Loïc Sentilhes1, Marie V Sénat1, Maëla Le Lous1, Norbert Winer1, Patrick Rozenberg1, Gilles Kayem1, Eric Verspyck1, Florent Fuchs1, Elie Azria1, Denis Gallot1, Diane Korb1, Raoul Desbrière1, Camille Le Ray1, Céline Chauleur1, Fanny de Marcillac1, Franck Perrotin1, Olivier Parant1, Laurent J Salomon1, Emilie Gauchotte1, Florence Bretelle1, Nicolas Sananès1, Caroline Bohec1, Nicolas Mottet1, Guillaume Legendre1, Vincent Letouzey1, Bassam Haddad1, Delphine Vardon1, Hugo Madar1, Aurélien Mattuizzi1, Valérie Daniel1, Sophie Regueme1, Caroline Roussillon1, Antoine Benard1, Aurore Georget1, Astrid Darsonval1, Catherine Deneux-Tharaux1. 1. From the Department of Obstetrics and Gynecology (L.S., H.M., A.M.), the Department of Clinical Research and Innovation (S.R.), and the Euclid-French Clinical Research Infrastructure Network (F-CRIN) Clinical Trials Platform, Department of Clinical Research and Innovation (C.R.), Bordeaux University Hospital, and the Public Health Department, Clinical Epidemiology Unit, Centre Hospitalier Universitaire (CHU) Bordeaux (A.B., A.G.), Bordeaux, the Department of Obstetrics and Gynecology, Bicêtre University Hospital (M.V.S.), the Department of Obstetrics and Gynecology, Trousseau Hospital (G.K.), the Department of Obstetrics and Gynecology, Robert Debré Hospital (D.K.), Port Royal Maternity Unit, Cochin Hospital (C.L.R.), and the Department of Obstetrics and Gynecology, Necker-Enfants Malades Hospital (L.J.S.), Assistance Publique-Hôpitaux de Paris, Université de Paris, Center of Research in Epidemiology and Statistics Sorbonne, Obstetrical, Perinatal, and Pediatric Epidemiology Research Team (EPOPé), INSERM, Institut National de la Recherche Agronomique (INRA), University Hospital Department-Risks in Pregnancy (G.K., E.A., C.L.R., C.D.-T.), and the Maternity Unit, Paris Saint Joseph Hospital, Paris Descartes University (E.A.), Paris, the Department of Obstetrics and Gynecology, Rennes University Hospital, Rennes (M.L.L.), the Department of Obstetrics and Gynecology, University Medical Center of Nantes, Centre d'Investigation Clinique Mère Enfant, University Hospital, and INRA, Unité Mixte de Recherche (UMR) 1280, Physiology of Nutritional Adaptations, University of Nantes, Institut des Maladie de l'Appareil Digestif, and Centre de Recherche en Nutrition Humaine-Ouest, Nantes (N.W.), the Department of Obstetrics and Gynecology, Poissy/Saint-Germain Hospital, Poissy (P.R.), the Department of Obstetrics and Gynecology, Rouen University Hospital, Rouen (E.V.), the Department of Obstetrics and Gynecology, Montpellier University Hospital, Montpellier (F.F.), INSERM, Center for Research in Epidemiology and Population Health, Unité 1018, Reproduction and Child Development, Villejuif (F.F.), the Department of Obstetrics and Gynecology, Clermont-Ferrand University Hospital, Clermont-Ferrand (D.G.), the Department of Obstetrics and Gynecology, Saint-Joseph Hospital (R.D.), and the Department of Obstetrics and Gynecology, Assistance Publique-Hôpitaux de Marseille, Aix Marseille Université (F.B.), Marseille, the Department of Obstetrics and Gynecology, Saint-Etienne University Hospital, Saint Etienne (C.C.), the Department of Obstetrics and Gynecology, University Hospital of Strasbourg, Strasbourg (F.M.), the Department of Obstetrics and Gynecology, Tours University Hospital, Tours (F.P.), the Department of Obstetrics and Gynecology, Toulouse University Hospital, Toulouse (O.P.), the Department of Obstetrics and Gynecology, Nancy University Hospital, Nancy (E.G.), the Department of Obstetrics and Gynecology, Centre Médico-chirurgical et Obstétrical, Schiltigheim (N.S.), the Department of Obstetrics and Gynecology, François Mitterrand Hospital, Pau (C.B.), the Department of Obstetrics and Gynecology, Besançon University Hospital, Besançon (N.M.), the Departments of Obstetrics and Gynecology (G.L.) and Pharmacy (V.D., A.D.), Angers University Hospital, Angers, the Department of Obstetrics and Gynecology, Carémeau University Hospital, Nîmes (V.L.), the Department of Obstetrics and Gynecology and Reproductive Medicine, University Paris Est Créteil, Centre Hospitalier Inter-Communal de Créteil, Créteil (B.H.), the Department of Obstetrics and Gynecology, Caen University Hospital, Caen (D.V.), and PPRIGO (Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest), Brest University Hospital, Brest (V.D., A.D.) - all in France.
Abstract
BACKGROUND: Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive. METHODS: In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion. RESULTS: Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08). CONCLUSIONS: Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).
BACKGROUND: Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive. METHODS: In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion. RESULTS: Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08). CONCLUSIONS: Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).
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