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NCT Number: NCT06820177

Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

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.

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Key information

Conditions

Abortion Blood Loss Dilatation, Pathologic Dilation and Evacuation Hemorrhage Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prophylactic Tranexamic Acid Use

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Planned Parenthood of the Pacific Southwest, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

1g tranexamic acid

Placebo

Drug

10 mL 0.9% normal saline

Primary outcomes

  1. Composite outcome of excessive bleeding

    Time frame: During the D&E procedure or immediately after

    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.

Secondary outcomes

  1. Mean intra-operative quantitative blood loss

    Time frame: During the D&E procedure

    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.

  2. Mean post-operative quantitative blood loss

    Time frame: on the day of the procedure up to 4 hours following the procedure

    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.

  3. Total number of interventions to control bleeding

    Time frame: During the D&E procedure or immediately after

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

  4. Individual interventions used to control bleeding for each participant

    Time frame: During the D&E procedure or immediately after

    Individual outcomes within the primary composite outcome will be assessed.

  5. Number of doses of uterotonics given

    Time frame: During the D&E procedure or immediately after

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

  6. Provider satisfaction with bleeding outcomes

    Time frame: Immediately after the D&E procedure

    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).

  7. Provider assessment of which treatment assignment they believe the participant received

    Time frame: Immediately after the D&E procedure

    D&E providers will be asked if they think the participant received the study drug or placebo.

  8. Length of the procedure

    Time frame: During the D&E 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).

  9. Adverse events

    Time frame: During the D&E procedure or immediately after

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Greiner, MD, MPH

CONTACT

[email protected]

858-329-4464

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Prophylactic Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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