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印度引入低成本子宫球囊压迫装置(ESM-UBT)治疗严重产后出血的影响:一项前后对比研究。

Impact of the introduction of a low-cost uterine balloon tamponade (ESM-UBT) device for managing severe postpartum hemorrhage in India: A comparative before-and-after study.

作者信息

Burke Thomas F, Shivkumar Poonam V, Priyadarshani Preeti, Garg Lorraine, Conde-Agudelo Agustin, Guha Moytrayee

机构信息

Department of Emergency Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.

Harvard Medical School, Boston, Massachusetts, USA.

出版信息

Int J Gynaecol Obstet. 2022 Nov;159(2):466-473. doi: 10.1002/ijgo.14156. Epub 2022 Mar 16.

Abstract

OBJECTIVE

To evaluate the impact of introducing a uterine balloon tamponade (ESM-UBT) device for managing severe postpartum hemorrhage (PPH), mainly due to uterine atony, in health facilities in India on the rates of PPH-related maternal death and invasive procedures for PPH control.

METHODS

We used a quasi-experimental, difference-in-difference (DID) design to compare changes in the rates of a composite outcome (PPH-related maternal death and/or artery ligation, uterine compression sutures, or hysterectomy) among women delivering in nine intervention facilities compared with those delivering in two control facilities, before and after the introduction of ESM-UBT.

RESULTS

The study sample included 214 123 deliveries (n = 78 509 before ESM-UBT introduction; n = 47 211 during ESM-UBT introduction; and n = 88 403 after ESM-UBT introduction). After introduction of ESM-UBT, there was a significant decline in the rate of the primary composite outcome in intervention facilities (21.0-11.4 per 10 000 deliveries; difference -9.6, 95% confidence interval -14.0 to -5.4). Change in the rate of the primary composite outcome was not significant in control facilities (11.7-17.2 per 10 000 deliveries; difference 5.4, 95% confidence interval -3.9 to 14.9). DID analyses showed there was a significant reduction in the rate of the primary composite outcome in intervention facilities relative to control facilities (adjusted DID estimate -15.0 per 10 000 points, 95% confidence interval -23.3 to -6.8; P = 0.005).

CONCLUSION

Introduction of the ESM-UBT in health facilities in India was associated with a significant reduction in PPH-related maternal death and/or invasive procedures for PPH control.

摘要

目的

评估在印度医疗机构引入一种用于处理主要由子宫收缩乏力导致的严重产后出血(PPH)的子宫球囊压迫装置(ESM-UBT),对PPH相关孕产妇死亡率及控制PPH的侵入性操作发生率的影响。

方法

我们采用了准实验性的差分法(DID)设计,比较在引入ESM-UBT之前和之后,9个干预设施中分娩的妇女与2个对照设施中分娩的妇女相比,复合结局(PPH相关孕产妇死亡和/或动脉结扎、子宫压迫缝合或子宫切除术)发生率的变化。

结果

研究样本包括214123例分娩(引入ESM-UBT前n = 78509例;引入ESM-UBT期间n = 47211例;引入ESM-UBT后n = 88403例)。引入ESM-UBT后,干预设施中主要复合结局的发生率显著下降(每10000例分娩中从21.0降至11.4;差值-9.6,95%置信区间-14.0至-5.4)。对照设施中主要复合结局的发生率变化不显著(每10000例分娩中从11.7升至17.2;差值5.4,95%置信区间-3.9至14.9)。DID分析表明,与对照设施相比,干预设施中主要复合结局的发生率显著降低(调整后的DID估计值为每10000例-15.0,95%置信区间-23.3至-6.8;P = 0.005)。

结论

在印度医疗机构引入ESM-UBT与PPH相关孕产妇死亡和/或控制PPH的侵入性操作的显著减少有关。

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