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一项比较米索前列醇与前列腺素E2凝胶用于引产术前宫颈成熟的随机临床试验。

A randomized clinical trial comparing misoprostol with prostaglandin E2 gel for preinduction cervical ripening.

作者信息

Gottschall D S, Borgida A F, Mihalek J J, Sauer F, Rodis J F

机构信息

Department of Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, USA.

出版信息

Am J Obstet Gynecol. 1997 Nov;177(5):1067-70. doi: 10.1016/s0002-9378(97)70016-4.

DOI:10.1016/s0002-9378(97)70016-4
PMID:9396895
Abstract

OBJECTIVE

Our purpose was to perform a randomized trial comparing intravaginal misoprostol to intravaginal prostaglandin E2 gel for preinduction cervical ripening evaluating efficacy and side effects.

STUDY DESIGN

Seventy-five women seen for induction of labor were randomized to receive 100 micrograms of intravaginal misoprostol or 5 mg of pharmacy-prepared intravaginal prostaglandin E2 gel for cervical ripening before oxytocin induction. Six hours after placement of the study agent, patients were given oxytocin if they were not in labor. The primary outcome measure was induction-to-delivery time; secondary measures were change in Bishop score, delivery mode, and side effects. Results were analyzed by the Student t test and Fisher's exact test, with p < 0.05 considered significant.

RESULTS

There was no difference in the incidence of primiparity or the median initial Bishop score between the two study groups. The mean time to delivery and the need for oxytocin was significantly less for subjects receiving misoprostol. There was no difference in the incidence of uterine hyperstimulation syndrome or cesarean delivery between the groups.

CONCLUSIONS

This randomized clinical trial indicates that misoprostol is efficacious for preinduction cervical ripening. Misoprostol use resulted in a significantly shorter induction-to-delivery time compared with prostaglandin E2 gel use. The side effects associated with misoprostol may be dose related, and further studies to identify the optimum dosage and interval are needed.

摘要

目的

我们的目的是进行一项随机试验,比较阴道内米索前列醇与阴道内前列腺素E2凝胶用于引产术前宫颈成熟的效果及副作用。

研究设计

75名因引产前来就诊的女性被随机分为两组,一组接受100微克阴道内米索前列醇,另一组接受5毫克药房配制的阴道内前列腺素E2凝胶,用于催产素引产术前的宫颈成熟。放置研究药物6小时后,如果患者尚未临产,则给予催产素。主要观察指标是引产至分娩的时间;次要指标包括Bishop评分的变化、分娩方式和副作用。结果采用Student t检验和Fisher精确检验进行分析,p<0.05被认为具有统计学意义。

结果

两个研究组之间初产妇的发生率或初始Bishop评分中位数没有差异。接受米索前列醇的受试者分娩的平均时间和催产素的使用需求显著减少。两组之间子宫过度刺激综合征或剖宫产的发生率没有差异。

结论

这项随机临床试验表明,米索前列醇用于引产术前宫颈成熟是有效的。与使用前列腺素E2凝胶相比,使用米索前列醇可显著缩短引产至分娩的时间。与米索前列醇相关的副作用可能与剂量有关,需要进一步研究以确定最佳剂量和间隔时间。

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