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Daily aspirin in early pregnancy may prevent dangerous pre-eclampsia

NCT ID NCT01729468

Prevention Sponsor: University Hospital, Tours 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether taking a low-dose aspirin (160 mg) each night, starting before 16 weeks of pregnancy, could prevent pre-eclampsia and small babies in first-time mothers at high risk. Over 1,100 women with abnormal blood flow in the uterine artery were randomly assigned to aspirin or a placebo until 34 weeks. The goal was to see if this simple, safe drug could reduce serious pregnancy complications.

What this could mean

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

Active substance
Aspirin (low-dose, 160 mg per day)
What this could lead to
If effective, this could offer a simple, low-cost way to prevent serious pregnancy complications like pre-eclampsia and restricted fetal growth in high-risk first-time mothers.
What could go wrong
The trial is completed, but results may not apply to all women or pregnancies. Aspirin carries a small risk of bleeding, and the benefit depends on strict early timing and correct dosing.

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

1,106 people

The number who actually took part.

Started

Jun 2012

Finished

Oct 2016

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 months 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 * Nulliparous (no previous pregnancy ≥ 22 SA) * Singleton pregnancy * Gestational age ≤ 15 +6 weeks * Bilateral uterine artery notch (grade ≥ 2) and/or bilateral uterine artery PI ≥ 1.7 during first trimester ultrasound (CRL between 45 and 84 mm) * Maternal informed consent obtained * Affiliated to social security system Exclusion Criteria: * Women considering voluntary pregnancy termination (≤ 14 weeks) * Pre-existing (maternal) indication for premature delivery before 37 weeks * Fetal condition detected during the first trimester scan (fetal malformation or nuchal translucency ≥ 95th percentile) * Women under anticoagulation * Allergy or hypersensitivity to Kardegic® or one of its constituents * Secondary hemostasis disorder responsible for bleeding or risk of bleeding * Peptic ulcer under evolution * Lupus or antiphospholipid syndrome

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Conditions

The condition(s) this trial relates to.

fetal growth restriction prevention target preeclampsia prevention target

As listed by the trial registrant

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

Intra-uterine growth restriction Pre-eclampsia

Contacts and locations

Locations

  • Cabinet Mosaïque Santé

    La Chaussée-Saint-Victor, 41260, France

  • Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP

    Paris, 75014, France

  • Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours

    Tours, 37044, France

  • Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux

    Bordeaux, 33000, France

  • Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon

    Bron, 69677, France

  • Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier

    Montpellier, 34295, France

  • Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes

    Nîmes, 30029, France

  • Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse

    Toulouse, 31059, France

  • Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans

    Orléans, 45032, France

  • Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille

    Lille, 59037, France

  • Service de gynécologie-obstétrique, CHR Le Mans

    Le Mans, 72037, France

  • Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble

    Grenoble, 38043, France

  • Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes

    Nantes, 44093, France

  • Service de gynécologie-obstétrique, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France

    Fort-de-France, 97261, Martinique

  • Service de gynécologie-obstétrique, Polyclinique de l'Atlantique

    Nantes, 44819, France

  • Service de gynécologie-obstétrique, Polyclinique du PARC

    Caen, 14052, France

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