A Comparison of Spot Test (Urine Protein/Creatinine Ratio) With 24 - Hour Urine Protein Excretion in Woman With Hypertensive Disorders of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
The presence of proteinuria (>300 mg/d) represents an important factor in the diagnosis and evaluation of the pregnant patient with an hypertensive disorder. The 24 hour collection of urine for proteinuria is the gold standard for the diagnosis of the condition and allows the physician to determine if an hypertensive disorder is related directly or not to the gestation.
The problem is the time it takes and the technical difficulties related to the sample collection. An alternative is the quantification of protein and creatinine in a random sample of urine. We seek to evaluate if this method is as affective as the gold standard in the diagnosis of proteinuria (>300 mg/d).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with 28 weeks or more of gestation.
- •Complete collection of the 24 hour urine sample.
排除标准
- •Failure to recollect the 24 hour urine sample.
- •Pregestational Diabetes
- •Kidney disease
- •24 hour urine protein > 8.0 g/dL or seric creatinine > 2.0 mg/dL (it could indicate kidney disease).
研究组 & 干预措施
Hypertensive disorder of pregnancy
Patients with an hypertensive disorder of pregnancy (28 weeks or more of gestation)will collect a random sample of urine for a spot test (protein/creatinine ratio) and urine for 24 hours. The level of proteinuria will be determined in this sample.
干预措施: Hypertensive disorder of pregnancy (Other)
结局指标
主要结局
Sensitivity and Specificity
时间窗: Six months
The number of patients with a 24 hour urine collection with a proteinuria \> 300mg will be compared with the number of patients with a Spot Test (protein/creatinine ratio in a random urine sample) \> 0.2 (equivalent to the 24 hour test \> 300 mg). This value will be used to calculate the Sensitivity and Specificity of the spot test.
次要结局
- Positive and Negative Predictive Value(six months)
研究者
Osvaldo A. Reyes T.
Coordinator of Research & Development
Saint Thomas Hospital, Panama