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Recruiting NCT04786587

Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.

Conditions: Alcohol Drinking Pregnancy

Sponsor: University Hospital, Lille

trial.available_in: БГ
Overview
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.
Who can participate
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)
Interventions
blood test
DIAGNOSTIC_TEST
self-administered questionnaire
OTHER
Locations 1
France (1)
University Hospital, Lille
Lille
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
08.04.2024
Completion date
01.04.2027
Registry ID
NCT04786587
Source
clinicaltrials.gov
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