Clinical trial NCT06892327: BIOmetric MEasurements in Diagnostics: Comparison of EXperts and IA-assisted Residents
Official title: BIOmetric MEasurements in Diagnostics: Comparison of EXperts and IA-assisted Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: ultrasound
Biometric measurements
artificial intelligence
obstetrics
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant woman

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Accuracy of biometric measurements: Assessment of agreement between manual and AI-assisted measurements.
timeFrame: 36 weeks amenorrhea
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon, Maternité Croix Rousse
Study officials:
References: