Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06820177
Phase
PHASE4
Status
Recruiting
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Conditions

  • Abortion
  • Blood Loss
  • Dilation and Evacuation
  • Hemorrhage
  • Prophylactic Tranexamic Acid Use

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Tranexamic Acid — DRUG
    1g tranexamic acid
  • Placebo — DRUG
    10 mL 0.9% normal saline

Study Details

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.

Key Dates

Start date
Apr 22, 2025
Status verified
Feb 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
276 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Placebo
    10 mL of normal saline administered via IV at the start of the D\&E procedure
  • Active Comparator: Tranexamic acid
    1g tranexamic acid administered via IV at the start of the D\&E procedure

Primary Outcome Measure

Composite outcome of excessive bleeding [ Time Frame: During the D&E procedure or immediately after ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Planned Parenthood of the Pacific SouthwestSan DiegoCalifornia92101
Karen Greiner, MD
[email protected]
858-329-4464
University of California San DiegoSan DiegoCalifornia92037
Karen Greiner, MD
[email protected]
858-329-4464

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By research site
Planned Parenthood of the Pacific Southwest· San Diego, CAUniversity of California San Diego· San Diego, CA

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