Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA)

Philips

Status: Completed

Conditions: Pregnancy Related

Treatments: Device: 3D volume acquisitions; Device: 2D standard measurements and 3D volumes acquisitions

Study type: Interventional

Funder types: Industry

Identifiers

NCT03812471

ICBE-2-24301

Details and patient eligibility

About

In the proposed clinical investigation, the investigational device (BabySize3D) will provide automated plane extraction and automated biometry measurements from 3D US volumes. The results obtained from the investigational software

Enrollment: 265 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• evolutive pregnancy with one fetus with a Gestational Age between 16 and 30 weeks
• aged between 18 and 65 years.
• social welfare benefit recipient
• willing and able to provide informed consent

Exclusion criteria

• under 18 years old
• multiple pregnancy
• over 18 years old and mentioned in French law articles L.1126-6 et L-1126-8,
• fetal malformation or suspected fetal malformation
• technical conditions that do not allow for standard fetal biometry (abdominal wall, fetal position, BMI > 25 kg/m2)
• fetal biometry non indicated in the standard pregnancy follow-up
• unwilling or unable to provide informed consent (e. g. physical, mental disability or linguistic factor that compromises patient information)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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265 participants in 2 patient groups

Main study: 3D volumes acquisitions

Experimental group

Description:

3D volume acquisitions

Treatment:

Device: 3D volume acquisitions

Ancillary study: 2D and 3D acquisitions

Experimental group

Description:

2D standard measurements and 3D volumes acquisitions

Treatment:

Device: 2D standard measurements and 3D volumes acquisitions