Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage
Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage
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DOI：
10.1056/nejmoa2303966
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发表时间：
2023-05-09
影响因子：
158.5
通讯作者：
Coomarasamy, Arri
中科院分区：
文献类型：
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作者：
Gallos, Ioannis;Devall, Adam;Coomarasamy, Arri
背景产后出血的发现或治疗延误可能导致并发症或死亡。采血布可以帮助提供客观、准确和早期的产后出血诊断，有效干预措施的延迟或不一致使用可能能够通过治疗捆绑解决。方法：我们进行了一项国际性的集群随机试验，以评估阴道分娩患者产后出血的多组分临床干预。干预包括用于早期发现产后出血的校准采血布和一系列第一反应治疗（子宫按摩、催产药物、氨甲环酸、静脉输液、检查和升级），并辅以实施策略（干预组）。对照组的医院提供常规护理。主要结局为产后严重出血（失血，>= 1000 ml）、剖腹手术出血或产妇出血死亡。关键的次要实施结果是产后出血的检测和对治疗方案的依从性。结果将肯尼亚、尼日利亚、南非和坦桑尼亚共80家二级医院的210,132例阴道分娩患者随机分为干预组和常规护理组。在有数据的医院和患者中，干预组1.6%的患者发生了主要结局事件，而常规护理组4.3%的患者发生了主要结局事件(风险比0.40；95%可信区间[CI]， 0.32 ~ 0.50； P
BACKGROUND Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle.METHODS We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, >= 1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle.RESULTS A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P