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AbortionPhase 4NCT06820177

Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

A Phase 4 study testing Tranexamic Acid in people with Abortion and Dilation and Evacuation, run by University of California, San Diego at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Abortion, Dilation and Evacuation, Hemorrhage
What is being tested?
Tranexamic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
3 sitesUnited States
Study dates
22 Apr 2025to May 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Karen Greiner, MD, MPH contact

858-329-4464

familyplanningresearch@health.ucsd.edu

United States3 sites, 3 recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Sadia Haider, MD, MPH, 312-563-6000, sadia_haider@rush.edu

    Recruiting

  • University of California San Diego

    San Diego, California, 92037

    Karen Greiner, MD, 858-329-4464, familyplanningresearch@health.ucsd.edu

    Recruiting

  • Planned Parenthood of the Pacific Southwest

    San Diego, California, 92101

    Karen Greiner, MD, 858-329-4464, familyplanningresearch@health.ucsd.edu

    Recruiting

Other trials in United States

About this study

Official title: Prophylactic Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes: A Randomized Controlled 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.

Being tested
Tranexamic Acid, Placebo
Keywords
abortion, dilation and evacuation, TXA, hemorrhage, Tranexamic acid, D&E
Medical subject headings
Dilatation, Pathologic, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06820177
Study groupRoleWhat they receive
PlaceboPlacebo comparator10 mL of normal saline administered via IV at the start of the D\&E procedure
Receives: Drug: Placebo
Tranexamic acidActive comparator1g tranexamic acid administered via IV at the start of the D\&E procedure
Receives: Drug: Tranexamic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During the D&E procedure or immediately after

Secondary outcomes (9)

  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.

    Measured: During the D&E procedure

  2. 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.

    Measured: on the day of the procedure up to 4 hours following the procedure

  3. Total number of interventions to control bleeding

    The total number of interventions performed within the primary composite outcome will be assessed.

    Measured: During the D&E procedure or immediately after

  4. Individual interventions used to control bleeding for each participant

    Individual outcomes within the primary composite outcome will be assessed.

    Measured: During the D&E procedure or immediately after

  5. Number of doses of uterotonics given

    We will assess the number of doses of uterotonics given for each participant

    Measured: During the D&E procedure or immediately after

  6. 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).

    Measured: Immediately after the D&E procedure

  7. 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.

    Measured: Immediately after the D&E procedure

  8. 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).

    Measured: During the D&E procedure

  9. 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

    Measured: During the D&E procedure or immediately after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2025
  2. Study start22 Apr 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06820177
Sponsor's protocol ID
811490
Status last verified
Apr 2026
First submitted
4 Feb 2025
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranexamic Acid in people with Abortion and Dilation and Evacuation, run by University of California, San Diego at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karen Greiner, MD, MPH (858-329-4464, familyplanningresearch@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite outcome of excessive bleeding (time frame: During the D&E procedure or immediately after). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06820177.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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