Prevention of Postpartum Hemorrhage With TXA

• Status: Unknown status
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: Female

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 shown to be an effective treatment in response to hemorrhage after a vaginal delivery. The aim of this study is to assess the impact of TXA on hemorrhage rates when given prophylactically prior to all deliveries.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: United States Naval Medical Center, San Diego
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Pregnant female presenting to Navy Medical Center San Diego for delivery

• Able to speak and understand English

• Planning to deliver at NMCSD

Exclusion Criteria:

• 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