Shear wave elastography to distinguish obstructive from pregnancy-related hydronephrosis
Renal Cortical Stiffness Measured by Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy: A Prospective Study
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 |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Banī Suwayf, Beni Suef Governorate) |
| Trial ID | NCT07547891 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Banī Suwayf, Beni Suef Governorate
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.