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Clinical Trials in France / NCT03371641
Recruiting Not applicable

In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions

NCT03371641 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Rouen
Phase
Not applicable
Started
2017-01-27
Last updated
2026-02-06

Condition(s) studied

Fetal Alcohol Syndrome

Investigational drug(s) / intervention(s)

ASQ parental questionnaireDevelopment scalesScale of ConnersSCQ QuestionnaireBlood sample (mother)Cord blood samplePlacenta sample

ASQ parental questionnaire: ASQ parental questionnaire

Development scales: WPPSI - IV and NEPSY development scales

Scale of Conners: Scale of Conners

SCQ Questionnaire: SCQ questionnaire

Blood sample (mother): Blood sample (mother) before delivery

Cord blood sample: Cord blood sample after delivery

Placenta sample: Placenta sample

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • PLGF concentrations in the umbilical cord — 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 placenta — 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.

Trial sites (1)

FacilityCityRegionStatus
UH ROUEN Rouen France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03371641 on ClinicalTrials.gov ↗ ← All trials in France