滴定口服米索前列醇溶液与静脉注射催产素用于引产的比较：一项随机对照试验。

Titrated oral misoprostol solution compared with intravenous oxytocin for labor augmentation: a randomized controlled trial.

机构信息

From the Department of Obstetrics and Gynecology, China Medical University Hospital, Taichung, Taiwan; the Department of Obstetrics and Gynecology, China Medical University Beigang Hospital, Beigang, Taiwan; and the School of Medicine and Biostatistics Center, China Medical University, Taichung, Taiwan.

出版信息

Obstet Gynecol. 2010 Sep;116(3):612-618. doi: 10.1097/AOG.0b013e3181ed36cc.

DOI:10.1097/AOG.0b013e3181ed36cc

PMID:20733443

Abstract

OBJECTIVE

To compare titrated oral misoprostol to intravenous oxytocin for labor augmentation among women at 36 to 42 weeks of gestation with spontaneous onset of active labor.

METHODS

Women meeting the general selection criteria with regular contractions and an effaced cervix dilated between 3 and 9 cm, and who had inadequate uterine contractions (two or fewer contractions every 10 minutes) during the first stage of labor, were randomly assigned to titrated oral misoprostol or intravenous oxytocin. Augmentation-to-vaginal delivery interval and vaginal delivery within 12 or 24 hours were the primary outcomes. The data were analyzed by intention to treat.

RESULTS

Of the 231 women, 118 (51.1%) were randomized to titrated oral misoprostol and 113 (48.9%) to titrated intravenous oxytocin. The median interval from the start of augmentation to vaginal delivery was 5.22 hours (3.77-8.58 hours, 25th-75th percentile) in the misoprostol group, and 5.20 hours (3.23-6.50 hours, 25th-75th percentile) in the intravenous oxytocin group (P=.019). Complete vaginal delivery occurred within 12 hours for 92 women (78.0%) in the misoprostol group and for 97 women (85.8%) in the oxytocin group (P=.121; relative risk 0.91, 95% confidence interval 0.80-1.03). There were no significant differences between the two groups who delivered vaginally within 24 hours. Side effects and neonatal outcomes also did not differ between the two groups.

CONCLUSION

Labor augmentation with titrated oral misoprostol or intravenous oxytocin resulted in similar rates of vaginal delivery within 12 and 24 hours.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, www.clinicaltrials.gov, NCT00695331.

LEVEL OF EVIDENCE

摘要

目的

比较经阴道给予滴定剂量米索前列醇与静脉给予催产素用于 36 至 42 周自发性临产且宫颈扩张 3 至 9cm 且第一产程宫缩不足（每 10 分钟少于 2 次宫缩）的产妇的引产效果。

方法

选择符合一般入选标准、具有规律宫缩且宫颈已展平（3cm 至 9cm）、但第一产程宫缩不足（每 10 分钟宫缩少于 2 次）的产妇，随机分为滴定剂量口服米索前列醇组或静脉给予催产素组。主要结局为引产至阴道分娩的时间间隔和 12 小时或 24 小时内阴道分娩率。采用意向治疗进行数据分析。

结果

231 例产妇中，118 例（51.1%）被随机分配至滴定剂量口服米索前列醇组，113 例（48.9%）被随机分配至滴定剂量静脉给予催产素组。米索前列醇组从引产开始至阴道分娩的中位时间为 5.22 小时（3.77 至 8.58 小时，25 百分位数至 75 百分位数），而催产素组为 5.20 小时（3.23 至 6.50 小时，25 百分位数至 75 百分位数）（P=0.019）。米索前列醇组有 92 例（78.0%）产妇在 12 小时内完成阴道分娩，催产素组有 97 例（85.8%）产妇在 12 小时内完成阴道分娩（P=0.121；相对风险 0.91，95%置信区间 0.80 至 1.03）。两组在 24 小时内阴道分娩率无显著差异。两组产妇的副作用和新生儿结局也无显著差异。