HydronephrosisNCT07547891
Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy
An observational study of Hydronephrosis and Pregnancy, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hydronephrosis, Pregnancy
- What is being tested?
- Shear Wave Elastography (SWE)
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Apr 2026to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women aged 18 years or older presenting with loin pain and sonographic evidence of hydronephrosis at Beni-Suef University Hospital.
Who may be able to join
- Pregnant women ≥12 weeks gestation with Loin Pain.
- Sonographic evidence of hydronephrosis.
- Age ≥18 years.
- Provided informed consent
Who cannot join
- Chronic kidney disease (CKD).
- Congenital renal anomalies.
- Pre-eclampsia
- Poor acoustic window.
- Contraindication to examination position.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Beni Suef university hospital
Banī Suwayf, Beni Suef Governorate, 62511
doaa mahmoud khalil, lecturer, 01152091011, drm_abdaalah_88@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hydronephrosis, Pregnancy
- Being tested
- Shear Wave Elastography (SWE)
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Shear Wave Elastography (SWE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment at presentation
Secondary 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.
Measured: Baseline assessment at presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start7 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydronephrosisStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdallah, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547891
- Sponsor's protocol ID
- FMBSUREC/07042026/Ahmed
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Cortical Stiffness Measured by Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy: A Prospective Study
- ClinicalTrials.gov ID
- NCT07547891
- Acronym / sponsor ID
- FMBSUREC/07042026/Ahmed
- Conditions
- Hydronephrosis, Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women with Hydronephrosis | – | Diagnostic Test: Shear Wave Elastography (SWE)Pregnant women with hydronephrosis undergoing clinical assessment and SWE. Participants will be classified post hoc into physiological or obstructive hydronephrosis based on final diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women aged 18 years or older presenting with loin pain and sonographic evidence of hydronephrosis at Beni-Suef University Hospital.
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Pregnant Women with Hydronephrosis |
Primary outcome
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.
1 secondary outcome
Optimal SWE cut-off value for detecting obstructive hydronephrosis
Time frame: Baseline assessment at presentation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydronephrosis and Pregnancy, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Abdallah Mahmoud, lecturer of urology (01155361979, mahmoud.abdalla@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of shear wave elastography (SWE) in differentiating obstructive from physiological hydronephrosis (time frame: Baseline assessment at presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.