NCT06025916 Postpartum Hemorrhage Reduction With Oral Tranexamic Acid: a Clinical Trial
| NCT ID | NCT06025916 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Karolinska Institutet |
| Condition | PPH |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-09-27 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,000 participants in total. It began in 2023-09-27 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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. This RCT was preceded by a pilot intervention, included in the current protocol, aiming to assess uptake of oral forms of Tranexamic acid (TA) during active labour. The study took place at Södersjukhuset, Stockholm, Sweden between December 2022 and February 2023 among 51 women ≥ 36 gestational weeks with planned vaginal delivery who were randomized 1:1:1:1 to receive two grams of TA as oral solution, tablets, effervescent tablets, or 1g of intravenous (IV) TA, near full cervical dilatation. Blood samples were taken 30, 60, 120, 240, 360, and 480 minutes after TA administration. Plasma concentration of TA was measured using Liquid Chromatography-Tandem Mass Spectrometry. Mean values were compared between groups using ANOVA. Our main outcomes measures were time-to-therapeutic level, therapeutic interval, and maximum plasma concentration of TA.
Eligibility 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
Contact & Investigator
Margit Endler, MD PhD, Associate Professor
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT06025916 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying PPH. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06025916 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06025916 currently recruiting?
Yes, NCT06025916 is actively recruiting participants. Contact the research team at margit.endler@ki.se for enrollment information.
Where is the NCT06025916 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06025916 clinical trial?
NCT06025916 is sponsored by Karolinska Institutet. The principal investigator is Margit Endler, MD PhD, Associate Professor at Karolinska Institutet. The trial plans to enroll 1,000 participants.