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Created on : 25 Aug 2018
Modified on : 25 Aug 2018

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Bibliographical entry (without author) :

Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery.

Author(s) :

Loïc Sentilhes, M.D., Ph.D., Norbert Winer, M.D., Ph.D., Elie Azria, M.D., Ph.D., Marie-Victoire Sénat, M.D., Ph.D., Camille Le Ray, M.D., Ph.D., Delphine Vardon, M.D., Franck Perrotin, M.D., Ph.D., Raoul Desbrière, M.D., Florent Fuchs, M.D., Ph.D., Gilles Kayem, M.D., Ph.D., Guillaume Ducarme, M.D., Ph.D., Muriel Doret-Dion, M.D., Ph.D., Cyril Huissoud, M.D., Ph.D., Caroline Bohec, M.D., Philippe Deruelle, M.D., Ph.D., Astrid Darsonval, Pharm.D., Jean-Marie Chrétien, M.Sc., Aurélien Seco, M.Sc., Valérie Daniel, Pharm.D., and Catherine Deneux-Tharaux, M.D., Ph.D.

Year of publication :

2018

URL(s) :

https://www.nejm.org/doi/full/10.1056/NEJMoa180094…
https://doi.org/10.1056/NEJMoa1800942

Résumé (français)  :

Abstract (English)  :

Background

The use of tranexamic acid reduces mortality due to postpartum hemorrhage. We investigated whether the prophylactic administration of tranexamic acid in addition to prophylactic oxytocin in women with vaginal delivery would decrease the incidence of postpartum hemorrhage.

Methods

In a multicenter, double-blind, randomized, controlled trial, we randomly assigned women in labor who had a planned vaginal delivery of a singleton live fetus at 35 or more weeks of gestation to receive 1 g of tranexamic acid or placebo, administered intravenously, in addition to prophylactic oxytocin after delivery. The primary outcome was postpartum hemorrhage, defined as blood loss of at least 500 ml, measured with a collector bag.

Results

Of the 4079 women who underwent randomization, 3891 had a vaginal delivery. The primary outcome occurred in 156 of 1921 women (8.1%) in the tranexamic acid group and in 188 of 1918 (9.8%) in the placebo group (relative risk, 0.83; 95% confidence interval [CI], 0.68 to 1.01; P=0.07). Women in the tranexamic acid group had a lower rate of provider-assessed clinically significant postpartum hemorrhage than those in the placebo group (7.8% vs. 10.4%; relative risk, 0.74; 95% CI, 0.61 to 0.91; P=0.004; P=0.04 after adjustment for multiple comparisons post hoc) and also received additional uterotonic agents less often (7.2% vs. 9.7%; relative risk, 0.75; 95% CI, 0.61 to 0.92; P=0.006; adjusted P=0.04). Other secondary outcomes did not differ significantly between the two groups. The incidence of thromboembolic events in the 3 months after delivery did not differ significantly between the tranexamic acid group and the placebo group (0.1% and 0.2%, respectively; relative risk, 0.25; 95% CI, 0.03 to 2.24).

Conclusions

Among women with vaginal delivery who received prophylactic oxytocin, the use of tranexamic acid did not result in a rate of postpartum hemorrhage of at least 500 ml that was significantly lower than the rate with placebo.

Sumário (português)  :

Resumen (español)  :

Comments :

Argument (français) :

Chez les femmes ayant eu un accouchement par voie vaginale ayant reçu de l’ocytocine à titre prophylactique, l’utilisation d’acide tranexamique n’a pas entraîné un taux d’hémorragie du postpartum d’au moins 500 ml, significativement inférieur à celui observé avec le placebo.

Argument (English):

Among women with vaginal delivery who received prophylactic oxytocin, the use of tranexamic acid did not result in a rate of postpartum hemorrhage of at least 500 ml that was significantly lower than the rate with placebo.

Argumento (português):

Entre as mulheres com parto vaginal que receberam ocitocina profilática, o uso de ácido tranexâmico não resultou em uma taxa de hemorragia pós-parto de pelo menos 500 ml que foi significativamente menor do que a taxa com placebo.

Argumento (español):

Keywords :

➡ postpartum hemorrhage ; oxytocin

Author of this record :

Bernard Bel — 25 Aug 2018