Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Sarah Averbach, MD MAS (ucsd)
Headshot of Sarah Averbach
Sarah Averbach

Description

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.

Official Title

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

Keywords

Abortion, Dilation and Evacuation, Hemorrhage, Prophylactic Tranexamic Acid Use, Blood Loss, TXA, Tranexamic acid, D&E, Pathologic Dilatation

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

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

Lead Scientist at University of California Health

  • Sarah Averbach, MD MAS (ucsd)
    Associate Adjunct Professor, Ob/Gyn & Reproductive sciences, Vc-health Sciences-schools. Authored (or co-authored) 72 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06820177
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 276 study participants
Last Updated