Using placental growth factor (PlGF) to signal fetal brain injury after prenatal alcohol exposure
In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
This project will test whether PlGF levels in pregnant women can help detect brain injury and predict developmental problems in children exposed to alcohol before birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 1 site (Rouen) |
| Trial ID | NCT03371641 on ClinicalTrials.gov |
What this trial studies
Researchers will collect a blood sample from pregnant women with and without alcohol exposure and measure placental growth factor (PlGF). Children will be followed and evaluated with standardized development and behavior scales, including ASQ, Conners, SCQ, and formal developmental testing at about 2 and 6 years of age. Alcohol exposure is defined as chronic consumption of ≥30 g/week or binge episodes, with a no-alcohol control group for comparison. The aim is to validate whether maternal PlGF correlates with later cerebral lesions and developmental outcomes.
Who should consider this trial
Good fit: Ideal participants are pregnant women aged 18 or older carrying one or two fetuses who either report chronic or binge alcohol use during pregnancy (≥30 g/week or binge episodes) or report no alcohol use and are willing to consent to long-term follow-up of the child.
Not a fit: Women with clinical suspicion of pre-eclampsia or HELLP syndrome, those under 18, or those unable to complete long-term follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this biomarker could allow earlier identification of infants at risk for alcohol-related brain injury so families can receive targeted monitoring and support sooner.
How similar studies have performed: Prior research has linked PlGF to placental and fetal health in other contexts, but using PlGF specifically to detect alcohol-related fetal brain lesions is relatively novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rouen
- Uh Rouen — Rouen, France (Recruiting)
Study contacts
- Study coordinator: Pourcher
- Email: cecile.pourcher@chu-rouen.fr
- Phone: 02 32 88 82 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.