Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

University of California San Diego

Status and phase: Enrolling; Phase 4

Conditions: Abortion; Hemorrhage; Prophylactic Tranexamic Acid Use; Blood Loss; Dilation and Evacuation

Treatments: Drug: Placebo; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06820177

811490

Details and patient eligibility

About

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.

Enrollment: 276 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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276 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Tranexamic acid

Active Comparator group

Description:

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

Treatment:

Drug: Tranexamic Acid