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Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: May 2026 to May 2027 Study sites: 2 to 3v3 Show 1 more changeShow less
    • Study sites: 2 to 3
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2025 to Apr 22, 2025 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 2025 to Apr 22, 2025
    • Site details revised at 2 of 2 sites
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06820177
Lead Sponsor University of California, San Diego
Conditions Abortion, Dilation and Evacuation, Hemorrhage, Prophylactic Tranexamic Acid Use, Blood Loss
Enrollment 276 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov