Status:
WITHDRAWN
Prevention of Postpartum Hemorrhage With TXA
Lead Sponsor:
United States Naval Medical Center, San Diego
Conditions:
Postpartum Hemorrhage
Eligibility:
FEMALE
18-54 years
Phase:
PHASE4
Brief Summary
Hemorrhage remains the leading cause of maternal death worldwide. Tranexamic acid has been shown to reduce rates of hemorrhage when given prophylactically prior to cesarean delivery. It has also been ...
Detailed Description
Hemorrhage remains the leading cause of maternal mortality worldwide. In a 2014 systematic analysis of the causes of maternal death, the World Health Organization (WHO) noted that even in the face of ...
Eligibility Criteria
Inclusion
- Pregnant female presenting to Navy Medical Center San Diego for delivery
- Able to speak and understand English
- Planning to deliver at NMCSD
Exclusion
- Age less than 18 years
- Unable to speak or understand English
- Not planning to deliver at NMCSD
- Planned cesarean hysterectomy
- Current anticoagulant use
- Current subarachnoid hemorrhage
- Any active/current intravascular clotting (i.e. venous thromboembolic events)
- Patients with a hypersensitivity to TXA or any of the ingredients
- Personal history of venous or arterial thrombotic events
- Conditions that predispose patients to thromboembolic events (e.g. thrombophilias, autoimmune diseases such as lupus, active cancer, congestive heart failure, family history of thrombosis in a first degree relative at age \< 30 years) due to increased risk of thrombosis
- Patients taking factor IX complex concentrates or anti-inhibitor coagulant concentrates (e.g. FEIBA NF)
- Eclampsia or seizure disorder because the use of tranexamic acid has been associated with postoperative seizures
- Patients with a baseline creatinine 1.2 or higher, history of renal insufficiency, or renal disease because of the risk of toxicity in patients with preexisting disease
- Patients with frank hematuria because ureteral obstruction due to clot formation has been reported in patients with upper urinary tract bleeding who were treated with tranexamic acid
- Patients with active or history of retinal diseases as cases of central retinal artery and central retinal vein obstruction have been reported in patients treated with intravenous tranexamic acid
- Patients with acquired defective color vision
Key Trial Info
Start Date :
April 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03326596
Start Date
April 20 2018
End Date
September 1 2019
Last Update
January 26 2024
Active Locations (1)
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1
Navy Medical Center
San Diego, California, United States, 92134