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

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ClinicalTrials.gov Identifier: NCT01729468
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:
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 or disease Intervention/treatment Phase
Pre-eclampsia Intra-uterine Growth Restriction Drug: Aspirin Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : June 27, 2012
Actual Primary Completion Date : October 25, 2016
Actual Study Completion Date : October 25, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]

Other Outcome Measures:
  1. 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 ]
  2. Mode of anesthesia for delivery [ Time Frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks ]


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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729468


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

Publications:
Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01729468     History of Changes
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 )
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

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