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

Hypertension Clinical Trial

— UPREE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654771
• Other study ID #: 0502110
• Status: Completed
• Phase: N/A
• First received: April 3, 2008
• Last updated: August 14, 2012
• Start date: July 2005
• Est. completion date: June 2006

Study information

• Verified date: August 2012
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Pre-Eclampsia
• Preeclampsia
• Pregnancy
• Proteinuria

Intervention

Other:
• urine collection
clean catch urine collection and catheterized urine collection

Locations

Country	Name	City	State
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Irene McLenahan Young Investigators Research Fund of the Magee-Womens Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between protein/creatinine ratios for clean catch and catheterized urine specimens		time of enrollment	No