- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03661749
Urinary Protein to Creatinine Ratio in Term Pregnant Women
Urinary Protein to Creatinine Ratio in Term Pregnant Women: What is the Effect of a Clean Catch Urine
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: James N Anasti, MD
- Phone Number: 484-526-8878
- Email: anastij@slhn.org
Study Locations
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, United States, 18015
- St Luke's University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- women of 37 weeks gestation or greater
Exclusion Criteria:
- Urinary tract infections
- Hypertension
- Pre-eclampsia
- Renal dysfunction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clean catch
women in this group will collect urine for PR/CR using a clean catch technique
|
clean catch technique applied to collect urine for PR/CR ratio
|
Placebo Comparator: Non-clean catch
women in this group will not employ clean catch technique
|
clean catch technique applied to collect urine for PR/CR ratio
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
elevated PR/CR ratio using clean catch technique
Time Frame: 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.
|
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
Time Frame: through study completion, average of 1 year
|
overall incident of elevated PR/CR ratio in healthy term pregnant women
|
through study completion, average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: James N Anasti, MD, St Luke's University Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLIR 2018-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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