Shear wave elastography to distinguish obstructive from pregnancy-related hydronephrosis
Official title: Renal Cortical Stiffness Measured by Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy: A Prospective Study
Run by Beni-Suef University · NCT07547891 · Data updated 2026-11-12
We will test whether a painless ultrasound method called shear wave elastography can tell if hydronephrosis in pregnant women with loin pain is due to obstruction or a normal pregnancy change.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Banī Suwayf, Beni Suef Governorate) |
| Status | Recruiting |
| Started | April 7, 2026 |
| Main results expected | March 2027 |
| Study ends | April 2027 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT07547891 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 18 years or older at ≥12 weeks gestation who present with loin pain and ultrasound-confirmed hydronephrosis and who can tolerate the exam position with an adequate acoustic window.
✕Probably not a fit
Patients with chronic kidney disease, congenital renal anomalies, preeclampsia, poor acoustic windows, or contraindications to the examination position are excluded and unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational diagnostic accuracy study enrolling pregnant women (≥12 weeks gestation) with sonographic hydronephrosis and loin pain at Beni-Suef University Hospital. Participants will have clinical and laboratory assessment plus conventional ultrasound and renal cortical stiffness measurements by shear wave elastography, with ten valid measurements per kidney and the median used for analysis. Measurements will be repeated at 2–4 weeks, after any intervention if performed, and at 6–8 weeks postpartum, and the reference diagnosis will be based on clinical course, need for intervention, and postpartum resolution. Diagnostic performance will be quantified using ROC analysis to determine the area under the curve and optimal SWE cut-off values.
Why it matters
Potential benefit: If successful, SWE could provide a safe, noninvasive, quantitative way to tell obstructive from physiological hydronephrosis and help avoid unnecessary interventions during pregnancy.
How similar studies have gone: Shear wave elastography has shown promise for detecting renal obstruction in nonpregnant populations, but its application specifically to differentiate hydronephrosis in pregnancy is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
* 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.
Where it's running
-
Beni Suef university hospital
Banī Suwayf, Beni Suef Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Mahmoud Abdallah Mahmoud, lecturer of urology
- Email: mahmoud.abdalla@med.bsu.edu.eg
- Phone: 01155361979
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.