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仅通过择期剖宫产分娩的女性在宫内节育器插入术前使用阴道米索前列醇:一项随机双盲临床试验。

Vaginal misoprostol prior to intrauterine device insertion in women delivered only by elective cesarean section: a randomized double-blind clinical trial.

作者信息

Abdellah Mohamed S, Abbas Ahmed M, Hegazy Aml M, El-Nashar Ihab M

机构信息

Department of Obstetrics & Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.

Department of Obstetrics & Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.

出版信息

Contraception. 2017 Jun;95(6):538-543. doi: 10.1016/j.contraception.2017.01.003. Epub 2017 Jan 11.

Abstract

OBJECTIVE

The current study aims to evaluate if vaginal misoprostol (400 mcg) administered prior to intrauterine device (IUD) insertion increases the ease and success of insertion among women who had delivered only by elective cesarean delivery (CD).

STUDY DESIGN

The current study was a randomized, double-blind, placebo-controlled trial conducted in Assiut Women's Health Hospital, Egypt, between the 1st of April 2015 and the 31st of March 2016 and included women who delivered only by elective CD. One hundred forty women were randomized into two groups; misoprostol group received two misoprostol 400-mcg tablets vaginally, and placebo group received two placebo tablets 3 h before a copper T380A IUD insertion. The primary outcome measure was the difference in the ease of insertion score using a 10-cm visual analog scale between both groups with 0=very easy insertion, and 10=terribly difficult insertion.

RESULTS

The ease of insertion score was lower in the misoprostol group (2.2±0.5 vs. 4.2±0.5, p=.0001) with higher number of successful IUD insertions than the placebo group (69 [98.6%] vs. 61 [87.1%], p=.009). The mean pain score reported by the women was lower in misoprostol group (2.7±0.6 vs. 4.3±0.8) with higher level of satisfaction from the whole procedure (8.9±0.4 vs. 7.9±0.2) with p=.001 for both.

CONCLUSIONS

Misoprostol 400 mcg vaginally prior to IUD insertion eases and increase the success of insertion with reduction of pain among women who had delivered only by elective CD.

IMPLICATIONS

The use of vaginal misoprostol before IUD insertion in women who had never delivered vaginally before may increase the ease and success of insertion. Moreover, it may reduce the pain felt by women during the procedure.

摘要

目的

本研究旨在评估在仅通过择期剖宫产分娩的女性中,宫内节育器(IUD)插入术前使用阴道米索前列醇(400微克)是否能提高插入的 ease 和成功率。

研究设计

本研究是一项随机、双盲、安慰剂对照试验,于2015年4月1日至2016年3月31日在埃及阿斯尤特妇女健康医院进行,纳入对象为仅通过择期剖宫产分娩的女性。140名女性被随机分为两组;米索前列醇组在插入铜T380A宫内节育器前3小时经阴道给予两片400微克米索前列醇片,安慰剂组给予两片安慰剂片。主要结局指标是使用10厘米视觉模拟量表评估两组插入 ease 评分的差异,0表示插入非常容易,10表示插入极其困难。

结果

米索前列醇组的插入 ease 评分较低(2.2±0.5 vs. 4.2±0.5,p = 0.0001),成功插入宫内节育器的数量高于安慰剂组(69例[98.6%] vs. 61例[87.1%],p = 0.009)。米索前列醇组女性报告的平均疼痛评分较低(2.7±0.6 vs. 4.3±0.8),对整个操作的满意度较高(8.9±0.4 vs. 7.9±0.2),两者的p值均为0.001。

结论

在仅通过择期剖宫产分娩的女性中,宫内节育器插入术前经阴道给予400微克米索前列醇可使插入 ease 增加、成功率提高,并减轻疼痛。

启示

在从未经阴道分娩的女性中,宫内节育器插入术前使用阴道米索前列醇可能会增加插入的 ease 和成功率。此外,它可能会减轻女性在手术过程中的疼痛。

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