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
2022
Sentilhes, Loïc | Madar, Hugo | Le Lous, Maëla | Senat, Marie-Victoire | Winer, Norbert | Rozenberg, Patrick | Kayem, Gilles | Verspyck, Eric | Fuchs, Florent | Azria, Elie | Gallot, Denis | Korb, Diane | Desbrière, Raoul | Le Ray, Camille | Chauleur, Céline | de Marcillac, Fanny | Perrotin, Franck | Parant, Olivier | Salomon, Laurent, J | Gauchotte, Emilie | Bretelle, Florence | Sananès, Nicolas | Bohec, Caroline | Mottet, Nicolas | Legendre, Guillaume | Letouzey, Vincent | Haddad, Bassam | Vardon, Delphine | Mattuizzi, Aurélien | Froeliger, Alizée | Bouchghoul, Hanane | Daniel, Valérie | Regueme, Sophie | Roussillon, Caroline | Georget, Aurore | Darsonval, Astrid | Benard, Antoine | Deneux‐tharaux, Catherine | Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux) | Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou] | Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) | Physiopathologie des Adaptations Nutritionnelles (PhAN) ; Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE) ; Nantes Université - pôle Santé ; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé ; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ) | Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes) | Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy] | Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques (CRESS (U1153 / UMR_A 1125)) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE) | CHU Trousseau [APHP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) | CHU Rouen ; Normandie Université (NU) | Centre de recherche en épidémiologie et santé des populations (CESP) ; Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay | Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier) | Centre hospitalier Saint-Joseph [Paris] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) | CHU Clermont-Ferrand | AP-HP Hôpital universitaire Robert-Debré [Paris] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) | Hôpital Saint-Joseph [Marseille] | Hôpital Cochin [AP-HP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) | PREMA: Fighting Prematurity (DRCI - AP-HP) ; Assistance Publique - Hôpitaux de Paris | Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E) | Centre Hospitalier Universitaire [Strasbourg] (CHU Strasbourg) ; Les Hôpitaux Universitaires de Strasbourg (HUS) | CHU Trousseau [Tours] ; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) | Centre Hospitalier Universitaire de Toulouse (CHU Toulouse) | Hôpital Necker - Enfants Malades [AP-HP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) | Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy) | Assistance Publique - Hôpitaux de Marseille (APHM) | Centre hospitalier de Pau | Service de Gynécologie Obstétrique [CHRU Besançon] ; Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon) | Centre Hospitalier Universitaire d'Angers (CHU Angers) ; PRES Université Nantes Angers Le Mans (UNAM) | Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes) ; Centre Hospitalier Universitaire de Nîmes (CHU Nîmes) | CHI Créteil | Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12) | CHU Caen ; Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN) | Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest (PPRIGO) ; Centre Hospitalier Régional Universitaire de Brest (CHRU Brest) | Obstetrical, Perinatal and Pediatric Epidemiology | Épidémiologie Obstétricale, Périnatale et Pédiatrique (EPOPé [CRESS - U1153 / UMR_A 1125]) ; Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques (CRESS (U1153 / UMR_A 1125)) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
International audience
Afficher plus [+] Moins [-]anglais. Background: 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.Objective: This study aimed to compare the effect of tranexamic acid vs placebo to prevent blood loss after cesarean delivery among women with multiple pregnancies.Study design: 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.Results: 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).Conclusion: 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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