Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage.

N Engl J Med

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).

Published: July 2023

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.).

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http://dx.doi.org/10.1056/NEJMoa2303966	DOI Listing

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