World Maternal Antifibrinolytic Trial

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.

Timeline

Start

2009-05

Primary completion

2016-06

Completion

2017-04

Publications

• Background Shakur H, Elbourne D, Gulmezoglu M, Alfirevic Z, Ronsmans C, Allen E, Roberts I. The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial. Trials. 2010 Apr 16;11:40. doi: 10.1186/1745-6215-11-40.
• Kolin DA, Shakur-Still H, Bello A, Chaudhri R, Bates I, Roberts I. Risk factors for blood transfusion in traumatic and postpartum hemorrhage patients: Analysis of the CRASH-2 and WOMAN trials. PLoS One. 2020 Jun 3;15(6):e0233274. doi: 10.1371/journal.pone.0233274. eCollection 2020.
• Brenner A, Shakur-Still H, Chaudhri R, Fawole B, Arulkumaran S, Roberts I; WOMAN Trial Collaborators. The impact of early outcome events on the effect of tranexamic acid in post-partum haemorrhage: an exploratory subgroup analysis of the WOMAN trial. BMC Pregnancy Childbirth. 2018 Jun 7;18(1):215. doi: 10.1186/s12884-018-1855-5.
• Roberts I, Shakur H, Fawole B, Kuti M, Olayemi O, Bello A, Ogunbode O, Kotila T, Aimakhu CO, Olutogun T, Hunt BJ, Huque S. Haematological and fibrinolytic status of Nigerian women with post-partum haemorrhage. BMC Pregnancy Childbirth. 2018 May 9;18(1):143. doi: 10.1186/s12884-018-1794-1.
• WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
• Dallaku K, Shakur H, Edwards P, Beaumont D, Roberts I, Huque S, Delius M, Mansmann U. Statistical analysis plan for the WOMAN-ETAPlaT study: Effect of tranexamic acid on platelet function and thrombin generation. Wellcome Open Res. 2016 Dec 15;1:30. doi: 10.12688/wellcomeopenres.10105.2.
• Shakur H, Fawole B, Kuti M, Olayemi O, Bello A, Ogunbode O, Kotila T, Aimakhu CO, Huque S, Gregg M, Roberts I. Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): protocol and statistical analysis plan for a randomized controlled trial. Wellcome Open Res. 2016 Dec 16;1:31. doi: 10.12688/wellcomeopenres.10383.1.
• Shakur H, Roberts I, Edwards P, Elbourne D, Alfirevic Z, Ronsmans C. The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial. Trials. 2016 May 17;17(1):249. doi: 10.1186/s13063-016-1332-2.

Drugs

Indications

No indication recorded.