's and Children's Health, The University of Liverpool, First Floor, Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool, UK, L8 7SS.
Cochrane Database Syst Rev. 2014 Jun 13;2014(6):CD001338. doi: 10.1002/14651858.CD001338.pub3.
Misoprostol is an orally active prostaglandin. In most countries misoprostol is not licensed for labour induction, but its use is common because it is cheap and heat stable.
To assess the use of oral misoprostol for labour induction in women with a viable fetus.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (17 January 2014).
Randomised trials comparing oral misoprostol versus placebo or other methods, given to women with a viable fetus for labour induction.
Two review authors independently assessed trial data, using centrally-designed data sheets.
Overall there were 76 trials (14,412) women) which were of mixed quality.In nine trials comparing oral misoprostol with placebo (1109 women), women using oral misoprostol were more likely to give birth vaginally within 24 hours (risk ratio (RR) 0.16, 95% confidence interval (CI) 0.05 to 0.49; one trial; 96 women), need less oxytocin (RR 0.42, 95% CI 0.37 to 0.49; seven trials; 933 women) and have a lower caesarean section rate (RR 0.72, 95% CI 0.54 to 0.95; eight trials; 1029 women).In 12 trials comparing oral misoprostol with vaginal dinoprostone (3859 women), women given oral misoprostol were less likely to need a caesarean section (RR 0.88, 95% CI 0.78 to 0.99; 11 trials; 3592 women). There was some evidence that they had slower inductions, but there were no other statistically significant differences.Nine trials (1282 women) compared oral misoprostol with intravenous oxytocin. The caesarean section rate was significantly lower in women who received oral misoprostol (RR 0.77, 95% CI 0.60 to 0.98; nine trials; 1282 women), but they had increased rates of meconium-stained liquor (RR 1.65, 95% CI 1.04 to 2.60; seven trials; 1172 women).Thirty-seven trials (6417 women) compared oral and vaginal misoprostol and found no statistically significant difference in the primary outcomes of serious neonatal morbidity/death or serious maternal morbidity or death. The results for vaginal birth not achieved in 24 hours, uterine hyperstimulation with fetal heart rate (FHR) changes, and caesarean section were highly heterogenous - for uterine hyperstimulation with FHR changes this was related to dosage with lower rates in those with lower doses of oral misoprostol. However, there were fewer babies born with a low Apgar score in the oral group (RR 0.60, 95% CI 0.44 to 0.82; 19 trials; 4009 babies) and a decrease in postpartum haemorrhage (RR 0.57, 95% CI 0.34 to 0.95; 10 trials; 1478 women). However, the oral misoprostol group had an increase in meconium-stained liquor (RR 1.22, 95% CI 1.03 to 1.44; 24 trials; 3634 women).
AUTHORS' CONCLUSIONS: Oral misoprostol as an induction agent is effective at achieving vaginal birth. It is more effective than placebo, as effective as vaginal misoprostol and results in fewer caesarean sections than vaginal dinoprostone or oxytocin.Where misoprostol remains unlicensed for the induction of labour, many practitioners will prefer to use a licensed product like dinoprostone. If using oral misoprostol, the evidence suggests that the dose should be 20 to 25 mcg in solution. Given that safety is the primary concern, the evidence supports the use of oral regimens over vaginal regimens. This is especially important in situations where the risk of ascending infection is high and the lack of staff means that women cannot be intensely monitored.
米索前列醇是一种口服活性前列腺素。在大多数国家,米索前列醇未被批准用于引产,但因其价格低廉且热稳定性好,其使用很普遍。
评估口服米索前列醇用于有存活胎儿的妇女引产的效果。
我们检索了Cochrane妊娠与分娩组试验注册库(2014年1月17日)。
比较口服米索前列醇与安慰剂或其他方法,用于有存活胎儿的妇女引产的随机试验。
两位综述作者使用中央设计的数据表独立评估试验数据。
总体上有76项试验(14412名妇女),质量参差不齐。在9项比较口服米索前列醇与安慰剂的试验(1109名妇女)中,使用口服米索前列醇的妇女在24小时内阴道分娩的可能性更高(风险比(RR)0.16,95%置信区间(CI)0.05至0.49;1项试验;96名妇女),需要的缩宫素更少(RR 0.42,95%CI 0.37至0.49;7项试验;933名妇女),剖宫产率更低(RR 0.72,95%CI 0.54至0.95;8项试验;1029名妇女)。在12项比较口服米索前列醇与阴道用地诺前列酮的试验(3859名妇女)中,给予口服米索前列醇的妇女剖宫产的可能性更小(RR 0.88,95%CI 0.78至0.99;11项试验;3592名妇女)。有一些证据表明她们引产较慢,但没有其他统计学上的显著差异。9项试验(1282名妇女)比较了口服米索前列醇与静脉用缩宫素。接受口服米索前列醇的妇女剖宫产率显著更低(RR 0.77,95%CI 0.60至0.98;9项试验;1282名妇女),但她们羊水粪染率增加(RR 1.65,95%CI 1.04至2.60;7项试验;1172名妇女)。37项试验(6417名妇女)比较了口服和阴道用米索前列醇,发现在严重新生儿发病率/死亡或严重孕产妇发病率或死亡的主要结局方面没有统计学上的显著差异。24小时内未实现阴道分娩、伴有胎儿心率(FHR)变化的子宫过度刺激和剖宫产的结果高度异质性——对于伴有FHR变化的子宫过度刺激,这与剂量有关,口服米索前列醇剂量较低者发生率较低。然而,口服组出生时阿氏评分低的婴儿较少(RR 0.60,95%CI 0.44至0.82;19项试验;4009名婴儿),产后出血减少(RR 0.57,95%CI 0.34至0.95;10项试验;1478名妇女)。然而,口服米索前列醇组羊水粪染率增加(RR 1.22,95%CI 1.03至1.44;24项试验;3634名妇女)。
口服米索前列醇作为引产剂在实现阴道分娩方面是有效的。它比安慰剂更有效,与阴道用米索前列醇一样有效,且比阴道用前列腺素或缩宫素导致的剖宫产更少。在米索前列醇仍未被批准用于引产的情况下,许多从业者会更倾向于使用像地诺前列酮这样的已获批准产品。如果使用口服米索前列醇,证据表明溶液中的剂量应为20至25微克。鉴于安全性是首要关注的问题,证据支持使用口服方案而非阴道方案。这在上行感染风险高且缺乏工作人员意味着无法对妇女进行密切监测的情况下尤为重要。