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Major trial tests if early aspirin stop is safe for Moms-to-Be

NCT ID NCT07665853

Prevention Sponsor: Hospital Universitari Vall d'Hebron Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether pregnant women at high risk for preeclampsia can safely stop taking daily aspirin at 24-28 weeks instead of continuing until 36 weeks. Over 15,000 women across Europe and Africa will be randomly assigned to stop or continue aspirin. The goal is to see if stopping early is just as effective at preventing preterm preeclampsia while reducing side effects like bleeding.

What this could mean

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

Active substance
aspirin (acetylsalicylic acid)
What this could lead to
If successful, this could show that stopping aspirin earlier is just as effective for preventing preeclampsia, reducing unnecessary medication and side effects for many pregnant women.
What could go wrong
This is a large phase 3 trial, but it's testing a non-inferiority hypothesis—meaning it aims to prove stopping early is not worse than continuing. There's a risk that stopping earlier might slightly increase preeclampsia cases in certain populations, especially women of African origin.

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 15,160 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

May 2028

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

18 years and older

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: * Age 18 years or older at time of enrollment. * Singleton pregnancy. * Ability to read and understand the informed consent form. * Having undergone first-trimester preeclampsia screening between 11+0 and 13+6 weeks of gestation using a validated multiparametric algorithm (FMF algorithm at a risk cutoff of 1:100, or Gaussian algorithm at a cutoff of 1:170) and being classified as high risk for preterm preeclampsia. * Currently taking aspirin 150 mg/day initiated after first-trimester high-risk classification, in accordance with standard clinical practice. * Voluntary signing of the informed consent form and willingness to comply with the study requirements, including acceptance of the assigned aspirin treatment duration, additional blood tests, and additional ultrasound assessments. Exclusion Criteria: * Early pregnancy loss, intrauterine fetal death, or fetus with major structural malformations diagnosed at the time of enrollment. * Fetus affected by a known genetic or chromosomal disease. * Contraindication, allergy, or intolerance to aspirin (acetylsalicylic acid). * Any medical condition that makes aspirin discontinuation unsafe or impossible (e.g., antiphospholipid syndrome, mechanical heart valve, or other conditions requiring indefinite antiplatelet or anticoagulant therapy).

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Conditions

The condition(s) this trial relates to.

preeclampsia prevention target

As listed by the trial registrant

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

Preeclampsia

How to take part

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

  1. The places running it

    38 sites in 7 countries. 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

  • Brikama District Hospital

    Brikama, The Gambia

  • Bundung Maternal and Child Health Hospital

    Banjul, The Gambia

  • Centre Hospitalier Régional de Saint-Louis

    Saint-Louis, Senegal

  • Clínica Universidad de Navarra

    Pamplona, Spain

  • Complejo Hospitalario Universitario de A Coruña

    A Coruña, Spain

  • Consorci Sanitari de Terrassa

    Terrassa, Spain

  • Dr Shterev Hospital

    Sofia, Bulgaria

  • Fundación Jiménez Díaz

    Madrid, Spain

  • Holy Family Hospital

    Techiman, Ghana

  • Hopital Phillipe Senghor

    Dakar, Senegal

  • Hospital Arnau de Vilanova de Lleida

    Lleida, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, Spain

  • Hospital Dr.Josep Trueta

    Girona, Girona, 17007, Spain

  • Hospital General de Alicante

    Alicante, Spain

  • Hospital Joan XXIII

    Tarragona, Tarragona, 43007, Spain

  • Hospital Materno Infantil de Gran Canaria

    Las Palmas de Gran Canaria, Spain

  • Hospital San Cecilio

    Granada, Andalusia, Spain

  • Hospital Universitari Dexeus

    Barcelona, BARCELONA, 08024, Spain

  • Hospital Universitari Mútua Terrassa

    Terrassa, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari Vall d'Hebrón

    Barcelona, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, Spain

  • Hospital Universitario Puerta del Mar

    Cadiz, Spain

  • Hospital Universitario Rey Juan Carlos

    Móstoles, Spain

  • Hospital Universitario Severo Ochoa

    Leganés, Spain

  • Hospital Universitario Virgen de las Nieve

    Granada, Spain

  • Hospital Universitario de Burgos

    Burgos, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Spain

  • Hospital Universitario de Jerez

    Jerez de la Frontera, Spain

  • Hospital Universitario de Torrejón

    Torrejón de Ardoz, Spain

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903, Spain

  • Hospital de León

    León, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • King's College Hospital

    London, United Kingdom

  • Medical University of Vienna

    Vienna, Austria

  • Medway Maritime Hospital

    London, United Kingdom

  • Saint Patrick Hospital

    Ofinso, Ghana

  • St Josef Hospital

    Vienna, Austria

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