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Prevention of Postpartum Hemorrhage With Tranexamic Acid

Study acronym: Optimum OB-TXA
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary endpoints: 1 to 2
    • Study description shortened, about 7 words
    • Secondary endpoints expanded, about 5 words
    v18
  2. Minor Primary completion date: Aug 2, 2026 to Nov 15, 2026
    • Study completion date: Dec 31, 2026 to Jun 1, 2027
    v17
  3. Minor Primary completion date: May 2, 2026 to Aug 2, 2026
    • Study completion date: Oct 30, 2026 to Dec 31, 2026
    v16
  4. Minor Primary completion date: Nov 30, 2025 to May 2, 2026v15
  5. Notable Primary endpoint revised
    • Interventions: Tranexamic acid (Drug) to No intervention (Other), Tranexamic acid (Drug), Tranexamic acid (Drug), Tranexamic acid (Drug)
    • Eligibility criteria expanded, about 36 words
    • Study description shortened, about 185 words
    v14
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  1. Minor Re-verified, no change to tracked fieldsv13
  2. Notable Lead sponsor: George Washington University to Inova Health Care Services
    • Collaborators: 1 to 4
    • Study title shortened, about 2 words
    v12
  3. Minor Study sites revised (2)
    • Collaborators expanded, about 4 words
    v11
  4. Notable Primary completion date: Jun 2024 to Nov 30, 2025
    • Study completion date: Jun 2024 to Oct 30, 2026
    v10
  5. Minor Study sites: 1 to 2v9
  6. Minor Study sites: 2 to 1v8
  7. Notable Phase: Phase 3 to Phase 2v7
  8. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 3, 2023 to Dec 28, 2022
    v6
  9. Notable Start date: Nov 2022 to Jan 3, 2023v5
  10. Minor Study title revisedv4
  11. Minor Re-verified, no change to tracked fieldsv3
  12. Notable Phase: Phase 2 to Phase 3
    • Start date: Jun 2022 to Nov 2022
    • Primary endpoint revised
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05370820
Lead Sponsor Inova Health Care Services
Collaborators: George Washington University, University of Maryland, University of North Carolina, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Post Partum Hemorrhage
Related terms Postpartum Hemorrhage
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov