Urinary Tract Dilations in Prenatal and Postnatal Life

March 11, 2024 updated by: SonoClinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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anomalies, as well as dilation diseases of the urinary tract, in different centers is different, often subjective and outdated.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

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Singleton pregnant women whose fetuses were diagnosed with dilatation of the urinary tract as an isolated finding before the 28th week of pregnancy. Dilatation of the urinary tract was categorized according to the 2014 UTD classification system.

Newborns and children with prenatally diagnosed UTD, which, depending on the severity, required a postnatal check-up by a pediatric nephrologist within a month after birth and then in his follow-up up to 6 months after birth.

Description

Inclusion criteria:

  • Singleton pregnant women whose fetuses were diagnosed with dilation of the urinary tract as an isolated US finding before the 28th week of pregnancy. Fetal patients with subsequent US control in the third trimester after the 28th week of pregnancy.
  • Newborns and children with prenatally diagnosed UTD, which, depending on the severity, required a postnatal examination by a pediatric nephrologist within a month after birth and then in his follow-up up to 6 months after birth.

Exclusion criteria:

  • Multiple pregnancies
  • Urinary tract dilation in fetuses diagnosed in the third trimester
  • Associated anomalies in fetuses
  • Aneuploidy
  • Newborns and children monitored by someone other than a selected pediatric nephrologist Patients who were lost from follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
UTD A1, low risk group
A group of fetuses and children with less severe dilation of the urinary tract in second or third trimester of pregnancy
Diagnostic test: Prenatal and postnatal ultrasound examination
Prenatal ultrasound examination of fetus with urinary tract dilation in second trimester and next in third trimester and when the dilation is persist, the child is managed after birth by pediatric nephrologist.
UTD A2-3, high risk group
A group of fetuses and children with severe dilation of the urinary tract in second or third trimester of pregnancy
Diagnostic test: Prenatal and postnatal ultrasound examination
Prenatal ultrasound examination of fetus with urinary tract dilation in second trimester and next in third trimester and when the dilation is persist, the child is managed after birth by pediatric nephrologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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).
20th week of pregnancy, 32th week of pregnancy, 2 days after birth, 6 months of child ´s life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SonoClinic

Investigators

  • Study Director: Svetlana Jánošová, SonoClinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0292/21/2023-00590

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from ultrasound examination of fetusus will be share with other specialist from pediatric nephrology

IPD Sharing Time Frame

After examination of fetuses in second trimester of pregnancy and 6 months after birth of child

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Tract Dilatation

Clinical Trials on Prenatal and postnatal ultrasound examination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe