Tranexamic acid for the prevention of blood loss after cesarean among women with twins: a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery randomized clinical trial

Loïc Sentilhes; Hugo Madar; Maëla Le Lous; Marie Victoire Sénat; Norbert Winer; Patrick Rozenberg; Gilles Kayem; Eric Verspyck; Florent Fuchs; Elie Azria; Denis Gallot; Diane Korb; Raoul Desbrière; Camille Le Ray; Céline Chauleur; Fanny de Marcillac; Franck Perrotin; Olivier Parant; Laurent J. Salomon; Emilie Gauchotte; Florence Bretelle; Nicolas Sananès; Caroline Bohec; Nicolas Mottet; Guillaume Legendre; Vincent Letouzey; Bassam Haddad; Delphine Vardon; Aurélien Mattuizzi; Alizée Froeliger; Hanane Bouchghoul; Valérie Daniel; Sophie Regueme; Caroline Roussillon; Aurore Georget; Astrid Darsonval; Antoine Benard; Catherine Deneux-Tharaux; Groupe de Recherche en Obstétrique et Gynécologie

doi:10.1016/j.ajog.2022.06.019

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Tranexamic acid for the prevention of blood loss after cesarean among women with twins: a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery randomized clinical trial

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Tranexamic acid for the prevention of blood loss after cesarean among women with twins: a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery randomized clinical trial

Loïc Sentilhes, Hugo Madar, Maëla Le Lous, Marie Victoire Sénat, Norbert Winer, Patrick Rozenberg, Gilles Kayem, Eric Verspyck, Florent Fuchs, Elie Azria, …

American journal of obstetrics and gynecology, Vol.227(6), pp.889.e1-889.e17

01/12/2022

DOI: https://doi.org/10.1016/j.ajog.2022.06.019

PMID: 35724759

Résumé

blood loss

cesarean delivery

multiple pregnancy

postpartum hemorrhage

prevention

tranexamic acid

Although prophylactic tranexamic acid administration after cesarean delivery resulted in a lower incidence of calculated estimated blood loss of >1000 mL or red cell transfusion by day 2, its failure to reduce the incidence of hemorrhage-related secondary clinical outcomes (TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial) makes its use questionable. The magnitude of its effect may differ in women at higher risk of blood loss, including those with multiple pregnancies. This study aimed to compare the effect of tranexamic acid vs placebo to prevent blood loss after cesarean delivery among women with multiple pregnancies. This was a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial data, a double-blind, randomized controlled trial from March 2018 to January 2020 in 27 French maternity hospitals, that included 319 women with multiple pregnancies. Women with a cesarean delivery before or during labor at ≥34 weeks of gestation were randomized to receive intravenously 1 g of tranexamic acid (n=160) or placebo (n=159), both with prophylactic uterotonics. The primary outcome was a calculated estimated blood loss of >1000 mL or a red blood cell transfusion by 2 days after delivery. The secondary outcomes included clinical and laboratory blood loss measurements. Of the 4551 women randomized in this trial, 319 had a multiple pregnancy and cesarean delivery, and 298 (93.4%) had primary outcome data available. This outcome occurred in 62 of 147 women (42.2%) in the tranexamic acid group and 67 of 152 (44.1%) receiving placebo (adjusted risk ratio, 0.97; 95% confidence interval, 0.68–1.38; P=.86). No significant between-group differences occurred for any hemorrhage-related clinical outcomes: gravimetrically estimated blood loss, provider-assessed clinically significant hemorrhage, additional uterotonics, postpartum blood transfusion, arterial embolization, and emergency surgery (P>.05 for all comparisons). Among women with a multiple pregnancy and cesarean delivery, prophylactic tranexamic acid did not reduce the incidence of any blood loss–related outcomes.

