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产后出血的早期检测与综合治疗策略:一项混合方法的过程评估

Early detection and a treatment bundle strategy for postpartum haemorrhage: a mixed-methods process evaluation.

作者信息

Bohren Meghan A, Miller Suellen, Mammoliti Kristie-Marie, Galadanci Hadiza, Fawcus Sue, Moran Neil, Hofmeyr G Justus, Qureshi Zahida, Alwy Al-Beity Fadhlun, Forbes Gillian, Akter Shahinoor, Osoti Alfred, Gwako George, Melo Santos Thiago, Evans Cherrie, Wakili Aminu Ado, Bakari Maisaratu, Takai Idris Usman, Umar Mohammad, Singata-Madliki Mandisa, Muller Elani, Mandondo Sibongile, Okore Jenipher, Banda Akwinata, Sambusa Masumbuko, Sindhu Kulandaipalayam N, Beeson Leanne, Easter Christina Louise, Devall Adam, Gülmezoglu A Metin, Althabe Fernando, Oladapo Olufemi T, Gallos Ioannis, Coomarasamy Arri, Lorencatto Fabiana

机构信息

Gender and Women's Health Unit, Nossal Institute for Global Health, School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia.

Department of Obstetrics and Reproductive Sciences, School of Medicine, University of California San Francisco, CA, USA.

出版信息

Lancet Glob Health. 2025 Feb;13(2):e329-e344. doi: 10.1016/S2214-109X(24)00454-6.

DOI:10.1016/S2214-109X(24)00454-6
PMID:39890233
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11782988/
Abstract

BACKGROUND

Postpartum haemorrhage is a leading cause of maternal mortality. A multicountry, cluster-randomised trial (E-MOTIVE) demonstrated a 60% reduction in adverse postpartum haemorrhage outcomes. The E-MOTIVE intervention included early postpartum haemorrhage detection using calibrated blood-collection drapes, followed by a postpartum haemorrhage treatment bundle (ie, uterine massage, oxytocics, tranexamic acid, intravenous fluids, examination and escalation [MOTIVE]), supported by implementation strategies. We report a mixed-methods process evaluation assessing the implementation of the E-MOTIVE intervention in Kenya, Nigeria, South Africa, and Tanzania.

METHODS

In this mixed-methods process evaluation, data sources were observations of health workers providing clinical care to pregnant women and pregnant people during vaginal birth and postpartum haemorrhage at intervention sites, and surveys and qualitative interviews with health workers at intervention and control sites. Intervention sites received the calibrated drapes, MOTIVE bundle, and implementation strategies and control sites used uncalibrated drapes. Primary implementation outcomes included fidelity, adoption, adaptation, acceptability, feasibility, and contamination to the calibrated drape, MOTIVE bundle, and implementation strategies.

FINDINGS

Between June 1, 2022, and Jan 31, 2023, 2578 births were observed, 295 pregnant women and people had postpartum haemorrhage, 47 qualitative interviews were done, and 889 surveys were completed. Fidelity to calibrated drape use was high (birth observations 2578 [100%] of 2578; survey 451 [98·3%] of 459). Among health workers, calibrated drape acceptability was high; however, they reported barriers to pregnant women's and people's acceptability. Fidelity to postpartum haemorrhage treatment bundle delivery was high (birth observations 286 [96·9%] of 295), with moderate to high fidelity in median time from postpartum haemorrhage diagnosis to final treatment initiation (≤15 min initiation time in 191 [66·8%] of 295 birth observations, 16-20 min in 42 [14·7%] birth observations), and high acceptability and feasibility. Research midwives participated in clinical assessments after birth and bundle delivery in some sites (mixed fidelity).

INTERPRETATION

This process evaluation shows generally high levels of fidelity, feasibility, and acceptability of the calibrated drape and treatment bundle across evaluation methods and countries. The E-MOTIVE intervention should be included in national policies, with consideration for health workforce, supplies, and medication issues, which might need addressing for successful implementation.

FUNDING

The Bill and Melinda Gates Foundation and the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction, a co-sponsored programme of WHO.

TRANSLATION

For the Swahili translation of the abstract see Supplementary Materials section.

