World Maternal Antifibrinolytic Trial

NCT00872469 | Completed Phase 3 DMC

• 1 other identifier: ISRCTN76912190
• Study Type: interventional
• Target: 20,060
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Haemorrhage

Keywords

Postpartum haemorrhage; randomised controlled trial; tranexamic acid; antifibrinolytic

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described.

  up to 42 days after randomisation

Secondary Outcomes (8)

• Surgical Interventions including hysterectomy; brace suture; selective arterial embolisation; laparotomy for other reasons; manual removal of placenta; intrauterine tamponade; artery ligation, to achieve haemostasis.

  up to 42 days after randomisation

• Need for blood transfusion - blood or blood component units transfused.

  up to 42 days after randomisation

• Health Status measured using the EQ-5D.

  up to 42 days after randomisation

• Thromboembolic events (myocardial infarction, strokes, pulmonary embolism, DVT).

  up to 42 days after randomisation

• Other relevant medical events

  up to 42 days after randomisation

Other Outcomes (4)

• Primary outcome - ETAC - effect of TXA on fibrinolysis

  30 minutes after first dose is given

• Secondary outcome - ETAC - Explore relationship between relationship between coagulation parameters and mortality

  42 days

• Primary Outcome - ETAPLAT - effect of TXA on thrombin generation

  30 to 60 minutes after first dose is given

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

Drug: Tranexamic acid

placebo

PLACEBO COMPARATOR

Drug: Placebo [Saline]

Interventions

Tranexamic acid DRUG

1-2 grams by intravenous injection

Tranexamic acid

Placebo [Saline] DRUG

Matched to active comparator

placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

University College Hospital

Ibadan, Nigeria

Location

Related Publications (8)

• 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.

  PMID: 20398351 BACKGROUND

• 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.

  PMID: 32492040 DERIVED

• 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.

  PMID: 29879947 DERIVED

• 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.

  PMID: 29743045 DERIVED

• 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.

  PMID: 28456509 DERIVED

• 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.

  PMID: 28413832 DERIVED

• 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.

  PMID: 28317031 DERIVED

• 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.

  PMID: 27188698 DERIVED

Related Links

• Trial website
• Sponsor

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ian G Roberts, MD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2016
• Study Completion: April 1, 2017
• Last Updated: February 26, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

NG (1)