WORLD MATERNAL ANTIFIBRINOLYTIC TRIA

Not Applicable

• Conditions: Circulatory System; Pregnancy and Childbirth; Postpartum haemorrhage

• Registration Number: PACTR201007000192283
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 0

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. Women for whom the responsible clinician considers there is a clear indication for TXA should not be randomised.
2. Women for whom the responsible clinician considers there is a clear contraindication for TXA should not be randomised.
There are no other pre-specified exclusion criteria. Where the responsible clinician is substantially uncertain as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage, the woman should be randomised.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Composite of Death, and Peripartum hysterectomy

Secondary Outcome Measures

Name	Time	Method
1. Surgical interventions used to treat obstetric haemorrhage: 1.1. Hysterectomy 1.2. Any brace suture 1.3. Arterial ligation 1.4. Artery selective embolisation ;2. Transfusion requirements (blood/components) ;3. Thromboembolic events: 3.1. Deep venous thrombosis 3.2. Pulmonary thromboembolism 3.3. Stroke 3.4. Myocardial infarction ;4. Length of stay in hospital ;5. If an Intensive Care Unit is available, time spent in the ICU ;6. Suspected Unexpected Serious Adverse Reactions (SUSAR) ;7. Death;8. Health Related Quality of life (HRQoL) ;9. Receipt of mechanical ventilation;10. Status of baby/ies up to 6 weeks of delivery;11. Cost-effectiveness analysis