Status:
RECRUITING
Postpartum Hemorrhage Reduction With Oral Tranexamic Acid: a Clinical Trial
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Stockholm South General Hospital
University of Cape Town
Conditions:
PPH
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This is a multicentre randomized placebo-controlled double-blinded phase IV study among 1000 women in Sweden and South Africa on the effect of oral tranexamic acid on PPH after vaginal delivery. The m...
Detailed Description
Background Severe PPH is the leading cause of maternal death worldwide especially in developing countries. Preventing PPH before onset is of key importance because once bleeding starts it is difficult...
Eligibility Criteria
Inclusion
- Enrolled women will be ≥18 years, ≥36 gestational weeks, and planned for vaginal delivery. Women with known bleeding disorders, known allergy to TA, ongoing treatment for venous thrombosis, or inability to make an informed consent will be ineligible.
Exclusion
- Opposite of above
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06025916
Start Date
September 27 2023
End Date
March 1 2026
Last Update
September 19 2024
Active Locations (1)
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1
Södersjukhuset (South General Hospital)
Stockholm, Sweden, 118 83