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培训传统助产妇在家中分娩时使用米索前列醇预防产后出血:一项随机安慰剂对照试验。

Administration of misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage in homebirths in Pakistan: a randomised placebo-controlled trial.

机构信息

Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan Gynuity Health Projects, New York, NY, USA.

出版信息

BJOG. 2011 Feb;118(3):353-61. doi: 10.1111/j.1471-0528.2010.02807.x. Epub 2010 Dec 23.

DOI:10.1111/j.1471-0528.2010.02807.x
PMID:21176086
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3041931/
Abstract

OBJECTIVE

to determine if misoprostol is safe and efficacious in preventing postpartum haemorrhage (PPH) when administered by trained traditional birth attendants (TBA) at home deliveries.

DESIGN

a randomised, double-blind, placebo-controlled trial.

SETTING

Chitral, Khyber Pakhtunkhwa Province, Pakistan.

POPULATION

a total of 1119 women giving birth at home.

METHODS

from June 2006 to June 2008, consenting women were randomised to receive 600 microg oral misoprostol (n = 534) or placebo (n = 585) after delivery to determine whether misoprostol reduced the incidence of PPH (≥ 500 ml).

MAIN OUTCOME MEASURES

the primary outcomes were measured blood loss ≥ 500 ml after delivery and drop in haemoglobin >2 g/dl from before to after delivery.

RESULTS

oral misoprostol was associated with a significant reduction in the rate of PPH (≥ 500 ml) (16.5 versus 21.9%; relative risk 0.76, 95% CI 0.59-0.97). There were no measurable differences between study groups for drop in haemoglobin >2 g/dl (relative risk 0.79, 95% CI 0.62-1.02); but significantly fewer women receiving misoprostol had a drop in haemoglobin >3 g/dl, compared with placebo (5.1 versus 9.6%; relative risk 0.53, 95% CI 0.34-0.83). Shivering and chills were significantly more common with misoprostol. There were no maternal deaths among participants.

CONCLUSIONS

postpartum administration of 600 microg oral misoprostol by trained TBAs at home deliveries reduces the rate of PPH by 24%. Given its ease of use and low cost, misoprostol could reduce the burden of PPH in community settings where universal oxytocin prophylaxis is not feasible. Continual training and skill-building for TBAs, along with monitoring and evaluation of programme effectiveness, should accompany any widespread introduction of this drug.

摘要

目的

确定在传统助产妇(TBA)家中分娩时,经培训的 TBA 给产妇使用米索前列醇预防产后出血(PPH)是否安全有效。

设计

随机、双盲、安慰剂对照试验。

地点

巴基斯坦开伯尔-普赫图赫瓦省奇特拉尔。

人群

共 1119 名在家中分娩的妇女。

方法

2006 年 6 月至 2008 年 6 月,同意参与的妇女被随机分配,在分娩后接受 600μg 口服米索前列醇(n=534)或安慰剂(n=585),以确定米索前列醇是否降低 PPH(≥500ml)的发生率。

主要观察指标

主要结局是测量分娩后出血量≥500ml 和血红蛋白从分娩前到分娩后下降≥2g/dl。

结果

口服米索前列醇显著降低 PPH(≥500ml)的发生率(16.5%比 21.9%;相对危险度 0.76,95%可信区间 0.59-0.97)。两组血红蛋白下降>2g/dl 的差异无统计学意义(相对危险度 0.79,95%可信区间 0.62-1.02);但与安慰剂相比,接受米索前列醇的妇女血红蛋白下降>3g/dl 的人数明显减少(5.1%比 9.6%;相对危险度 0.53,95%可信区间 0.34-0.83)。米索前列醇组出现颤抖和寒战的情况明显更多。参与者中无产妇死亡。

结论

由经过培训的 TBA 在家庭分娩时给予 600μg 口服米索前列醇可将 PPH 的发生率降低 24%。鉴于其使用方便且成本低,米索前列醇可减少在无法普遍使用催产素预防的社区环境中 PPH 的负担。在广泛推广该药物时,应伴随对 TBA 的持续培训和技能建设,以及对方案有效性的监测和评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30da/3041931/7b32429278ab/bjo0118-0353-f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30da/3041931/8212fdca547a/bjo0118-0353-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30da/3041931/082558cdd159/bjo0118-0353-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30da/3041931/7b32429278ab/bjo0118-0353-f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30da/3041931/8212fdca547a/bjo0118-0353-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30da/3041931/082558cdd159/bjo0118-0353-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30da/3041931/7b32429278ab/bjo0118-0353-f3.jpg

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