Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition

NCT03812471 | Completed

• 1 other identifier: ICBE-2-24301
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (4)

• Bi-parietal diameter in mm.

  The bi-parietal diameter in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.

  Day 1

• Head circumference in mm

  The Head circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.

  Day 1

• Abdominal circumference in mm

  The Abdominal circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.

  Day 1

• Femur length in mm

  The Femur length in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported

  Day 1

Secondary Outcomes (24)

• Failure rate of the automated measurements

  Day 1

• Exam and post-processing duration

  Day 1

• Difference of scores of the 2D standard cephalic plane and cephalic plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

  Day 1

• Difference of scores of the 2D standard abdominal plane and abdominal plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

  Day 1

• Difference of scores of the 2D standard femoral plane and femoral plane extracted from the 3D volume, based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

  Day 1

Study Arms (2)

Main study: 3D volumes acquisitions

EXPERIMENTAL

3D volume acquisitions

Device: 3D volume acquisitions

Ancillary study: 2D and 3D acquisitions

EXPERIMENTAL

2D standard measurements and 3D volumes acquisitions

Device: 2D standard measurements and 3D volumes acquisitions

Interventions

3D volume acquisitions DEVICE

2 abdominal volumes 2 thigh volumes 2 head volumes

Main study: 3D volumes acquisitions

2D standard measurements and 3D volumes acquisitions DEVICE

* 1 abdomen circumference measurement * 1 femur length measurement * 1 head circumference measurement * 1 bi-parietal diameter measurement * 1 abdominal volume * 1 thigh volume * 1 head volume

Ancillary study: 2D and 3D acquisitions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization: lead

Study Sites (1)

CHRU de Nancy Brabois

Nancy, 54511, France

Location

Related Publications (1)

• Ambroise Grandjean G, Hossu G, Banasiak C, Ciofolo-Veit C, Raynaud C, Rouet L, Morel O, Beaumont M. Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study. BMJ Open. 2019 Dec 15;9(12):e031777. doi: 10.1136/bmjopen-2019-031777.

  PMID: 31843832 DERIVED

Study Officials

• Gaëlle Gaëlle AMBROISE-GRANDJEAN

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: January 23, 2019
• Study Start: October 23, 2018
• Primary Completion: March 11, 2021
• Study Completion: March 17, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)