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NCT Number: NCT07547891

Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Beni Suef university hospital

Banī Suwayf, Beni Suef Governorate, 62511, Egypt

Location status: Recruiting

Location contact

doaa mahmoud khalil, lecturer

CONTACT

[email protected]

01152091011

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Pregnant women ≥12 weeks gestation with Loin Pain.
  • Sonographic evidence of hydronephrosis.
  • Age ≥18 years.
  • Provided informed consent
  • Exclusion Criteria:
  • Chronic kidney disease (CKD).
  • Congenital renal anomalies.
  • Pre-eclampsia
  • Poor acoustic window.
  • Contraindication to examination position.

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic accuracy of shear wave elastography (SWE) in differentiating obstructive from physiological hydronephrosis

    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.

Secondary outcomes

  1. Optimal SWE cut-off value for detecting obstructive hydronephrosis

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Abdallah Mahmoud, lecturer of urology

CONTACT

[email protected]

01155361979

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Renal Cortical Stiffness Measured by Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy: A Prospective Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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