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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital, Tours
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01729468
First received: November 2, 2012
Last updated: October 1, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pre-eclampsia
Intra-uterine Growth Restriction
Drug: Aspirin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Mode of anesthesia for delivery [ Time Frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 4972
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspirin
Aspirin 160 mg per day
Drug: Aspirin
Aspirin, 160 mg per day until 34 weeks of gestation
Other Name: Aspirin
Placebo Comparator: Placebo
Placebo 160 mg per day
Drug: Placebo
Placebo, 160 mg per day until 34 weeks of gestation
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729468

Contacts
Contact: Franck PERROTIN, MD-PhD +33(0)2.47.47.47.39 franck.perrotin@med.univ-tours.fr
Contact: Yoann DESVIGNES +33(0)2.47.47.46.32 yoann.desvignes@med.univ-tours.fr

Locations
France
Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Dominique Dallay, MD-PhD         
Principal Investigator: Dominqiue Dallay, MD-PhD         
Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon Recruiting
Bron, France, 69677
Contact: Muriel Doret, MD         
Principal Investigator: Muriel Doret, MD         
Service de Gynécologie-Obstétrique, Hôpital Côte de Nacre, CHU de Caen Not yet recruiting
Caen, France, 14033
Contact: Guillaume Benoist, MD         
Principal Investigator: Guillaume Benoist, MD         
Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Didier Lemery, MD-PhD         
Principal Investigator: Didier Lemery, MD-PhD         
Cabinet Mosaïque Santé Recruiting
La Chaussée St Victor, France, 41260
Contact: Georges Haddad, MD         
Principal Investigator: Georges Haddad, MD         
Centre Européen de Diagnostic et d'Exploration de la Femme Not yet recruiting
Le Chesnay, France, 78150
Contact: Jean Pierre Bernard, MD         
Principal Investigator: Jean Pierre Bernard, MD         
Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille Recruiting
Lille, France, 59037
Contact: Véronique Houfflin-Debarge, MD-PhD         
Principal Investigator: Véronique Houfflin-Debarge, MD-PhD         
Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Anaig Flandrin, MD         
Principal Investigator: Anaig Flandrin, MD         
Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes Recruiting
Nantes, France, 44093
Contact: Norbert Winer, MD         
Principal Investigator: Norbert Winer, MD         
Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes Recruiting
Nîmes, France, 30029
Contact: Pierre Marès, MD-PhD         
Principal Investigator: Pierre Marès, MD-PhD         
Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans Recruiting
Orléans, France, 45032
Contact: Pascal Megier, MD         
Principal Investigator: Pascal Megier, MD         
Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP Recruiting
Paris, France, 75014
Contact: Yves Ville, Md-PhD         
Principal Investigator: Yves Ville, MD-PhD         
Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse Recruiting
Toulouse, France, 31059
Contact: Christophe Vayssière, MD-PhD         
Principal Investigator: Christophe Vayssière, MD-PhD         
Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours Recruiting
Tours, France, 37044
Contact: Franck Perrotin, MD-PhD         
Principal Investigator: Franck Perrotin, MD-PhD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Franck PERROTIN, MD-PhD University Hospital, Tours
  More Information

Publications:
Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01729468     History of Changes
Other Study ID Numbers: PHRN08-FP/PERASTUN, 2011-003536-30, 2012-R8, A120316-72, 912140
Study First Received: November 2, 2012
Last Updated: October 1, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
Low Dose Acetylsalicylic Acid
Prevention
Pre-eclampsia
Intra-uterine Growth Restriction
Primiparous Women
Bilateral Uterine Artery Notches
First Quarter

Additional relevant MeSH terms:
Pre-Eclampsia
Eclampsia
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014