Back to resultsPrevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers (PERASTUN)
Primary Purpose
Pre-eclampsia, Intra-uterine Growth Restriction
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Aspirin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pre-eclampsia focused on measuring Low Dose Acetylsalicylic Acid, Prevention, Pre-eclampsia, Intra-uterine Growth Restriction, Primiparous Women, Bilateral Uterine Artery Notches, First Quarter
Eligibility 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
Sites / Locations
- Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux
- Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon
- Service de gynécologie-obstétrique, Polyclinique du PARC
- Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand
- Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble
- Cabinet Mosaïque Santé
- Service de gynécologie-obstétrique, CHR Le Mans
- Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille
- Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier
- Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes
- Service de gynécologie-obstétrique, Polyclinique de l'Atlantique
- Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes
- Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans
- Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP
- Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse
- Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours
- Service de gynécologie-obstétrique, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aspirin
Placebo
Arm Description
Aspirin 160 mg per day
Placebo 160 mg per day
Outcomes
Primary Outcome Measures
Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves)
Secondary Outcome Measures
Small for gestational age at birth (≤5th percentile on customized growth curves)
Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks
Severe pre-eclampsia (ACOG criteria)
Perinatal death (22 weeks of gestation to 7 days postnatal)
Pre-eclampsia (ACOG criteria)
Adverse effects of treatment
Full Information
NCT ID
NCT01729468
First Posted
November 2, 2012
Last Updated
February 16, 2018
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT01729468
Brief Title
Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
Acronym
PERASTUN
Official Title
Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 27, 2012 (Actual)
Primary Completion Date
October 25, 2016 (Actual)
Study Completion Date
October 25, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-eclampsia, Intra-uterine Growth Restriction
Keywords
Low Dose Acetylsalicylic Acid, Prevention, Pre-eclampsia, Intra-uterine Growth Restriction, Primiparous Women, Bilateral Uterine Artery Notches, First Quarter
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aspirin
Arm Type
Experimental
Arm Description
Aspirin 160 mg per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 160 mg per day
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin, 160 mg per day until 34 weeks of gestation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, 160 mg per day until 34 weeks of gestation
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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 Pre-specified Outcome Measures:
Title
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
Title
Mode of anesthesia for delivery
Time Frame
women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck PERROTIN, MD-PhD
Organizational Affiliation
University Hospital, Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Service de gynécologie-obstétrique, Polyclinique du PARC
City
Caen
ZIP/Postal Code
14052
Country
France
Facility Name
Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Cabinet Mosaïque Santé
City
La Chaussée St Victor
ZIP/Postal Code
41260
Country
France
Facility Name
Service de gynécologie-obstétrique, CHR Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Service de gynécologie-obstétrique, Polyclinique de l'Atlantique
City
Nantes
ZIP/Postal Code
44819
Country
France
Facility Name
Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans
City
Orléans
ZIP/Postal Code
45032
Country
France
Facility Name
Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Service de gynécologie-obstétrique, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France
City
Fort de France
ZIP/Postal Code
97261
Country
Martinique
12. IPD Sharing Statement
Citations:
PubMed Identifier
22986844
Citation
Poon LC, Syngelaki A, Akolekar R, Lai J, Nicolaides KH. Combined screening for preeclampsia and small for gestational age at 11-13 weeks. Fetal Diagn Ther. 2013;33(1):16-27. doi: 10.1159/000341712. Epub 2012 Sep 13.
Results Reference
background
PubMed Identifier
23004922
Citation
Ayala DE, Ucieda R, Hermida RC. Chronotherapy with low-dose aspirin for prevention of complications in pregnancy. Chronobiol Int. 2013 Mar;30(1-2):260-79. doi: 10.3109/07420528.2012.717455. Epub 2012 Sep 24.
Results Reference
background
PubMed Identifier
18634131
Citation
Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.
Results Reference
background
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Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
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