Intramuscular tranexamic acid to prevent heavy bleeding after childbirth in women at higher risk

Phase 3

• Conditions: Postpartum haemorrhage; Pregnancy and Childbirth

• Registration Number: ISRCTN12590098
• Lead Sponsor: ondon School of Hygiene & Tropical Medicine

Brief Summary

2023 Protocol article in https://doi.org/10.1186/s13063-023-07687-1 (added 04/12/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-20
• Last Update Posted: 13 May 2024
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 30000

Inclusion Criteria

1. Women thought to be aged 18 years and over admitted to the hospital for a vaginal or caesarean birth
2. One or more known risk factors for PPH

Exclusion Criteria

The fundamental eligibility criterion is the responsible doctor’s ‘uncertainty’ about whether to use tranexamic acid in a particular woman. Women should not be randomised if the responsible doctor believes that tranexamic acid is clearly indicated (e.g., tranexamic acid has been given within 12 hours or planned to be given) or clearly contraindicated (e.g., known allergy to tranexamic acid).

Study & Design

• Study Type: Interventional
• Study Design: Not specified