Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

NCT06820177 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 811490
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite outcome of excessive bleeding

  The use of any of the following interventions to manage excessive bleeding: at least one uterotonic medication given (i.e. methylergonovine maleate, carboprost tromethamine, misoprostol or additional oxytocin after the standard 30 units), blood transfusion, re-aspiration for bleeding or hematometra, intra-uterine balloon tamponade, uterine artery embolization, major surgery for bleeding, admission for bleeding, or prescription given for any uterotonic medication at discharge.

  During the D&E procedure or immediately after

Secondary Outcomes (9)

• Mean intra-operative quantitative blood loss

  During the D&E procedure

• Mean post-operative quantitative blood loss

  on the day of the procedure up to 4 hours following the procedure

• Total number of interventions to control bleeding

  During the D&E procedure or immediately after

• Individual interventions used to control bleeding for each participant

  During the D&E procedure or immediately after

• Number of doses of uterotonics given

  During the D&E procedure or immediately after

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Tranexamic acid

ACTIVE COMPARATOR

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

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

1g tranexamic acid

Tranexamic acid

Placebo DRUG

10 mL 0.9% normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

University of California San Diego

San Diego, California, 92037, United States

RECRUITING

Planned Parenthood of the Pacific Southwest

San Diego, California, 92101, United States

RECRUITING

MeSH Terms

Conditions

Dilatation, Pathologic; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Karen Greiner, MD, MPH

CONTACT

858-329-4464; familyplanningresearch@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 11, 2025
• Study Start: April 22, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)