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Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth

From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); Statistika Consultoria, Campinas, Brazil (G.P., J.F.C.); the Department of Obstetrics and Gynecology, School of Medicine, University of Nairobi, Nairobi, Kenya (A.O., Z.Q.); the Department of Obstetrics and Gynecology, Mother and Child Hospital, Akure (O.O.O.), and the Department of Obstetrics and Gynecology, College of Medicine, University of Ibadan, Ibadan (B.F.) - both in Nigeria; Sriram Chandra Bhanja Medical College, Cuttack (S.M.), S. Nijalingappa Medical College and Hangal Shri Kumareshwar Hospital and Medical Research Center (A.A.M.), Karnatak Lingayat Education Academy of Higher Education and Research, Jawaharlal Nehru Medical College (S.S.G., Y.V.P.), and Shri B.M. Patil Medical College, Hospital and Research Center (S.S.S.), Karnataka, Lata Medical Research Foundation and Daga Women's Hospital, Maharashtra (A.B.P.), and the Department of Obstetrics and Gynecology, Institute of Medical Sciences, Banaras Hindu University, Varanasi (U.P.) - all in India; the Institute of Metabolism and Systems Research, University of Birmingham, Birmingham (A.C.), and the Department of Obstetrics and Gynaecology, University of Liverpool, Liverpool (J.N.) - both in the United Kingdom; the Department of Obstetrics and Gynecology, Women's Health Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt (H.A.-A.); the Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand (P.L.); Centro Rosarino de Estudios Perinatales, Rosario, Argentina (G.C., D.G.); the Effective Care Research Unit, Universities of Witwatersrand-Johannesburg, Fort Hare-Alice, and Walter Sisulu-Eastern Cape, and the Eastern Cape Department of Health, Eastern Cape - all in South Africa (G.J.H.); the Department of Obstetrics and Gynecology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore (L.L.S.); and the Department of Obstetrics and Gynecology, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda (K.M., J.B.).

The New England Journal of Medicine. 2018;379((8):):743-752
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Abstract
Background Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin. Methods We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 mug) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8 degrees C) to maintain double-blinding. There were two primary outcomes: the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively. Results A total of 29,645 women underwent randomization. The frequency of blood loss of at least 500 ml or the use of additional uterotonic agents was 14.5% in the carbetocin group and 14.4% in the oxytocin group (relative risk, 1.01; 95% confidence interval [CI], 0.95 to 1.06), a finding that was consistent with noninferiority. The frequency of blood loss of at least 1000 ml was 1.51% in the carbetocin group and 1.45% in the oxytocin group (relative risk, 1.04; 95% CI, 0.87 to 1.25), with the confidence interval crossing the margin of noninferiority. The use of additional uterotonic agents, interventions to stop bleeding, and adverse effects did not differ significantly between the two groups. Conclusions Heat-stable carbetocin was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents. Noninferiority was not shown for the outcome of blood loss of at least 1000 ml; low event rates for this outcome reduced the power of the trial. (Funded by Merck Sharpe & Dohme; CHAMPION Australian New Zealand Clinical Trials Registry number, ACTRN12614000870651 ; EudraCT number, 2014-004445-26 ; and Clinical Trials Registry-India number, CTRI/2016/05/006969 .).
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Language : English
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine