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

NCT ID: NCT00654771

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Preeclampsia Proteinuria Hypertension Pregnancy

Keywords

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protein/creatinine ratio clean catch urine catheterized urine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

women undergoing evaluation for pre-eclampsia

urine collection

Intervention Type OTHER

clean catch urine collection and catheterized urine collection

Interventions

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urine collection

clean catch urine collection and catheterized urine collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Irene McLenahan Young Investigators Research Fund of the Magee-Womens Foundation

UNKNOWN

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Principal Investigators

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Beatrice A Chen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

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Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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0502110

Identifier Type: -

Identifier Source: org_study_id