Recruiting NCT03371641
In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ASQ parental questionnaire, Development scales, Scale of Conners, SCQ Questionnaire.
- Who it may be relevant to
- Registry conditions: Fetal Alcohol Syndrome. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral ASQ parental questionnaire
ASQ parental questionnaire - Behavioral Development scales
WPPSI - IV and NEPSY development scales - Behavioral Scale of Conners
Scale of Conners - Behavioral SCQ Questionnaire
SCQ questionnaire - Procedure Blood sample (mother)
Blood sample (mother) before delivery - Procedure Cord blood sample
Cord blood sample after delivery - Procedure Placenta sample
Placenta sample
Primary outcome measures
- PLGF concentrations in the umbilical cord [Time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions]
- PLGF concentrations in placenta [Time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions]
Secondary outcome measures (10)
- Assessment of the concentration of PLGF in maternal blood [Time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions]
- Studies of metabolomic profile on blood sample [Time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions]
- Studies of metabolomic profile on placenta [Time frame: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions]
- Neurological clinical evaluation [Time frame: The day of birth]
- Follow-up at 2 years in pediatric consultation for evaluation of neuro-development [Time frame: 2 years]
- Follow-up at 6 years in consultation for assessment of neurodevelopment with [Time frame: 6 years]
- Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Wechsler Preschool and Primary Scale of Intelligence: WPPSI IV [Time frame: 6 years]
- Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Developmental NEuroPSYchological Assessment [Time frame: 6 years]
- Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale [Time frame: 6 years]
- Follow-up at 6 years in consultation for assessment of neuropsychological assessment: SCQ Social Communication Questionnaire [Time frame: 6 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- UH ROUEN — Rouen
Identifiers
NCT: NCT03371641 · 2016/0337/HP