Status:
RECRUITING
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Lead Sponsor:
Inova Health Care Services
Collaborating Sponsors:
George Washington University
University of Maryland
Conditions:
Post Partum Hemorrhage
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
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. ...
Detailed Description
The study will enroll 45 additional third trimester pregnant women scheduled for nonemergent cesarean sections who are at high risk for hemorrhage. The investigators plan to enroll 30, but to account ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05370820
Start Date
December 28 2022
End Date
December 31 2026
Last Update
November 3 2025
Active Locations (2)
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1
George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037
2
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042