Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers (PERASTUN)

December 15, 2025 updated by: University Hospital, Tours
The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux
      • Bron, France, 69677
        • Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon
      • Caen, France, 14052
        • Service de gynécologie-obstétrique, Polyclinique du PARC
      • Clermont-Ferrand, France, 63003
        • Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand
      • Grenoble, France, 38043
        • Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble
      • La Chaussée-Saint-Victor, France, 41260
        • Cabinet Mosaïque Santé
      • Le Mans, France, 72037
        • Service de gynécologie-obstétrique, CHR Le Mans
      • Lille, France, 59037
        • Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille
      • Montpellier, France, 34295
        • Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier
      • Nantes, France, 44093
        • Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes
      • Nantes, France, 44819
        • Service de gynécologie-obstétrique, Polyclinique de l'Atlantique
      • Nîmes, France, 30029
        • Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes
      • Orléans, France, 45032
        • Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans
      • Paris, France, 75014
        • Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP
      • Toulouse, France, 31059
        • Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse
      • Tours, France, 37044
        • Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours
  • Martinique
      • Fort-de-France, Martinique, 97261
        • Service de gynécologie-obstétrique, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aspirin
Aspirin 160 mg per day
Drug: Aspirin
Aspirin, 160 mg per day until 34 weeks of gestation
Placebo Comparator: Placebo
Placebo 160 mg per day
Drug: Placebo
Placebo, 160 mg per day until 34 weeks of gestation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves)
Time Frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Small for gestational age at birth (≤5th percentile on customized growth curves)
Time Frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks
Time Frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Severe pre-eclampsia (ACOG criteria)
Time Frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Perinatal death (22 weeks of gestation to 7 days postnatal)
Time Frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Pre-eclampsia (ACOG criteria)
Time Frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Adverse effects of treatment
Time Frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Mode of delivery (vaginal or cesarean)
Time Frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
Mode of anesthesia for delivery
Time Frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Franck PERROTIN, MD-PhD, University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2012

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHRN08-FP/PERASTUN
  • 2011-003536-30 (EudraCT Number)
  • 2012-R8 (Other Identifier: CPP)
  • A120316-72 (Other Identifier: Afssaps)
  • 912140 (Other Identifier: CNIL)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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