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人道主义背景下的产后出血:在南苏丹开展的热稳定卡贝缩宫素和氨甲环酸应用研究

Postpartum Hemorrhage in Humanitarian Settings: Heat-Stable Carbetocin and Tranexamic Acid Implementation Study in South Sudan.

作者信息

Tran Nguyen Toan, Ochan Awatta Walter, Sake Jemelia, Sukere Okpwoku, Zeck Willibald, Seuc Armando, Schulte-Hillen Catrin

机构信息

Australian Center for Public and Population Health Research, Faculty of Health, University of Technology, Sydney, NSW, Australia.

Faculty of Medicine, University of Geneva, Switzerland.

出版信息

Int J MCH AIDS. 2024 Sep 23;13(Suppl 1):S55-S63. doi: 10.25259/IJMA_8_2023. eCollection 2024 Sep.

DOI:10.25259/IJMA_8_2023
PMID:39629301
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11583825/
Abstract

BACKGROUND AND OBJECTIVE

Postpartum hemorrhage (PPH) remains a significant concern in crisis-affected contexts, where the implementation of heat-stable carbetocin (HSC) and tranexamic acid (TXA) for PPH prevention and treatment lacks evidence. This study aims to evaluate the effects of a capacity-strengthening package on the use of uterotonics for PPH prevention and detection, and the use of TXA for PPH treatment in basic maternity facilities in South Sudan.

METHODS

In this implementation study, the six chosen facilities followed a stepwise sequence of PPH management: T1 (routine care), a transition period for package design; T2 (package without HSC and TXA); T3 (package and HSC); and T4 (package with HSC and TXA). The intervention comprised refresher training, an online provider community, PPH readiness kits, alarm bells, and displayed algorithms. The main outcomes were trends in prophylactic uterotonic use, including HSC, visual diagnosis of bleeding, and oxytocin and TXA use for PPH treatment. Analyses were adjusted for cluster effect and baseline characteristics. The study was registered in the Pan-African Clinical Trials Registry (PACTR202302476608339).

RESULTS

From February 1, 2022, to February 17, 2023, 3142 women were recruited. Nearly all women received prophylactic uterotonics across all four phases, with a significant increase after T3 (T4-T1: 100%-98%; 95% CI: 4.4-0.4). Oxytocin alone was the most used in T1 (98%) and T2 (94%) and HSC alone in T3 (87%) and T4 (82%) (T4-T1: 95% CI: 75.5-83.3). PPH diagnosis tripled from 1.2% of all births to 3.6% (T2-T1: 95% CI: 0.4-5.2) and stayed roughly at 3% in T3 and T4. For treatment, universal oxytocin use in T1 and T2 decreased in T3 upon HSC initiation (T3-T2: 27%-100%; 95% CI: 95.5-49.9), whereas TXA use increased in T4 (T4-T1: 95%-0%; 95% CI: 54.6-99.0).

CONCLUSION AND GLOBAL HEALTH IMPLICATIONS

An intervention package to improve the quality of PPH prevention and treatment can effectively increase HSC and TXA use in crisis settings. It could be scaled up in similar contexts with ongoing supervision to mitigate confusion between the existing and new medications, such as the reduced use of oxytocin for PPH treatment. Sustaining cold chain investments remain vital to ensure oxytocin quality.

摘要

背景与目的

产后出血(PPH)在受危机影响地区仍是一个重大问题,在这些地区,缺乏关于使用热稳定卡贝缩宫素(HSC)和氨甲环酸(TXA)预防和治疗产后出血的证据。本研究旨在评估一项能力强化方案对南苏丹基础产科设施中用于预防和检测产后出血的宫缩剂使用情况,以及对用于治疗产后出血的氨甲环酸使用情况的影响。

方法

在这项实施研究中,所选的六个设施遵循产后出血管理的逐步流程:T1(常规护理),即方案设计的过渡期;T2(无HSC和TXA的方案);T3(有HSC的方案);以及T4(有HSC和TXA的方案)。干预措施包括进修培训、在线提供者社区、产后出血准备包、警报器以及展示的算法。主要结果是预防性宫缩剂使用的趋势,包括HSC、出血的视觉诊断,以及用于治疗产后出血的缩宫素和氨甲环酸的使用情况。分析对聚类效应和基线特征进行了调整。该研究已在泛非临床试验注册中心注册(注册号:PACTR202302476608339)。

结果

从2022年2月1日至2023年2月17日,招募了3142名妇女。几乎所有妇女在所有四个阶段都接受了预防性宫缩剂,在T3之后有显著增加(T4 - T1:100% - 98%;95%置信区间:4.4 - 0.4)。仅缩宫素在T1(98%)和T2(94%)中使用最多,而仅HSC在T3(87%)和T4(82%)中使用最多(T4 - T1:95%置信区间:75.5 - 83.3)。产后出血的诊断从所有分娩的1.2%增至3.6%(T2 - T1:95%置信区间:0.4 - 5.2),在T3和T4中大致保持在3%。在治疗方面,开始使用HSC后,T3中T1和T2普遍使用的缩宫素减少(T3 - T2:27% - 100%;95%置信区间:95.5 - 49.9),而T4中氨甲环酸的使用增加(T4 - T1:95% - 0%;95%置信区间:54.6 - 99.0)。

结论及对全球健康的影响

一项旨在提高产后出血预防和治疗质量的干预方案能够在危机环境中有效增加HSC和氨甲环酸的使用。在持续监督下,该方案可在类似环境中扩大规模,以减轻现有药物和新药之间的混淆,例如减少用于治疗产后出血的缩宫素的使用。持续进行冷链投资对于确保缩宫素质量仍然至关重要。

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