NCT03371641 In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
| NCT ID | NCT03371641 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Rouen |
| Condition | Fetal Alcohol Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2017-01-27 |
| Primary Completion | 2026-03-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2017-01-27 with a primary completion date of 2026-03-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03371641 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fetal Alcohol Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03371641 currently recruiting?
Yes, NCT03371641 is actively recruiting participants. Contact the research team at cecile.pourcher@chu-rouen.fr for enrollment information.
Where is the NCT03371641 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT03371641 clinical trial?
NCT03371641 is sponsored by University Hospital, Rouen. The trial plans to enroll 60 participants.