Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Post Partum Hemorrhage, Fibrinolysis; Hemorrhage, Blood Loss
In brief
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 utilize a prophylactic dose of TXA prior to incision followed by a subsequent prophylactic dose at placental delivery in obstetric patients undergoing scheduled cesareans. The purpose of this study is to quantify blood loss during uncomplicated repeat cesarean deliveries with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in women undergoing repeat cesarean sections.
Key facts
- Study ID
- NCT03856164
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 110
- Starts
- 2019-06-17
- Expected to finish
- 2020-08-31
- Last updated by the study team
- 2021-01-19
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Intrauterine pregnancy
- Age ≥ 18
- Gestation age ≥ 37 weeks 0 days
- Scheduled cesarean delivery
- Second or third cesarean delivery
- Singleton pregnancy
You may not qualify if…
- 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
Where it is running
- Parkland Hospital — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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