WOrld Maternal ANtifibrinolytic Trial

Phase 3

Completed

• Conditions: Postpartum haemorrhage; Pregnancy and Childbirth

• Registration Number: ISRCTN76912190
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine (LSHTM) (UK)

Brief Summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20398351 2016 statistical analysis plan in: http://www.ncbi.nlm.nih.gov/pubmed/27188698 2016 WOMAN-ETAC sub-study protocol and statistical analysis plan in: https://www.ncbi.nlm.nih.gov/pubmed/28317031 2016 WOMAN-ETAPlaT sub-study statistical analysis plan in: https://www.ncbi.nlm.nih.gov/pubmed/28413832 2017 results in: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30638-4/fulltext 2018 exploratory subgroup analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/29879947

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-10
• Study Completion: 2016-05-30
• Last Update Posted: 2 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20000

Inclusion Criteria

Immediately after delivery, all usual care should be given for the prevention of PPH. If bleeding continues and a clinician diagnosis of PPH is made, all usual treatments should be given and at the same time assessment for inclusion in the WOMAN Trial should be done. As most women die within 2 - 4 hours of delivery, it is important to consider inclusion as early as possible. Clinician diagnosis of PPH may be based on any of the following:
1. Blood loss after vaginal delivery greater than 500 ml, or
2. Greater than 1000 ml after caesarian section, or
3. Blood loss enough to compromise the haemodynamic status of the woman

Other inclusion criteria:
4. All women who are clinician-diagnosed with postpartum haemorrhage following vaginal delivery or caesarean section
5. Consent has been obtained in line with local procedures

Exclusion Criteria

1. The responsible clinician is uncertain as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage
2. The responsible doctor considers there to be a clear indication for antifibrinolytic therapy
3. Women for whom there is considered to be a clear contraindication to antifibrinolytic therapy

When 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified