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
(1)
,
Hugo Madar
(1)
,
Maëla Le Lous
(2)
,
Marie-Victoire Senat
(3)
,
Norbert Winer
(4, 5)
,
Patrick Rozenberg
(6, 7)
,
Gilles Kayem
(8)
,
Eric Verspyck
(9)
,
Florent Fuchs
(10, 11, 12)
,
Elie Azria
(8)
,
Denis Gallot
(13)
,
Diane Korb
(14)
,
Raoul Desbrière
(15)
,
Camille Le Ray
(16)
,
Céline Chauleur
(17)
,
Fanny de Marcillac
(18)
,
Franck Perrotin
(19)
,
Olivier Parant
(20, 21)
,
Laurent J Salomon
(22)
,
Emilie Gauchotte
(23)
,
Florence Bretelle
(24)
,
Nicolas Sananès
,
Caroline Bohec
,
Nicolas Mottet
(25)
,
Guillaume Legendre
(26)
,
Vincent Letouzey
(27, 28)
,
Bassam Haddad
(29)
,
Delphine Vardon
(30)
,
Aurélien Mattuizzi
(1)
,
Alizée Froeliger
(1)
,
Hanane Bouchghoul
(1)
,
Valérie Daniel
(31)
,
Sophie Regueme
(1)
,
Caroline Roussillon
(1)
,
Aurore Georget
(1)
,
Astrid Darsonval
(26)
,
Antoine Benard
(32)
,
Catherine Deneux‐tharaux
(33)
1
CHU Bordeaux
2 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
3 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
4 PhAN - Physiopathologie des Adaptations Nutritionnelles
5 CHU Nantes - Centre Hospitalier Universitaire de Nantes
6 Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy]
7 RISCQ - Risques cliniques et sécurité en santé des femmes et en santé périnatale
8 INSERM - Institut National de la Santé et de la Recherche Médicale
9 CHU Rouen
10 CESP - Centre de recherche en épidémiologie et santé des populations
11 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
12 IDESP - Institut Desbrest de santé publique
13 CHU Clermont-Ferrand
14 AP-HP Hôpital universitaire Robert-Debré [Paris]
15 Hôpital Saint-Joseph [Marseille]
16 Hôpital Cochin [AP-HP]
17 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
18 CHU Strasbourg - Centre Hospitalier Universitaire [Strasbourg]
19 CHU Trousseau [Tours]
20 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
21 Equipe SPHERE (CERPOP)
22 INEM - UM 111 (UMR 8253 / U1151) - Institut Necker Enfants-Malades
23 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
24 APHM - Assistance Publique - Hôpitaux de Marseille
25 Service de Gynécologie Obstétrique [CHRU Besançon]
26 CHU Angers - Centre Hospitalier Universitaire d'Angers
27 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
28 IBMM - Institut des Biomolécules Max Mousseron [Pôle Chimie Balard]
29 CHI Créteil
30 CHU Caen
31 CIC Brest
32 BPH - Bordeaux population health
33 EPOPé [CRESS - U1153 / UMR_A 1125] - Obstetrical, Perinatal and Pediatric Epidemiology | Épidémiologie Obstétricale, Périnatale et Pédiatrique
2 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
3 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
4 PhAN - Physiopathologie des Adaptations Nutritionnelles
5 CHU Nantes - Centre Hospitalier Universitaire de Nantes
6 Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy]
7 RISCQ - Risques cliniques et sécurité en santé des femmes et en santé périnatale
8 INSERM - Institut National de la Santé et de la Recherche Médicale
9 CHU Rouen
10 CESP - Centre de recherche en épidémiologie et santé des populations
11 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
12 IDESP - Institut Desbrest de santé publique
13 CHU Clermont-Ferrand
14 AP-HP Hôpital universitaire Robert-Debré [Paris]
15 Hôpital Saint-Joseph [Marseille]
16 Hôpital Cochin [AP-HP]
17 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
18 CHU Strasbourg - Centre Hospitalier Universitaire [Strasbourg]
19 CHU Trousseau [Tours]
20 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
21 Equipe SPHERE (CERPOP)
22 INEM - UM 111 (UMR 8253 / U1151) - Institut Necker Enfants-Malades
23 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
24 APHM - Assistance Publique - Hôpitaux de Marseille
25 Service de Gynécologie Obstétrique [CHRU Besançon]
26 CHU Angers - Centre Hospitalier Universitaire d'Angers
27 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
28 IBMM - Institut des Biomolécules Max Mousseron [Pôle Chimie Balard]
29 CHI Créteil
30 CHU Caen
31 CIC Brest
32 BPH - Bordeaux population health
33 EPOPé [CRESS - U1153 / UMR_A 1125] - Obstetrical, Perinatal and Pediatric Epidemiology | Épidémiologie Obstétricale, Périnatale et Pédiatrique
Loïc Sentilhes
- Fonction : Auteur
- PersonId : 768118
- ORCID : 0000-0003-0009-3625
- IdRef : 092892582
Marie-Victoire Senat
- Fonction : Auteur
- PersonId : 1231495
- ORCID : 0000-0002-2329-6575
Norbert Winer
- Fonction : Auteur
- PersonId : 764667
- ORCID : 0000-0001-9897-8493
Patrick Rozenberg
- Fonction : Auteur
- PersonId : 757708
- ORCID : 0000-0002-8566-015X
- IdRef : 030832683
Olivier Parant
- Fonction : Auteur
Nicolas Sananès
- Fonction : Auteur
Caroline Bohec
- Fonction : Auteur
Vincent Letouzey
- Fonction : Auteur
- PersonId : 989211
Catherine Deneux‐tharaux
- Fonction : Auteur
- PersonId : 757379
- ORCID : 0000-0002-6561-3321
- IdRef : 035797975
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.