Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.

• Conditions: Alcohol Drinking; Pregnancy
• Interventions: Diagnostic Test: blood test; Other: self-administered questionnaire

• Registration Number: NCT04786587
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06
• Study Start: 2022-09
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2425

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant woman	blood test	-
Pregnant woman	self-administered questionnaire	-

Primary Outcome Measures

Name	Time	Method
Calcul of sensitivity of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L)	At Baseline	the calcul of sensitivity of the self-report T-ACE to detect a high-risk alcohol consumption in pregnant women, compared to the result of phosphatidylethanol dosage in blood sampling used as gold standard of an alcohol consumption during the previous three weeks; The blood sampling for dosage of phosphatidylethanol is done when the self-report is returned to the medical practitioner by the pregnant woman, if she is included in the study after giving her informed consent.

Secondary Outcome Measures

Name	Time	Method
Calcul of specificity, PPV and NPV of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L)	At Baseline	The calcul of specificity, PPV and NPV of the self-report T-ACE to detect a high-risk alcohol consumption in pregnant women, compared to the result of phosphatidylethanol dosage in blood sampling used as gold standard of an alcohol consumption during the previous three weeks.; The blood sampling for dosage of phosphatidylethanol is done when the self-report is returned to the medical practitioner by the pregnant woman, if she is included in the study after giving her informed consent