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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

Tracking Information
First Submitted Date  ICMJE November 2, 2012
First Posted Date  ICMJE November 20, 2012
Last Update Posted Date February 19, 2018
Actual Study Start Date  ICMJE June 27, 2012
Actual Primary Completion Date October 25, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01729468 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 14, 2012)
  • 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 ]
  • Mode of anesthesia for delivery [ Time Frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
Official Title  ICMJE Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pre-eclampsia
  • Intra-uterine Growth Restriction
Intervention  ICMJE
  • Drug: Aspirin
    Aspirin, 160 mg per day until 34 weeks of gestation
  • Drug: Placebo
    Placebo, 160 mg per day until 34 weeks of gestation
Study Arms  ICMJE
  • Experimental: Aspirin
    Aspirin 160 mg per day
    Intervention: Drug: Aspirin
  • Placebo Comparator: Placebo
    Placebo 160 mg per day
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2016)
1106
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2012)
4972
Actual Study Completion Date  ICMJE October 25, 2016
Actual Primary Completion Date October 25, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Martinique
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01729468
Other Study ID Numbers  ICMJE PHRN08-FP/PERASTUN
2011-003536-30 ( EudraCT Number )
2012-R8 ( Other Identifier: CPP )
A120316-72 ( Other Identifier: Afssaps )
912140 ( Other Identifier: CNIL )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Tours
Study Sponsor  ICMJE University Hospital, Tours
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Franck PERROTIN, MD-PhD University Hospital, Tours
PRS Account University Hospital, Tours
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP