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低剂量米索前列醇与地诺前列酮阴道栓剂用于宫颈预处理的随机对照试验。

A randomised controlled trial of low-dose misoprostol and dinoprostone vaginal pessaries for cervical priming.

机构信息

Department of Obstetrics and Gynaecology, KK Women's and Children's Hospital, University Hospital, Singapore.

出版信息

BJOG. 2010 Sep;117(10):1270-7. doi: 10.1111/j.1471-0528.2010.02602.x.

Abstract

OBJECTIVE

We studied the efficacy of 25-microg misoprostol pessaries as either single or double dose compared with a 3-mg dinoprostone pessary for cervical priming.

DESIGN AND SETTING

A randomised controlled trial in Singapore.

POPULATION

One hundred and seventy-one women with term pregnancies and modified Bishop scores (mBS) < or =6 from 2003 to 2004.

METHOD

Patients were randomised to single misoprostol dose, double misoprostol dose or the current dinoprostone regimen.

MAIN OUTCOME MEASURES

Primary outcome was number of women who achieved favourable mBS >6 or active labour by day 2. Secondary outcomes were time interval from insertion to delivery, cardiotocographic abnormalities, delivery and neonatal outcome.

RESULTS

More women in the misoprostol double-dose group (96.6%) and dinoprostone group (93%) achieved the primary outcome compared with the single-dose group (77.8%) (P = 0.003 and P = 0.03, respectively). There was no difference in secondary outcomes. More multiparous women achieve primary outcome compared with nulliparous women (odds ratio 0.21, 95% confidence interval 0.06-0.77).

CONCLUSION

Double-dose misoprostol 25 microg is as effective as dinoprostone 3 mg inserts for cervical priming; both are more efficacious than a single-dose misoprostol pessary. Parity prognosticates the success of induction.

摘要

目的

我们研究了与 3mg 地诺前列酮栓相比,25μg米索前列醇阴道栓剂单次或双次给药用于宫颈预处理的效果。

设计和设置

在新加坡进行的一项随机对照试验。

人群

2003 年至 2004 年期间,171 名足月妊娠且改良 Bishop 评分(mBS)≤6 的妇女。

方法

患者被随机分为米索前列醇单次剂量组、米索前列醇双次剂量组或现行地诺前列酮方案组。

主要观察指标

主要结局为 mBS>6 或第 2 天进入活跃期的妇女人数。次要结局为从放置到分娩的时间间隔、胎心监护异常、分娩和新生儿结局。

结果

米索前列醇双次剂量组(96.6%)和地诺前列酮组(93%)的妇女比米索前列醇单次剂量组(77.8%)更能达到主要结局(P=0.003 和 P=0.03)。次要结局无差异。与初产妇相比,多产妇更能达到主要结局(优势比 0.21,95%置信区间 0.06-0.77)。

结论

双次剂量 25μg米索前列醇与 3mg 地诺前列酮栓用于宫颈预处理同样有效;两者均优于单次剂量米索前列醇栓。产次预测了引产的成功率。

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