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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03371641
Other study ID # 2016/337/HP
Secondary ID
Status Recruiting
Phase N/A
First received November 29, 2017
Last updated December 12, 2017
Start date January 27, 2017
Est. completion date January 27, 2025

Study information

Verified date December 2017
Source University Hospital, Rouen
Contact POURCHER
Phone 02 32 88 82 65
Email cecile.pourcher@chu-rouen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 27, 2025
Est. primary completion date January 27, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

Behavioral:
ASQ parental questionnaire
ASQ parental questionnaire
Development scales
WPPSI - IV and NEPSY development scales
Scale of Conners
Scale of Conners
SCQ Questionnaire
SCQ questionnaire
Procedure:
Blood sample (mother)
Blood sample (mother) before delivery
Cord blood sample
Cord blood sample after delivery
Placenta sample
Placenta sample

Locations

Country Name City State
France UH ROUEN Rouen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary Neurological clinical evaluation Clinical exam The day of birth
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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