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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control | Other | Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASQ parental questionnaire | Behavioral | ASQ parental questionnaire |
|
| 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 |
| 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 |
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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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| POURCHER | Contact | 02 32 88 82 65 | cecile.pourcher@chu-rouen.fr | |
| BLOT | Contact | 02 32 88 82 65 | julien.blot@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH ROUEN | Recruiting | Rouen | 76000 | France |
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| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 |
|
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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |