Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage.
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Gallos Ioannis, Devall Adam, Martin James, Middleton Lee, Beeson Leanne, Galadanci Hadiza, Alwy Al-Beity Fadhlun, Qureshi Zahida, Hofmeyr G Justus, Moran Neil, Fawcus Sue, Sheikh Lumaan, Gwako George, Osoti Alfred, Aswat Ashraf, Mammoliti Kristie-Marie, Sindhu Kulandaipalayam N, Podesek Marcelina, Horne Isobelle, Timms Rebecca, Yunas Idnan, Okore Jenipher, Singata-Madliki Mandisa, Arends Edna, Wakili Aminu A, Mwampashi Ard, Nausheen Sidrah, Muhammad Shah, Latthe Pallavi, Evans Cherrie, Akter Shahinoor, Forbes Gillian, Lissauer David, Meher Shireen, Weeks Andrew, Shennan Andrew, Ammerdorffer Anne, Williams Eleanor, Roberts Tracy, Widmer Mariana, Oladapo Olufemi T, Lorencatto Fabiana, Bohren Meghan A, Miller Suellen, Althabe Fernando, Gülmezoglu Metin, Smith Jeffrey M, Hemming Karla, Coomarasamy Arri
Аннотация
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.).