Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery - Université Paris Cité Access content directly
Journal Articles New England Journal of Medicine Year : 2021

Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery

1 CHU Bordeaux
2 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
3 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
4 CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
5 PhAN - Physiopathologie des Adaptations Nutritionnelles
6 CRNH Ouest - Centre de Recherche en Nutrition Humaine Ouest
7 Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy]
8 CHU Trousseau [APHP]
9 EPOPé [CRESS - U1153 / UMR_A 1125] - Obstetrical, Perinatal and Pediatric Epidemiology | Épidémiologie Obstétricale, Périnatale et Pédiatrique
10 CHU Rouen
11 CHU Montpellier
12 CESP - Centre de recherche en épidémiologie et santé des populations
13 Centre hospitalier Saint-Joseph [Paris]
14 CHU Clermont-Ferrand
15 AP-HP Hôpital universitaire Robert-Debré [Paris]
16 UPCité - Université Paris Cité
17 Hôpital Saint-Joseph [Marseille]
18 Maternité Port-Royal [CHU Cochin]
19 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
20 CHU Strasbourg - Centre Hospitalier Universitaire [Strasbourg]
21 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
22 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
23 Hôpital Necker - Enfants Malades [AP-HP]
24 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
25 APHM - Assistance Publique - Hôpitaux de Marseille
26 MEPHI - Microbes évolution phylogénie et infections
27 UNISTRA - Université de Strasbourg
28 Centre hospitalier de Pau
29 CHRU Besançon - Centre Hospitalier Régional Universitaire de Besançon
30 CHU Angers - Centre Hospitalier Universitaire d'Angers
31 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
32 CHIC - Centre Hospitalier Intercommunal de Créteil
33 CHU Caen
34 CHRU Brest - Centre Hospitalier Régional Universitaire de Brest
35 BPH - Bordeaux population health
Loïc Sentilhes
  • Function : Correspondent author
  • PersonId : 925211

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Eric Verspyck
  • Function : Author
Vincent Letouzey
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  • PersonId : 989211
  • IdRef : 13095327X
Delphine Vardon
  • Function : Author
Hugo Madar
  • Function : Author
Aurélien Mattuizzi
  • Function : Author
Sophie Regueme
  • Function : Author
Caroline Roussillon
  • Function : Author
Antoine Benard
  • Function : Author

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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Dates and versions

hal-03238593 , version 1 (24-03-2022)

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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, 2021, 384 (17), pp.1623-1634. ⟨10.1056/NEJMoa2028788⟩. ⟨hal-03238593⟩
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