Alcohol DrinkingAUTOQUESTNCT04786587
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
An observational study of Alcohol Drinking and Pregnancy, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Alcohol Drinking, Pregnancy
- What is being tested?
- blood test and self-administered questionnaire
- How many people
- 2,425 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2024to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women followed in 3 maternity hospitals in the North of France
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital, Lille
Lille, 59000
Damien SUBTIL, MD,PhD, 0320445962 ext. +33, damien.subtil@chru-lille.fr
About this 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.
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.
Read more
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.
- Conditions
- Alcohol Drinking, Pregnancy
- Being tested
- blood test, self-administered questionnaire
- Keywords
- screening, alcohol consumption, pregnancy, self report
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testDiagnostic test
Each pregnant woman completes the self-report during her prenatal consultation and will have a unique blood sampling for dosage of phosphatidylethanol after she returned her self-report to the practitioner and if she is included in the study (informed consent given).
the blood test for dosage of phosphatidylethanol will be offered to all eligible pregnant women in each maternity clinic of the study during the recruitment period. There will not be different arms in this study.
self-administered questionnaireOther
Each pregnant woman completes the self-report during her prenatal consultation and will have a unique blood sampling for dosage of phosphatidylethanol after she returned her self-report to the practitioner and if she is included in the study (informed consent given).
A self-report, including the T-ACE, is the usual prenatal consultation procedure in the three maternities of the study. The specific procedure for the study is to perform a blood test for dosage of phosphatidylethanol in eligible pregnant women after informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant woman | Not described Receives: Diagnostic Test: blood test; Other: self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcul of sensitivity of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L)
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.
Measured: At Baseline
Secondary outcomes (1)
Calcul of specificity, PPV and NPV of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L)
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
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start8 Apr 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien SUBTIL, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786587
- Sponsor's protocol ID
- 2018_85
- Other IDs
- 2021-A00058-33
- Acronym
- AUTOQUEST
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04786587
- Acronym / sponsor ID
- AUTOQUEST / 2018_85
- Conditions
- Alcohol Drinking, Pregnancy
- Keywords
- screening, alcohol consumption, pregnancy, self report
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,425 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant woman | – | Diagnostic Test: blood test, Other: self-administered questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women followed in 3 maternity hospitals in the North of France
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood testEach pregnant woman completes the self-report during her prenatal consultation and will have a unique blood sampling for dosage of phosphatidylethanol after she returned her self-report to the practitioner and if she is included in the study (informed consent given). the blood test for dosage of phosphatidylethanol will be offered to all eligible pregnant women in each maternity clinic of the study during the recruitment period. There will not be different arms in this study. | Diagnostic test | Pregnant woman |
| self-administered questionnaireEach pregnant woman completes the self-report during her prenatal consultation and will have a unique blood sampling for dosage of phosphatidylethanol after she returned her self-report to the practitioner and if she is included in the study (informed consent given). A self-report, including the T-ACE, is the usual prenatal consultation procedure in the three maternities of the study. The specific procedure for the study is to perform a blood test for dosage of phosphatidylethanol in eligible pregnant women after informed consent. | Other | Pregnant woman |
Primary outcome
Calcul of sensitivity of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L)
Time frame: 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.
1 secondary outcome
Calcul of specificity, PPV and NPV of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L)
Time frame: At Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
Related trials for Alcohol Drinking
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Recruiting
Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
Alcohol Use, Adolescent
Not yet recruiting
Using Virtual Reality to Augment Brief Interventions for Heavy Drinking Young Adults
Alcohol Misuse
Recruiting
Peer Support for Liver Transplant Recipients With History of ALD
Alcohol Use Disorder, Alcohol Related Liver Disease
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damien SUBTIL, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Drinking and Pregnancy, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien SUBTIL, MD,PhD (0320445962 ext. +33, damien.subtil@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcul of sensitivity of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L) (time frame: At Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.