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.


Journal

American journal of obstetrics and gynecology
ISSN: 1097-6868
Titre abrégé: Am J Obstet Gynecol
Pays: United States
ID NLM: 0370476

Informations de publication

Date de publication:
12 2022
Historique:
received: 08 03 2022
revised: 05 06 2022
accepted: 08 06 2022
pubmed: 21 6 2022
medline: 26 1 2023
entrez: 20 6 2022
Statut: ppublish

Résumé

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.

Sections du résumé

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.

Identifiants

pubmed: 35724759
pii: S0002-9378(22)00466-5
doi: 10.1016/j.ajog.2022.06.019
pii:
doi:

Substances chimiques

Tranexamic Acid 6T84R30KC1
Antifibrinolytic Agents 0

Types de publication

Randomized Controlled Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

889.e1-889.e17

Informations de copyright

Copyright © 2022 Elsevier Inc. All rights reserved.

Auteurs

Loïc Sentilhes (L)

Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France. Electronic address: loicsentilhes@hotmail.com.

Hugo Madar (H)

Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France.

Maëla Le Lous (M)

Department of Obstetrics and Gynecology, Rennes University Hospital, Rennes, France.

Marie Victoire Sénat (MV)

Department of Obstetrics and Gynecology, Bicêtre University Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.

Norbert Winer (N)

Department of Obstetrics and Gynecology, University Medical Center of Nantes, Centre d'Investigation Clinique Mère Enfant, University Hospital, Nantes, France; National Institute of Agricultural Research, Unité Mixte de Recherche 1280, Physiology of Nutritional Adaptations, University of Nantes, Institute of Digestive Disease and Centre de Recherche en Nutrition Humaine-Ouest, Nantes, France.

Patrick Rozenberg (P)

Department of Obstetrics and Gynecology, Poissy/Saint-Germain Hospital, Poissy, France.

Gilles Kayem (G)

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; Department of Obstetrics and Gynecology, Trousseau Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.

Eric Verspyck (E)

Department of Obstetrics and Gynecology, Rouen University Hospital, Rouen, France.

Florent Fuchs (F)

Department of Obstetrics and Gynecology, Montpellier University Hospital, Montpellier, France; Institut National de la Santé et de la Recherche Médicale, Centre for Research in Epidemiology and Population Health, U1018, Reproduction and Child Development, Villejuif, France.

Elie Azria (E)

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; Maternity Unit, Paris Saint-Joseph Hospital, Paris Descartes University, Paris, France.

Denis Gallot (D)

Department of Obstetrics and Gynecology, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.

Diane Korb (D)

Department of Obstetrics and Gynecology, Robert Debré Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.

Raoul Desbrière (R)

Department of Obstetrics and Gynecology, Saint-Joseph Hospital, Marseille, France.

Camille Le Ray (C)

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; Port Royal Maternity Unit, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Universitéde Paris, Fighting Prematurity University Hospital Federation, Paris, France.

Céline Chauleur (C)

Department of Obstetrics and Gynecology, Saint-Etienne University Hospital, Saint-Etienne, France.

Fanny de Marcillac (F)

Department of Obstetrics and Gynecology, University Hospital of Strasbourg, Strasbourg, France.

Franck Perrotin (F)

Department of Obstetrics and Gynecology, Tours University Hospital, Tours, France.

Olivier Parant (O)

Department of Obstetrics and Gynecology, Toulouse University Hospital, Toulouse, France.

Laurent J Salomon (LJ)

Department of Obstetrics and Gynecology, Necker-Enfants Malades Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.

Emilie Gauchotte (E)

Department of Obstetrics and Gynecology, Nancy University Hospital, Nancy, France.

Florence Bretelle (F)

Department of Obstetrics and Gynecology, Assistance Publique-Hôpitaux de Marseille, Aix-Marseille Université, Marseille, France.

Nicolas Sananès (N)

Department of Obstetrics and Gynecology, Hôpital Centre Médico-Chirurgical et Obstétrical, Schiltigheim, France.

Caroline Bohec (C)

Department of Obstetrics and Gynecology, François Mitterrand Hospital, Pau, France.

Nicolas Mottet (N)

Department of Obstetrics and Gynecology, Besançon University Hospital, Besançon, France.

Guillaume Legendre (G)

Department of Obstetrics and Gynecology, Angers University Hospital, Angers, France.

Vincent Letouzey (V)

Department of Obstetrics and Gynecology, Carémeau University Hospital, Nimes, France.

Bassam Haddad (B)

Department of Obstetrics, Gynecology and Reproductive Medicine, University Paris Est Créteil, Centre Hospitalier Intercommunal de Créteil, Créteil, France.

Delphine Vardon (D)

Department of Obstetrics and Gynecology, Caen University Hospital, Caen, France.

Aurélien Mattuizzi (A)

Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France.

Alizée Froeliger (A)

Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France.

Hanane Bouchghoul (H)

Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France.

Valérie Daniel (V)

Department of Pharmacy, Angers University Hospital, Angers, France; Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest, Brest University Hospital, Brest, France.

Sophie Regueme (S)

Department of Clinical Research and Innovation, Bordeaux University Hospital, Bordeaux, France.

Caroline Roussillon (C)

European Clinical Trials Platform & Development, French Clinical Research Infrastructure Network, Department of Clinical Research and Innovation, Bordeaux University Hospital, Bordeaux, France.

Aurore Georget (A)

Epidemiology Unit, Public Health Department, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France.

Astrid Darsonval (A)

Department of Pharmacy, Angers University Hospital, Angers, France; Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest, Brest University Hospital, Brest, France.

Antoine Benard (A)

Epidemiology Unit, Public Health Department, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France.

Catherine Deneux-Tharaux (C)

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.

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