Tranexamic acid to reduce bleeding during second-trimester dilation and evacuation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled trial enrolling pregnant people aged 18 and older undergoing dilation and evacuation (D&E) at 18 weeks 0 days to 24 weeks 0 days for pregnancy termination or fetal demise. Participants will be randomly assigned to receive prophylactic tranexamic acid or a placebo prior to the procedure. The primary outcome is whether tranexamic acid reduces the need for additional interventions to control bleeding at the time of D&E, and secondary outcomes include measured blood loss and other bleeding-related complications. Key exclusions include a history of thromboembolism, coagulopathy, recent anticoagulant use, severe renal impairment, active infection, suspected placenta accreta, or known allergy to tranexamic acid.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California San Diego
  San Diego, California, United States Recruiting
• Planned Parenthood of the Pacific Southwest
  San Diego, California, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.