Echography in Pregnant Obese Women and Ultrasound Speed.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 596
- 试验地点
- 5
- 主要终点
- image quality of fetal ultrasound exam
研究概览
简要总结
Ultrasound (US) image construction uses equations that contain the value of the propagation velocity of sound waves; this velocity is assumed conventionally to be constant and equal to 1540 m/s in the human body. Since 1977, all manufacturers of US scanners have used this value, which was first established in 1950. In fatty tissue, however, the actual propagation velocity is only in the order of 1450 m/s. US velocity in fat tissue is slower than in other soft tissues (ie:1450 m/s vs 1540 m/s) therefore the intrinsic image quality in terms of sharpness and precision is improved when considering this parameter for image construction The main objective of this study is to evaluate the impact of ultrasound propagation velocity setting on completeness of ultrasound exams and images quality during the second and third trimester fetal ultrasound examination in obese patients.
详细描述
Obese pregnant women will be included before the second trimester fetal ultrasound examination.
Women will be allocated to one intervention group or to the control group. In the intervention group, the ultrasonographer will be able to use several ultrasound propagation velocities to perform the exam.
In the control group, exam will be performed using the conventional ultrasound velocity.
An exam will be considered to be complete if all the images recommended by national guideline are acquired. If ultrasound images are missing, other ultrasound exams may be performed until completeness is reached.
The protocol will be applied for the second and the third fetal ultrasound examination which are recommended by national guideline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Scans will be evaluated by independent experts who had not performed the exams. Scans will be anonymized and ultrasound propagation velocity will not be reported on the images.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index>30
- •Between 20 and 25 weeks of gestation
排除标准
- •Multiple pregnancy
- •Uterine scare
研究组 & 干预措施
free ultrasound propagation velocity
ultrasound exams will be performed using several ultrasound propagation velocities
干预措施: ultrasound propagation velocities, ultrasound fetal quality (Device)
conventional ultrasound propagation velocity
ultrasound exams will be performed using the 1540m/s conventional celerity
结局指标
主要结局
image quality of fetal ultrasound exam
时间窗: second trimester and third trimester ultrasound exam
Quality will be assessed by calculating Salomon's score for each image.
completeness of fetal ultrasound exam
时间窗: second trimester and third trimester ultrasound exam
completeness will be assessed by the number of the recommended images which could have been registered during the first ultrasound exam in each trimester.
次要结局
- use of supplementary ultrasound exams in order to assess completeness(through study completion, an average of 1 year)
- description of ultrasonographist method in order to improve ultrasound exam(through study completion, an average of 1 year)
- economic analysis of the intervention(through study completion, an average of 1 year)