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脐带静脉注射 400 与 800μg 米索前列醇治疗胎盘滞留:一项多中心、随机、双盲对照试验。

Umbilical vein injection of 400 versus 800 μg misoprostol for the treatment of retained placenta: A multicenter, randomized double-blind controlled trial.

机构信息

Department of Obstetrics and Gynecology, Hawler Medical University, College of Medicine, Erbil City, Iraq.

Department of Community Medicine, Hawler Medical University, College of Medicine, Erbil City, Iraq.

出版信息

J Obstet Gynaecol Res. 2020 May;46(5):727-735. doi: 10.1111/jog.14232. Epub 2020 Mar 10.

Abstract

AIMS

This trial was conducted to determine the efficacy of umbilical vein injection of 400 versus 800 μg misoprostol to deliver retained placenta and to compare both regimens regarding the time of placental delivery and amount of vaginal blood loss.

METHODS

A double-blind, multicenter randomized clinical trial was undertaken in four teaching hospitals in the North of Iraq and Al-Azhar University Hospital in Egypt, from March 2016 to May 2019. Group I (274 women) received 400 μg misoprostol and group II (249 women) received 800 μg misoprostol. Data regarding the time of placental separation and amount of vaginal blood loss were analyzed and proportions were compared between groups using Chi-squared test. Mean values were compared using the Student's t-test. The Mann-Whitney test was used to determine the median of vaginal blood loss.

RESULTS

The proportion of placental separation was 84.3% among women in group I and 86.7% of women in group II. The mean time of placental separation was 18.86 ± 234.2 and 17.86 ± 213.09 min in groups I and II, respectively (P < 0.05).The mean hemoglobin levels on admission and 24 h after placental deliveries were significantly higher in group I than group II.

CONCLUSIONS

Intra-umbilical injection of 400 and 800 μg misoprostol were both safe and effective methods for delivery of retained placenta.

摘要

目的

本试验旨在比较 400μg 与 800μg 米索前列醇经脐静脉注射治疗胎盘滞留的疗效,并比较两种方案在胎盘娩出时间和阴道出血量方面的差异。

方法

本双盲、多中心随机临床试验于 2016 年 3 月至 2019 年 5 月在伊拉克北部的四家教学医院和埃及的爱资哈尔大学医院进行。第 I 组(274 例)接受 400μg 米索前列醇,第 II 组(249 例)接受 800μg 米索前列醇。分析胎盘分离时间和阴道出血量等数据,并采用卡方检验比较组间比例。采用 Student's t 检验比较均值,采用 Mann-Whitney 检验比较阴道出血量的中位数。

结果

第 I 组和第 II 组分别有 84.3%和 86.7%的妇女胎盘分离。胎盘分离的平均时间分别为 18.86±234.2 分钟和 17.86±213.09 分钟(P<0.05)。第 I 组入院时和胎盘娩出后 24 小时的平均血红蛋白水平明显高于第 II 组。

结论

脐静脉注射 400μg 和 800μg 米索前列醇均为治疗胎盘滞留的安全有效方法。

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