Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy

NCT07547891 | Recruiting

• 1 other identifier: FMBSUREC/07042026/Ahmed
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hydronephrosis; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Optimal SWE cut-off value for detecting obstructive hydronephrosis

  Baseline assessment at presentation

Study Arms (1)

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)

Interventions

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.

Pregnant Women with Hydronephrosis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pregnant women ≥12 weeks gestation with Loin Pain.
• Sonographic evidence of hydronephrosis.
• Age ≥18 years.
• Provided informed consent

You may not qualify if:

• Chronic kidney disease (CKD).
• Congenital renal anomalies.
• Pre-eclampsia
• Poor acoustic window.
• Contraindication to examination position.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni Suef university hospital

Banī Suwayf, Beni Suef Governorate, 62511, Egypt

RECRUITING

MeSH Terms

Conditions

Hydronephrosis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Mahmoud Abdallah Mahmoud, lecturer of urology

CONTACT

01155361979; mahmoud.abdalla@med.bsu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

EG (1)