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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clean catch | Experimental | women in this group will collect urine for PR/CR using a clean catch technique |
|
| Non-clean catch | Placebo Comparator | women in this group will not employ clean catch technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clean catch | Other | clean catch technique applied to collect urine for PR/CR ratio |
|
| Measure | Description | Time Frame |
|---|---|---|
| elevated PR/CR ratio using clean catch technique | 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Report the incident of PR/CR ratio greater than 0.3 | overall incident of elevated PR/CR ratio in healthy term pregnant women | through study completion, average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
pregnant females 37 weeks gestation or greater
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James N Anasti, MD | Contact | 484-526-8878 | anastij@slhn.org |
| Name | Affiliation | Role |
|---|---|---|
| James N Anasti, MD | St Luke's University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Luke's University Hospital | Bethlehem | Pennsylvania | 18015 | United States |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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PR/CR urine collected by clean catch or non -clean catch technique will be compared in term pregnancy
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