Clinical trial NCT03812471: Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition
Official title: Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 265
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: 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)

Primary outcomes:
measure: Bi-parietal diameter in mm.
timeFrame: Day 1
measure: Head circumference in mm
timeFrame: Day 1
measure: Abdominal circumference in mm
timeFrame: Day 1
measure: Femur length in mm
timeFrame: Day 1
Secondary outcomes:
measure: Failure rate of the automated measurements
timeFrame: Day 1
measure: Exam and post-processing duration
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: Title: Intraclass correlation coefficient of the bi-parietal diameter in mm (same operator)
timeFrame: Day 1
measure: Bland-Altman representation of the bi-parietal diameter in mm (same operator)
timeFrame: Day 1
measure: Intraclass correlation coefficient of the bi-parietal diameter in mm (different operators)
timeFrame: Day 1
measure: Bland-Altman representation of the bi-parietal diameter in mm (different operators)
timeFrame: Day 1
measure: Intraclass correlation coefficient of the head circumference in mm (same operator)
timeFrame: Day 1
measure: Bland-Altman representation of the head circumference in mm (same operator)
timeFrame: Day 1
measure: Intraclass correlation coefficient of the head circumference in mm (different operators)
timeFrame: Day 1
measure: Bland-Altman representation of the head circumference in mm (different operators)
timeFrame: Day 1
measure: Intraclass correlation coefficient of the abdominal circumference in mm (same operator)
timeFrame: Day 1
measure: Bland-Altman representation of the abdominal circumference in mm (same operator)
timeFrame: Day 1
measure: Intraclass correlation coefficient of the abdominal circumference in mm (different operators)
timeFrame: Day 1
measure: Bland-Altman representation of the abdominal circumference in mm (different operators)
timeFrame: Day 1
measure: Intraclass correlation coefficient of the femoral length in mm (same operator)
timeFrame: Day 1
measure: Bland-Altman representation of the femoral length in mm (same operator)
timeFrame: Day 1
measure: Title: Intraclass correlation coefficient of the femoral length in mm (different operators)
timeFrame: Day 1
measure: Bland-Altman representation of the femoral length in mm (different operators)
timeFrame: Day 1
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy Brabois
Study officials:
affiliation: CHRU de Nancy
name: Gaëlle Gaëlle AMBROISE-GRANDJEAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.