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子宫内羊膜外使用米索前列醇与经阴道使用米索前列醇终止中期流产的比较:一项随机对照试验。

Intra uterine extra-amniotic versus vaginal misoprostol for termination of second trimester miscarriage: A randomized controlled trial.

作者信息

Abbas Mitwaly Abo Bakr, Abbas Ahmed Mohamed, Abdellah Mohamed Sayed

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine-Assiut University, Assiut, Egypt.

出版信息

Int J Reprod Biomed. 2016 Oct;14(10):643-648.

Abstract

BACKGROUND

Termination of pregnancy in the second trimester using prostaglandins has been shown to be safe and effective. Misoprostol has multiple routes of administration; oral, vaginal, buccal, rectal and sublingual.

OBJECTIVE

The study aims to compare the efficacy and safety of intrauterine extra-amniotic and vaginal misoprostol in a dose of 200 microgram every 4 hours for the termination of pregnancy in cases of second trimester miscarriage.

MATERIALS AND METHODS

A prospective randomized open labeled clinical trial included 180 women with missed miscarriage in gestational age between 13 and 24 wks. Patients were randomized to receive subsequent doses of 200 µg misoprostol every 4 hrs either intra uterine extra-amniotic by Foley catheter or vaginally administered. Randomization was completed using a computer-generated random table. The primary outcome of this study was the mean duration from the initial misoprostol dose until complete fetal expulsion (induction-expulsion interval).

RESULTS

The mean gestational age was 17.74 wks. The mean time to complete miscarriage in the intra uterine extra-amniotic group was 5.27 hrs, which was significantly lower than the vaginal group (9.92 hrs, p=0.001). Side effects were more common in vaginal group.

CONCLUSION

Intra uterine extra-amniotic misoprostol with a dose of 200 µg every 4 hrs appears to be more effective and safer than vaginal misoprostol in induction of second trimester miscarriage.

摘要

背景

已证明在妊娠中期使用前列腺素终止妊娠是安全有效的。米索前列醇有多种给药途径,包括口服、阴道、颊部、直肠和舌下给药。

目的

本研究旨在比较每4小时给予200微克剂量的羊膜外宫腔内米索前列醇与阴道米索前列醇在妊娠中期流产病例中终止妊娠的有效性和安全性。

材料与方法

一项前瞻性随机开放标签临床试验纳入了180例孕周在13至24周之间的稽留流产妇女。患者被随机分为两组,分别通过Foley导管经羊膜外宫腔内给药或经阴道给药,每4小时给予200微克米索前列醇后续剂量。使用计算机生成的随机表完成随机分组。本研究的主要结局是从初始米索前列醇剂量至胎儿完全排出的平均持续时间(引产 - 排出间隔)。

结果

平均孕周为17.74周。羊膜外宫腔内给药组完全流产的平均时间为5.27小时,显著低于阴道给药组(9.92小时,p = 0.001)。副作用在阴道给药组更为常见。

结论

每4小时给予200微克剂量的羊膜外宫腔内米索前列醇在引产妊娠中期流产方面似乎比阴道米索前列醇更有效且更安全。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b18b/5124327/81d4386859b7/ijrb-14-643-g001.jpg

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