Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial

BMC Pregnancy and Childbirth

Catherine Deneux-Tharaux⁸  Françoise Maillard⁸  Norbert Winer⁶  Marie-Victoire Senat⁷  Camille Le Ray⁸  Franck Perrotin⁵  Delphine Vardon¹  Philippe Deruelle⁴  Astrid Darsonval²  Valérie Daniel²  Loïc Sentilhes³ 

[1] Department of Obstetrics and Gynecology, Caen University Hospital, Caen, France;PPRIGO (Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest) Brest University Hospital, Brest, France;Department of Obstetrics and Gynecology, Angers University Hospital, 4, rue Larrey, Angers, 49933, France;Department of Obstetrics and Gynecology, Jeanne de Flandre University Hospital, Lille, France;Department of Obstetrics and Gynecology, Tours University Hospital, Tours, France;Department of Obstetrics and Gynecology, Nantes University Hospital, Nantes, France;Department of Obstetrics and Gynecology, Kremlin-Bicetre University Hospital, APHP, Paris, France;INSERM, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Epidemiology and Biostatistics (U1153), Risks in pregnancy DHU, Paris-Descartes University, Paris, France

关键词: Thrombosis;    Cesarean and vaginal deliveries;    Tranexamic acid;    Prevention;    Treatment;    Postpartum hemorrhage;   

Others  :  1213798
DOI  :  10.1186/s12884-015-0573-5

 received in 2014-12-15, accepted in 2015-05-28,  发布年份 2015

【 摘 要 】

Background

Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one quarter of all maternal deaths worldwide. Estimates of its incidence in the literature vary widely, from 3 % to 15 % of deliveries. Uterotonics after birth are the only intervention that has been shown to be effective in preventing PPH. Tranexamic acid (TXA), an antifibrinolytic agent, has been investigated as a potentially useful complement to uterotonics for prevention because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. Randomized controlled trials for PPH prevention after cesarean (n = 10) and vaginal (n = 2) deliveries show that women who received TXA had significantly less postpartum blood loss without any increase in their rate of severe adverse effects. However, the quality of these trials was poor and they were not designed to test the effect of TXA on the reduction of PPH incidence. Large, adequately powered, multicenter randomized controlled trials are required before the widespread use of TXA to prevent PPH can be recommended.

Methods and design

A multicenter, double-blind, randomized controlled trial will be performed. It will involve 4000 women in labor for a planned vaginal singleton delivery, at a term ≥ 35 weeks. Treatment (either TXA 1 g or placebo) will be administered intravenously just after birth. Prophylactic oxytocin will be administered to all women. The primary outcome will be the incidence of PPH, defined by blood loss ≥500 mL, measured with a graduated collector bag. This study will have 80 % power to show a 30 % reduction in the incidence of PPH, from 10.0 % to 7.0 %.

Discussion

In addition to prophylactic uterotonic administration, a complementary component of the management of third stage of labor acting on the coagulation process may be useful in preventing PPH. TXA is a promising candidate drug, inexpensive, easy to administer, and simple to add to the routine management of deliveries in hospitals. This large, adequately powered, multicenter, randomized placebo-controlled trial seeks to determine if the risk-benefit ratio favors the routine use of TXA after delivery to prevent PPH.

Trial registration

ClinicalTrials.gov NCT02302456 webcite (November 17, 2014)

【 授权许可】

   
2015 Sentilhes et al.

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