In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
NCT ID: NCT03371641
Last Updated: 2017-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-01-27
2025-01-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Alcoholic exposure group
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
ASQ parental questionnaire
ASQ parental questionnaire
Development scales
WPPSI - IV and NEPSY development scales
Scale of Conners
Scale of Conners
SCQ Questionnaire
SCQ questionnaire
Blood sample (mother)
Blood sample (mother) before delivery
Cord blood sample
Cord blood sample after delivery
Placenta sample
Placenta sample
Control
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
ASQ parental questionnaire
ASQ parental questionnaire
Development scales
WPPSI - IV and NEPSY development scales
Scale of Conners
Scale of Conners
SCQ Questionnaire
SCQ questionnaire
Blood sample (mother)
Blood sample (mother) before delivery
Cord blood sample
Cord blood sample after delivery
Placenta sample
Placenta sample
Interventions
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ASQ parental questionnaire
ASQ parental questionnaire
Development scales
WPPSI - IV and NEPSY development scales
Scale of Conners
Scale of Conners
SCQ Questionnaire
SCQ questionnaire
Blood sample (mother)
Blood sample (mother) before delivery
Cord blood sample
Cord blood sample after delivery
Placenta sample
Placenta sample
Eligibility Criteria
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Inclusion Criteria
* Pregnant woman (monofetal or twin pregnancy, whatever the parity)
* Age\> or = to 18 years
* Person affiliated to a social security system
* Person who read and understood the information form and signed the consent form
* Alcohol exposure group Chronic consumption of at least 30 g of alcohol per week or acute consumption of "binge drinking" type during pregnancy (knowing that a unit of 10 g of pure alcohol corresponds to 25 cl of beer 4 ° 5, 10 cl of wine at 12 °, 3 cl of whiskey, 7 cl of Porto ...)
* Control group No alcohol consumption during pregnancy
* Child Informed parents and written consent signed by the father and mother for the child's participation in this research (unless one of the parents does not have parental authority)
Exclusion Criteria
* Pregnant woman with clinical suspicion of pre-eclampsia and / or HELLP syndrome
* Person deprived of liberty by an administrative or judicial decision or protected major subject (under tutorship or curatorship)
* Patient participating in another interventional trial or who participated in another interventional trial during pregnancy
18 Years
FEMALE
Yes
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Locations
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UH ROUEN
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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POURCHER
Role: primary
BLOT
Role: backup
Other Identifiers
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2016/337/HP
Identifier Type: -
Identifier Source: org_study_id