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Urinary Tract Dilations in Prenatal and Postnatal Life

Urinary Tract Dilations in Prenatal and Postnatal Life

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06317623
Enrollment
200
Registered
2024-03-19
Start date
2023-01-01
Completion date
2026-06-30
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Dilatation

Keywords

prenatal diagnosis, prenatal ultrasound

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anomalies, as well as dilation diseases of the urinary tract, in different centers is different, often subjective and outdated.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

Interventions

DIAGNOSTIC_TESTPrenatal 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.

Sponsors

SonoClinic
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 lifeFirst 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).

Countries

Slovakia

Contacts

Primary ContactSvetlana Jánošová
svetlana.janosova@gmail.com+421908369470
Backup ContactRóbert Dankovčík
dankovcik@gmail.com+421905129129

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026