In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PLGF concentrations in placenta
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Alcoholic exposure group
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: ASQ parental questionnaire (Behavioral)
Alcoholic exposure group
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: Development scales (Behavioral)
Alcoholic exposure group
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: Scale of Conners (Behavioral)
Alcoholic exposure group
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: SCQ Questionnaire (Behavioral)
Alcoholic exposure group
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: Blood sample (mother) (Procedure)
Alcoholic exposure group
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: Cord blood sample (Procedure)
Alcoholic exposure group
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: Placenta sample (Procedure)
Control
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: ASQ parental questionnaire (Behavioral)
Control
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: Development scales (Behavioral)
Control
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: Scale of Conners (Behavioral)
Control
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: SCQ Questionnaire (Behavioral)
Control
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: Blood sample (mother) (Procedure)
Control
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: Cord blood sample (Procedure)
Control
Blood sample (mother) Cord blood sample Placenta sample ASQ parental questionnaire WPPSI - IV and NEPSY development scales Scale of Conners SCQ questionnaire
干预措施: Placenta sample (Procedure)
结局指标
主要结局
PLGF concentrations in placenta
时间窗: 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
时间窗: 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.
次要结局
- Follow-up at 2 years in pediatric consultation for evaluation of neuro-development(2 years)
- Follow-up at 6 years in consultation for assessment of neurodevelopment with(6 years)
- 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)
- Neurological clinical evaluation(The day of birth)
- Follow-up at 6 years in consultation for assessment of neuropsychological assessment: SCQ Social Communication Questionnaire(6 years)
- 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)
- Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Wechsler Preschool and Primary Scale of Intelligence: WPPSI IV(6 years)
- Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Developmental NEuroPSYchological Assessment(6 years)
- Follow-up at 6 years in consultation for assessment of neuropsychological assessment: Conners' scale(6 years)