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OpenTrials
Completed

NCT Number: NCT03812471

Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition

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

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Key information

Conditions

Pregnancy Related

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nancy Brabois

Nancy, 54511, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

3D volume acquisitions

Device

2 abdominal volumes 2 thigh volumes 2 head volumes

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

Primary outcomes

  1. Bi-parietal diameter in mm.

    Time frame: Day 1

    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.

  2. Head circumference in mm

    Time frame: Day 1

    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.

  3. Abdominal circumference in mm

    Time frame: Day 1

    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.

  4. Femur length in mm

    Time frame: Day 1

    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

Secondary outcomes

  1. Failure rate of the automated measurements

    Time frame: Day 1

    Failure rate of the automated measurements

  2. Exam and post-processing duration

    Time frame: Day 1

    Exam and post-processing duration

  3. 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)

    Time frame: Day 1

    The cephalic plane extracted from the 3D volume and the 2D standard cephalic plane will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.

  4. 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)

    Time frame: Day 1

    The abdominal plane extracted from the 3D volume and the 2D standard abdominal plane will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.

  5. 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)

    Time frame: Day 1

    The femoral plane extracted from the 3D volume and the 2D standard femoral plane will be scored according to the four criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.

  6. Difference of scores of (i) the 2D standard cephalic plane and of (ii) the frames of a sequence of 2D images including the fetus head (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

    Time frame: Day 1

    The 2D standard cephalic plane and the frames of a sequence of 2D images including the fetus head will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.

  7. Difference of scores of (i) the 2D standard abdominal plane and of (ii) the frames of a sequence of 2D images including the fetus abdomen (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

    Time frame: Day 1

    The 2D standard abdominal plane and the frames of a sequence of 2D images including the fetus abdomen will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.

  8. Difference of scores of (i) the 2D standard femoral plane and of (ii) the frames of a sequence of 2D images including the fetus femur (cine-loop), based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

    Time frame: Day 1

    The 2D standard femoral plane and the frames of a sequence of 2D images including the fetus femur will be scored according to the four criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.

  9. Title: Intraclass correlation coefficient of the bi-parietal diameter in mm (same operator)

    Time frame: Day 1

    The intraclass correlation coefficient of the bi-parietal diameter in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.

  10. Bland-Altman representation of the bi-parietal diameter in mm (same operator)

    Time frame: Day 1

    A Bland-Altman representation of the the bi-parietal diameter in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.

  11. Intraclass correlation coefficient of the bi-parietal diameter in mm (different operators)

    Time frame: Day 1

    The intraclass correlation coefficient of the bi-parietal diameter in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.

  12. Bland-Altman representation of the bi-parietal diameter in mm (different operators)

    Time frame: Day 1

    A Bland-Altman representation of the bi-parietal diameter in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.

  13. Intraclass correlation coefficient of the head circumference in mm (same operator)

    Time frame: Day 1

    the intraclass correlation coefficient of the head circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.

  14. Bland-Altman representation of the head circumference in mm (same operator)

    Time frame: Day 1

    A Bland-Altman representation of the head circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.

  15. Intraclass correlation coefficient of the head circumference in mm (different operators)

    Time frame: Day 1

    The intraclass correlation coefficient of the head circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.

  16. Bland-Altman representation of the head circumference in mm (different operators)

    Time frame: Day 1

    A Bland-Altman representation of the head circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.

  17. Intraclass correlation coefficient of the abdominal circumference in mm (same operator)

    Time frame: Day 1

    The intraclass correlation coefficient of the abdominal circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.

  18. Bland-Altman representation of the abdominal circumference in mm (same operator)

    Time frame: Day 1

    A Bland-Altman representation of the abdominal circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.

  19. Intraclass correlation coefficient of the abdominal circumference in mm (different operators)

    Time frame: Day 1

    The intraclass correlation coefficient of the abdominal circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.

  20. Bland-Altman representation of the abdominal circumference in mm (different operators)

    Time frame: Day 1

    A Bland-Altman representation of the abdominal circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators built.

  21. Intraclass correlation coefficient of the femoral length in mm (same operator)

    Time frame: Day 1

    The intraclass correlation coefficient of the femoral length in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.

  22. Bland-Altman representation of the femoral length in mm (same operator)

    Time frame: Day 1

    A Bland-Altman representation of the femoral length in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.

  23. Title: Intraclass correlation coefficient of the femoral length in mm (different operators)

    Time frame: Day 1

    The intraclass correlation coefficient of the femoral length in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.

  24. Bland-Altman representation of the femoral length in mm (different operators)

    Time frame: Day 1

    A Bland-Altman representation of the femoral length in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.

Sponsors and collaborators

Lead sponsor

Philips Electronics Nederland B.V. acting through Philips CTO organization

Industry

Registry information

Acronym: EPICEA

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Jan 23, 2019
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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