Sentilhes 2014.

Trial name or title	Tranexamic acid for preventing postpartum haemorrhage following a vaginal delivery (TRAAP).
Methods	Randomised controlled double blind trial.
Participants	Estimated 4000 women undergoing planned vaginal delivery, older than 18 years, with singleton pregnancy, more than 35 weeks' gestation.
Interventions	1 g TA IV within 2 minutes of birth and prophylactic oxytocin administration versus placebo.
Outcomes	Primary ‐ incidence of PPH (> 500 mL) , Secondary ‐ mean blood loss at 15 minutes after birth, mean total blood loss up to 24 hours after birth, incidence of severe PPH (> 1000 mL) 24 hours after birth, need for supplementary uterotonic treatment, proportion of women requiring supplementary uterotonic treatment including sulprostone, postpartum transfusion, proportion of women transfused in postpartum, need for invasive second‐line procedures for PPH (any of the following: arterial embolization, pelvic arterial ligation, uterine compression suture, hysterectomy), haemoglobin peripartum delta (2 days postpartum), mean difference between the haemoglobin values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells, haematocrit peripartum delta (2 days postpartum), mean difference between the haematocrit values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells, haemodynamic tolerance (time frame: 15, 30, 45, 60 and 120 minutes after delivery ‐ heart rate, blood pressure), mild adverse effects, stay in labour ward, nausea, vomiting, phosphenes, dizziness, tolerance lab tests (urea, creatinaemia, prothrombin time, active prothrombin time, fibrinogenaemia, aspartate and alanine transaminase, total bilirubin). Severe adverse effects (up to 12 weeks after delivery ‐ deep venous thrombosis, pulmonary embolism, myocardial infarction, renal failure needing dialysis), other outcome measures: women's satisfaction, psychological status.
Starting date	January 2015.
Contact information	Mathilde Moreau Angers Univeristy Hospital, Angers, France 49933 Ph:+33241356329, E‐mail: mathilde.moreau@chu‐angers.fr
Notes