Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation
Phase 2
Completed
- Conditions
- AbortionDilation and EvacuationHemorrhageBlood Loss
- Interventions
- Drug: Placebo
- Registration Number
- NCT04651166
- Lead Sponsor
- University of Hawaii
- Brief Summary
Prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with dilation and evacuation (D\&E). We propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (IV) tranexamic acid will decrease the need for interventions to control bleeding at the time of D\&E at 16 to 24 weeks gestation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 48
Inclusion Criteria
- Requesting pregnancy termination
- Intrauterine pregnancy at 16 to 24 weeks gestation
- Participants must be willing and capable of giving informed consent and able to understand and sign written consents in English.
Exclusion Criteria
- History of thromboembolic events (i.e. deep vein thrombosis, stroke, pulmonary embolism)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 100mL saline or lactated ringer without tranexamic acid added given intravenously over 10 minutes at start of procedure Active Comparator Tranexamic acid 1g tranexamic acid mixed in 100mL saline or lactated ringer given intravenously over 10 minutes at start of procedure
- Primary Outcome Measures
Name Time Method Intervention to control blood loss At time of procedure Rate at which providers perform interventions to control blood loss during D\&E procedures
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Queens Medical Center
🇺🇸Honolulu, Hawaii, United States