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RecruitingAccepts healthy volunteersPhase 2

Prevention of Postpartum Hemorrhage With Tranexamic Acid

Inova Health Care Services · with George Washington University, University of Maryland · NCT05370820

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–50 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
120
US sites recruiting
2
Study start
December 28, 2022
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Tranexamic acid; Tranexamic acid; Tranexamic acid; No intervention

Conditions: Post Partum Hemorrhage

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • George Washington University Hospital

    Washington D.C., DC 20037

    Site contact: Jaclyn Phillips, MD · 202-741-2500 · japhillips@mfa.gwu.edu

  • Inova Fairfax Medical Campus

    Falls Church, VA 22042

    Site contact: Homa Ahmadzia, MD · 706-776-6650 · homa.ahmadzia@inova.org

Study contacts (from the official record)

  • Homa K Ahmadzia, MD · 706-776-6650 · homa.ahmadzia@inova.org
  • Jaclyn Phillips
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Prevention of Postpartum Hemorrhage With Tranexamic Acid (NCT05370820) | Bored Studies