Status:
COMPLETED
Tranexamic Acid Pharmacokinetics During Postpartum Hemorrhage
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Postpartum Hemorrhage
Eligibility:
FEMALE
18-50 years
Phase:
EARLY_PHASE1
Brief Summary
Postpartum hemorrhage (PPH) accounts for 20-25 percent of maternal deaths worldwide. Tranexamic Acid (TXA) is an antifibrinolytic agent that has been shown to reduce the estimated blood loss after del...
Detailed Description
PPH occurs in approximately 1-5% of deliveries in the United States and accounts for 20-25% of maternal deaths worldwide. PPH is difficult to predict, but classically, risk factors for PPH- uterine at...
Eligibility Criteria
Inclusion
- Age 18 and 50 years, gestational age \> to 23 weeks at the time of admission for labor and delivery, and normal serum creatinine (\< 0.9). Patients having either vaginal or cesarean delivery are eligible. Patients must have (1) major or (2 or more) minor risk factors for PPH as described here:
- Major (1) or more:
- Suspected abnormal placentation
- Placenta previa
- Known coagulopathy
- Active concern for bleeding per care team
- Minor (2) or more:
- 2 prior cesarean deliveries
- 3 prior deliveries
- Prior history of PPH
- Chorioamnionitis
- Polyhydramnios
- Macrosomia
- Obesity
- Suspected placental abruption
Exclusion
- Allergy to tranexamic acid, inherited thrombophilia, history/current/intrapartum venous thrombosis, seizure disorder, renal or liver dysfunction, preeclampsia, anticoagulation therapy, or category III fetal heart rate tracing.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03863964
Start Date
June 1 2019
End Date
March 1 2021
Last Update
April 13 2021
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115