Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-01-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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SonoClinic
NETWORK
Responsible Party
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Principal Investigators
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Svetlana Jánošová
Role: STUDY_DIRECTOR
SonoClinic
Locations
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Svetlana Jánošová
Záborské, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Nguyen 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.
Nguyen 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.
Mileto 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.
Sugar E, Gall J. [Orbital phlebography (author's transl)]. Fortschr Geb Rontgenstr Nuklearmed. 1974 Jul;121(1):20-4. No abstract available. German.
Braga 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.
Nelson 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.
Gray 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.
Suson 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.
Maizels 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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0292/21/2023-00590
Identifier Type: -
Identifier Source: org_study_id
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