CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 122 enrolled
Drug / intervention
Classification and segmentation deep learning modelsother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05059093
NCT05059093N/ACompleted

Developing and Testing Deep Learning Models for Fetal Biometry and Amniotic Volume Assessment in Routine Fetal Ultrasound Scans

Deepecho·observational·Posted Sep 28, 2021·Updated Jul 27, 2022

In Brief

An observational study evaluating Classification and segmentation deep learning models for Small for Gestational Age Infant and 3 related conditions. Completed, enrolled 122 participants across 6 sites.

Detailed Summary

Routine fetal ultrasound scan during the second trimester of the pregnancy is a low-cost, noninvasive screening modality that has been proven to lower fetal mortality by up to 20%. One of the critical elements of this exam is the measurement of fetal biometric parameters, which are the head circumference (HC), biparietal diameter (BPD), abdominal circumference (AC), and femur length (FL) measured on biometry standard planes. Those standard planes are taken according to quality standards first described by Salomon et al. and used as the guidelines of the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG). The biometric parameters extracted from them are essential to diagnose fetal growth restriction (FGR), the world's first cause of perinatal fetal mortality. Such measurements and image quality assessment are time-consuming tasks that are prone to inter and intraobserver variability depending on the level of skill of the sonographer or the physician performing the exam. Amniotic fluid (AF) volume assessment is also an essential step in routine screening scans allowing the diagnosis of oligo or hydramnios, both associated with increased fetal mortality rates. The AF is measured by two main "semi-quantitative" techniques: Amniotic Fluid Index (AFI) and the single deepest pocket (SDP). The latter is more specific as it lowers the overdiagnosis of oligo-amnios without any impact on mortality or morbidity and is easier to perform for the sonographer (only one measurement versus four in the case of the AFI technique). However, AF assessment remains a time-consuming and poorly reproducible task. Attempts to automate such biometric measurements and AF volume assessment have been made using Artificial Intelligence (AI) and deep learning (DL) tools. Studies showed excellent results "in silico," reaching up to 98 %, 95%, 93 % dice score coefficients for HC, AC, and FL measurements and 89 % DSC for AFI measurements. However, they were all conducted retrospectively without validation on prospectively acquired images. Reviews and experts have stressed the need for quality peer-reviewed prospective studies to assess AI tools' performance with real-world data. Their performance is expected to be worse and to reflect better their use in the clinical workflow. This study aims to develop DL models to automate HC, BPD, AC, and FL measurements and AF volume assessment from retrospectively acquired data and test their performances to those of clinicians and experts on prospective real-world fetal US scans.

Study Details

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 28, 2021
Enrollment StartOct 25, 2021
Primary CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.8 years ago

Interventions

Classification and segmentation deep learning modelsother

Models that will be trained on retrospectively acquired data and run on the prospectively acquired data to extract biometric parameters and amniotic volume estimation.