A Phase 4 interventional study of Tranexamic Acid and Placebo in Abortion, Dilation and Evacuation and Hemorrhage, sponsored by University of California, San Diego. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by University of California, San Diego · Phase 4, Interventional, and Prevention
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.
120 studies on the registry are indexed under Dilatation, Pathologic; 18 are open to participants now.
This study's planned enrollment of 276 is above the median of 82 across 84 interventional studies indexed under Dilatation, Pathologic.
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Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 mL of normal saline administered via IV at the start of the D\&E procedure
Drug: Placebo
1g tranexamic acid administered via IV at the start of the D\&E procedure
Drug: Tranexamic Acid
1g tranexamic acid
10 mL 0.9% normal saline
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 after
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 procedure
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 procedure
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 after
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 after
Number of doses of uterotonics given
We will assess the number of doses of uterotonics given for each participant
Time frame: During the D&E procedure or immediately after
Provider satisfaction with bleeding outcomes
Each D\&E provider will be asked about their satisfaction with bleeding outcomes for the procedure using a 5 point Likert scale (from 0 being very unsatisfied to 5 being very satisfied).
Time frame: Immediately after the D&E procedure
Provider assessment of which treatment assignment they believe the participant received
D\&E providers will be asked if they think the participant received the study drug or placebo.
Time frame: Immediately after the D&E procedure
Length of the procedure
The length of the D\&E procedure will be recorded in minutes from the time the speculum is first instrument is placed in the uterus until the speculum is removed (minus any time for IUD placement).
Time frame: During the D&E procedure
Adverse events
Adverse events will be assessed including: thromboembolic event, nausea, vomiting, dizziness or hypersensitivity will be ascertained on day of the procedure and by patient self report after
Time frame: During the D&E procedure or immediately after
Plan to share: No
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Studies of the drug tested here: Tranexamic Acid
University of California, San Diego →