Beni Suef university hospital
Banī Suwayf, Beni Suef Governorate, 62511, Egypt
Location status: Recruiting
NCT Number: NCT07547891
Hydronephrosis is common during pregnancy and is often physiological; however, it may also result from true obstruction requiring intervention. Differentiating between physiological and obstructive hydronephrosis remains a clinical challenge using conventional ultrasound.
This prospective observational study aims to evaluate the diagnostic accuracy of renal cortical stiffness measured by shear wave elastography (SWE) in differentiating obstructive from physiological hydronephrosis in pregnant women. Participants presenting with hydronephrosis will undergo clinical assessment, laboratory investigations, and ultrasound evaluation including SWE measurements.
The diagnostic performance of SWE will be assessed using receiver operating characteristic (ROC) analysis, and optimal cut-off values will be determined. The study aims to provide a safe, non-invasive, and quantitative tool to improve diagnosis and guide management in pregnant patients with hydronephrosis.
Interested in participating?
Request Info18 year and older
Female
Observational
Banī Suwayf, Beni Suef Governorate, 62511, Egypt
Location status: Recruiting
This is a prospective observational diagnostic accuracy study conducted at Beni-Suef University Hospital from April 2026 to April 2027.
Pregnant women aged 18 years or older, at ≥12 weeks of gestation, presenting with loin pain and sonographic evidence of hydronephrosis will be included. Patients with chronic kidney disease, congenital renal anomalies, preeclampsia, or poor acoustic window will be excluded.
All participants will undergo clinical evaluation, laboratory investigations, and conventional ultrasound assessment including hydronephrosis grading and cortical thickness measurement. Renal cortical stiffness will be assessed using shear wave elastography (SWE). Measurements will be obtained with the patient in a semi-left lateral position, with the region of interest placed within the renal cortex at a depth of 1.5-3.5 cm. Ten valid measurements will be recorded for each kidney, and the median value will be used for analysis.
Measurements will be performed at baseline, with follow-up at 2-4 weeks, after any intervention (if applicable), and 6-8 weeks postpartum.
The reference standard for diagnosing obstructive hydronephrosis will be based on clinical course, need for intervention (e.g., ureteral stenting or nephrostomy), and postpartum resolution of hydronephrosis.
The primary outcome is the diagnostic accuracy of SWE, assessed by the area under the receiver operating characteristic (ROC) curve. Secondary outcomes include determination of optimal SWE cut-off values and correlation with hydronephrosis grade and cortical thickness.
Statistical analysis will include ROC curve analysis, calculation of sensitivity and specificity, logistic regression analysis, and assessment of reproducibility using intraclass correlation coefficient (ICC). A p-value <0.05 will be considered statistically significant.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Shear wave elastography (SWE) is a non-invasive ultrasound-based imaging technique used to measure renal cortical stiffness. In this study, SWE is performed as a diagnostic assessment tool in pregnant women with hydronephrosis to evaluate its ability to differentiate between obstructive and physiological causes. No therapeutic intervention is applied.
Time frame: Baseline assessment at presentation
Diagnostic performance of renal cortical stiffness measured by SWE will be evaluated using receiver operating characteristic (ROC) analysis, including area under the curve (AUC), sensitivity, and specificity based on final diagnosis.
Time frame: Baseline assessment at presentation
Determination of the optimal renal cortical stiffness cut-off value using ROC analysis to differentiate obstructive from physiological hydronephrosis.
Contact information is provided by the study sponsor or research team.
Beni-Suef University
Other
Renal Cortical Stiffness Measured by Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy: A Prospective Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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