Urinary Protein to Creatinine Ratio in Term Pregnant Women: What is the Effect of a Clean Catch Urine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- elevated PR/CR ratio using clean catch technique
研究概览
简要总结
This study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.
详细描述
Clean catch urine should be used due to possible vaginal secretion contamination with falsely elevated U Pr/Cr ratio. However, no supporting reference was found in the article and no control group with random urine collection for comparison to clean catch specimen U Pr/Cr was included in their study. The original studies that validated spot Pr/Cr urine as a predictor of 24 -hour total urine protein used random non-clean catch random urines . They had an r value of .93-.99 in estimating total protein excreted in 24 hours. At our institution we use Siemens-base test to determine U Pr/Cr. In the product insert the company states that no special patient preparation is necessary.
Thus, this study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women of 37 weeks gestation or greater
排除标准
- •Urinary tract infections
- •Hypertension
- •Pre-eclampsia
- •Renal dysfunction
研究组 & 干预措施
Clean catch
women in this group will collect urine for PR/CR using a clean catch technique
干预措施: clean catch (Other)
Non-clean catch
women in this group will not employ clean catch technique
干预措施: clean catch (Other)
结局指标
主要结局
elevated PR/CR ratio using clean catch technique
时间窗: through study completion, an average of 1 year
this will be the proportion of patients with PR/CR ratio greater than or equal to 0.3 in urine using a clean catch method.
次要结局
- Report the incident of PR/CR ratio greater than 0.3(through study completion, average of 1 year)
研究者
James Anasti, MD
Clinical Professor of OB/GYN
St. Luke's Hospital, Pennsylvania