Renal Cortical Stiffness Measured by Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of shear wave elastography (SWE) in differentiating obstructive from physiological hydronephrosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Pregnant women ≥12 weeks gestation with Loin Pain.
- •Sonographic evidence of hydronephrosis.
- •Age ≥18 years.
- •Provided informed consent
排除标准
- •Chronic kidney disease (CKD).
- •Congenital renal anomalies.
- •Pre-eclampsia
- •Poor acoustic window.
- •Contraindication to examination position.
研究组 & 干预措施
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.
干预措施: Shear Wave Elastography (SWE) (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of shear wave elastography (SWE) in differentiating obstructive from physiological hydronephrosis
时间窗: 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.
次要结局
- Optimal SWE cut-off value for detecting obstructive hydronephrosis(Baseline assessment at presentation)
研究者
Mahmoud Abdallah
lecturer of urology
Beni-Suef University