Comparison of Catheterized and Clean Catch Urine Specimens for Protein/Creatinine Ratio in Preeclampsia Evaluation

Completed

• Conditions: Preeclampsia; Proteinuria; Hypertension; Pregnancy

• Registration Number: NCT00654771
• Lead Sponsor: University of Pittsburgh

Brief Summary

The purpose of this prospective study was to examine whether protein/creatinine ratios in catheterized urine specimens correlate to clean catch specimens in pregnant patients being evaluated for preeclampsia.

Detailed Description

Preeclampsia is the new onset of hypertension and proteinuria after twenty weeks of gestation in pregnant women. The gold standard for evaluation of proteinuria in the diagnosis of preeclampsia is a twenty-four hour urine collection. However, single-specimen protein/creatinine ratios have been used to detect preeclampsia without the delay and inconvenience that a twenty-four hour urine collection would entail. At our institution, women are routinely catheterized for urine collection of protein/creatinine ratios because of concerns that vaginal contaminants would falsely elevate protein measurement in urine. However, no studies have specifically evaluated whether catheterized urine specimens correlate to clean catch urine specimens in protein estimation. Thus, the purpose of this prospective study was to examine whether protein/creatinine ratios in catheterized urine specimens correlate to clean catch specimens in pregnant patients being evaluated for preeclampsia.

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2006-05
• Study Completion: 2006-06
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-09
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-14
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• Pregnant hypertensive patients between the ages of 14 - 50 of any gestational age greater than 20 weeks undergoing evaluation for preeclampsia

Exclusion Criteria

• Ruptured membranes
• Any vaginal bleeding or spotting
• Pre-existing urinary tract infections or patients who are found to have a concurrent urinary tract infection upon culture of urine
• Patients who have previously been enrolled in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between protein/creatinine ratios for clean catch and catheterized urine specimens	time of enrollment

Trial Locations

Locations (1)

Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States