随机试验：产后出血的早期检测与治疗。
Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage.
机构信息
From the United Nations (UN) Development Program-UN Population Fund-UN Children's Fund-World Health Organization (WHO)-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, the Department of Sexual and Reproductive Health and Research, WHO (I.G., M.W., O.T.O., F.A.), and the Concept Foundation (A. Ammerdorffer, M.G.) - both in Geneva; the College of Medical and Dental Sciences, University of Birmingham (A.D., J.M., L.M., L.B., A. Aswat, K.-M.M., K.N.S., M.P., I.H., R.T., E.W., T.R., K.H., A.C.), Health Education England (I.Y.), and the Department of Obstetrics and Gynaecology, Birmingham Women's and Children's NHS Foundation Trust (P.L., S.M.), Birmingham, the Centre for Behaviour Change, University College London (G.F., F.L.), and the Department of Women and Children's Health, School of Life Course Sciences, King's College London (A.S.), London, and the Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool (D.L., A.W.) - all in the United Kingdom; the African Center of Excellence for Population Health and Policy, College of Health Sciences, Bayero University, Kano, Nigeria (H.G., A.A.W.); the Department of Obstetrics and Gynecology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (F.A.A., A.M.); the Department of Obstetrics and Gynecology, University of Nairobi, Nairobi, Kenya (Z.Q., G.G., A.O., J.O.); the Department of Obstetrics and Gynecology, University of Botswana, Gaborone (G.J.H.); the KwaZulu-Natal Department of Health, Pietermaritzburg (N.M.), the Department of Obstetrics and Gynaecology, University of Cape Town, Cape Town (S.F., E.A.), and the Effective Care Research Unit, University of the Witwatersrand, Johannesburg (G.J.H., M.S.-M.) - all in South Africa; the Department of Obstetrics and Gynecology, Aga Khan University, Karachi, Pakistan (L.S., S.N., S.M.); the Maternal and Newborn Health Unit, Technical Leadership and Innovation, Jhpiego, and Johns Hopkins University, Baltimore (C.E.); the Gender and Women's Health Unit, Centre for Health Equity, School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia (S.A., M.A.B.); the Department of Obstetrics and Reproductive Sciences, School of Medicine, University of California, San Francisco, San Francisco (S.M.); and the Maternal, Newborn, and Child Health Team, Bill and Melinda Gates Foundation, Seattle (J.M.S).
出版信息
N Engl J Med. 2023 Jul 6;389(1):11-21. doi: 10.1056/NEJMoa2303966. Epub 2023 May 9.
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<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28).
CONCLUSIONS
Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery. (Funded by the Bill and Melinda Gates Foundation; E-MOTIVE ClinicalTrials.gov number, NCT04341662.).
背景
产后出血的检测或治疗延误可能导致并发症或死亡。集血巾有助于提供产后出血的客观、准确和早期诊断，而延迟或不一致地使用有效的干预措施可能可以通过治疗包来解决。
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措施。该干预措施包括使用校准的集血巾进行早期检测产后出血和一整套的初步治疗措施（子宫按摩、催产素药物、氨甲环酸、静脉输液、检查和升级），并辅之以实施策略（干预组）。对照组中的医院提供常规护理。主要结局是产后出血严重（失血量≥1000 毫升）、剖腹手术止血或出血导致产妇死亡的复合结局。关键的次要实施结局是产后出血的检测和治疗包的依从性。
结果
在肯尼亚、尼日利亚、南非和坦桑尼亚的 80 家二级医院中，共有 210132 名患者接受了阴道分娩，这些医院被随机分配到干预组或常规护理组。在有数据的医院和患者中，干预组的患者中有 1.6%发生了主要结局事件，而常规护理组的患者中有 4.3%发生了主要结局事件（风险比为 0.40；95%置信区间[CI]为 0.32 至 0.50；P<0.001）。干预组的患者中有 93.1%的患者检测到产后出血，而常规护理组的患者中有 51.1%的患者检测到产后出血（发生率比为 1.58；95%CI 为 1.41 至 1.76），并且分别有 91.2%和 19.4%的患者使用了治疗包（发生率比为 4.94；95%CI 为 3.88 至 6.28）。
结论
与阴道分娩患者的常规护理相比，早期检测产后出血和使用捆绑治疗可降低主要结局（严重产后出血、剖腹手术止血或出血导致产妇死亡的复合结局）的风险。（由比尔及梅琳达·盖茨基金会资助；E-MOTIVE ClinicalTrials.gov 编号，NCT04341662）。
Zotero 插件