RecruitingNot ApplicableNCT03371641
In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
Sponsor
University Hospital, Rouen
Enrollment
60 participants
Start Date
Jan 27, 2017
Study Type
INTERVENTIONAL
Conditions
Summary
This study aims to validate that PLGF is a biomarker of cerebral lesions and therefore of secondary developmental disorders and disabilities that will be best diagnosed at 2 and 6 years of age.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria8
- Mother:
- 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 Criteria4
- Female under 18
- 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
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Interventions
BEHAVIORALASQ parental questionnaire
ASQ parental questionnaire
BEHAVIORALDevelopment scales
WPPSI - IV and NEPSY development scales
BEHAVIORALScale of Conners
Scale of Conners
BEHAVIORALSCQ Questionnaire
SCQ questionnaire
PROCEDUREBlood sample (mother)
Blood sample (mother) before delivery
PROCEDURECord blood sample
Cord blood sample after delivery
PROCEDUREPlacenta sample
Placenta sample
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03371641