Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, San Diego

About 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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tranexamic Acid
  • Placebo

Treatment groups

276 Participants
are divided into 2 treatment groups