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Evaluation of the Diagnostic Value of the Self-report T-ACE for Screening of High-risk Alcohol Consumption During Pregnancy by Comparison With a Blood Biomarker. AUTOQUEST Study
Led by University Hospital, Lille · Updated on 2026-04-22
2425
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the value of the T-ACE self-report questionnaire in identifying high-risk alcohol consumption during pregnancy. This observational study aims to compare the T-ACE results with a blood biomarker test measuring phosphatidylethanol, which reflects alcohol use in the prior three weeks. The study involves pregnant women receiving prenatal care at three hospitals in northern France, seeking to confirm whether T-ACE can reliably detect risky drinking during pregnancy. Each eligible pregnant woman completes the T-ACE self-report during her prenatal consultation. If she consents to participate, a one-time blood sample is taken to measure phosphatidylethanol levels as the gold standard for alcohol consumption. An alcohol level of 20 µg/L or higher indicates high-risk use. This single blood test will be offered during the recruitment period, with no separate treatment or control groups. Participants will provide their self-report and blood samples during routine prenatal visits, enabling researchers to assess the accuracy of the T-ACE questionnaire by calculating sensitivity, specificity, and predictive values compared to the blood test. The study plans to enroll 2,425 women over about one year. This research may validate the T-ACE as a practical tool to identify high-risk drinking early in pregnancy, potentially improving prenatal care and outcomes.
CONDITIONS
Brief Title
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant woman over 18 years old
- Presenting in one of the three maternities of the study for prenatal care
- Having returned her self-report questionnaire
- Having given written consent to participate
You will not qualify if you...
- Woman under 18 years old
- Not pregnant
- Has not returned her self-report questionnaire
- Refused to participate or did not provide written consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants complete a self-report questionnaire including the T-ACE during their prenatal consultation, followed by a blood test for phosphatidylethanol dosage.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital, Lille
Lille, France, 59000
Actively Recruiting
Research Team
D
Damien SUBTIL, MD,PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1