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OpenTrials
Completed

NCT Number: NCT07133165

Comparison of EXperts and IA-assisted Residents

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospices Civils de Lyon, Maternité Croix Rousse

Lyon, France, 69004

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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)

Treatment and study plan

standard biometric ultrasound

Other

In this study, biometric measurements were systematically performed for each patient using both manual methods and an artificial intelligence (AI) system (Live View Assist, Samsung). The AI system provided real-time guidance by identifying anatomical landmarks and assisting in the measurement of key biometric parameters, including Femur Length (FL), Abdominal Circumference (AC), Head Circumference (HC), and Biparietal Diameter (BPD). This dual approach ensured that both manual and AI-assisted methods were applied uniformly as part of routine clinical care.

Primary outcomes

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

    Time frame: During the procedure

    The parameters assessed will be biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femur length (FL).Concordance will be determined by comparing the accuracy and reproducibility of the measurements, providing a better understanding of the reliability of AI-assisted biometric measurements.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: BIOMEDEXIA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.