Data Sheet 1_Clinical care processes for early postpartum haemorrhage diagnosis: a nested observational study within the E-MOTIVE trial.pdf

BackgroundPostpartum haemorrhage (PPH) is the leading cause of maternal mortality, particularly in low- and- middle-income countries. The E-MOTIVE trial demonstrated a 60% reduction in severe PPH and related complications with the E-MOTIVE intervention compared to usual care. This nested observational study explored clinical care practices between the time of vaginal birth and the removal of the obstetric drape. Specifically, we assessed the frequency of postpartum maternal assessments, including blood pressure, pulse, uterine tone, vaginal blood flow, and cumulative blood loss assessment—unique to the intervention. We also evaluated diagnostic methods, and blood loss thresholds used for PPH, and how these practices may have contributed to differences in PPH diagnosis and outcomes between E-MOTIVE intervention hospitals and usual care hospitals.
MethodsThis prospective observational study, nested within the E-MOTIVE trial, involved passive, direct observations of healthcare workers providing postpartum care to women and managing PPH across 78 hospitals in Nigeria, Kenya, Tanzania, and South Africa. We conducted a descriptive analysis of the frequency and timing of postpartum maternal assessments, diagnostic methods and blood loss thresholds used to diagnose PPH, comparing clinical practices between E-MOTIVE care and usual care.
ResultsBetween June and December 2022, the study included 2,578 women at E-MOTIVE care hospitals and 2,834 at usual care hospitals. At E-MOTIVE hospitals, 88% (2,272/2,578) of women received at least one postpartum maternal assessment, 71% (1,825/2,578) at least two, 57% (1,479/2,578) at least three, and 48% (1,234/2,578) four, with assessments conducted earlier and more frequently than at usual care hospitals. Objective blood loss quantification improved diagnosis, with the most common method and blood loss threshold at E-MOTIVE hospitals being ≥300 mL plus at least one abnormal clinical sign, used in 47% (140/295) of PPHs. Postpartum haemorrhage was diagnosed earlier and more frequently at E-MOTIVE hospitals: 76% (223/295) within 30 min, 97% (287/295) within 60 min, and 100% 295/295) within 90 min (median: 17 min; IQR 11–30), compared to 54% (119/219), 79% (173/219), 96% (210/219) respectively, and 100% within 134 min in usual care (median: 26 min; IQR 13–56).
DiscussionFrequent and timely postpartum maternal assessments, along with objective blood loss thresholds of with at least one abnormal clinical sign and ≥500 mL may enhance early PPH diagnosis. The first 90 min postpartum has been identified as a critical window for early diagnosis, termed the “Golden 90 min for PPH diagnosis.” Incorporating these insights into clinical training and guidelines may support improved maternal outcomes related to PPH.

背景：产后出血（postpartum haemorrhage, PPH）是孕产妇死亡的首要原因，在中低收入国家尤为高发。E-MOTIVE试验结果显示，相较于常规护理，E-MOTIVE干预措施可使严重产后出血及相关并发症的发生率降低60%。本项嵌套观察研究旨在探讨阴道分娩后至移除产科铺单前的临床护理实践。具体而言，我们评估了产后产妇评估的频率，涵盖血压、脉搏、子宫张力、阴道出血量以及累计失血量评估——这是干预组特有的评估项目。我们还评估了用于诊断产后出血的诊断方法及失血量阈值，并分析了这些实践差异如何导致E-MOTIVE干预医院与常规护理医院在产后出血诊断及临床结局上的不同。
方法：本项前瞻性观察研究嵌套于E-MOTIVE试验之中，对尼日利亚、肯尼亚、坦桑尼亚及南非78家医院中，为产妇提供产后护理并处理产后出血的医护人员开展了被动直接观察。我们对产后产妇评估的频率与时机、用于诊断产后出血的诊断方法及失血量阈值进行描述性分析，对比了E-MOTIVE护理组与常规护理组的临床实践差异。
结果：2022年6月至12月期间，本研究共纳入E-MOTIVE护理医院的2578名产妇，以及常规护理医院的2834名产妇。在E-MOTIVE医院中，88%（2272/2578）的产妇接受了至少1次产后产妇评估，71%（1825/2578）接受至少2次，57%（1479/2578）接受至少3次，48%（1234/2578）接受4次评估，且评估时机更早、频率高于常规护理医院。客观量化失血量可提升诊断准确性，E-MOTIVE医院最常用的诊断方法及失血量阈值为≥300mL且伴至少1项异常临床体征，该方案应用于47%（140/295）的产后出血病例。E-MOTIVE医院的产后出血诊断时机更早、频率更高：76%（223/295）的病例在30分钟内完成诊断，97%（287/295）在60分钟内完成，100%（295/295）在90分钟内完成（中位时间17分钟；四分位距11~30）；而常规护理医院的对应比例分别为54%（119/219）、79%（173/219）、96%（210/219），且所有病例均在134分钟内完成诊断（中位时间26分钟；四分位距13~56）。
讨论：频繁且及时的产后产妇评估，结合≥500mL且伴至少1项异常临床体征的客观失血量阈值，或可提升产后出血的早期诊断效能。产后最初90分钟被确定为早期诊断的关键窗口，即“产后出血诊断黄金90分钟”。将这些研究结论纳入临床培训与指南，或有助于改善与产后出血相关的孕产妇临床结局。