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

This study has been completed.
Sponsor:
Collaborator:
Irene McLenahan Young Investigators Research Fund of the Magee-Womens Foundation
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00654771
First received: April 3, 2008
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Preeclampsia
Proteinuria
Hypertension
Pregnancy
Other: urine collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Comparison of Catheterized and Clean Catch Urine Specimens for Determination of Protein/Creatinine Ratio in Evaluation of Preeclampsia

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Correlation between protein/creatinine ratios for clean catch and catheterized urine specimens [ Time Frame: time of enrollment ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: July 2005
Study Completion Date: June 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
women undergoing evaluation for pre-eclampsia
Other: urine collection
clean catch urine collection and catheterized urine collection

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.

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any pregnant woman between the ages of 14 - 50 who is being evaluated for preeclampsia is eligible for this study.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654771

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Irene McLenahan Young Investigators Research Fund of the Magee-Womens Foundation
Investigators
Principal Investigator: Beatrice A Chen, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Beatrice Chen
ClinicalTrials.gov Identifier: NCT00654771     History of Changes
Other Study ID Numbers: 0502110
Study First Received: April 3, 2008
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
protein/creatinine ratio
clean catch urine
catheterized urine

Additional relevant MeSH terms:
Hypertension
Pre-Eclampsia
Proteinuria
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014