In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions (ALCOBRAIN)

University Hospital, Rouen

Status: Enrolling

Conditions: Fetal Alcohol Syndrome

Treatments: Behavioral: Scale of Conners; Behavioral: Development scales; Behavioral: SCQ Questionnaire; Procedure: Blood sample (mother); Procedure: Cord blood sample; Behavioral: ASQ parental questionnaire; Procedure: Placenta sample

Study type: Interventional

Funder types: Other

Identifiers

NCT03371641

2016/0337/HP

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Alcoholic exposure group

Other group

Description:

Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire

Treatment:

Procedure: Placenta sample

Behavioral: ASQ parental questionnaire

Procedure: Cord blood sample

Procedure: Blood sample (mother)

Behavioral: SCQ Questionnaire

Behavioral: Development scales

Behavioral: Scale of Conners

Control

Other group

Description:

Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire

Treatment:

Procedure: Placenta sample

Behavioral: ASQ parental questionnaire

Procedure: Cord blood sample

Procedure: Blood sample (mother)

Behavioral: SCQ Questionnaire

Behavioral: Development scales

Behavioral: Scale of Conners