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Higher aspirin dose may better protect pregnant women from dangerous hypertension

NCT ID NCT06468202

Prevention Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking 162 mg of aspirin daily is better than the standard 81 mg dose for preventing high blood pressure disorders (like preeclampsia) in pregnant women at risk. Over 10,000 participants will be assigned to one of the two doses early in pregnancy. The goal is to find the most effective dose to reduce serious complications for both mother and baby.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aspirin (81 mg or 162 mg daily)
What this could lead to
If it works, this could show that a higher aspirin dose is better at preventing dangerous pregnancy complications like preeclampsia, potentially saving lives.
What could go wrong
This is a large trial, but results may not apply to all populations. Aspirin can cause side effects like bleeding, and the higher dose may not be more effective or could increase risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 10,742 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 35 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. live intrauterine gestation ≤16 6/7 weeks gestational age based on best clinical obstetric estimate, 2. age 14 years or older and able to provide informed consent, 3. at least one of the following high-risk criteria: i) any prior pregnancy complicated by preeclampsia ii) current pregnancy complicated by chronic hypertension diagnosed before randomization (ACOG) iii) pre-gestational diabetes (on medication for diabetes prior to pregnancy, or diabetes is diagnosed prior to randomization with hemoglobin A1C of 6.5% or greater or abnormal 3-hour glucose tolerance test) iv) twin gestation (including higher order pregnancy reduced to twins prior to 14 weeks) v) chronic kidney disease vi) autoimmune disease (e.g., antiphospholipid syndrome, systemic lupus erythematous) 4. or two or more moderate-risk criteria for HDP (per USPSTF), i) nulliparity (no prior delivery at or after 20 weeks 0 days of gestation) ii) obesity (body mass index ≥30 kg/m2 at time of randomization) iii) age ≥35 years (at time of expected estimated due date) iv) Black race v) low income vi) personal risk factors (previous pregnancy with low birth weight or SGA infant, previous adverse pregnancy outcome \[unexplained stillbirth\], placental abruption, interval \>10 years between pregnancies) vii) Family history of preeclampsia (i.e., mother or sister) viii) In vitro fertilization 5. patient not currently on aspirin OR patient on aspirin for obstetrical indications (e.g., related to IVF, or HDP) and: i- randomized before 130/7 weeks gestation, or ii- randomized on or after 13 0/7 weeks gestation and started aspirin within 2 weeks prior to randomization (e.g., aspirin started for HDP prevention at 12 0/7 weeks and patient randomized at 13 2/7 weeks). Exclusion Criteria: 1. known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., active peptic ulcer disease, nasal polyps, NSAID-induced asthma, active gastrointestinal bleeding, known G6PD deficiency, severe hepatic dysfunction, bleeding disorders, history of bariatric surgery), 2. current or planned aspirin use in pregnancy for non-obstetrical indication (e.g., prior stroke/prior myocardial infraction), 3. age \< 14 years, 4. involuntarily confined or detained, 5. considered as having a diminished decision-making capacity, 6. obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy, fetal demise, or planned pregnancy termination, 7. participation in another trial that affects the primary outcome, without prior approval of the PI, 8. plan to deliver at an outside participating site with inability to obtain medical records, 9. monoamniotic twin gestation because of the risk of fetal demise and preterm delivery, 10. participation in this trial in prior pregnancy, 11. triplet or higher order pregnancy.

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Conditions

The condition(s) this trial relates to.

hypertensive disorder preeclampsia hypertension, pregnancy-induced prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational hypertension Hypertensive disorders of pregnancy Preeclampsia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brown University

    RECRUITING

    Providence, Rhode Island, 02905, United States

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Eastern Virginia Medical School - Old Dominion University

    RECRUITING

    Norfolk, Virginia, 23501, United States

  • Inova HealthSystem

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Mississippi

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 27710, United States

  • University of North Carolina, Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Pittsburg Magee

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas, Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

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