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

NCT03371641 | Recruiting

• 1 other identifier: 2016/0337/HP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Alcohol Syndrome

Keywords

Fetal Alcohol Syndrome; Pregnancy; Biomarker; PlGF; Cognitive development; Behavior troubles

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Assessment of the concentration of PLGF in maternal blood

  Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions

• Studies of metabolomic profile on blood sample

  Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions

• Studies of metabolomic profile on placenta

  Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions

• Neurological clinical evaluation

  The day of birth

• Follow-up at 2 years in pediatric consultation for evaluation of neuro-development

  2 years

Study Arms (2)

Alcoholic exposure group

OTHER

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

Control

OTHER

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

Interventions

Blood sample (mother) PROCEDURE

Blood sample (mother) before delivery

Alcoholic exposure group; Control

Cord blood sample PROCEDURE

Cord blood sample after delivery

Alcoholic exposure group; Control

Placenta sample PROCEDURE

Placenta sample

Alcoholic exposure group; Control

ASQ parental questionnaire BEHAVIORAL

ASQ parental questionnaire

Alcoholic exposure group; Control

Development scales BEHAVIORAL

WPPSI - IV and NEPSY development scales

Alcoholic exposure group; Control

Scale of Conners BEHAVIORAL

Scale of Conners

Alcoholic exposure group; Control

SCQ Questionnaire BEHAVIORAL

SCQ questionnaire

Alcoholic exposure group; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

UH ROUEN

Rouen, 76000, France

RECRUITING

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

POURCHER

CONTACT

02 32 88 82 65; cecile.pourcher@chu-rouen.fr

BLOT

CONTACT

02 32 88 82 65; julien.blot@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 13, 2017
• Study Start: January 27, 2017
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)