Tranexamic acid to reduce bleeding during second-trimester dilation and evacuation
Prophylactic Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes: A Randomized Controlled Trial
We will test whether giving prophylactic tranexamic acid before a second-trimester dilation and evacuation reduces bleeding for people aged 18 and older at 18–24 weeks of pregnancy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT06820177 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled trial enrolling pregnant people aged 18 and older undergoing dilation and evacuation (D&E) at 18 weeks 0 days to 24 weeks 0 days for pregnancy termination or fetal demise. Participants will be randomly assigned to receive prophylactic tranexamic acid or a placebo prior to the procedure. The primary outcome is whether tranexamic acid reduces the need for additional interventions to control bleeding at the time of D&E, and secondary outcomes include measured blood loss and other bleeding-related complications. Key exclusions include a history of thromboembolism, coagulopathy, recent anticoagulant use, severe renal impairment, active infection, suspected placenta accreta, or known allergy to tranexamic acid.
Who should consider this trial
Good fit: Adults (18+) requesting dilation and evacuation at 18+0 to 24+0 weeks for pregnancy termination or fetal demise who can consent, speak English or Spanish, and do not have excluded medical conditions are ideal candidates.
Not a fit: People with prior or current blood clots, known coagulopathy, recent anticoagulant use, severe kidney disease, chorioamnionitis/sepsis, suspected placenta accreta, or allergy to tranexamic acid may be ineligible and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, prophylactic tranexamic acid could reduce bleeding and the need for additional procedures or transfusions during D&E, improving patient safety.
How similar studies have performed: Tranexamic acid has reduced blood loss and mortality in intrapartum and postpartum hemorrhage, but randomized data on its prophylactic use specifically for second-trimester D&E are not yet published.
Eligibility criteria
Show full inclusion / exclusion criteria
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 planned to be given) at the start of the D\&E * Known allergic reaction or hypersensitivity to TXA
Where this trial is running
San Diego, California and 1 other locations
- University of California San Diego — San Diego, California, United States (Recruiting)
- Planned Parenthood of the Pacific Southwest — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Karen Greiner, MD, MPH
- Email: familyplanningresearch@health.ucsd.edu
- Phone: 858-329-4464
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.