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Could a higher aspirin dose stop preterm births? large trial launches

NCT ID NCT06980025

Prevention Sponsor: The George Washington University Biostatistics Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether taking 162 mg of aspirin daily (two baby aspirins) is better than the usual 81 mg for preventing another early birth. It includes 1,800 pregnant women who have previously delivered before 35 weeks. Participants start the medicine between 10 and 15 weeks of pregnancy and continue until nearly 37 weeks. The goal is to see if the higher dose reduces the chance of preterm delivery or fetal death before 35 weeks.

What this could mean

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

Active substance
Aspirin
What this could lead to
If successful, this could establish a higher dose of aspirin as a standard to prevent preterm birth in women with a history of early delivery.
What could go wrong
This is a phase 3 trial, but it only compares two aspirin doses—not a placebo—so the benefit over no treatment is already assumed. Results may not apply to all women, and aspirin carries bleeding 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,800 people

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

Started

Jul 2025

Expected to finish

Feb 2029

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 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * 14 years or older * Singleton gestation. Twin gestation reduced to a singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 13 weeks 6 days project gestational age. Higher-order multifetal gestations reduced to singletons are not eligible. * Gestational age at randomization between 10 weeks 0 days and 15 weeks 6 days based on clinical information and evaluation of the earliest ultrasound. * Prior preterm birth between 20 weeks 0 days and 34 weeks 6 days with one of the following in the proximal birth reaching 20 weeks or greater: * Spontaneous preterm birth is defined as spontaneous preterm labor or premature rupture of membranes * Ischemic placental disease is defined as preeclampsia, small for gestational age, fetal growth restriction, or placental abruption, as defined clinically. * Stillbirth excluding those with known genetic disorders or major congenital anomalies. Exclusion Criteria: * Known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., history of peptic ulcer disease, nasal polyps, NSAID-induced asthma, history of gastrointestinal bleeding, known G6PD deficiency, severe hepatic dysfunction, bleeding disorders, and consumption of 3 or more alcoholic drinks per day) * Taking other anticoagulants such as Heparin or Low-Molecular weight Heparin * Thrombocytopenia defined as a platelet count defined as a platelet count \<100,000 microliters * Gastric bypass surgery, regardless of type * Aspirin use \>81 mg daily during the current pregnancy who are not willing or able to go through a 2-week washout before randomization. * Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery. * Known fetal genetic disease or major malformations * Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from twins to singleton, is not an exclusion. * Any fetal/maternal condition requiring invasive in-utero assessment or treatment, for example, significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia. * Patients with any of the following medical conditions because of increased risk for adverse pregnancy outcome or indicated preterm birth: * Treated hypertension requiring more than one agent * Chronic renal disease with baseline serum creatinine ≥1.5 mg/dL * Conditions treated with chronic oral glucocorticoid therapy (e.g., systemic lupus erythematosus) * Uncontrolled hyper- and hypothyroid disease * New York Heart Association (NYHA) stage II or greater cardiac disease * Planned indicated delivery prior to 37 weeks. * Participation in another interventional study that influences the primary outcome in this study (gestational age at delivery). * Participation in this trial in a previous pregnancy. * Delivery planned at a non-participating site

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Conditions

The condition(s) this trial relates to.

obstetric disorder pregnancy disorder Premature Birth Stillbirth

As listed by the trial registrant

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

Obstetrical complications Preterm delivery

How to take part

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

  1. The places running it

    14 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

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Brown University

    RECRUITING

    Providence, Rhode Island, 02905, United States

  • Case Western Reserve University

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Magee Women's Hospital of UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Regents of the University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Alabama - Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of North Carolina - Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas - Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Utah Medical Center

    RECRUITING

    Salt Lake City, Utah, 84132, United States

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