Urinary Tract DilatationNCT06317623
Urinary Tract Dilations in Prenatal and Postnatal Life
An observational study of Urinary Tract Dilatation, run by SonoClinic at 1 site in Slovakia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Dilatation
- What is being tested?
- Prenatal and postnatal ultrasound examination
- How many people
- 200 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Jan 2023to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
Svetlana Jánošová
Záborské, 08253
Svetlana Jánošová, +421908369470, svetlana.janosova@gmail.com
Róbert Dankovčík, +4219051291297, dankovcik@gmail.com
About this study
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.
Read the 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.
- Conditions
- Urinary Tract Dilatation
- Being tested
- Prenatal and postnatal ultrasound examination
- Keywords
- prenatal diagnosis, prenatal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal and postnatal ultrasound examinationDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Prenatal and postnatal ultrasound examination | |
| 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 Receives: Diagnostic Test: Prenatal and postnatal ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: 20th week of pregnancy, 32th week of pregnancy, 2 days after birth, 6 months of child ´s life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jan 2023
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract DilatationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SonoClinic
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Svetlana Jánošová, Study director, SonoClinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317623
- Sponsor's protocol ID
- 0292/21/2023-00590
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from ultrasound examination of fetusus will be share with other specialist from pediatric nephrology
Publications
Nguyen HT, Herndon CD, Cooper C, Gatti J, Kirsch A, Kokorowski P, Lee R, Perez-Brayfield M, Metcalfe P, Yerkes E, Cendron M, Campbell JB. The Society for Fetal Urology consensus statement on the evaluation and management of antenatal hydronephrosis. J Pediatr Urol. 2010 Jun;6(3):212-31. doi: 10.1016/j.jpurol.2010.02.205. Epub 2010 Apr 15.
PubMed 20399145Nguyen HT, Benson CB, Bromley B, Campbell JB, Chow J, Coleman B, Cooper C, Crino J, Darge K, Herndon CD, Odibo AO, Somers MJ, Stein DR. Multidisciplinary consensus on the classification of prenatal and postnatal urinary tract dilation (UTD classification system). J Pediatr Urol. 2014 Dec;10(6):982-98. doi: 10.1016/j.jpurol.2014.10.002. Epub 2014 Nov 15.
PubMed 25435247Nguyen HT, Phelps A, Coley B, Darge K, Rhee A, Chow JS. 2021 update on the urinary tract dilation (UTD) classification system: clarifications, review of the literature, and practical suggestions. Pediatr Radiol. 2022 Apr;52(4):740-751. doi: 10.1007/s00247-021-05263-w. Epub 2022 Jan 4.
PubMed 34981177Mileto A, Itani M, Katz DS, Siebert JR, Dighe MK, Dubinsky TJ, Moshiri M. Fetal Urinary Tract Anomalies: Review of Pathophysiology, Imaging, and Management. AJR Am J Roentgenol. 2018 May;210(5):1010-1021. doi: 10.2214/AJR.17.18371. Epub 2018 Feb 15.
PubMed 29446682Sugar E, Gall J. [Orbital phlebography (author's transl)]. Fortschr Geb Rontgenstr Nuklearmed. 1974 Jul;121(1):20-4. No abstract available. German.
PubMed 4369632Braga LH, McGrath M, Farrokhyar F, Jegatheeswaran K, Lorenzo AJ. Society for Fetal Urology Classification vs Urinary Tract Dilation Grading System for Prognostication in Prenatal Hydronephrosis: A Time to Resolution Analysis. J Urol. 2018 Jun;199(6):1615-1621. doi: 10.1016/j.juro.2017.11.077. Epub 2017 Dec 2.
PubMed 29198999Nelson CP, Lee RS, Trout AT, Servaes S, Kraft KH, Barnewolt CE, Logvinenko T, Chow JS. Interobserver and Intra-Observer Reliability of the Urinary Tract Dilation Classification System in Neonates: A Multicenter Study. J Urol. 2019 Jun;201(6):1186-1192. doi: 10.1097/JU.0000000000000026.
PubMed 30676479Gray MC, Zillioux JM, Varda B, Herndon CDA, Kurtz MP, Chow JS, Kern NG. Assessment of urinary tract dilation grading amongst pediatric urologists. J Pediatr Urol. 2020 Aug;16(4):457.e1-457.e6. doi: 10.1016/j.jpurol.2020.04.025. Epub 2020 Apr 30.
PubMed 32430210Suson KD, Preece J. Do current scientific reports of hydronephrosis make the grade? J Pediatr Urol. 2020 Oct;16(5):597.e1-597.e6. doi: 10.1016/j.jpurol.2020.04.003. Epub 2020 Apr 10.
PubMed 32345558Maizels M, Braga L, Gong EM, Liu D, Meade P, Nelson LD, Dungan JS. "1 Voice": Learn urinary tract dilation (UTD) classification to assess fetal & newborn urological ultrasound findings. J Pediatr Urol. 2017 Dec;13(6):559-562. doi: 10.1016/j.jpurol.2017.11.002. No abstract available.
