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

International Journal of MCH and AIDS Pub Date : 2024-09-23 eCollection Date: 2024-09-01 DOI:10.25259/IJMA_8_2023
Nguyen Toan Tran, Awatta Walter Ochan, Jemelia Sake, Okpwoku Sukere, Willibald Zeck, Armando Seuc, Catrin Schulte-Hillen
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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.

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人道主义环境下的产后出血:南苏丹热稳定的卡霉素和氨甲环酸实施研究。
背景和目的:产后出血(PPH)仍然是一个重要的问题,在危机影响的背景下,实施热稳定性卡霉素(HSC)和氨甲环酸(TXA)预防和治疗PPH缺乏证据。本研究旨在评估南苏丹基本产科设施中使用子宫张力剂预防和检测PPH以及使用TXA治疗PPH的能力增强方案的效果。方法:在本实施性研究中,所选的6家医院按照PPH管理的逐步顺序进行:T1(常规护理),包装设计的过渡期;T2(不含HSC和TXA的包装);T3(封装和HSC);和T4(与HSC和TXA包装)。干预措施包括复习培训、在线提供者社区、PPH准备工具包、警报铃和显示算法。主要结果是预防性子宫扩张使用的趋势,包括HSC,出血的视觉诊断,以及催产素和TXA用于PPH治疗。根据聚类效应和基线特征对分析进行了调整。该研究已在泛非临床试验登记处注册(PACTR202302476608339)。结果:从2022年2月1日到2023年2月17日,招募了3142名女性。几乎所有妇女在所有四个阶段都接受了预防性子宫强张,在T3后显著增加(T4-T1: 100%-98%;95% ci: 4.4-0.4)。催产素单用在T1(98%)和T2 (94%), HSC单用在T3(87%)和T4 (82%) (T4-T1: 95% CI: 75.5-83.3)。PPH诊断从所有新生儿的1.2%增加到3.6% (T2-T1: 95% CI: 0.4-5.2),并且在T3和T4大约保持在3%。在治疗方面,在HSC开始后T1和T2的普遍催产素使用在T3中减少(T3-T2: 27%-100%;95% CI: 95.5-49.9),而T4期TXA使用增加(T4- t1: 95%-0%;95% ci: 54.6-99.0)。结论和全球健康意义:改善PPH预防和治疗质量的一揽子干预措施可有效增加危机环境中HSC和TXA的使用。在类似的情况下,它可以在持续的监督下扩大规模,以减轻现有药物和新药物之间的混淆,例如减少催产素用于PPH治疗。维持冷链投资对于确保催产素质量至关重要。
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