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1: Tranexamic acid for the prevention of postpartum hemorrhage after vaginal delivery: the TRAAP trial

  • Loïc Sentilhes
    Affiliations
    Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France

    Department of Obstetrics and Gynecology, Angers University Hospital, Angers, France
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  • Norbert Winer
    Affiliations
    Department of Obstetrics and Gynecology, University Medical Center of Nantes; Centre d'Investigation Clinique CIC Mere enfant, Nantes, France

    National Institute of Agricultural Research (INRA), UMR 1280, Physiology of Nutritional Adaptations, University of Nantes, IMAD and CRNH-Ouest, Nantes 44000, France
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  • Elie Azria
    Affiliations
    Maternity unit, Paris Saint Joseph Hospital, Paris Descartes University, Paris, France

    INSERM U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Epidemiology and Statistics, Sorbonne Paris Cité, DHU Risks in Pregnancy, Paris Descartes University, Paris, France
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  • Marie-Victoire Sénat
    Affiliations
    Department of Obstetrics and Gynecology, Kremlin-Bicetre University Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
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  • Camille Le Ray
    Affiliations
    INSERM U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Epidemiology and Statistics, Sorbonne Paris Cité, DHU Risks in Pregnancy, Paris Descartes University, Paris, France

    Port Royal Maternity Unit, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France; DHU Risks in Pregnancy; Paris Descartes University, Paris, France
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  • Delphine Vardon
    Affiliations
    Department of Obstetrics and Gynecology, Caen University Hospital, Caen, France
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  • Franck Perrotin
    Affiliations
    Department of Obstetrics and Gynecology, Tours University Hospital, Tours, France
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  • Raoul Desbrière
    Affiliations
    Department of Obstetrics and Gynecology, Saint-Jospeh Hospital, Marseille, France
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  • Florent Fuchs
    Affiliations
    Department of Obstetrics and Gynecology, Montpelier University Hospital, Montpellier, France

    Inserm, CESP Centre for research in Epidemiology and Population Health, U1018, Reproduction and child development, Villejuif, France
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  • Gilles Kayem
    Affiliations
    INSERM U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Epidemiology and Statistics, Sorbonne Paris Cité, DHU Risks in Pregnancy, Paris Descartes University, Paris, France

    Department of Obstetrics and Gynecology, Trousseau Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
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  • Guillaume Ducarme
    Affiliations
    Department of Obstetrics and Gynecology, Centre Hospitalier Departemental, La Roche sur Yon, France
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  • Muriel Doret-Dion
    Affiliations
    Department of Obstetrics and Gynecology, Hospices Civils de Lyon, Hospital Femme-Mère-Enfant, University Lyon 1, France
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  • Cyril Huissoud
    Affiliations
    Department of Obstetrics and Gynecology, Croix Rousse University Hospital, Lyon, France
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  • Caroline Bohec
    Affiliations
    Department of Obstetrics and Gynecology, François Mitterrand Hospital, Pau, France
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  • Philippe Deruelle
    Affiliations
    Department of Obstetrics and Gynecology, Jeanne de Flandre University Hospital, Lille, France
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  • Astrid Darsonval
    Affiliations
    Department of Pharmacy, Angers University Hospital, Angers, France

    PPRIGO (Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest), Brest University Hospital, Brest, France
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  • Jean-Marie Chrétien
    Affiliations
    Department of Clinical Research, Angers University Hospital Angers, France
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  • Aurélien Séco
    Affiliations
    INSERM U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Epidemiology and Statistics, Sorbonne Paris Cité, DHU Risks in Pregnancy, Paris Descartes University, Paris, France
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  • Valérie Daniel
    Affiliations
    Department of Pharmacy, Angers University Hospital, Angers, France

    PPRIGO (Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest), Brest University Hospital, Brest, France
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  • Catherine Deneux-Tharaux
    Affiliations
    INSERM U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Epidemiology and Statistics, Sorbonne Paris Cité, DHU Risks in Pregnancy, Paris Descartes University, Paris, France
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  • Groupe de Recherche en Obstétrique et Gynécologie (GROG)

      Objective

      To test the impact of 1g of tranexamic acid (TXA) after vaginal delivery on the incidence of postpartum hemorrhage (PPH).

      Study Design

      In this multicenter double-blind randomized controlled trial with 2 parallel arms, women in labor for a planned vaginal delivery, at a term ≥35 weeks, with a singleton live fetus were randomly assigned to receive 1 g intravenous tranexamic acid or placebo in addition to prophylactic oxytocin within 2 minutes after delivery. The primary outcome was the incidence of PPH defined by blood loss ≥500 mL, measured with a graduated collector bag. Secondary outcomes were other measures of postpartum blood loss and potential adverse effects of TXA up to 3 months after delivery. Assuming a 10 % incidence of the primary outcome, two groups of 1,814 women were required to demonstrate a 30% decrease in primary outcome, with α=0.05 and 90% power.

      Results

      Of the 4079 women who were enrolled and provided consent, 3891 underwent vaginal delivery (modified intention-to-treat population).The primary outcome occurred in 156 women (8.1%) in the TXA group and in 188 women (9.8%) in the placebo group [relative risk (RR), 0.83; 95% confidence interval (95% CI), 0.68-1.01); P=0.07]. Incidences of PPH defined by blood loss > 500 mL in the collector bag and of clinically-significant PPH according to caregivers were both reduced in the TXA group (respectively 6.6% versus 8.8%; P=0.01 and 7.8% versus 10.4%; P=0.004), as well as the need for additional uterotonics (7.3 versus 9.7%; P=0.003). Nausea or vomiting in labor ward were more common in the TXA group (7.0 % versus 3.2%; P<0.001). No significant differences were found for thrombotic events or other adverse outcomes (Table 1). Pre-specified subgroup analyses found that TXA reduced the primary outcome in women who had instrumental delivery [9.6% versus 14.5%; RR, 0.66; 95% CI; 0.44-1.00; P=0.0498] but not in those with spontaneous delivery; and in women with episiotomy [12.3% versus 17.3%; RR, 0.73; 95% CI: 0.53-1.00; P=0.049] but not in those without episiotomy.

      Conclusion

      Among women who delivered vaginally and received prophylactic oxytocin, TXA was associated with a lower risk of postpartum bleeding than placebo without higher risk of severe adverse events including thrombotic complications within 3 months after delivery.
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