Urinary Tract Dilations in Prenatal and Postnatal Life

Recruiting

• Conditions: Urinary Tract Dilatation
• Interventions: Diagnostic Test: Prenatal and postnatal ultrasound examination

• Registration Number: NCT06317623
• Lead Sponsor: SonoClinic

Brief Summary

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.

Detailed Description

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anomalies, as well as dilation diseases of the urinary tract, in different centers is different, often subjective and outdated.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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2024-02-26
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UTD A1, low risk group	Prenatal and postnatal ultrasound examination	A group of fetuses and children with less severe dilation of the urinary tract in second or third trimester of pregnancy
UTD A2-3, high risk group	Prenatal and postnatal ultrasound examination	A group of fetuses and children with severe dilation of the urinary tract in second or third trimester of pregnancy

Primary Outcome Measures

Name	Time	Method
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.	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).

Trial Locations

Locations (1)

Svetlana Jánošová; 🇸🇰 Záborské, Slovakia