Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

Last updated: July 29, 2025
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting

Phase

4

Condition

Hemorrhage

Treatment

Placebo

Tranexamic Acid

Clinical Study ID

NCT06820177
811490
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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

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

Exclusion Criteria:

  • History of or current thromboembolic event (deep vein thrombosis, stroke, pulmonaryembolism)

  • 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 thestart of the D&E

  • Known allergic reaction or hypersensitivity to TXA

Study Design

Total Participants: 276
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
April 22, 2025
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Planned Parenthood of the Pacific Southwest

    San Diego, California 92101
    United States

    Active - Recruiting

  • University of California San Diego

    San Diego, California 92037
    United States

    Active - Recruiting

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