Urinary Protein to Creatinine Ratio in Term Pregnant Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Urinary Protein to Creatinine Ratio in Term Pregnant Women: What is the Effect of a Clean Catch Urine

Conditions
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Pregnancy Complications

Intervention / Treatment
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* Other: clean catch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women of 37 weeks gestation or greater Exclusion Criteria: Urinary tract infections Hypertension Pre-eclampsia Renal dysfunction

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: PR/CR urine collected by clean catch or non -clean catch technique will be compared in term pregnancy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clean catch<br>women in this group will collect urine for PR/CR using a clean catch technique | Other: clean catch<br>* clean catch technique applied to collect urine for PR/CR ratio<br>|
| Placebo Comparator: Non-clean catch<br>women in this group will not employ clean catch technique | Other: clean catch<br>* clean catch technique applied to collect urine for PR/CR ratio<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |