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

February 16, 2018 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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1106

Phase

  • 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 St 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

Ages Eligible for Study

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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
Intervention / Treatment
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

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

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

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

University Hospital, Tours

Investigators

  • 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)

June 27, 2012

Primary Completion (Actual)

October 25, 2016

Study Completion (Actual)

October 25, 2016

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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