WOMAN: The World Maternal Antifibrinolytic Trial (Version 1)
Research type
Research Study
Full title
Tranexamic acid for the treatment of postpartum haemorrhage: An international randomised, double blind, placebo controlled trial
IRAS ID
14170
Contact name
Ian Roberts
Sponsor organisation
London School Of Hygiene and Tropical Medicine
Eudract number
2008-008441-38
ISRCTN Number
ISRCTN76912190
Clinicaltrials.gov Identifier
Research summary
The WOMAN trial (World Maternal Antifibrinolytic Trial) aims to determine the effect of the administration of the antifibrinolytic drug tranexamic acid on death and hysterectomy, and other clinically relevant outcomes in women with clinically diagnosed postpartum haemorrhage. About 14 million mothers have a postpartum haemorrhage (PPH) each year and about 1% of these women will die. Many more will have a hysterectomy leading to permanent sterility. Other consequences of PPH include the need for a blood transfusion, which is not always available or safe, and severe anaemia which can seriously reduce a mother??s ability to look after her children or to work. A simple and cost effective drug treatment to reduce blood loss after delivery could therefore have important consequences for global maternal health. Systemic antifibrinolytic drugs, including tranexamic acid, are widely used in surgery to prevent clot breakdown (fibrinolysis) and thus reduce surgical blood loss. Currently there is insufficient reliable evidence to assess the effectiveness of tranexamic acid in obstetric bleeding. This trial would provide a reliable basis for recommending whether or not tranexamic acid should be administered to women with severe postpartum haemorrhage. The WOMAN trial is a large, international, randomised, placebo controlled trial, to quantify the safety and effect on mortality and morbidity of the administration of tranexamic acid in women with postpartum haemorrhage. Women who have clinician diagnosed postpartum haemorrhage after vaginal or caesarean section delivery will be eligible for the trial, except those for whom antifibrinolytic agents are thought to be clearly indicated or clearly contraindicated. Treatment will be allocated randomly and numbered drug or placebo packs will be available in participating obstetric departments. Outcomes will be collected up to 42 days after treatment. The primary outcome is death or hysterectomy, and the secondary outcomes include the occurrence of thromboembolic events in both mother and breastfed baby.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
10/H0505/111
Date of REC Opinion
17 Feb 2011
REC opinion
Further Information Favourable Opinion