Developing and Testing Deep Learning Models for Fetal Biometry and Amniotic Volume Assessment in Routine Fetal Ultrasound Scans
Trial ID: NCT05059093
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2021-10-25
Completion date: 2022-04-01
Sponsor: Deepecho
Collaborators: Centre Hospitalier Universitaire Ibn Rochd; Hassan II University; Mohammed VI University Hospital; Mohammed V Souissi University
Conditions: Small for Gestational Age Infant; Fetal Growth Restriction; Oligohydramnios; Polyhydramnios
Interventions: Classification and segmentation deep learning models
Locations: Centre de Radiologie Abou Madi; Centre Hospitalier Cheikh Khalifa; Centre Hospitalier Universitaire Ibn Rochd; Mohamed VI University International Hospital; Centre Hospitalier Universitaire Hassan II Fes; Centre Hospitalier Universitaire Mohammed VI Oujda
Countries: Morocco; Morocco; Morocco; Morocco; Morocco; Morocco
Enrollment: 122
Age range: 18 Years - None
Sex: FEMALE

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.

Eligibility criteria:
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Emergency indication for the fetal ultrasound
* Major morphological malformations that do not allow proper measurement of the cranium, abdominal or lower limb, for example, anencephaly, omphalocele, lower limb phocomelia.
* Fetal death.

Outcomes:
Overall accuracy for the biometric parameters measurement and amniotic fluid volume assessment