NCT06820177 Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes
| NCT ID | NCT06820177 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, San Diego |
| Condition | Abortion |
| Study Type | INTERVENTIONAL |
| Enrollment | 276 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 276 participants in total. It began in 2025-04-22 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06820177 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Abortion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06820177 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06820177 currently recruiting?
Yes, NCT06820177 is actively recruiting participants. Contact the research team at familyplanningresearch@health.ucsd.edu for enrollment information.
Where is the NCT06820177 trial being conducted?
This trial is being conducted at San Diego, United States, San Diego, United States.
Who is sponsoring the NCT06820177 clinical trial?
NCT06820177 is sponsored by University of California, San Diego. The trial plans to enroll 276 participants.