Tranexamic Acid for Bleeding

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of California, San Diego

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for pregnant patients aged 18 and older who are planning to undergo a dilation and evacuation (D&E) procedure for abortion or fetal demise at 18-24 weeks gestation. Specific eligibility criteria details were not provided.

Inclusion Criteria

Able to understand and sign informed consent

I speak English or Spanish.

Requesting pregnancy termination or procedural management of fetal demise - Intrauterine pregnancy, 18 weeks 0 days and 24 weeks and 0 days gestation

Exclusion Criteria

Suspected placenta accreta spectrum

I will receive medication other than oxytocin to prevent bleeding during my procedure.

Known allergic reaction or hypersensitivity to TXA

+5 more

Participant Groups

The study tests whether Tranexamic Acid (TXA), compared to a placebo, can reduce the need for additional interventions to control bleeding during D&E procedures in the second trimester. It's a randomized, controlled trial focusing on blood loss outcomes.

2Treatment groups

Active Control

Placebo Group

Group I: Tranexamic acidActive Control1 Intervention

1g tranexamic acid administered via IV at the start of the D\&E procedure

Group II: PlaceboPlacebo Group1 Intervention

10 mL of normal saline administered via IV at the start of the D\&E procedure