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Sponsors and Collaborators: |
University of Pittsburgh Irene McLenahan Young Investigators Research Fund of the Magee-Womens Foundation |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00654771 |
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 |
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Preeclampsia Proteinuria Hypertension Pregnancy Urinary Catheterization |
Other: urine collection |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Prospective Comparison of Catheterized and Clean Catch Urine Specimens for Determination of Protein/Creatinine Ratio in Evaluation of Preeclampsia |
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 |
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1
women undergoing evaluation for pre-eclampsia
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Other: urine collection
clean catch urine collection and catheterized urine collection
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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.
Ages Eligible for Study: | 14 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Any pregnant woman between the ages of 14 - 50 who is being evaluated for preeclampsia is eligible for this study.
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Magee-Womens Hospital of UPMC | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Beatrice A Chen, MD | University of Pittsburgh |
Responsible Party: | ( Beatrice Chen ) |
Study ID Numbers: | 0502110 |
Study First Received: | April 3, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00654771 History of Changes |
Health Authority: | United States: Institutional Review Board |
protein/creatinine ratio clean catch urine catheterized urine |
Signs and Symptoms Hypertension, Pregnancy-Induced Proteinuria Pregnancy Complications Urologic Diseases Eclampsia |
Urination Disorders Vascular Diseases Pre-Eclampsia Preeclampsia Hypertension |
Signs and Symptoms Urological Manifestations Hypertension, Pregnancy-Induced Proteinuria Pregnancy Complications Urologic Diseases |
Urination Disorders Vascular Diseases Pre-Eclampsia Cardiovascular Diseases Hypertension |