Postpartum Hemorrhage Reduction With Oral Tranexamic Acid: a Clinical Trial
Status:
Recruiting
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
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 main purpose of the study is to evaluate the effect of orally administered
tranexamic acid (TA) compared to placebo on rate of postpartum hemorrhage (PPH) after vaginal
birth. Participants will be randomized to receive either 20 ml (2g) of the investigational
medicinal product (TA100mg/ml) or 20ml of a placebo solution during labor. Our main endpoint,
assessed at 24 hours after delivery is PPH defined as blood loss >=500ml and assessed both by
weight and pre-postpartum hemoglobin (Hb) decrease >10 units difference in vaginal deliveries
Phase:
Phase 4
Details
Lead Sponsor:
Karolinska Institutet
Collaborators:
Stockholm South General Hospital University of Cape Town