Reducing postpartum hemorrhage with oral tranexamic acid
Postpartum Hemorrhage Reduction With Oral Tranexamic Acid (PROTECT): a Multicenter Randomized Controlled Trial
This study is testing if giving oral tranexamic acid to women after vaginal delivery can help prevent severe bleeding.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06025916 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, placebo-controlled, double-blinded phase IV study aims to evaluate the effect of oral tranexamic acid (TA) on postpartum hemorrhage (PPH) in 1000 women after vaginal delivery. Participants will be randomly assigned to receive either tranexamic acid or a placebo during labor. The primary endpoint is the rate of PPH, defined as blood loss of 500ml or more, assessed 24 hours post-delivery. The study is conducted across multiple sites in Sweden and South Africa, focusing on the potential of oral TA to prevent severe bleeding, which is a leading cause of maternal mortality.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older, at least 36 weeks pregnant, and planning to deliver vaginally.
Not a fit: Patients with known bleeding disorders, allergies to tranexamic acid, or those undergoing treatment for venous thrombosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postpartum hemorrhage, thereby improving maternal health outcomes.
How similar studies have performed: Previous studies have indicated the effectiveness of tranexamic acid in reducing bleeding, but the specific use of oral TA in vaginal deliveries is less explored, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: Opposite of above
Where this trial is running
Stockholm
- Södersjukhuset (South General Hospital) — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Margit Endler, MD PhD, Associate Professor — Karolinska Institutet
- Study coordinator: Margit Endler, MD PhD
- Email: margit.endler@ki.se
- Phone: 0706747227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.