Alcohol use screening in pregnancy with a questionnaire and a blood test
Official title: 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.
Run by University Hospital, Lille · NCT04786587 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 2425 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | April 8, 2024 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT04786587 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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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.