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舌下含服米索前列醇与 Foley 导尿管用于子痫前期或妊娠高血压妇女促宫颈成熟的随机对照试验。

Sublingual Misoprostol versus Foley catheter for cervical ripening in women with preeclampsia or gestational hypertension: A randomized control trial.

作者信息

Ayati Sedigheh, Hasanzadeh Elahe, Pourali Leila, Shakeri Mohammadtaghi, Vatanchi Atiye

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

出版信息

Int J Reprod Biomed. 2019 Jul 31;17(7):513-520. doi: 10.18502/ijrm.v17i7.4863. eCollection 2019 Jul.

Abstract

BACKGROUND

Delivery is the only definite cure for hypertensive disorders. Therefore, cervical ripening and labor induction are important to achieve favorable outcomes.

OBJECTIVE

This Randomized Control Trial (RCT) is aimed to compare the effects of sublingual misoprostol and Foley catheter in cervical ripening and labor induction among patients with preeclampsia or gestational hypertension.

MATERIALS AND METHODS

A total number of 144 women with preeclampsia or gestational hypertention with indication of pregnancy termination, who were referred to academic hospitals of the University of Medical Sciences in Mashhad, Iran, between March 2015 and December 2016, were randomly divided into two groups. In group one (n = 72), 25 µg of misoprostol tablet was administrated sublingually every 4 hr up to six doses. In group two (n = 72), a 16F Foley catheter was placed through the internal cervical os, inflated with 60 cc of sterile saline.

RESULTS

There were no significant differences between groups regarding the demographic characteristics, primary bishop score, and pregnancy termination indication. The cervical ripening time (primary outcome) (8.2 vs 14.2 hr, p 0.00), induction to delivery interval (15.5 vs 19.9 hr, p 0.00), and vaginal delivery before 24 hr (63.9% vs 40%, p = 0.03) were significantly different between the two groups. There was no significant difference between groups in view of oxytocin requirement (p = 0.12), neonatal Apgar score (p = 0.84), or neonatal intensive care unit admission (p = 78).

CONCLUSION

This trial showed that the application of sublingual misoprostol, compared to the Foley catheter, can reduce cervical ripening period and other parameters related to the duration of vaginal delivery. This misoprostol regimen showed inconsiderable maternal complications.

摘要

背景

分娩是治疗高血压疾病的唯一确切方法。因此,宫颈成熟和引产对于取得良好结局很重要。

目的

本随机对照试验(RCT)旨在比较舌下含服米索前列醇和Foley尿管在子痫前期或妊娠期高血压患者宫颈成熟和引产中的效果。

材料与方法

2015年3月至2016年12月间,共有144名单胎妊娠、因子痫前期或妊娠期高血压而需终止妊娠的孕妇被转诊至伊朗马什哈德医科大学的教学医院,并随机分为两组。第一组(n = 72),每4小时舌下含服25μg米索前列醇片,最多6剂。第二组(n = 72),将16F Foley尿管经宫颈内口置入,注入60cc无菌生理盐水使其膨胀。

结果

两组在人口统计学特征、初始Bishop评分和终止妊娠指征方面无显著差异。两组之间的宫颈成熟时间(主要结局)(8.2小时对14.2小时,p < 0.00)、引产至分娩间隔时间(15.5小时对19.9小时,p < 0.00)和24小时内阴道分娩率(63.9%对40%,p = 0.03)存在显著差异。两组在缩宫素需求量(p = 0.12)、新生儿阿氏评分(p = 0.84)或新生儿重症监护病房入住率(p = 0.78)方面无显著差异。

结论

本试验表明,与Foley尿管相比,舌下含服米索前列醇可缩短宫颈成熟时间及与阴道分娩持续时间相关的其他参数。该米索前列醇方案显示产妇并发症较少。

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