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NCT05370820 · ClinicalTrials.gov registry record · Phase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
A Phase 2 study of Post Partum Hemorrhage, sponsored by Inova Health Care Services.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT05370820 is a Phase 2 study of Post Partum Hemorrhage that is actively recruiting participants, run by Inova Health Care Services. The registered enrollment target is 120 participants, below the 1,779-participant average among 7 other Post Partum Hemorrhage trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05370820, a Phase 2 study of Post Partum 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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05370820
The ClinicalTrials.gov registry entry for NCT05370820 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,779-participant average among 7 other Post Partum Hemorrhage trials with a reported enrollment target (93% lower). The listed sponsor is Inova Health Care Services, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Post Partum Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which No intervention is the first listed.
NCT05370820 reports 2 study locations spanning 2 distinct geographic areas - top geographies include 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: Post Partum 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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