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临床试验/NCT06317623
NCT06317623招募中不适用

Urinary Tract Dilations in Prenatal and Postnatal Life

SonoClinic1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
SonoClinic
入组人数
200
试验地点
1
主要终点
The goal is the prediction of severe postnatal course and surgical intervention in fetuses with dilatation of the urinary tract according to the UTD classification created in 2014.

研究概览

简要总结

The goals of this study are to use a questionnaire survey to determine the state of awareness of the diagnosis and management of patients with urinary tract dilation across several medical professionals, to predict the severity of the postnatal course and surgical intervention in fetuses with urinary tract dilation detected during pregnancy, and to create a model of prenatal and postnatal care for patients with dilation of the urinary tract for multidisciplinary use.

详细描述

Currently, in Slovakia, a multidisciplinary standard of health care for patients with dilation of the urinary tract is not present. Prenatal diagnosis of anomalies of the urinary system includes the entire spectrum of anomalies, genetic diseases or anatomical deviations, which have a non-uniform classification and different terminology in a wide range of literature. Therefore, prenatal diagnosis of these anomalies, as well as dilation diseases of the urinary tract, in different centers is different, often subjective and outdated. However, some findings on the urinary tract, even with regard to the sex of the fetus, require great attention, defining the degree of severity and precisely targeted management, the task of which is to prevent serious complications in postnatal life. Dilative diseases of the urinary tract may not be clinically obvious after birth, but in the long term, if they are not detected, serious and irreversible kidney damage may occur. The goals of this study are therefore 1. to confuse the current situation in the multidisciplinary medical sector regarding the issue of dilations of the urinary tract; 2. in the conducted study to identify fetuses with such a degree of dilation of the urinary tract (according to the UTD classification from 2014) that requires stricter management in the prenatal and postnatal period and which are at high risk of surgical intervention postnatally and 3. subsequently create a model of health care for multidisciplinary cooperation for a patient with dilation of the urinary tract.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The goal is the prediction of severe postnatal course and surgical intervention in fetuses with dilatation of the urinary tract according to the UTD classification created in 2014.

时间窗: 20th week of pregnancy, 32th week of pregnancy, 2 days after birth, 6 months of child ´s life

First part - Ultrasound examination of the fetus in the second trimester of pregnancy between the 18th and 24th weeks of pregnancy, no later than the 28th week of pregnancy. Examiner will be measure by ultrasound anteroposterior diameter renal pelvis in milimeters (mm). The second part - Classification of dilation of the urinary tract. The laterality and the detected finding is assigned the corresponding risk - for UTD A1 low risk, for UTD A2-3 high risk. Third part - Ultrasound control in the third trimester after the 32nd week of pregnancy. Renal pelvis will be examine by ultrasound and anteroposterior diameter will by measure in milimeters (mm). The fourth part - management of a child with UTD by a pediatric nephrologist. The child is followed in the study until the age of 6 months. Nephrologist will be measure anteroposterior diameter renal pelvis in milimeters (mm).

次要结局

未报告次要终点

研究者

发起方
SonoClinic
申办方类型
Network
责任方
Sponsor

研究点 (1)

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