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Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, FranceDepartment of Obstetrics and Gynecology, Angers University Hospital, Angers, France
Department of Obstetrics and Gynecology, University Medical Center of Nantes; Centre d'Investigation Clinique CIC Mere enfant, Nantes, FranceNational Institute of Agricultural Research (INRA), UMR 1280, Physiology of Nutritional Adaptations, University of Nantes, IMAD and CRNH-Ouest, Nantes 44000, France
Maternity unit, Paris Saint Joseph Hospital, Paris Descartes University, Paris, FranceINSERM 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
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, FrancePort Royal Maternity Unit, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France; DHU Risks in Pregnancy; Paris Descartes University, Paris, France
Department of Obstetrics and Gynecology, Montpelier University Hospital, Montpellier, FranceInserm, CESP Centre for research in Epidemiology and Population Health, U1018, Reproduction and child development, Villejuif, 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, FranceDepartment of Obstetrics and Gynecology, Trousseau Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
Department of Pharmacy, Angers University Hospital, Angers, FrancePPRIGO (Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest), Brest University Hospital, Brest, 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
Department of Pharmacy, Angers University Hospital, Angers, FrancePPRIGO (Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest), Brest University Hospital, Brest, 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
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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