In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions (NCT03371641) | Clinical Trial Compass
RecruitingNot Applicable
In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
France60 participantsStarted 2017-01-27
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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
* 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
What they're measuring
1
PLGF concentrations in the umbilical cord
Timeframe: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions
2
PLGF concentrations in placenta
Timeframe: Through inclusion completion and samples analyses, an average of 4 months after the end of inclusions