用于宫颈条件不佳时引产的羊膜外生理盐水、海藻棒或前列腺素E2凝胶：一项随机对照试验

Extra-amniotic saline, laminaria, or prostaglandin E(2) gel for labor induction with unfavorable cervix: a randomized controlled trial.

作者信息

Guinn D A, Goepfert A R, Christine M, Owen J, Hauth J C

机构信息

Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of Alabama at Birmingham, USA.

出版信息

Obstet Gynecol. 2000 Jul;96(1):106-12. doi: 10.1016/s0029-7844(00)00856-5.

DOI:10.1016/s0029-7844(00)00856-5

PMID:10862852

Abstract

OBJECTIVE

To determine which of three methods of cervical ripening resulted in the lowest cesarean rate in women with unfavorable cervices and indications for labor induction.

METHODS

Consenting women with singleton gestations, vertex presentations, and unfavorable cervices (dilatation under 2 cm and effacement under 75%) were randomly assigned to laminaria and standard intravenous oxytocin, serial doses of intracervical prostaglandin (PG) E(2) gel (Prepidil, Pharmacia & Upjohn, Inc., Kalamazoo, MI) 0.5 microg every 6 hours for two doses followed by oxytocin if indicated, or extra-amniotic saline infusion and oxytocin.

RESULTS

An interim analysis after recruitment of 321 subjects, 67% of the planned sample, found similar cesarean rates for the three groups (laminaria 36%; PGE(2) gel 33%; saline infusion 29%; P =.59); however, the mean randomization-to-delivery interval was significantly longer in the PGE(2) group. Stochastic curtailment, as part of the interim analysis, indicated a low likelihood of achieving a statistically significant difference in cesarean rates between PGE(2) gel and the other two groups. Therefore, we completed the study with saline infusion and laminaria. The saline infusion and laminaria groups had similar preinduction characteristics. The cesarean rates were similar (saline infusion 25.4% versus laminaria 30.3%; P =.32), but the mean interval from randomization to delivery was shorter in the saline infusion group (18.0 versus 21.5 hours, P =.002). There were no significant differences in selected maternal and neonatal morbidities.

CONCLUSION

Cervical ripening with extra-amniotic saline infusion, PGE(2), or laminaria resulted in comparable cesarean rates in women with an unfavorable cervix and indications for labor induction. Extra-amniotic saline infusion had the shortest randomization-to-delivery interval without increasing maternal or neonatal morbidity.

摘要

目的

确定三种宫颈成熟方法中哪一种能使宫颈条件不佳且有引产指征的女性剖宫产率最低。

方法

符合条件的单胎妊娠、头先露且宫颈条件不佳（宫颈扩张小于2厘米且宫颈消退小于75%）的孕妇，被随机分配至海带棒联合标准静脉滴注缩宫素组、每6小时宫颈内给予前列腺素（PG）E₂凝胶（普贝生，法玛西亚公司，密歇根州卡拉马祖）0.5微克共两剂，必要时后续给予缩宫素组，或羊膜外生理盐水输注联合缩宫素组。

结果

在招募了321名受试者（占计划样本的67%）后进行的中期分析发现，三组的剖宫产率相似（海带棒组36%；PGE₂凝胶组33%；生理盐水输注组29%；P = 0.59）；然而，PGE₂组从随机分组到分娩的平均间隔时间显著更长。作为中期分析的一部分，随机截尾表明PGE₂凝胶组与其他两组在剖宫产率上出现统计学显著差异的可能性较低。因此，我们完成了生理盐水输注组和海带棒组的研究。生理盐水输注组和海带棒组在引产前置条件相似。剖宫产率相似（生理盐水输注组25.4%，海带棒组30.3%；P = 0.32），但生理盐水输注组从随机分组到分娩的平均间隔时间更短（18.0小时对21.5小时，P = 0.002）。在选定的孕产妇和新生儿发病率方面无显著差异。