Actively Recruiting
Prophylactic Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes: A Randomized Controlled Trial
Led by University of California, San Diego · Updated on 2025-08-01
276
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of tranexamic acid (TXA) in pregnant patients aged 18 and older undergoing dilation and evacuation (D&E) for abortion or fetal demise between 18 and 24 weeks gestation. The study focuses on determining if prophylactic TXA affects the need for additional interventions to control bleeding and its impact on blood loss during the procedure. Although second trimester abortions are generally safe, bleeding remains a significant risk, and TXA is commonly used in obstetrics to reduce bleeding but has not yet been studied specifically in abortion procedures. Participants will be randomly assigned to receive either 1 gram of tranexamic acid or a placebo of 10 mL normal saline, both administered intravenously at the start of the D&E procedure. The study is a randomized, placebo-controlled trial with quadruple masking to compare these two groups. The intervention is given only once at the procedure's start, and no other prophylactic uterotonics besides oxytocin are allowed at that time. Throughout the procedure and immediately afterward, researchers will monitor bleeding outcomes, including the need for additional bleeding control interventions and quantitative blood loss measured during and up to four hours after the D&E. Other measures include the number of uterotonic doses, provider satisfaction, procedure length, and any adverse events. Participants are involved during the procedure and monitored closely for safety and bleeding outcomes, with the total participation lasting the day of the procedure and immediate recovery.
CONDITIONS
Brief Title
Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Speaks English or Spanish
- Requesting pregnancy termination or procedural management of fetal demise
- Intrauterine pregnancy between 18 weeks 0 days and 24 weeks 0 days gestation
- Female gender
- Age 18 years or older
You will not qualify if you...
- History of or current thromboembolic event such as deep vein thrombosis, stroke, or pulmonary embolism
- History of coagulopathy
- Anticoagulant use within the past five days
- Severe renal impairment
- Chorioamnionitis or sepsis
- Suspected placenta accreta spectrum
- Prophylactic uterotonics other than oxytocin given or planned at the start of the D&E
- Known allergy or hypersensitivity to tranexamic acid
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - During the D&E procedure and immediately after
Participants receive either tranexamic acid or placebo administered via IV at the start of the dilation and evacuation procedure to prevent excessive bleeding.
1 procedure visit (in-person)
Trial Site Locations
Total: 2 locations
1
University of California San Diego
San Diego, California, United States, 92037
Actively Recruiting
2
Planned Parenthood of the Pacific Southwest
San Diego, California, United States, 92101
Actively Recruiting
Research Team
K
Karen Greiner, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here