Loïc Sentilhes1, Norbert Winer1, Elie Azria1, Marie-Victoire Sénat1, Camille Le Ray1, Delphine Vardon1, Franck Perrotin1, Raoul Desbrière1, Florent Fuchs1, Gilles Kayem1, Guillaume Ducarme1, Muriel Doret-Dion1, Cyril Huissoud1, Caroline Bohec1, Philippe Deruelle1, Astrid Darsonval1, Jean-Marie Chrétien1, Aurélien Seco1, Valérie Daniel1, Catherine Deneux-Tharaux1. 1. From the Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux (L.S.), the Departments of Obstetrics and Gynecology (L.S.), Pharmacy (A.D., V.D.), and Clinical Research (J.-M.C.), Angers University Hospital, Angers, the Department of Obstetrics and Gynecology, University Medical Center of Nantes and the Centre d'Investigation Clinique Mère Enfant, University Hospital, the National Institute of Agricultural Research, Physiology of Nutritional Adaptations, University of Nantes, the Institute of Digestive Disease and Centre de Recherche en Nutrition Humaine Ouest, Nantes (N.W.), the Maternity Unit, Paris Saint Joseph Hospital (E.A.), INSERM Unité 1153, Obstetrical, Perinatal, and Pediatric Epidemiology Research Team, the Center for Epidemiology and Statistics, Sorbonne Paris Cité, University Hospital Department of Risks in Pregnancy (E.A., C.L.R., G.K., A.S., C.D.-T.), the Port Royal Maternity Unit, Cochin Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), University Hospital Department of Risks in Pregnancy (C.L.R.), Paris Descartes University, the Department of Obstetrics and Gynecology, Bicêtre University Hospital, AP-HP (M.-V.S.), and the Department of Obstetrics and Gynecology, Trousseau Hospital, AP-HP (G.K.), Paris, the Department of Obstetrics and Gynecology, Caen University Hospital, Caen (D.V.), the Department of Obstetrics and Gynecology, Tours University Hospital, Tours (F.P.), the Department of Obstetrics and Gynecology, Saint Joseph Hospital, Marseille (R.D.), the Department of Obstetrics and Gynecology, Montpellier University Hospital, Montpellier (F.F.), the Center for Research in Epidemiology and Population Health, INSERM Unité 1018, Reproduction and Child Development, Villejuif (F.F.), the Department of Obstetrics and Gynecology, Centre Hospitalier Departemental, La Roche-sur-Yon (G.D.), the Hospices Civils de Lyon, Hôpital Femme Mère Enfant, Department of Obstetrics and Gynecology, University Lyon 1 (M.D.-D.), and the Department of Obstetrics and Gynecology, Croix Rousse University Hospital (C.H.), Lyon, the Department of Obstetrics and Gynecology, François Mitterrand Hospital, Pau (C.B.), the Department of Obstetrics and Gynecology, Jeanne de Flandre University Hospital, Lille (P.D.), and the Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest, Brest University Hospital, Brest (A.D., V.D.) - all in France.
Abstract
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. (Funded by the French Ministry of Health; TRAAP ClinicalTrials.gov number, NCT02302456 .).
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. (Funded by the French Ministry of Health; TRAAP ClinicalTrials.gov number, NCT02302456 .).
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