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NCT Number: NCT03371641

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASQ parental questionnaire

Behavioral

ASQ parental questionnaire

Development scales

Behavioral

WPPSI - IV and NEPSY development scales

Scale of Conners

Behavioral

Scale of Conners

SCQ Questionnaire

Behavioral

SCQ questionnaire

Blood sample (mother)

Procedure

Blood sample (mother) before delivery

Cord blood sample

Procedure

Cord blood sample after delivery

Placenta sample

Procedure

Placenta sample

Primary outcomes

  1. PLGF concentrations in the umbilical cord

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

    Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.

  2. PLGF concentrations in placenta

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

    Compare concentrations between 2 groups of mother / child pairs: in utero exposure to alcohol versus control.

Secondary outcomes

  1. 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

    Blood sample

  2. 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

    blood sample metabolomic profile

  3. Studies of metabolomic profile on placenta

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

    placenta metabolomic profile

  4. Neurological clinical evaluation

    Time frame: The day of birth

    Clinical exam

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

    Time frame: 2 years

    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.

  6. Follow-up at 6 years in consultation for assessment of neurodevelopment with

    Time frame: 6 years

    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.

  7. 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

    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.

  8. Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Developmental NEuroPSYchological Assessment

    Time frame: 6 years

    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

  9. Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale

    Time frame: 6 years

    Conners scale is assessing for attention deficit hyperactivity disorder (ADHD)

  10. Follow-up at 6 years in consultation for assessment of neuropsychological assessment: SCQ Social Communication Questionnaire

    Time frame: 6 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: ALCOBRAIN

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2017
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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