Using placental growth factor (PlGF) to signal fetal brain injury after prenatal alcohol exposure
Official title: In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
Run by University Hospital, Rouen · NCT03371641 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 1 site (Rouen) |
| Status | Recruiting |
| Started | January 27, 2017 |
| Main results expected | March 27, 2026 |
| Study ends | March 27, 2026 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT03371641 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Uh Rouen
Rouen, France Recruiting
Study contacts
- Study coordinator: Pourcher
- Email: cecile.pourcher@chu-rouen.fr
- Phone: 02 32 88 82 65
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.