NCT04786587 Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
| NCT ID | NCT04786587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Alcohol Drinking |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,425 participants |
| Start Date | 2024-04-08 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,425 participants in total. It began in 2024-04-08 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The effects of alcohol consumption during pregnancy have been known for decades. However, alcohol consumption in pregnant women remains today a public health problem and its identification is primordial. During pregnancy, standardized self-reports such as T-ACE would help identify early women with high-risk alcohol consumption. T-ACE appears to be one of the most used during pregnancy but its diagnostic value is not objectively known. To evaluate the diagnostic value of T-ACE self-report in the detection of high-risk alcohol consumption during pregnancy, by comparison with the dosage of a biomarker in blood. Material and methods Multicentric diagnostic prospective study of 2425 pregnant women followed in 3 hospitals of North of France. The self-report will be offered to all women during their prenatal consultation in these 3 maternity clinics. When they returned their self-report to the medical practitioner, a unique blood test of phosphatidylethanol will be proposed to them for a period of one year. Made after informed consent, this dosage will be used as a gold standard of an alcohol consumption during the previous three weeks to establish the diagnostic value of T-ACE. An alcohol consumption will be considered " at high risk " if blood phosphatidylethanol is ≥ 20 µg/L. With a predictable 25% rejection rate and a positive 4% T-ACE frequency, the inclusion of 2425 patients should permit to estimate sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of T-ACE with a satisfactory 95% confidence interval in this population. The evidence of a link between positive T-ACE and real high-risk alcohol consumption in pregnant women would objectively validate the use of this self-report during pregnancy. The T-ACE within the self-report (self-administered questionnaire) set up in these 3 maternity hospitals in the North of France is already a reference thanks to its several advantages to better identify psychosocial risk situations and especially high-risk alcohol consumption during pregnancy than medical history. If T-ACE appeared to be a sensitive and specific method for identifying high-risk alcohol use during pregnancy, it could be generalized in the follow-up of pregnant women in our country.
Eligibility 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)
Contact & Investigator
Damien SUBTIL, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04786587 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Alcohol Drinking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04786587 currently recruiting?
Yes, NCT04786587 is actively recruiting participants. Contact the research team at damien.subtil@chru-lille.fr for enrollment information.
Where is the NCT04786587 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT04786587 clinical trial?
NCT04786587 is sponsored by University Hospital, Lille. The principal investigator is Damien SUBTIL, MD,PhD at University Hospital, Lille. The trial plans to enroll 2,425 participants.