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New treatment option for Fetal Alcohol Syndrome
Official title In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
ClinicalTrials.gov ID: NCT03371641
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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 treatment trial or who participated in another treatment trial during pregnancy
See the full eligibility 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...
- 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)
- 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 treatment trial or who participated in another treatment trial during pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.