Status:
COMPLETED
Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Post Partum Hemorrhage
Fibrinolysis; Hemorrhage
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators prepared a novel study of tranexamic acid (TXA) designed to estimate the quantity of blood loss in women undergoing elective repeat cesarean deliveries. This is the first trial to ut...
Detailed Description
Obstetric hemorrhage has been identified as a contributory cause for the United States' suboptimal and inequitable outcomes among pregnant women. As such, obstetric hemorrhage has become a formal focu...
Eligibility Criteria
Inclusion
- Intrauterine pregnancy
- Age ≥ 18
- Gestation age ≥ 37 weeks 0 days
- Scheduled cesarean delivery
- Second or third cesarean delivery
- Singleton pregnancy
Exclusion
- First cesarean delivery
- Four or more cesarean deliveries
- Intrauterine fetal death
- Fetal anomalies
- Documented coagulopathy (Elevated Prothrombin Time (PT), Elevated Partial Thromboplastin Time (PTT), Elevated International Normalized Ratio (INR))
- Thrombocytopenia (Platelet count \< 100k)
- Internal bleeding, external bleeding, easy bruising
- History of thrombotic event
- Hypertension
- Diagnosis of renal insufficiency (Creatinine\> 1 mg/dL)
- Insulin-treated diabetes
- Suspected morbidly adherent placenta
- Placenta previa
- Multiple Gestations
- BMI ≥ 50
- Hematocrit ≤ 25
- Blood transfusion within 24 hours prior to cesarean delivery
- History of abnormal bleeding or blood disorder
- Planned general anesthesia
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03856164
Start Date
June 17 2019
End Date
August 31 2020
Last Update
January 19 2021
Active Locations (1)
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1
Parkland Hospital
Dallas, Texas, United States, 75235