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

Not Applicable

Recruiting

• Conditions: Fetal Alcohol Syndrome
• Interventions: 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

• Registration Number: NCT03371641
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-27
• Study First Submitted: 2017-11-29
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-12
• Last Update Submitted: 2017-12-12
• Study First Posted: 2017-12-13
• Last Update Posted: 2017-12-13
• Primary Completion: 2019-01-27
• Study Completion: 2025-01-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcoholic exposure group	ASQ parental questionnaire	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Alcoholic exposure group	Development scales	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Alcoholic exposure group	Cord blood sample	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Control	Scale of Conners	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Control	SCQ Questionnaire	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Alcoholic exposure group	SCQ Questionnaire	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Alcoholic exposure group	Scale of Conners	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Alcoholic exposure group	Placenta sample	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Control	ASQ parental questionnaire	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Control	Blood sample (mother)	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Control	Placenta sample	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Alcoholic exposure group	Blood sample (mother)	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Control	Development scales	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
Control	Cord blood sample	Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire

Primary Outcome Measures

Name	Time	Method
PLGF concentrations in placenta	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.
PLGF concentrations in the umbilical cord	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 Outcome Measures

Name	Time	Method
Follow-up at 2 years in pediatric consultation for evaluation of neuro-development	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.
Follow-up at 6 years in consultation for assessment of neurodevelopment with	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.
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	Blood sample
Neurological clinical evaluation	The day of birth	Clinical exam
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: SCQ Social Communication Questionnaire	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.
Studies of metabolomic profile on blood sample	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions	blood sample metabolomic profile
Studies of metabolomic profile on placenta	Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions	placenta metabolomic profile
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Wechsler Preschool and Primary Scale of Intelligence: WPPSI IV	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.
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Developmental NEuroPSYchological Assessment	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
Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale	6 years	Conners scale is assessing for attention deficit hyperactivity disorder (ADHD)

Trial Locations

Locations (1)

UH ROUEN; 🇫🇷 Rouen, France