Prevention of Postpartum Hemorrhage With Tranexamic Acid
NCT ID: NCT05370820
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2022-12-28
2027-06-01
Brief Summary
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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 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.
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Detailed Description
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A total of 1 gram of TXA will be administered to patients prior to fetal delivery via three different routes of administration: IV infusion, IV push, and IM injection. The subjects in each group will be divided into three subgroups:
Group 1: Up to 15 subjects, TXA dose: 1 gram, Route: IV infusion over 10 minutes Group 2: Up to 15 subjects, TXA dose: 1 gram, Route: IV Push for \<2 minutes Group 3: Up to 15 subjects, TXA dose: 1 gram, Route: IM Injection
Plasma sampling: Timing of samples will be relative to the end of drug administration (t = 0) and include: Pre-drug administration, 5-10 minutes, 30-60 minutes, 60-90 minutes, 1.5-3 hours, 3-4 hours, 4-5 hours, 7-8 hours, and 10-18 hours. Each volume of blood draw will be approximately 7-9 mL. Actual times of plasma sampling will be documented. A second IV will be required for participating in the study. Citrated plasma samples will be centrifuged and supernatant will be stored at -70 degree Celsius. Breast milk sampling of no more than 2 mL per time point will occur at time points coinciding with maternal feedings.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Cesarean Delivery
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.
Vaginal Delivery
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.
Morbidly Obese
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.
No TXA
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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George Washington University
OTHER
University of Maryland
OTHER
University of North Carolina
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Inova Health Care Services
OTHER
Responsible Party
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Homa Ahmadzia, MD
MD, PI
Principal Investigators
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Homa K Ahmadzia, MD
Role: PRINCIPAL_INVESTIGATOR
Inova Health Care Services
Locations
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George Washington University Hospital
Washington D.C., District of Columbia, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Countries
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Central Contacts
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Jaclyn Phillips
Role: CONTACT
Facility Contacts
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Other Identifiers
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INOVA-2024-39
Identifier Type: -
Identifier Source: org_study_id
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