RECRUITING

Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-22
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06820177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to understand and sign informed consent
  2. * Speaks English or Spanish language,
  3. * Requesting pregnancy termination or procedural management of fetal demise - Intrauterine pregnancy, 18 weeks 0 days and 24 weeks and 0 days gestation
  1. * History of or current thromboembolic event (deep vein thrombosis, stroke, pulmonary embolism)
  2. * History of coagulopathy
  3. * Anticoagulant use in the preceding five days
  4. * Severe renal impairment
  5. * Chorioamnionitis or sepsis
  6. * Suspected placenta accreta spectrum
  7. * Prophylactic uterotonics other than oxytocin given (or planned to be given) at the start of the D\&E
  8. * Known allergic reaction or hypersensitivity to TXA

Contacts and Locations

Study Contact

Karen Greiner, MD, MPH
CONTACT
858-329-4464
familyplanningresearch@health.ucsd.edu

Study Locations (Sites)

University of California San Diego
San Diego, California, 92037
United States
Planned Parenthood of the Pacific Southwest
San Diego, California, 92101
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-22
Study Completion Date2026-05

Study Record Updates

Study Start Date2025-04-22
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Abortion
  • Dilation and Evacuation
  • Hemorrhage
  • Prophylactic Tranexamic Acid Use
  • Blood Loss