NCT05370820 Prevention of Postpartum Hemorrhage With Tranexamic Acid
| NCT ID | NCT05370820 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Inova Health Care Services |
| Condition | Post Partum Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-12-28 |
| Primary Completion | 2026-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2022-12-28 with a primary completion date of 2026-11-15.
⚠ 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
In part 1 of the study, the investigators conducted a prospective, open-label, dose finding pharmacokinetic (PK) study in 43 pregnant 3rd trimester women scheduled for non-emergent cesarean section. The investigators administered three doses of the drug (5 mg/kg, 10 mg/kg and 15 mg/kg) in an escalating fashion by cohort with the lowest dose first. The drug was administered intravenously at the time of umbilical cord clamping for a non-emergent cesarean section. A maximum of 1 g was administered. TXA serum levels at several time points after delivery were assayed to see if they reach the target plasma concentration of 10 ug/mL. A PK model was constructed for determining the optimal TXA dose administered at parturition. In part 2 of the study, the investigators aim to compare PKPD endpoints using prophylactic TXA via IV and IM routes administered pre-cord clamp. The investigators will administer 1 g TXA within 10 minutes of skin incision via intravenous infusion (up to n=15), intravenous bolus \< 2 minutes (up to n=15) and intramuscular injection (up to n=15). The investigators will target women undergoing scheduled cesarean delivery \> 34 weeks gestation, women undergoing vaginal delivery \> 34 weeks of gestation and morbidly obese women (BMI\>=40) undergoing either a vaginal or cesarean delivery. The investigators will use advanced modeling techniques to determine time to achieve PKPD targets and duration remaining at those targets. The goal will be to determine how the optimal dose may vary if route of administration is modified. The investigators plan to enroll 45 patients in addition to the 43 that were enrolled during part 1. Our goal is to 30 participants, but the investigators will enroll 45 to account for lost to follow-up. The investigators also aim to enroll 30 patients undergoing vaginal delivery and 30 morbidly obese women (BMI \>= 40) undergoing either a vaginal or cesarean delivery but the investigators will enroll 45 patients for each of these groups to account for loss to follow up. In addition, the investigators will enroll 30 pregnant patients receiving no medication acting as the control group, but the investigators will enroll 45 to account for loss to follow up.
Eligibility Criteria
Inclusion Criteria: * Women who are scheduled to under medically indicated cesarean section at greater than 34+0 weeks gestation or women who are scheduled to undergo an elective cesarean section at 39+0 weeks gestation in accordance with recommendations from the American Congress of Obstetricians and Gynecologists * Women who are indicated to have a vaginal delivery at \> 34+0 weeks gestation. * Pregnant women with normal serum creatinine (serum creatinine \< 0.9) within 2 weeks of estimated/scheduled delivery * Women between the ages of 18 and 50 years old * Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization. Exclusion Criteria: * active thrombotic or thromboembolic disease * a history of arterial or venous thromboembolic event * inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome, thrombocytosis or thrombophilic thrombocytopathy) * a subarachnoid hemorrhage * acquired defective color vision * history of seizure disorder * known renal dysfunction (serum creatinine = or \>0.9) * multiple gestations (twin or triplet pregnancies) * hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy * history of liver dysfunction at the discretion of the investigator
Contact & Investigator
Homa K Ahmadzia, MD
PRINCIPAL INVESTIGATOR
Inova Health Care Services
Frequently Asked Questions
Who can join the NCT05370820 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Post Partum Hemorrhage. 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 NCT05370820 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05370820 currently recruiting?
Yes, NCT05370820 is actively recruiting participants. Contact the research team at homa.ahmadzia@inova.org for enrollment information.
Where is the NCT05370820 trial being conducted?
This trial is being conducted at Washington D.C., United States, Falls Church, United States.
Who is sponsoring the NCT05370820 clinical trial?
NCT05370820 is sponsored by Inova Health Care Services. The principal investigator is Homa K Ahmadzia, MD at Inova Health Care Services. The trial plans to enroll 120 participants.