Clinical trial NCT04786587: Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcohol Drinking
Pregnancy
Keywords: screening
alcohol consumption
pregnancy
self report
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 2425
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women followed in 3 maternity hospitals in the North of France

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)

Primary outcomes:
measure: Calcul of sensitivity of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L)
timeFrame: At Baseline
Secondary outcomes:
measure: Calcul of specificity, PPV and NPV of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L)
timeFrame: At Baseline
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Damien SUBTIL, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: