Comparison of Catheterized and Clean Catch Urine Specimens for Protein/Creatinine Ratio in Preeclampsia Evaluation (UPREE)
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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 |
- 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 |
Any pregnant woman between the ages of 14 - 50 who is being evaluated for preeclampsia is eligible for this study.
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| United States, Pennsylvania | |
| Magee-Womens Hospital of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| 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 May 22, 2013