Status:
COMPLETED
World Maternal Antifibrinolytic Trial
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Conditions:
Postpartum Haemorrhage
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
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 ...
Detailed Description
BACKGROUND: Each year, worldwide about 530,000 women die from causes related to pregnancy and childbirth. Almost all (99%) of the deaths are in low and middle income countries. Obstetric haemorrhage i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
20060 Patients enrolled
Trial Details
Trial ID
NCT00872469
Start Date
May 1 2009
End Date
April 1 2017
Last Update
February 26 2018
Active Locations (1)
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1
University College Hospital
Ibadan, Nigeria