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World Maternal Antifibrinolytic Trial

Sponsored by London School of Hygiene and Tropical Medicine

About this trial

Last updated 7 years ago

Study ID

ISRCTN76912190

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
16+ Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

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.

What are the Participation Requirements?

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.

Locations

Location

Status