Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

NCT ID: NCT06820177

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-22
• Study Completion Date: 2026-05-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

10 mL of normal saline administered via IV at the start of the D\&E procedure

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

10 mL 0.9% normal saline

Tranexamic acid

1g tranexamic acid administered via IV at the start of the D\&E procedure

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

1g tranexamic acid

Interventions

Tranexamic Acid

1g tranexamic acid

Intervention Type: DRUG

Placebo

10 mL 0.9% normal saline

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sarah Averbach, MD MAS

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California San Diego

San Diego, California, United States

Site Status: RECRUITING

Planned Parenthood of the Pacific Southwest

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karen Greiner, MD, MPH

Role: CONTACT

familyplanningresearch@health.ucsd.edu

858-329-4464

Facility Contacts

Karen Greiner, MD

Role: primary

familyplanningresearch@health.ucsd.edu

858-329-4464

Karen Greiner, MD

Role: primary

familyplanningresearch@health.ucsd.edu

858-329-4464

Other Identifiers

811490

Identifier Type: -

Identifier Source: org_study_id