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临床试验/NCT04786587
NCT04786587招募中不适用

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.

University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 2,425 人开始时间: 2024年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,425
试验地点
2
主要终点
Calcul of sensitivity of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Pregnant woman

干预措施: blood test (Diagnostic Test)

Pregnant woman

干预措施: self-administered questionnaire (Other)

结局指标

主要结局

Calcul of sensitivity of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L)

时间窗: 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.

次要结局

  • Calcul of specificity, PPV and NPV of the self-report T-ACE compared to the result of phosphatidylethanol dosage (µg/L)(At Baseline)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (2)

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