Recruiting
Phase 2

Tranexamic Acid

Sponsor:

Inova Health Care Services

Code:

NCT05370820

Conditions

Post Partum Hemorrhage

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Tranexamic acid

Tranexamic acid

Tranexamic acid

No intervention

Study Details

Brief 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 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.

Conditions

Post Partum Hemorrhage

Study ID

NCT05370820

Start date

Dec 28, 2022

Status verified date

Oct, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cesarean Delivery

experimental: Vaginal Delivery

experimental: Morbidly Obese

no intervention: No TXA

Interventions

Tranexamic acid

Tranexamic Acid 1000 mg administered intravenously via infusion over 10 minutes.

Tranexamic acid

Tranexamic Acid 1000 mg administered intravenously via push over 2 minutes.

Tranexamic acid

Tranexamic Acid 1000 mg administered intramuscularly.

No intervention

Control group with no administration of Tranexamic Acid.

Primary outcome measure

  • PK Model Parameter Estimates [ Time Frame: Different time points ranging from surgery (T0) to 1 day postpartum. ]
  • Pharmacodynamics of Tranexamic Acid [ Time Frame: Different time points ranging from surgery (T0) to 1 day postpartum. ]

Central Contacts and Locations

Central contacts

Homa K Ahmadzia, MD

706-776-6650homa.ahmadzia@inova.org

Locations

George Washington University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Jaclyn Phillips, MD

202-741-2500japhillips@mfa.gwu.edu

Principal Investigator:

Jaclyn Phillips, MD

Inova Fairfax Medical Campus

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Homa Ahmadzia, MD

706-776-6650homa.ahmadzia@inova.org

Principal Investigator:

Homa Ahmadzia, MD

More Information

Sponsor

Inova Health Care Services

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.