Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorBeni-Suef University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women ≥12 weeks gestation with Loin Pain.
Sonographic evidence of hydronephrosis.
Age ≥18 years.
Provided informed consent
Disqualifiers
Chronic kidney disease (CKD).
Congenital renal anomalies.
Pre-eclampsia
Poor acoustic window.
Trial population
Pregnant women aged 18 years or older presenting with loin pain and sonographic evidence of hydronephrosis at Beni-Suef University Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Shear Wave Elastography (SWE)
Diagnostic testShear 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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Pregnant Women with Hydronephrosis1 intervention
Trial outcomes
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.
Time frame
Baseline assessment at presentationSecondary outcomes
1
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.
Time frame
Baseline assessment at presentationSponsors and contacts
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Source ClinicalTrials.gov