In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
ConditionFetal Alcohol Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Rouen
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ASQ parental questionnaire
BehavioralASQ parental questionnaire
Development scales
BehavioralWPPSI - IV and NEPSY development scales
Scale of Conners
BehavioralScale of Conners
SCQ Questionnaire
BehavioralSCQ questionnaire
Blood sample (mother)
Procedure/SurgeryBlood sample (mother) before delivery
Cord blood sample
Procedure/SurgeryCord blood sample after delivery
Placenta sample
Procedure/SurgeryPlacenta sample
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Alcoholic exposure groupOther 7 interventions
Group B: ControlOther 7 interventions
Trial outcomes
Primary outcomes
1
PLGF concentrations in the umbilical cord
Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.
Time frame
Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions2
PLGF concentrations in placenta
Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.
Time frame
Through inclusion completion and samples analyses, an average of 4 months after the end of inclusionsSecondary outcomes
1
Assessment of the concentration of PLGF in maternal blood
Blood sample
Time frame
Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions2
Studies of metabolomic profile on blood sample
blood sample metabolomic profile
Time frame
Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions3
Studies of metabolomic profile on placenta
placenta metabolomic profile
Time frame
Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions4
Neurological clinical evaluation
Clinical exam
Time frame
The day of birthSponsors and contacts
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Source ClinicalTrials.gov