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

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.

Study Overview

• Status: Recruiting
• Conditions: Fetal Alcohol Syndrome
• Intervention / Treatment: Behavioral: ASQ parental questionnaire; Behavioral: Development scales; Behavioral: Scale of Conners; Behavioral: SCQ Questionnaire; Procedure: Blood sample (mother); Procedure: Cord blood sample; Procedure: Placenta sample

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: POURCHER; Phone Number: 02 32 88 82 65; Email: cecile.pourcher@chu-rouen.fr
• Study Contact Backup: Name: BLOT; Phone Number: 02 32 88 82 65; Email: julien.blot@chu-rouen.fr

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • UH Rouen
    • Contact: POURCHER; Phone Number: 02 32 88 82 65; Email: cecile.pourcher@chu-rouen.fr
    • Contact: BLOT; Phone Number: 02 32 88 82 65; Email: julien.blot@chu-rouen.fr
    • Principal Investigator: MARRET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Alcoholic exposure group; Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire	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
Other: Control; Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PLGF concentrations in the umbilical cord	Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
PLGF concentrations in placenta	Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the concentration of PLGF in maternal blood	Blood sample	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Studies of metabolomic profile on blood sample	blood sample metabolomic profile	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Studies of metabolomic profile on placenta	placenta metabolomic profile	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
Neurological clinical evaluation	Clinical exam	The day of birth
Follow-up at 2 years in pediatric consultation for evaluation of neuro-development	ASQ: Ages & Stages Questionnaires. This questionnaire screens and assesses the developmental performance of children in the areas of communication, gross motor skills, fine motor skills, problem solving, and personal-social skills. It is used to identify children that would benefit from in-depth evaluation for developmental delays.	2 years
Follow-up at 6 years in consultation for assessment of neurodevelopment with	parental ASQ: Ages & Stages Questionnaire screens and assesses the developmental performance of children in the areas of communication, gross motor skills, fine motor skills, problem solving, and personal-social skills. It is used to identify children that would benefit from in-depth evaluation for developmental delays.	6 years
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Wechsler Preschool and Primary Scale of Intelligence: WPPSI IV	WPPSI - IV: The Wechsler Preschool and Primary Scale of Intelligence consist of 14 subtests. They are designated as one of three types: core, supplemental, or optional. The core subtests are required for the computation of the Verbal, Performance, and Full Scale IQ. The supplemental subtests provide additional information about cognitive abilities or can be used as replacement for inappropriate subtests. The optional subtests provide additional information about cognitive functioning but cannot be used as replacements for core subtests. Quotient and Composite scores have a mean of 100 and a standard deviation of 15. Subtest scaled scores have a mean of 10 and a standard deviation of 3.elow 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+ is Very Superior.	6 years
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Developmental NEuroPSYchological Assessment	NEPSY -NEuroPSYchological Assessment. The six functional domains are made up of 32 subtests and four delayed tasks. These domains are theoretically, not statistically, derived. The subtests were designed to assess cognitive abilities related to disorders that are typically diagnosed in childhood and that are required for success in an academic environment. These tests supposedly help detect any underlying deficiencies that may impede a child's learning	6 years
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale	Conners scale is assessing for attention deficit hyperactivity disorder (ADHD)	6 years
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: SCQ Social Communication Questionnaire	SCQ: The Social Communication is a 40 item, parent report screening measure that taps the symptomatology associaed with autism Spectrum disorder (ASD). The items are administered in a yes/non response format.	6 years

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2017
• Primary Completion (Estimated): March 27, 2026
• Study Completion (Estimated): March 27, 2026

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Biomarker; Pregnancy; Cognitive development; Fetal Alcohol Syndrome; PlGF; Behavior troubles
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Fetal Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcohol-Induced Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fetal Alcohol Spectrum Disorders; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 2016/0337/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No