Recruiting

Tranexamic Acid

Sponsor:

UCLA

Code:

NCT06820177

Conditions

Abortion

Dilation and Evacuation

Hemorrhage

Prophylactic Tranexamic Acid Use

Blood Loss

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tranexamic Acid

Placebo

Study Details

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.

Conditions

Abortion

Dilation and Evacuation

Hemorrhage

Prophylactic Tranexamic Acid Use

Blood Loss

Study ID

NCT06820177

Start date

Apr 22, 2025

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

276 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Tranexamic Acid

1g tranexamic acid

Placebo

10 mL 0.9% normal saline

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of California San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Planned Parenthood of the Pacific Southwest

Recruiting

San Diego, California, United States, 92101

Contacts

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 15, 2026

Last verified

Apr, 2026

Keywords

  • abortion
  • dilation and evacuation
  • TXA
  • hemorrhage
  • Tranexamic acid
  • D&E

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-06-15.