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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Tranexamic Acid
Drug1g tranexamic acid
Placebo
Drug10 mL 0.9% normal saline
Treatment groups
276 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Tranexamic acidActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite outcome of excessive bleeding
The use of any of the following interventions to manage excessive bleeding: at least one uterotonic medication given (i.e. methylergonovine maleate, carboprost tromethamine, misoprostol or additional oxytocin after the standard 30 units), blood transfusion, re-aspiration for bleeding or hematometra, intra-uterine balloon tamponade, uterine artery embolization, major surgery for bleeding, admission for bleeding, or prescription given for any uterotonic medication at discharge.
Time frame
During the D&E procedure or immediately afterSecondary outcomes
1
Mean intra-operative quantitative blood loss
Blood loss measured from the start of the procedure (after removal of cervical dilators) until the end of the procedure (after removal of the speculum). Blood loss will be measured in mL by collecting the blood in a draped bag underneath the patient and weighing all gauze/chux used during the procedure.
Time frame
During the D&E procedure2
Mean post-operative quantitative blood loss
Any bleeding that occurs after speculum removal in the procedural room until the patient leaves clinic on the day of the procedure up to 4 hours following the procedure. The patient's menstrual pad(s) in the recovery room will be weighed.
Time frame
on the day of the procedure up to 4 hours following the procedure3
Total number of interventions to control bleeding
The total number of interventions performed within the primary composite outcome will be assessed.
Time frame
During the D&E procedure or immediately after4
Individual interventions used to control bleeding for each participant
Individual outcomes within the primary composite outcome will be assessed.
Time frame
During the D&E procedure or immediately afterSponsors and contacts
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Source ClinicalTrials.gov