Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

Prophylactic Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhage; Blood Loss; Abortion; Dilation and Evacuation; Prophylactic Tranexamic Acid Use
• Intervention / Treatment: Drug: Placebo; Drug: Tranexamic Acid

• Study Type: Interventional
• Enrollment (Estimated): 276
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Karen Greiner, MD, MPH; Phone Number: 858-329-4464; Email: familyplanningresearch@health.ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Recruiting
      • University of California San Diego
      • Contact: Karen Greiner, MD; Phone Number: 858-329-4464; Email: familyplanningresearch@health.ucsd.edu
    • San Diego, California, United States, 92101
      • Recruiting
      • Planned Parenthood of the Pacific Southwest
      • Contact: Karen Greiner, MD; Phone Number: 858-329-4464; Email: familyplanningresearch@health.ucsd.edu
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Sadia Haider, MD, MPH; Phone Number: 312-563-6000; Email: sadia_haider@rush.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 10 mL of normal saline administered via IV at the start of the D&E procedure	Drug: Placebo; 10 mL 0.9% normal saline
Active Comparator: Tranexamic acid; 1g tranexamic acid administered via IV at the start of the D&E procedure	Drug: Tranexamic Acid; 1g tranexamic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean intra-operative quantitative blood loss	Blood loss measured from the start of the procedure (after removal of cervical dilators) until the end of the procedure (after removal of the speculum). Blood loss will be measured in mL by collecting the blood in a draped bag underneath the patient and weighing all gauze/chux used during the procedure.	During the D&E procedure
Mean post-operative quantitative blood loss	Any bleeding that occurs after speculum removal in the procedural room until the patient leaves clinic on the day of the procedure up to 4 hours following the procedure. The patient's menstrual pad(s) in the recovery room will be weighed.	on the day of the procedure up to 4 hours following the procedure
Total number of interventions to control bleeding	The total number of interventions performed within the primary composite outcome will be assessed.	During the D&E procedure or immediately after
Individual interventions used to control bleeding for each participant	Individual outcomes within the primary composite outcome will be assessed.	During the D&E procedure or immediately after
Number of doses of uterotonics given	We will assess the number of doses of uterotonics given for each participant	During the D&E procedure or immediately after
Provider satisfaction with bleeding outcomes	Each D&E provider will be asked about their satisfaction with bleeding outcomes for the procedure using a 5 point Likert scale (from 0 being very unsatisfied to 5 being very satisfied).	Immediately after the D&E procedure
Provider assessment of which treatment assignment they believe the participant received	D&E providers will be asked if they think the participant received the study drug or placebo.	Immediately after the D&E procedure
Length of the procedure	The length of the D&E procedure will be recorded in minutes from the time the speculum is first instrument is placed in the uterus until the speculum is removed (minus any time for IUD placement).	During the D&E procedure
Adverse events	Adverse events will be assessed including: thromboembolic event, nausea, vomiting, dizziness or hypersensitivity will be ascertained on day of the procedure and by patient self report after	During the D&E procedure or immediately after

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hemorrhage; abortion; Tranexamic acid; TXA; dilation and evacuation; D&E
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hemorrhage; Dilatation, Pathologic; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 811490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No