Overview

World Maternal Antifibrinolytic Trial

Status:
Completed
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
Summary
The WOMAN trial is a large pragmatic randomised double-blind, placebo controlled trial to quantify the effects of the early administration of tranexamic acid on death, hysterectomy and other relevant outcomes. 20,000 adult women, after delivery who have clinically diagnosed postpartum haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Additionally, TWO nested studies will be conducted in a subset of women trial participants. The first nested study (ETAC) aims to evaluate the effect of tranexamic acid (TXA) on markers of coagulation in 400 women randomised to the WOMAN trial. The second nested study (ETAPLAT) aims to evaluate the haemostatic effect and antithrombotic effect of TXA in 128 women randomised to the WOMAN trial.
Phase:
Phase 3
Details
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Treatments:
Antifibrinolytic Agents
Tranexamic Acid