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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women with Hydronephrosis | Pregnant women with hydronephrosis undergoing clinical assessment and SWE. Participants will be classified post hoc into physiological or obstructive hydronephrosis based on final diagnosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shear Wave Elastography (SWE) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of shear wave elastography (SWE) in differentiating obstructive from physiological hydronephrosis | 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. | Baseline assessment at presentation |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal SWE cut-off value for detecting obstructive hydronephrosis | Determination of the optimal renal cortical stiffness cut-off value using ROC analysis to differentiate obstructive from physiological hydronephrosis. | Baseline assessment at presentation |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women
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Pregnant women aged 18 years or older presenting with loin pain and sonographic evidence of hydronephrosis at Beni-Suef University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud Abdallah Mahmoud, lecturer of urology | Contact | 01155361979 | mahmoud.abdalla@med.bsu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni Suef university hospital | Recruiting | Banī Suwayf | Beni Suef Governorate | 62511 | Egypt |
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| ID | Term |
|---|---|
| D006869 | Hydronephrosis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |