World maternal antifibrinolytic trial-2

Phase 3

Completed

• Conditions: Prevention of postpartum haemorrhage in women with moderate or severe anaemia having given birth vaginally; Pregnancy and Childbirth; Women with moderate or severe anaemia having given birth vaginally

• Registration Number: ISRCTN62396133
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30594227 protocol 2023 Other publications in https://doi.org/10.1016/S2214-109X(23)00245-0 Cohort analysis of association between pre-birth anaemia and postpartum haemorrhage (added 21/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-07
• Study Completion: 2023-09-20
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 15068

Inclusion Criteria

Women with moderate or severe anaemia (haemoglobin level <100 g/ L or packed cell volume <30%) after giving birth vaginally where the responsible clinician is substantially uncertain whether to use tranexamic acid.

Exclusion Criteria

1. Women who are not legally adult (<18 years) and not accompanied by a guardian
2. Women with a known allergy to tranexamic acid or its excipients
3. Women who develop postpartum haemorrhage before randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 08/08/2018:<br>Postpartum haemorrhage is measured using a clinical assessment (estimated blood loss of more than 500 mL or any blood loss sufficient to compromise haemodynamic stability) within 24 hours after administration of trial medication or discharge from hospital (whichever is earlier). The cause of postpartum haemorrhage will be described.<br><br>Previous primary outcome measure:<br>Postpartum haemorrhage is measured using a clinical assessment (estimated blood loss of more than 500 mL or any blood loss sufficient to compromise haemodynamic stability) within 24 hours after administration of trial medication or discharge from discharge hospital whichever is earlier.