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临床试验/NCT06892327
NCT06892327已完成不适用

BIOmetric MEasurements in Diagnostics: Comparison of EXperts and IA-assisted Residents

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Accuracy of biometric measurements: Assessment of agreement between manual and AI-assisted measurements.

研究概览

简要总结

Obstetric ultrasound is the cornerstone of fetal growth assessment. It provides essential biometric measurements for estimating fetal weight, monitoring growth and identifying conditions such as intrauterine growth retardation (IUGR) or macrosomia. The accuracy of these measurements depends largely on the expertise of the operator. Experienced practitioners excel at positioning the probe, identifying anatomical landmarks and obtaining reproducible measurements. In contrast, novice operators, such as medical residents, may find it difficult to capture optimal images or identify precise landmarks, resulting in significant variability. This inter-observer variability, well documented even among experts, can have an impact on clinical decisions and obstetric management. For novices, variability is more pronounced, which can affect diagnostic reliability and patient care. Improving resident training is therefore essential to reduce this variability. Traditional solutions to minimizing variability, such as increased supervision, face limitations due to time constraints and resource availability. Recent advances in Artificial Intelligence (AI) could help in the training of residents. In obstetrics, AI could potentially automate biometric measurements by identifying key anatomical landmarks and performing precise, consistent measurements. These systems might standardize acquisition and reduce variability, making measurements less dependent on operator experience. AI technologies could significantly improve novice performance by potentially shortening the learning curve and enhancing measurement reliability. This might enable residents to work more independently while maintaining accuracy. Despite these potential advantages, few studies would have rigorously compared AI-assisted novice performance with that of expert practitioners under real-world conditions.This study aims to assess the possible effectiveness of AI in supporting novice operators during obstetric biometric measurements. The primary objective would be to determine whether AI assistance could enable novices to achieve measurement accuracy comparable to that of experienced practitioners, while potentially improving reproducibility and reducing inter-observer variability.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women aged between 18 and 40 years.
  • Singleton or twin ongoing pregnancies.
  • Gestational age between 20 and 36 weeks of amenorrhea (WA).
  • Patients scheduled for a biometric ultrasound (standard follow-up).

排除标准

  • Known major fetal anomalies that could affect biometric measurements.
  • Technical difficulties during the ultrasound (e.g., maternal obesity, complex abdominal scars).
  • History of severe maternal conditions affecting biometric measurements (e.g., uterine malformations)

结局指标

主要结局

Accuracy of biometric measurements: Assessment of agreement between manual and AI-assisted measurements.

时间窗: 36 weeks amenorrhea

The individual biometric measurements, such as biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC), and femur length (FL), will be presented separately based on their respective units (cm). The estimated fetal weight, which will be based on the aggregation of these various measurements (BPD, HC, AC, FL), will be reported in kilograms (kg). This estimate will be calculated using fetal growth formulas adapted to these parameters. We will clarify that the fetal weight estimate will be calculated based on a model that incorporates these different measurements in the appropriate units. In summary, each measurement will be clearly separated based on its unit, and the fetal weight estimate will be explained to show how the different measurements are combined.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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