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Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery

Loïc Sentilhes 1, * Marie Sénat 2 Maëla Le Lous 3 Norbert Winer 4, 5, 6 Patrick Rozenberg 7 Gilles Kayem 8, 9 Eric Verspyck 10 Florent Fuchs 11, 12 Elie Azria 13, 9 Denis Gallot 14 Diane Korb 15, 16 Raoul Desbrière 17 Camille Le Ray 16, 18, 9 Céline Chauleur 19 Fanny de Marcillac 20 Franck Perrotin 21 Olivier Parant 22 Laurent Salomon 23, 16 Emilie Gauchotte 24 Florence Bretelle 25, 26 Nicolas Sananès 27 Caroline Bohec 28 Nicolas Mottet 29 Guillaume Legendre 30 Vincent Letouzey 31 Bassam Haddad 32 Delphine Vardon 33 Hugo Madar 1 Aurélien Mattuizzi 1 Valérie Daniel 30, 34 Sophie Regueme 1 Caroline Roussillon 1 Antoine Benard 1 Aurore Georget 1, 35 Astrid Darsonval 30, 34 Catherine Deneux-Tharaux 9 
* Corresponding author
9 CRESS - U1153 - Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique
CRESS (U1153 / UMR_A_1125 / UMR_S_1153) - Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité
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.) Blood-Loss Prevention after Cesarean Delivery In this trial involving women undergoing cesarean delivery (all of whom received prophylactic uterotonic medication), tranexamic acid treatment resulted in a significantly lower incidence of estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not reduce the risk of hemorrhage-related secondary clinical outcomes.
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Submitted on : Thursday, March 24, 2022 - 4:21:36 PM
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Loïc Sentilhes, Marie Sénat, Maëla Le Lous, Norbert Winer, Patrick Rozenberg, et al.. Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery. New England Journal of Medicine, Massachusetts Medical Society, 2021, 384 (17), pp.1623-1634. ⟨10.1056/NEJMoa2028788⟩. ⟨hal-03238593⟩

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