Clinical trial NCT03371641: In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
Official title: In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fetal Alcohol Syndrome
Keywords: Fetal Alcohol Syndrome
Pregnancy
Biomarker
PlGF
Cognitive development
Behavior troubles
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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 criteria: Inclusion Criteria:

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 Criteria:

* 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

Primary outcomes:
measure: PLGF concentrations in the umbilical cord
timeFrame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
measure: PLGF concentrations in placenta
timeFrame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Secondary outcomes:
measure: Assessment of the concentration of PLGF in maternal blood
timeFrame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
measure: Studies of metabolomic profile on blood sample
timeFrame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
measure: Studies of metabolomic profile on placenta
timeFrame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
measure: Neurological clinical evaluation
timeFrame: The day of birth
measure: Follow-up at 2 years in pediatric consultation for evaluation of neuro-development
timeFrame: 2 years
measure: Follow-up at 6 years in consultation for assessment of neurodevelopment with
timeFrame: 6 years
measure: Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Wechsler Preschool and Primary Scale of Intelligence: WPPSI IV
timeFrame: 6 years
measure: Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Developmental NEuroPSYchological Assessment
timeFrame: 6 years
measure: Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale
timeFrame: 6 years
measure: Follow-up at 6 years in consultation for assessment of neuropsychological assessment: SCQ Social Communication Questionnaire
timeFrame: 6 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: UH ROUEN
Study officials:
References: