Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

World Maternal Antifibrinolytic Trial (WOMAN)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine Identifier:
First received: March 30, 2009
Last updated: September 8, 2016
Last verified: September 2015
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.

Condition Intervention Phase
Postpartum Haemorrhage
Drug: Tranexamic acid
Drug: Placebo [Saline]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid for the Treatment of Postpartum Haemorrhage: An International Randomised, Double Blind, Placebo Controlled Trial

Resource links provided by NLM:

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Surgical Interventions including hysterectomy; brace suture; selective arterial embolisation; laparotomy for other reasons; manual removal of placenta; intrauterine tamponade; artery ligation, to achieve haemostasis. [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: Yes ]
  • Need for blood transfusion - blood or blood component units transfused. [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: Yes ]
  • Health Status measured using the EQ-5D. [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: No ]
  • Thromboembolic events (myocardial infarction, strokes, pulmonary embolism, DVT). [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: Yes ]
  • Other relevant medical events [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: Yes ]
  • Length of stay at hospital/time spent at an intensive care unit [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: No ]
  • Need for mechanical ventilation. [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: No ]
  • Status of baby/ies [ Time Frame: up to 42 weeks after randomisation of mother ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Primary outcome - ETAC - effect of TXA on fibrinolysis [ Time Frame: 30 minutes after first dose is given ] [ Designated as safety issue: No ]
    Fibrinolysis will be measured with D-dimer, fibrinogen level and using ROTEM parameters previously reported to be associated with fibrinolysis (ie MCF, CA10, CA15, CLI30, and CLI60)

  • Secondary outcome - ETAC - Explore relationship between relationship between coagulation parameters and mortality [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Primary Outcome - ETAPLAT - effect of TXA on thrombin generation [ Time Frame: 30 to 60 minutes after first dose is given ] [ Designated as safety issue: No ]
    (2) Thrombin Generation Assay [Lag Time (LT, min), peak height or time to peak (nMol) and area under the curve or endogenous thrombin potential (ETP, measured in nmol/L per min.)]

  • Secondary Outcome - ETAPLAT - TXA on platelet function, fibrinogen, D-Dimer and coagulation factor V, VIII and vWF levels [ Time Frame: 30 to 60 minutes after first dose is given ] [ Designated as safety issue: No ]
    (1) Multiplate®tests (ADPtest and TRAPtest measured using AU per min) which will be performed with whole blood immediately after sampling. Fibrinogen level (Claus method, in g/L), D-Dimer (mg/L), Coagulation Factors V, VIII and vWF (measured with % of the norm) which will be performed on processed and separated platelet poor plasma

Enrollment: 20060
Study Start Date: May 2009
Estimated Study Completion Date: October 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tranexamic acid Drug: Tranexamic acid
1-2 grams by intravenous injection
Placebo Comparator: placebo Drug: Placebo [Saline]
Matched to active comparator

  Show Detailed Description


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

All legally adult women with postpartum haemorrhage following vaginal or caesarean section delivery who have a clinical diagnosis of postpartum haemorrhage. The clinical diagnosis of PPH may be based on any of the following:

  • Blood loss after vaginal delivery > 500 mL OR
  • > 1,000 mL after caesarean section OR blood loss sufficient to compromise the haemodynamic status of the woman The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage.
  • Women for whom the responsible doctor considers there is a clear indication for antifibrinolytic therapy should not be randomised.
  • Women for whom there is considered to be a clear contraindication to antifibrinolytic therapy should not be randomised.

Where the responsible clinician is substantially uncertain as to whether or not to use an antifibrinolytic, all these women are eligible for randomisation and should be considered for the trial.

There are no other pre-specified exclusion criteria.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00872469

University College Hospital
Ibadan, Nigeria
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Principal Investigator: Ian G Roberts, MD London School of Hygiene and Tropical Medicine
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: London School of Hygiene and Tropical Medicine Identifier: NCT00872469     History of Changes
Other Study ID Numbers: ISRCTN76912190 
Study First Received: March 30, 2009
Last Updated: September 8, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
India: Drugs Controller General of India
India: Indian Council of Medical Research
Nigeria: The National Agency for Food and Drug Administration and Control
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Will be available at in the future

Keywords provided by London School of Hygiene and Tropical Medicine:
Postpartum haemorrhage
randomised controlled trial
tranexamic acid

Additional relevant MeSH terms:
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Coagulants processed this record on December 08, 2016