Urinary Protein to Creatinine Ratio in Term Pregnant Women
- Conditions
- Pregnancy Complications
- Registration Number
- NCT03661749
- Lead Sponsor
- St. Luke's Hospital, Pennsylvania
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 240
- women of 37 weeks gestation or greater
- Urinary tract infections
- Hypertension
- Pre-eclampsia
- Renal dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method elevated PR/CR ratio using clean catch technique 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.
- Secondary Outcome Measures
Name Time Method Report the incident of PR/CR ratio greater than 0.3 through study completion, average of 1 year overall incident of elevated PR/CR ratio in healthy term pregnant women
Trial Locations
- Locations (1)
St Luke's University Hospital
🇺🇸Bethlehem, Pennsylvania, United States
St Luke's University Hospital🇺🇸Bethlehem, Pennsylvania, United States