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SWE Measures Renal Stiffness for Hydronephrosis in Pregnancy

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Summary

This prospective observational clinical trial (NCT07547891) will evaluate shear wave elastography (SWE) as a diagnostic tool to differentiate obstructive from physiological hydronephrosis in pregnant women, addressing a clinical challenge where conventional ultrasound cannot reliably distinguish between the two conditions. The study aims to establish optimal SWE cut-off values using receiver operating characteristic (ROC) analysis to guide clinical management of hydronephrosis in pregnancy. Participants will undergo clinical assessment, laboratory investigations, and ultrasound evaluation including SWE measurements to assess renal cortical stiffness as a non-invasive quantitative marker.

“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.”

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ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

This clinical trial registration documents a prospective observational study evaluating shear wave elastography (SWE) as a diagnostic modality for assessing hydronephrosis in pregnant women. The study will recruit pregnant participants presenting with hydronephrosis and measure renal cortical stiffness using SWE, comparing results against clinical assessment and laboratory investigations to determine whether SWE can reliably distinguish physiological hydronephrosis (common and benign during pregnancy) from obstructive hydronephrosis requiring intervention.

For healthcare providers and diagnostic imaging specialists, this study represents a potential advance in non-invasive prenatal diagnosis. If SWE demonstrates adequate diagnostic performance with determined cut-off values, it could become a standard tool for evaluating hydronephrosis in pregnant patients, reducing reliance on more invasive or ionizing-radiation-based procedures. Clinical investigators in maternal-fetal medicine and radiology departments may wish to monitor trial outcomes for incorporation into future diagnostic protocols.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Renal Cortical Stiffness Measured by Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy

Observational NCT07547891 Kind: OBSERVATIONAL Apr 23, 2026

Abstract

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 in Pregnancy

Interventions: Shear Wave Elastography (SWE)

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Last updated

Classification

Agency
NIH
Published
April 23rd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Docket
NCT07547891

Who this affects

Applies to
Clinical investigators Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial research Diagnostic imaging Prenatal diagnosis
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Topics
Healthcare Public Health

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