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

Trial Information
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic Test
Study Type: Observational
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.

Am I eligible for this trial?
Participation Requirements
Sex:
Female
Minimum Age:
18
Healthy Volunteers:
Accepts Healthy Volunteers

• Single or multiple viable pregnancies with a gestational age of 14 weeks or more as dated on a first trimester US scan with the crown-rump length (CRL) measurement or grossly estimated from the last menstrual period (LMP).

• Routine programmed US scan.

• Patient's consent is obtained.

• Patient over 18 years old.

Where is this trial taking place?
Other Locations
Morocco
6 locations
Centre de Radiologie Abou Madi
Not yet recruiting
Casablanca
Centre Hospitalier Cheikh Khalifa
Recruiting
Casablanca
Centre Hospitalier Universitaire Ibn Rochd
Recruiting
Casablanca
Mohamed VI University International Hospital
Recruiting
Casablanca
Centre Hospitalier Universitaire Hassan II Fes
Not yet recruiting
Fes
Centre Hospitalier Universitaire Mohammed VI Oujda
Recruiting
Oujda
Who do I contact about this trial?
Primary
Saad Slimani, M.D.
saadslimani@outlook.com
+212661054053
Backup
Elhoussine Bouyakhf, PhD.
bouillac.lhou@gmail.com
00212661225628
When is this trial taking place?
Start Date: October 25, 2021
Estimated Completion Date: March 25, 2022
How many participants will be in this trial?
Target number of participants: 387
Who are the authors of this trial?
Dalal Loudiyi, Saad Slimani, Amal Bouzyiane, Mustapha Akiki, Hanane Saadi, Abdelaziz Banani, Amine Lamrissi
What other conditions are being studied in this trial?

This content was sourced from clinicaltrials.gov

Department of Obstetrics and Gynecology Modena Policlinico Hospital Vial Del Pozzo 71, 41125 Modena
Status:Not yet recruiting
Start Date:October 20, 2021
Study Type:Other
Phase: Not Applicable