Intestinal Hyperechogenicity Confirmed by Evaluation of Gray Spectra
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Grey level comparison
研究概览
简要总结
Hyperechoic bowel is an ultrasound anomaly observed in screening and diagnostic ultrasound, and associated with various fetal pathologies including cystic fibrosis, chromosomal abnormalities, maternal-fetal infections (notably Cytomegalovirus CMV) and intrauterine growth retardation. Suspicion of hyperechogenic intestines in a fetus during a screening ultrasound leads to referral of the mother to a specialized antenatal diagnostic consultation. If the diagnosis is confirmed, this may lead to further investigations, including genetic analyses, which are costly for the healthcare system. However, many of the patients referred after a screening examination for this reason actually have their diagnosis invalidated during the specialized consultation. These "false alarms" lead to an overload of specialist consultations, and are a source of concern for couples.
. However, many of the patients referred after a screening examination for this reason actually have their diagnosis invalidated during the specialist consultation. These "false alarms" lead to an overload of specialist consultations, and are a source of concern for couples.
The diagnosis of intestinal hyperechogenicity is difficult because it is based on the sonographer's subjective impression, with a 3-grade gradation according to the echogenicity of the intestine in relation to the bone (Slotnick and Abuhamad. 1996). According to this method, the evaluation is carried out by progressively decreasing the gain applied to the image: if the hyperechoic bowel disappears before the iliac bone, it's a grade 1; if the bowel and iliac bone disappear at the same time, it's a grade 2; and finally if the bowel is still visible on the image while the iliac bone has disappeared, it's a grade 3.
In addition to gain, which, if too high, tends to overestimate the diagnosis of hyperechoic bowel, other ultrasound parameters can vary the subjective impression of bowel echogenicity, such as the use of high-frequency probes or the application of harmonics, which also lead to overdiagnosis (Lee and Cho. 2003).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women
- •in the second and third trimesters of pregnancy,
- •singletons or twins, diamniotics, adults,
- •undergoing screening or diagnostic ultrasound at obstetric and gynecology department,
- •on the Samsung Hera W10 ultrasound machine during the study
- •Patient able to understand the ins and outs of the study
- •Patient has been informed of the study and has expressed no objection to participating in it.
排除标准
- •Minor patients
- •Persons deprived of their liberty by judicial or administrative decision
- •Persons under psychiatric care
- •Persons admitted to a health or social institution for purposes other than research
- •Adults under legal protection
结局指标
主要结局
Grey level comparison
时间窗: At inclusion
The gray levels measured on the fetal intestines will be compared before and after the application of a pre-established "intestines" adjustment program to the same patient carrying a healthy fetus during an ultrasound scan performed in the second or third trimester of pregnancy, by producing two gray level histograms covering two groups of pixels contained in 10x10mm ellipses containing either the fetal intestines or part of the fetal bone. The histograms obtained are associated with a greyscale average, provided by the camera. We will calculate the ratio between the average grey levels of the intestines and the bone, before and after applying the settings. The aim is therefore to compare, quantitatively and accurately, the gray levels at intestinal and bone levels in second- and third-trimester fetuses, before and after the application of specific presettings.
次要结局
未报告次要终点