Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

Phase 4

Not yet recruiting

• Conditions: Hemorrhage; Abortion; Blood Loss; Dilation and Evacuation; Prophylactic Tranexamic Acid Use
• Interventions: Drug: Tranexamic Acid; Drug: Placebo

• Registration Number: NCT06820177
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Start: 2025-03
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 276

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic Acid	1g tranexamic acid administered via IV at the start of the D\&E procedure
Placebo	Placebo	10 mL of normal saline administered via IV at the start of the D\&E procedure

Primary Outcome Measures

Name	Time	Method
Composite outcome of excessive bleeding	During the D&E procedure or immediately after	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.

Secondary Outcome Measures

Name	Time	Method
Mean intra-operative quantitative blood loss	During the D&E procedure	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.
Mean post-operative quantitative blood loss	on the day of the procedure up to 4 hours following the procedure	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.
Total number of interventions to control bleeding	During the D&E procedure or immediately after	The total number of interventions performed within the primary composite outcome will be assessed.
Individual interventions used to control bleeding for each participant	During the D&E procedure or immediately after	Individual outcomes within the primary composite outcome will be assessed.
Number of doses of uterotonics given	During the D&E procedure or immediately after	We will assess the number of doses of uterotonics given for each participant
Provider satisfaction with bleeding outcomes	Immediately after the D&E procedure	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).
Provider assessment of which treatment assignment they believe the participant received	Immediately after the D&E procedure	D\&E providers will be asked if they think the participant received the study drug or placebo.
Length of the procedure	During the D&E 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).
Adverse events	During the D&E procedure or immediately after	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

Trial Locations

Locations (2)

University of California San Diego; 🇺🇸 San Diego, California, United States

Planned Parenthood of the Pacific Southwest; 🇺🇸 San Diego, California, United States