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Prevention of Postpartum Hemorrhage With Tranexamic Acid

RecruitingPhase 2Ages 18 Years - 50 YearsFemaleInova Health Care Services
NCT05370820 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ad

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📋 Eligibility rules (as published)
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
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What it tests

  • Tranexamic acid
  • Tranexamic acid
  • Tranexamic acid
  • No intervention
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Where

2 sites
George Washington University Hospital
Washington D.C., United States
Inova Fairfax Medical Campus
Falls Church, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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