Status:
UNKNOWN
In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
Lead Sponsor:
University Hospital, Rouen
Conditions:
Fetal Alcohol Syndrome
Eligibility:
FEMALE
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 27 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03371641
Start Date
January 27 2017
End Date
January 27 2025
Last Update
December 13 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UH ROUEN
Rouen, France, 76000