Prophylactic Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes: A Randomized Controlled Trial
University of California, San Diego
Summary
Although procedural abortion in the second trimester is extremely safe, hemorrhage is one of the leading causes of morbidity and mortality. Tranexamic acid (TXA) is used commonly in obstetrics to prevent or manage intrapartum or postpartum hemorrhage and has been associated with decreased mortality and decreased blood loss at the time of birth. Some guidelines are recommending the use of TXA for both the prevention and management of bleeding for abortion care. However, there are currently no published studies assessing the association between TXA and bleeding outcomes for abortion procedures. This study will involve a randomized, placebo-controlled trial of pregnant patients aged 18 and older desiring dilation and evacuation (D\&E) for abortion or fetal demise at 18-24 weeks gestation. The primary aim is to determine whether prophylactic TXA has an effect on the need for additional interventions to control bleeding at the time of D\&E. The secondary aim is to determine whether prophylactic TXA has an effect on the mean quantitative procedural blood loss.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Able to understand and sign informed consent * Speaks English or Spanish language, * Requesting pregnancy termination or procedural management of fetal demise - Intrauterine pregnancy, 18 weeks 0 days and 24 weeks and 0 days gestation Exclusion Criteria: * History of or current thromboembolic event (deep vein thrombosis, stroke, pulmonary embolism) * History of coagulopathy * Anticoagulant use in the preceding five days * Severe renal impairment * Chorioamnionitis or sepsis * Suspected placenta accreta spectrum * Prophylactic uterotonics other than oxytocin given (or p…
Interventions
- DrugTranexamic Acid
1g tranexamic acid
- DrugPlacebo
10 mL 0.9% normal saline
Locations (2)
- University of California San DiegoSan Diego, California
- Planned Parenthood of the Pacific SouthwestSan Diego, California