PubMed 29248273
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Tract Dilations in Prenatal and Postnatal Life
- ClinicalTrials.gov ID
- NCT06317623
- Acronym / sponsor ID
- 0292/21/2023-00590
- Conditions
- Urinary Tract Dilatation
- Keywords
- prenatal diagnosis, prenatal ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- SonoClinicResearch network
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UTD A1, low risk group | – | Diagnostic Test: Prenatal and postnatal ultrasound examinationA 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 | – | Diagnostic Test: Prenatal and postnatal ultrasound examinationA group of fetuses and children with severe dilation of the urinary tract in second or third trimester of pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal and postnatal ultrasound examinationPrenatal 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. | Diagnostic test | UTD A1, low risk group, UTD A2-3, high risk group |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 20399145Nguyen HT, Herndon CD, Cooper C, Gatti J, Kirsch A, Kokorowski P, Lee R, Perez-Brayfield M, Metcalfe P, Yerkes E, Cendron M, Campbell JB. The Society for Fetal Urology consensus statement on the evaluation and management of antenatal hydronephrosis. J Pediatr Urol. 2010 Jun;6(3):212-31. doi: 10.1016/j.jpurol.2010.02.205. Epub 2010 Apr 15.
- Background: PubMed 25435247Nguyen HT, Benson CB, Bromley B, Campbell JB, Chow J, Coleman B, Cooper C, Crino J, Darge K, Herndon CD, Odibo AO, Somers MJ, Stein DR. Multidisciplinary consensus on the classification of prenatal and postnatal urinary tract dilation (UTD classification system). J Pediatr Urol. 2014 Dec;10(6):982-98. doi: 10.1016/j.jpurol.2014.10.002. Epub 2014 Nov 15.
- Background: PubMed 34981177Nguyen HT, Phelps A, Coley B, Darge K, Rhee A, Chow JS. 2021 update on the urinary tract dilation (UTD) classification system: clarifications, review of the literature, and practical suggestions. Pediatr Radiol. 2022 Apr;52(4):740-751. doi: 10.1007/s00247-021-05263-w. Epub 2022 Jan 4.
- Background: PubMed 29446682Mileto A, Itani M, Katz DS, Siebert JR, Dighe MK, Dubinsky TJ, Moshiri M. Fetal Urinary Tract Anomalies: Review of Pathophysiology, Imaging, and Management. AJR Am J Roentgenol. 2018 May;210(5):1010-1021. doi: 10.2214/AJR.17.18371. Epub 2018 Feb 15.
- Background: PubMed 4369632Sugar E, Gall J. [Orbital phlebography (author's transl)]. Fortschr Geb Rontgenstr Nuklearmed. 1974 Jul;121(1):20-4. No abstract available. German.
- Background: PubMed 29198999Braga LH, McGrath M, Farrokhyar F, Jegatheeswaran K, Lorenzo AJ. Society for Fetal Urology Classification vs Urinary Tract Dilation Grading System for Prognostication in Prenatal Hydronephrosis: A Time to Resolution Analysis. J Urol. 2018 Jun;199(6):1615-1621. doi: 10.1016/j.juro.2017.11.077. Epub 2017 Dec 2.
- Background: PubMed 30676479Nelson CP, Lee RS, Trout AT, Servaes S, Kraft KH, Barnewolt CE, Logvinenko T, Chow JS. Interobserver and Intra-Observer Reliability of the Urinary Tract Dilation Classification System in Neonates: A Multicenter Study. J Urol. 2019 Jun;201(6):1186-1192. doi: 10.1097/JU.0000000000000026.
- Background: PubMed 32430210Gray MC, Zillioux JM, Varda B, Herndon CDA, Kurtz MP, Chow JS, Kern NG. Assessment of urinary tract dilation grading amongst pediatric urologists. J Pediatr Urol. 2020 Aug;16(4):457.e1-457.e6. doi: 10.1016/j.jpurol.2020.04.025. Epub 2020 Apr 30.
- Background: PubMed 32345558Suson KD, Preece J. Do current scientific reports of hydronephrosis make the grade? J Pediatr Urol. 2020 Oct;16(5):597.e1-597.e6. doi: 10.1016/j.jpurol.2020.04.003. Epub 2020 Apr 10.
- Background: PubMed 29248273Maizels M, Braga L, Gong EM, Liu D, Meade P, Nelson LD, Dungan JS. "1 Voice": Learn urinary tract dilation (UTD) classification to assess fetal & newborn urological ultrasound findings. J Pediatr Urol. 2017 Dec;13(6):559-562. doi: 10.1016/j.jpurol.2017.11.002. No abstract available.
- Individual participant dataSharing planned: Yes. Data from ultrasound examination of fetusus will be share with other specialist from pediatric nephrology
Related trials for Urinary Tract Dilatation
RecruitingObservational study
Retrospective Evaluation of a Cohort of Patients Diagnosed With Pre- and Postnatal Urinary Dilatation: Outcome and Long-term Follow-up
Urinary Tract Dilatation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svetlana Jánošová study director
SonoClinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Dilatation, run by SonoClinic at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Svetlana Jánošová (+421908369470, svetlana.janosova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06317623, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.