子宫球囊填塞联合米索前列醇治疗难治性产后出血：在贝宁和马里进行的一项随机对照试验

Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in Benin and Mali.

作者信息

Dumont Alexandre, Bodin Cécile, Hounkpatin Benjamin, Popowski Thomas, Traoré Mamadou, Perrin René, Rozenberg Patrick

机构信息

Research Institute for Development, Université Paris Descartes, Paris, France.

Community of Practice QUAHOR, Quality of Care in Referral Hospitals, Paris, France.

出版信息

BMJ Open. 2017 Sep 1;7(9):e016590. doi: 10.1136/bmjopen-2017-016590.

OBJECTIVE

To assess the effectiveness of low-cost uterine tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage (PPH) in low-resource settings.

DESIGN

Randomised controlled trial.

SETTING

Seven healthcare facilities in Cotonou, Benin and Bamako, Mali.

POPULATION

Women delivering vaginally who had clinically diagnosed PPH that was suspected to be due to uterine atony, who were unresponsive to oxytocin and who needed additional uterotonics.

METHODS

Women were randomly assigned to receive uterine balloon tamponade with a condom-catheter device or no tamponade; both groups were also given intrarectal or sublingual misoprostol.

MAIN OUTCOME MEASURE

Proportion of women with invasive surgery or who died before hospital discharge.

RESULTS

The proportion of primary composite outcome did not differ significantly between the tamponade arm (16%; 9/57) and the standard second line treatment arm (7%; 4/59): relative risk 2.33 (95% CI 0.76 to 7.14, p=0.238). A significantly increased proportion of women with tamponade and misoprostol versus misoprostol alone had total blood loss more than 1000 mL: relative risk 1.52 (95% CI 1.15 to 2.00, p=0.01). Case fatality rate was higher in the tamponade group (10%; 6/57) than in the control group (2%; 1/59) (p=0.059).

TRIAL REGISTRATION NUMBER

ISRCT Registry Number 01202389; Post-results.

目的

评估在资源匮乏地区，低成本子宫压迫法作为米索前列醇辅助治疗手段用于治疗难治性产后出血（PPH）的有效性。

设计

随机对照试验。

地点

贝宁科托努和马里巴马科的七家医疗机构。

研究对象

经临床诊断为PPH、怀疑因子宫收缩乏力引起、对催产素无反应且需要额外宫缩剂的阴道分娩妇女。

方法

将妇女随机分为两组，一组使用避孕套导管装置进行子宫球囊压迫，另一组不进行压迫；两组均给予直肠内或舌下含服米索前列醇。

主要观察指标

接受侵入性手术或出院前死亡的妇女比例。

结果

压迫组（16%；9/57）和标准二线治疗组（7%；4/59）的主要复合结局比例无显著差异：相对风险2.33（95%CI 0.76至7.14，p = 0.238）。与单独使用米索前列醇相比，使用压迫法和米索前列醇的妇女总失血量超过1000 mL的比例显著增加：相对风险1.52（95%CI 1.15至2.00，p = 0.01）。压迫组的病死率（10%；6/57）高于对照组（2%；1/59）（p = 0.059）。

试验注册号

ISRCT注册号01202389；结果公布后。