Please use this identifier to cite or link to this item: https://doi.org/10.1056/NEJMoa1805489
Title: Heat-stable carbetocin versus oxytocin to prevent hemorrhage after vaginal birth
Authors: Widmer M.
Piaggio G.
Nguyen T.M.H.
Osoti A.
Owa O.O.
Misra S.
Coomarasamy A.
Abdel-Aleem H.
Mallapur A.A.
Qureshi Z.
Lumbiganon P.
Patel A.B.
Carroli G.
Fawole B.
Goudar S.S.
Pujar Y.V.
Neilson J.
Hofmeyr G.J.
Su L.L. 
Ferreira De Carvalho J.
Pandey U.
Mugerwa K.
Shiragur S.S.
Byamugisha J.
Giordano D.
Gülmezoglu A.M.
Widmer M.
Piaggio G.
Nguyen T.M.H.
Osoti A.
Owa O.O.
Misra S.
Coomarasamy A.
Abdel-Aleem H.
Mallapur A.A.
Qureshi Z.
Lumbiganon P.
Patel A.B.
Carroli G.
Fawole B.-K.
Goudar S.S.
Pujar Y.V.
Neilson J.
Justus Hofmeyr G.
Su L.L. 
De Carvalho J.F.
Pandey U.
Mugerwa K.
Shiragur S.S.
Byamugisha J.
Giordano D.
Metin Gülmezoglu A.
the WHO CHAMPION Trial Group
Issue Date: 2018
Publisher: Massachussetts Medical Society
Citation: Widmer M., Piaggio G., Nguyen T.M.H., Osoti A., Owa O.O., Misra S., Coomarasamy A., Abdel-Aleem H., Mallapur A.A., Qureshi Z., Lumbiganon P., Patel A.B., Carroli G., Fawole B., Goudar S.S., Pujar Y.V., Neilson J., Hofmeyr G.J., Su L.L., Ferreira De Carvalho J., Pandey U., Mugerwa K., Shiragur S.S., Byamugisha J., Giordano D., Gülmezoglu A.M., Widmer M., Piaggio G., Nguyen T.M.H., Osoti A., Owa O.O., Misra S., Coomarasamy A., Abdel-Aleem H., Mallapur A.A., Qureshi Z., Lumbiganon P., Patel A.B., Carroli G., Fawole B.-K., Goudar S.S., Pujar Y.V., Neilson J., Justus Hofmeyr G., Su L.L., De Carvalho J.F., Pandey U., Mugerwa K., Shiragur S.S., Byamugisha J., Giordano D., Metin Gülmezoglu A., the WHO CHAMPION Trial Group (2018). Heat-stable carbetocin versus oxytocin to prevent hemorrhage after vaginal birth. New England Journal of Medicine 379 (8) : 743-752. ScholarBank@NUS Repository. https://doi.org/10.1056/NEJMoa1805489
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 ?g) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°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. Copyright © 2018 Massachusetts Medical Society.
Source Title: New England Journal of Medicine
URI: http://scholarbank.nus.edu.sg/handle/10635/151654
ISSN: 00284793
DOI: 10.1056/NEJMoa1805489
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