一项比较普萘洛尔和米索前列醇与米索前列醇和安慰剂用于初产妇引产的初步研究；一项随机、单盲、安慰剂对照试验。
A pilot study to compare propranolol and misoprostol versus misoprostol and placebo for induction of labor in primigravidae; a randomized, single-blinded, placebo-controlled trial.
机构信息
Department of Obstetrics & Gynecology, Faculty of Medicine, Ain Shams University, Abbaseyya Square, Cairo, Egypt.
出版信息
BMC Pregnancy Childbirth. 2023 Apr 4;23(1):226. doi: 10.1186/s12884-023-05537-1.
BACKGROUND
The Induction of labor is the most common obstetric procedure in daily practice. Introducing propranolol as a new drug to augment the action of prostaglandins will help in the induction process and decrease CS rates. Several researchers have used propranolol in the augmentation of labor.
AIM
This pilot study compares propranolol and misoprostol versus misoprostol alone for labor induction in primigravids.
METHODS
This is a Randomized clinical trial, single-blinded, placebo-controlled trial at Ain Shams University Maternity hospital. This study included 128 pregnant full-term primigravid women candidates for labor induction, randomized into two groups. All candidates underwent labor induction with 25 µg of vaginal misoprostol. Group I received 20 mg of oral propranolol tablets, while group II received sugary pills as a placebo. Candidates who responded successfully to induction were assessed for possible augmentation of labor by amniotomy or oxytocin infusion. The Primary outcome was induction to delivery interval, while the secondary outcomes were the duration of the latent phase, mode of delivery, and APGAR score of the neonate.
RESULTS
The induction-delivery time was (11.8 ± 8.1 h. vs. 12.6 ± 8.9 h., P value = 0.027) and the duration of the latent phase of labor (7.9 ± 5.6 h. vs. 9.2 ± 6.03 h., P value = 0.017) were significantly shorter in the group of misoprostol and propranolol compared to the group of misoprostol and placebo. There was no statistically significant difference between both groups' mode of delivery, indications for cesarean section, misoprostol, and oxytocin doses, or neonatal outcome. (P value > 0.05).
CONCLUSION
Propranolol, when used with misoprostol for induction of labor, results in augmentation of action of misoprostol and a significantly shorter induction-delivery interval.
TRIAL REGISTRATION
We retrospectively registered this trial in clinicaltrial.gov on 01/09/2020 (NCT04533841). https://clinicaltrials.gov/ct2/show/NCT04533841.
背景
引产是日常实践中最常见的产科程序。将普萘洛尔作为一种新的药物引入，以增强前列腺素的作用，将有助于引产过程，并降低剖宫产率。一些研究人员已经在引产中使用普萘洛尔。
目的
本研究旨在比较普萘洛尔和米索前列醇与米索前列醇单独用于初产妇引产的效果。
方法
这是一项随机临床试验，单盲，安慰剂对照试验，在艾因夏姆斯大学妇产医院进行。本研究纳入了 128 名足月初产妇，作为引产候选者，随机分为两组。所有候选者均接受 25μg 阴道米索前列醇引产。组 I 给予 20mg 口服普萘洛尔片，而组 II 给予糖丸作为安慰剂。对成功引产的患者进行评估，以确定是否需要羊膜切开术或缩宫素输注来增强产力。主要结局是引产至分娩的时间间隔，次要结局是潜伏期的持续时间、分娩方式和新生儿的 Apgar 评分。
结果
米索前列醇和普萘洛尔组的引产至分娩时间（11.8±8.1 小时与 12.6±8.9 小时，P 值=0.027）和潜伏期（7.9±5.6 小时与 9.2±6.03 小时，P 值=0.017）明显短于米索前列醇和安慰剂组。两组的分娩方式、剖宫产指征、米索前列醇和缩宫素剂量以及新生儿结局无统计学差异（P 值>0.05）。
结论
普萘洛尔与米索前列醇联合用于引产可增强米索前列醇的作用，并显著缩短引产至分娩的时间间隔。
试验注册
我们于 2020 年 9 月 1 日（NCT04533841）在 clinicaltrial.gov 上对该试验进行了回顾性注册。https://clinicaltrials.gov/ct2/show/NCT04533841。
Zotero 插件