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Titre: Tranexamic acid for the prevention of blood loss after cesarean among women with twins: a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery randomized clinical trial
Créateurs - sans rôle: Loïc Sentilhes - Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France
Hugo Madar - Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France
Maëla Le Lous - Department of Obstetrics and Gynecology, Rennes University Hospital, Rennes, France
Marie Victoire Sénat - Department of Obstetrics and Gynecology, Bicêtre University Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
Norbert Winer - Department of Obstetrics and Gynecology, University Medical Center of Nantes, Centre d'Investigation Clinique Mère Enfant, University Hospital, Nantes, France
Patrick Rozenberg - Department of Obstetrics and Gynecology, Poissy/Saint-Germain Hospital, Poissy, France
Gilles Kayem - Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Centre de Recherche en Épidémiologie et StatistiqueS, Institut National de la Santé et de la Recherche Médicale, Institut National de la Recherche Agronomique, Universitary Hospital Departement - Risks in Pregnancy, Université de Paris, Paris, France
Eric Verspyck - Department of Obstetrics and Gynecology, Rouen University Hospital, Rouen, France
Florent Fuchs - Department of Obstetrics and Gynecology, Montpellier University Hospital, Montpellier, France
Elie Azria - Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Centre de Recherche en Épidémiologie et StatistiqueS, Institut National de la Santé et de la Recherche Médicale, Institut National de la Recherche Agronomique, Universitary Hospital Departement - Risks in Pregnancy, Université de Paris, Paris, France
Denis Gallot - Department of Obstetrics and Gynecology, Clermont-Ferrand University Hospital, Clermont-Ferrand, France
Diane Korb - Department of Obstetrics and Gynecology, Robert Debré Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
Raoul Desbrière - Department of Obstetrics and Gynecology, Saint-Joseph Hospital, Marseille, France
Camille Le Ray - Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Centre de Recherche en Épidémiologie et StatistiqueS, Institut National de la Santé et de la Recherche Médicale, Institut National de la Recherche Agronomique, Universitary Hospital Departement - Risks in Pregnancy, Université de Paris, Paris, France
Céline Chauleur - Department of Obstetrics and Gynecology, Saint-Etienne University Hospital, Saint-Etienne, France
Fanny de Marcillac - Department of Obstetrics and Gynecology, University Hospital of Strasbourg, Strasbourg, France
Franck Perrotin - Department of Obstetrics and Gynecology, Tours University Hospital, Tours, France
Olivier Parant - Department of Obstetrics and Gynecology, Toulouse University Hospital, Toulouse, France
Laurent J. Salomon - Assistance Publique – Hôpitaux de Paris
Emilie Gauchotte - Department of Obstetrics and Gynecology, Nancy University Hospital, Nancy, France
Florence Bretelle - Assistance Publique Hôpitaux de Marseille
Nicolas Sananès - Department of Obstetrics and Gynecology, Hôpital Centre Médico-Chirurgical et Obstétrical, Schiltigheim, France
Caroline Bohec - Department of Obstetrics and Gynecology, François Mitterrand Hospital, Pau, France
Nicolas Mottet - Department of Obstetrics and Gynecology, Besançon University Hospital, Besançon, France
Guillaume Legendre - Department of Obstetrics and Gynecology, Angers University Hospital, Angers, France
Vincent Letouzey - Department of Obstetrics and Gynecology, Carémeau University Hospital, Nimes, France
Bassam Haddad - Paris-Est Sup
Delphine Vardon - Department of Obstetrics and Gynecology, Caen University Hospital, Caen, France
Aurélien Mattuizzi - Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France
Alizée Froeliger - Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France
Hanane Bouchghoul - Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France
Valérie Daniel - Department of Pharmacy, Angers University Hospital, Angers, France
Sophie Regueme - Department of Clinical Research and Innovation, Bordeaux University Hospital, Bordeaux, France
Caroline Roussillon - European Clinical Trials Platform & Development, French Clinical Research Infrastructure Network, Department of Clinical Research and Innovation, Bordeaux University Hospital, Bordeaux, France
Aurore Georget - Epidemiology Unit, Public Health Department, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France
Astrid Darsonval - Department of Pharmacy, Angers University Hospital, Angers, France
Antoine Benard - Epidemiology Unit, Public Health Department, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France
Catherine Deneux-Tharaux - Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Centre de Recherche en Épidémiologie et StatistiqueS, Institut National de la Santé et de la Recherche Médicale, Institut National de la Recherche Agronomique, Universitary Hospital Departement - Risks in Pregnancy, Université de Paris, Paris, France
Groupe de Recherche en Obstétrique et Gynécologie
Détails de publication: American journal of obstetrics and gynecology, Vol.227(6), pp.889.e1-889.e17
Éditeur: Elsevier Inc
Note de subvention: French Ministry of Health
Identifiants: 99149972709311
Unité académique: Institut Desbrest d Epidemiologie et de Sante Publique - IDESP
Langue: English
Type de ressource: Journal article