Clinical trial NCT06820177: Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes
Official title: Prophylactic Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Abortion
Dilation and Evacuation
Hemorrhage
Prophylactic Tranexamic Acid Use
Blood Loss
Keywords: abortion
dilation and evacuation
TXA
hemorrhage
Tranexamic acid
D&E
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite outcome of excessive bleeding
timeFrame: During the D&E procedure or immediately after
Secondary outcomes:
measure: Mean intra-operative quantitative blood loss
timeFrame: During the D&E procedure
measure: Mean post-operative quantitative blood loss
timeFrame: on the day of the procedure up to 4 hours following the procedure
measure: Total number of interventions to control bleeding
timeFrame: During the D&E procedure or immediately after
measure: Individual interventions used to control bleeding for each participant
timeFrame: During the D&E procedure or immediately after
measure: Number of doses of uterotonics given
timeFrame: During the D&E procedure or immediately after
measure: Provider satisfaction with bleeding outcomes
timeFrame: Immediately after the D&E procedure
measure: Provider assessment of which treatment assignment they believe the participant received
timeFrame: Immediately after the D&E procedure
measure: Length of the procedure
timeFrame: During the D&E procedure
measure: Adverse events
timeFrame: During the D&E procedure or immediately after
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Diego
country: United States
facility: Planned Parenthood of the Pacific Southwest
state: California
Study officials:
References: