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NCT05370820 · ClinicalTrials.gov registry record · Phase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
A Phase 2 study of Postpartum Hemorrhage, sponsored by Inova Health Care Services.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT05370820: Recruiting Phase 2 study of Postpartum Hemorrhage, sponsored by Inova Health Care Services.
NCT05370820 is a Phase 2 study of Postpartum Hemorrhage that is actively recruiting participants, run by Inova Health Care Services. The registered enrollment target is 120 participants, below the 774-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05370820, a Phase 2 study of Postpartum Hemorrhage, is actively recruiting participants, sponsored by Inova Health Care Services.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
Study 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 gram was administered. TXA serum levels at several time points after delivery were assayed to see if they reach the target plasma concentration of 10 microg/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 1000 mg 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 greater than 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 investigatorsalso aim to enroll 30 patients undergoing vaginal delivery and 30 morbidly obese women (BMI \> 50) undergoing either a vaginal or cesarean delivery but the investigators will enroll 45 patients for e
Primary Outcome
Data obtained from assays of TXA in blood, dose group and patient characteristics; parameter estimates in 2 compartment model includes the clearance of the drug (L/hr).
Conditions Studied
Interventions
- OTHER No intervention
- DRUG Tranexamic acid
Study Locations (2)
District of Columbia
- George Washington University Hospital - Washington D.C.
Virginia
- Inova Fairfax Medical Campus - Falls Church
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-12-28 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 2 |
What NCT05370820 shows while recruiting
NCT05370820 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 774-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Postpartum Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which No intervention is the first listed.
NCT05370820 reports a single indexed study location in District of Columbia, Virginia.
Frequently Asked Questions
What is clinical trial NCT05370820 about?
NCT05370820 is a clinical study titled "Prevention of Postpartum Hemorrhage With Tranexamic Acid". 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 escala...
What is the current status of trial NCT05370820?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2022-12-28. Estimated completion is 2027-06-01.
What conditions does trial NCT05370820 study?
This clinical trial studies the following conditions: Postpartum Hemorrhage.
What interventions are being tested in trial NCT05370820?
The interventions under investigation include: No intervention (OTHER), Tranexamic acid (DRUG).
Who is sponsoring clinical trial NCT05370820?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05370820 being conducted?
This trial has 2 study locations across District of Columbia, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postpartum Hemorrhage
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05370820's enrollment target sits among peer trials
120 7th of 19 higher than 12 of 19 other Postpartum Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Prevention of Postpartum Hemorrhage With Tranexamic Acid
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