Alcohol use screening in pregnancy with a questionnaire and a blood test
Evaluation of the Diagnostic Value of the Self-report T-ACE for Screening of High-risk Alcohol Consumption During Pregnancy : Comparison With the Dosage of a Blood Biomarker Used as Gold Standard. AUTOQUEST Study.
This project will test whether a short self-report questionnaire (T-ACE) can reliably detect high alcohol use in pregnant women by comparing answers with a blood biomarker (phosphatidylethanol).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2425 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT04786587 on ClinicalTrials.gov |
What this trial studies
This is a multicenter prospective diagnostic study enrolling 2,425 pregnant women at three maternity hospitals in northern France. Participants complete a self-administered T-ACE questionnaire during a prenatal visit and are offered a single blood test for phosphatidylethanol (PEth). The study compares questionnaire results against the PEth biomarker to determine how well the T-ACE identifies high-risk alcohol consumption during pregnancy. Inclusion requires age 18 or older, returned self-report, and written consent.
Who should consider this trial
Good fit: Adult pregnant women (18+) receiving prenatal care at one of the three participating maternity hospitals in northern France who return the self-report and give written consent are eligible.
Not a fit: Women under 18, those not pregnant, those who do not return the self-report or who refuse consent will not participate and therefore will not receive any direct benefit from this study.
Why it matters
Potential benefit: If successful, this could give clinics a simple questionnaire to identify pregnant women who drink heavily so they can be offered earlier support or interventions.
How similar studies have performed: T-ACE is widely used in pregnancy but its diagnostic accuracy against biomarkers like PEth is not well established, and prior biomarker comparisons have produced mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * pregnant woman over 18 years old, presenting in one of the three maternities of the study for her prenatal care * and having returned her self-report * and having given her written consent * no exclusion criteria Exclusion Criteria: * woman under 18 years old * or not pregnant * or not having returned her self-report * or woman who refused to participate in the study (absence of written consent)
Where this trial is running
Lille
- University Hospital, Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: Damien SUBTIL, MD,PhD — University Hospital, Lille
- Study coordinator: Damien SUBTIL, MD,PhD
- Email: damien.subtil@chru-lille.fr
- Phone: 0320445962
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.