Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery

• Status: Completed
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

1. Intrauterine pregnancy

2. Age ≥ 18

3. Gestation age ≥ 37 weeks 0 days

4. Scheduled cesarean delivery

5. Second or third cesarean delivery

6. Singleton pregnancy

Exclusion Criteria:

1. First cesarean delivery

2. Four or more cesarean deliveries

3. Intrauterine fetal death

4. Fetal anomalies

5. Documented coagulopathy (Elevated Prothrombin Time (PT), Elevated Partial Thromboplastin Time (PTT), Elevated International Normalized Ratio (INR))

6. Thrombocytopenia (Platelet count < 100k)

7. Internal bleeding, external bleeding, easy bruising

8. History of thrombotic event

9. Hypertension

10. Diagnosis of renal insufficiency (Creatinine> 1 mg/dL)

11. Insulin-treated diabetes

12. Suspected morbidly adherent placenta

13. Placenta previa

14. Multiple Gestations

15. BMI ≥ 50

16. Hematocrit ≤ 25

17. Blood transfusion within 24 hours prior to cesarean delivery

18. History of abnormal bleeding or blood disorder

19. Planned general anesthesia