Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Hydronephrosis
• Intervention / Treatment: Diagnostic test: Shear Wave Elastography (SWE)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Mahmoud Abdallah Mahmoud, lecturer of urology; Phone Number: 01155361979; Email: mahmoud.abdalla@med.bsu.edu.eg

Study Locations

• Egypt
  • Beni Suef Governorate
    • Banī Suwayf, Beni Suef Governorate, Egypt, 62511
      • Recruiting
      • Beni suef University hospital
      • Contact: doaa mahmoud khalil, lecturer; Phone Number: 01152091011; Email: drm_abdaalah_88@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women aged 18 years or older presenting with loin pain and sonographic evidence of hydronephrosis at Beni-Suef University Hospital.

Description

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: Shear Wave Elastography (SWE); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Hydronephrosis
• Other Study ID Numbers: FMBSUREC/07042026/Ahmed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No