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Created on : 28 Jun 2018
Modified on : 28 Jun 2018

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Bibliographical entry (without author) :

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

Author(s) :

Mariana Widmer, M.Sc., Gilda Piaggio, Ph.D., Thi M.H. Nguyen, Ph.D., Alfred Osoti, M.P.H., Olorunfemi O. Owa, M.D., Sujata Misra, M.D., Arri Coomarasamy, M.R.C.O.G., Hany Abdel-Aleem, M.D., Ashalata A. Mallapur, M.D., Zahida Qureshi, M.D., Pisake Lumbiganon, M.D., Archana B. Patel, Ph.D., Guillermo Carroli, M.D., Bukola Fawole, M.D., Shivaprasad S. Goudar, M.D., Yeshita V. Pujar, M.D., James Neilson, Ph.D., G. Justus Hofmeyr, D.Sc., Lin L. Su, M.R.C.O.G., Jose Ferreira de Carvalho, Ph.D., Uma Pandey, M.D., Kidza Mugerwa, M.D., Shobha S. Shiragur, M.D., Josaphat Byamugisha, Ph.D., Daniel Giordano, B.Sc., and A. Metin Gülmezoglu, Ph.D. et al.

Year of publication :

2018

URL(s) :

https://www.nejm.org/doi/full/10.1056/NEJMoa180548…
https://doi.org/10.1056/NEJMoa1805489

Résumé (français)  :

Abstract (English)  :

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 μg) 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. (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.)

Sumário (português)  :

Resumen (español)  :

Full text (public) :

Comments :

Argument (français) :

La carbétocine thermostable était non inférieure à l’ocytocine pour la prévention de la perte de sang d’au moins 500 ml ou l’utilisation d’agents utérotoniques supplémentaires

Argument (English):

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

Argumento (português):

Carbetocina estável ao calor não foi inferior à ocitocina para a prevenção de perda de sangue de pelo menos 500 ml ou o uso de agentes uterotônicos adicionais

Argumento (español):

Keywords :

➡ prevention ; postpartum hemorrhage ; oxytocin-3rd stage of labour

Author of this record :

Bernard Bel — 28 Jun 2018
➡ latest update : Marion Corbe — 28 Jun 2018