Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 265
- 试验地点
- 2
- 主要终点
- Bi-parietal diameter in mm.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Bi-parietal diameter in mm.
时间窗: 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.
Head circumference in mm
时间窗: 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.
Femur length in mm
时间窗: 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
Abdominal circumference in mm
时间窗: 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.
次要结局
- 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)
- Intraclass correlation coefficient of the head circumference in mm (different operators)(Day 1)
- Bland-Altman representation of the head circumference in mm (different operators)(Day 1)
- 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 (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)(Day 1)
- 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)(Day 1)
- Intraclass correlation coefficient of the bi-parietal diameter in mm (different operators)(Day 1)
- Bland-Altman representation of the head circumference in mm (same operator)(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)
- 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)(Day 1)
- Title: Intraclass correlation coefficient of the bi-parietal diameter in mm (same operator)(Day 1)
- Bland-Altman representation of the bi-parietal diameter in mm (same operator)(Day 1)
- Bland-Altman representation of the bi-parietal diameter in mm (different operators)(Day 1)
- Intraclass correlation coefficient of the head circumference in mm (same operator)(Day 1)
- Intraclass correlation coefficient of the abdominal circumference in mm (same operator)(Day 1)
- Bland-Altman representation of the abdominal circumference in mm (same operator)(Day 1)
- Intraclass correlation coefficient of the femoral length in mm (same operator)(Day 1)
- Intraclass correlation coefficient of the abdominal circumference in mm (different operators)(Day 1)
- Bland-Altman representation of the abdominal circumference in mm (different operators)(Day 1)
- Bland-Altman representation of the femoral length in mm (same operator)(Day 1)
- Title: Intraclass correlation coefficient of the femoral length in mm (different operators)(Day 1)
- Bland-Altman representation of the femoral length in mm (different operators)(Day 1)