摘要

背景

产后出血是孕产妇死亡的主要原因。一项多国整群随机试验(E-MOTIVE)表明,不良产后出血结局减少了60%。E-MOTIVE干预措施包括使用校准过的采血单进行产后早期出血检测,随后是产后出血治疗包(即子宫按摩、宫缩剂、氨甲环酸、静脉输液、检查及病情升级 [MOTIVE]),并辅以实施策略。我们报告了一项混合方法的过程评估,评估E-MOTIVE干预措施在肯尼亚、尼日利亚、南非和坦桑尼亚的实施情况。

方法

在这项混合方法的过程评估中,数据来源包括对干预地点在阴道分娩和产后出血期间为孕妇提供临床护理的卫生工作者的观察,以及对干预和对照地点的卫生工作者进行的调查和定性访谈。干预地点使用校准过的单子、MOTIVE治疗包和实施策略,对照地点使用未校准的单子。主要实施结果包括校准单子、MOTIVE治疗包和实施策略的保真度、采用率、适应性、可接受性、可行性和污染情况。

结果

在2022年6月1日至2023年1月31日期间,观察了2578例分娩,295名孕妇发生了产后出血,进行了47次定性访谈,完成了889份调查问卷。校准单子使用的保真度很高(分娩观察2578例中的2578例 [100%];调查459例中的451例 [98.3%])。在卫生工作者中,校准单子的可接受性很高;然而,他们报告了孕妇可接受性方面的障碍。产后出血治疗包交付的保真度很高(分娩观察295例中的286例 [96.9%]),从产后出血诊断到最终开始治疗的中位时间保真度为中等到高(295例分娩观察中有191例 [66.8%] 的开始时间≤15分钟,42例 [14.7%] 分娩观察中的开始时间为16 - 20分钟),并且可接受性和可行性都很高。在一些地点,研究助产士在产后和治疗包交付后参与了临床评估(保真度不一)。

解读

该过程评估表明,在校准单子和治疗包的保真度、可行性和可接受性方面,总体上在各种评估方法和国家中都处于较高水平。E-MOTIVE干预措施应纳入国家政策,并考虑卫生人力、物资和药物问题,这些问题可能需要解决以成功实施。

资金来源

比尔及梅琳达·盖茨基金会以及联合国开发计划署 - 联合国人口基金 - 联合国儿童基金会 - 世界卫生组织 - 世界银行人类生殖研究、发展和研究培训特别规划,这是世界卫生组织的一个联合赞助项目。

翻译

摘要的斯瓦希里语翻译见补充材料部分。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25b2/11782988/abbc6a59866f/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25b2/11782988/abbc6a59866f/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25b2/11782988/abbc6a59866f/gr1.jpg

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Glob Health Sci Pract. 2024 Oct 29;12(5). doi: 10.9745/GHSP-D-23-00387.
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Perceptions and experiences of the prevention, detection, and management of postpartum haemorrhage: a qualitative evidence synthesis.预防、检测和管理产后出血的认知和经验:定性证据综合。
Cochrane Database Syst Rev. 2023 Nov 27;11(11):CD013795. doi: 10.1002/14651858.CD013795.pub2.
3
Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage.
随机试验:产后出血的早期检测与治疗。
N Engl J Med. 2023 Jul 6;389(1):11-21. doi: 10.1056/NEJMoa2303966. Epub 2023 May 9.
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Factors influencing postpartum haemorrhage detection and management and the implementation of a new postpartum haemorrhage care bundle (E-MOTIVE) in Kenya, Nigeria, and South Africa.影响产后出血检测和管理的因素以及在肯尼亚、尼日利亚和南非实施新的产后出血护理包(E-MOTIVE)。
Implement Sci. 2023 Jan 11;18(1):1. doi: 10.1186/s13012-022-01253-0.
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Detection and management of postpartum haemorrhage: Qualitative evidence on healthcare providers' knowledge and practices in Kenya, Nigeria, and South Africa.产后出血的检测与管理:关于肯尼亚、尼日利亚和南非医疗服务提供者知识与实践的定性证据
Front Glob Womens Health. 2022 Nov 18;3:1020163. doi: 10.3389/fgwh.2022.1020163. eCollection 2022.
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Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol.为产后出血初始应对治疗包(E-MOTIVE)设计实施策略的形成性研究:研究方案
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