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Could a daily aspirin save mothers and babies from hypertension risks?

NCT ID NCT04356326

Prevention Sponsor: Centre Hospitalier Intercommunal Creteil 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 150 mg of aspirin daily, starting before 20 weeks of pregnancy, can prevent serious problems like preeclampsia, poor fetal growth, placental abruption, preterm birth, and death in pregnant women with chronic high blood pressure. About 500 women will be randomly assigned to receive either aspirin or a placebo. The goal is to find a safe, simple way to improve outcomes 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 150 mg daily
What this could lead to
If it works, this could offer a simple, low-cost way to prevent life-threatening complications like preeclampsia and preterm birth in pregnant women with chronic hypertension.
What could go wrong
This is a large Phase 3 trial, but aspirin may not reduce risks enough to change practice, and there is a small chance of side effects like bleeding.

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 500 people

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

Started

Feb 2021

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

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: * Pregnant patient between 10 and 19 weeks of gestation + 6 days * Chronic hypertension, whether treated or not, know before pregnancy or diagnosed before randomization * Singleton pregnancy * Signed the written informed consent * Affiliation to social security Exclusion Criteria: * ---Medical history requiring anticoagulation (antiphospholipid syndrome, deep vein thromboembolic disease, pulmonary embolism, atherothrombosis, patient with mechanical heart valves), * Patient receiving aspirin for another indication outside pregnancy, * Patient with significant proteinuria (\> 300mg/24 hours or a proteinuria/creatininuria ratio ≥ 30mg/mmol), * Active bleeding, * History of severe PE with delivery \< 34 weeks of gestation, * Hypersensitivity to salicylates such as aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs), * Platelet count lower than 100,000 cells/microliter (dosage less than 6 months old), * Hemostasis disorders, including hemophilia (with thrombocytopenia) * Any constitutional or acquired hemorrhagic disease, (including digestive hemorrhages, history of hemorrhagic stroke and thrombocytopenia * Human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus positive serum, * Patient included in another interventional study which could interfere with the results of the study, * Age \<18 years old, * Women under the protection of justice, * Patients with psychiatric follow-up, poor understanding of French or cognitive problems, * Duodenal ulcer, * Severe renal impairment, * Severe hepatic insufficiency, * Severe cardiac impairment, * Gout, * Patients with known glucose-6-phosphate dehydrogenase deficiency,

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Conditions

The condition(s) this trial relates to.

hypertension, pregnancy-induced Perinatal Death pregnancy disorder with abortive outcome fetal growth restriction prevention target placental abruption prevention target preeclampsia prevention target

As listed by the trial registrant

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

Aspirin Chronic hypertension complicating pregnancy Intrauterine growth restriction Perinatal death Placental abruption Pre-eclampsia

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

  • CH Poissy

    RECRUITING

    Poissy, France

  • CHRU Lille

    NOT_YET_RECRUITING

    Lille, France

  • CHRU Nancy

    WITHDRAWN

    Nancy, France

  • CHU Antoine Béclère, AP-HP

    RECRUITING

    Clamart, France

  • CHU Bicêtre, AP-HP

    RECRUITING

    Le Kremlin-Bicêtre, France

  • CHU Bordeaux

    RECRUITING

    Bordeaux, France

  • CHU Caen

    WITHDRAWN

    Caen, 14000, France

  • CHU Cochin- Port Royal, AP-HP

    RECRUITING

    Paris, France

  • CHU Dijon

    RECRUITING

    Dijon, France

  • CHU Lyon

    RECRUITING

    Lyon, France

  • CHU Nantes

    RECRUITING

    Nantes, France

  • CHU Robert Débré, AP-HP

    RECRUITING

    Paris, France

  • CHU St Etienne

    RECRUITING

    Saint-Etienne, France

  • CHU Tenon

    RECRUITING

    Paris, France

  • CHU Toulouse

    NOT_YET_RECRUITING

    Toulouse, France

  • CHU Tours

    WITHDRAWN

    Tours, France

  • Centre Hospitalier Intercommunal de Créteil

    RECRUITING

    Créteil, 94000, France

  • Hôpital Louis Mourier, AP-HP

    RECRUITING

    Colombes, France

  • Hôpital St Joseph

    WITHDRAWN

    Marseille, France

  • Hôpital Trousseau, AP-HP

    RECRUITING

    Paris, France

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