View Clinical Trial (Medical Research Study)
The Predictive Use of Spot Urine Protein/Creatinine Ratios and Decreased Sample Collection Time in the Diagnosis of Preeclampsia
| City: |
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Long Beach |
| State: |
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California |
| Zip Code: |
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90806 |
| Conditions: |
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Preeclampsia |
| Purpose: |
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The investigators intend to perform a large prospective study looking at the predictability
of the random urine protein-to-creatinine ratio compared to the gold standard 24-hour urine
protein collection. Furthermore, the investigators plan to investigate whether analysis of
proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-hour collection
period is predictive of the 24-hour sample. Lastly, the investigators plan to determine
whether a combination of the random test with a shorter collection interval is comparable to
the 24-hour collection.
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| Study Summary: |
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Preeclampsia affects approximately 5-8% of pregnancies in the United States with
approximately 10% occurring before 34 weeks gestation. The diagnosis of preeclampsia is
determined by the presence of hypertension with proteinuria after 20 weeks gestation. The
gold standard for measuring proteinuria is a 24-h urine collection for total protein. In
the non-pregnant patient, a random urinary protein-to-creatinine ratio has been shown to be
a reliable indicator of significant proteinuria. The reliability of this test remains
unclear in the pregnant population. Because there are relatively few studies in the
pregnant population and many of these studies were poorly designed, limited by sample size,
or confounded by other variables, further research in this area is still necessary. The
purpose of this study is to determine if there are alternative diagnostic tools for the
quantification of total protein excretion in 24-hours to aid in the diagnosis of
preeclampsia that can be performed more quickly and efficiently than the gold standard
24-hour urine collection. We intend to perform a large prospective study looking at the
predictability of the random urine protein-to-creatinine ratio compared to the gold standard
24-h urine protein collection. Furthermore, we plan to investigate whether analysis of
proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-h collection
period is predictive of the 24-h sample. Lastly, we plan to determine whether a combination
of the random test with a shorter collection interval is comparable to the 24-h collection.
The goal would be to make the diagnosis of preeclampsia in a more timely fashion to aid in
the prevention of maternal and neonatal morbidity and mortality including eclampsia, HELLP
syndrome, acute renal failure, pulmonary edema, DIC, IUGR, IUFD, intracranial bleeding and
stroke, Additionally, an earlier diagnosis could also impact patient care by reducing
hospital stay, nursing demands, and eliminating the need for cumbersome and likely
inaccurate patient 24-h home collections.
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| Criteria: |
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Inclusion Criteria:
- Pregnant women over the age of 18 between 24-42 weeks who are being evaluated for
preeclampsia with a 24 hour urine protein
Exclusion Criteria:
- Patients with pre-existing proteinuria (>300mg)
- Renal disease
- Evidence of a current or recent (within two weeks of admission) urinary tract
infection
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| NCT ID: |
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NCT00870428 |
| Primary Contact: |
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Principal Investigator
Deborah Wing, MD
Univeristy of California Irvine
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| Backup Contact: |
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N/A |
| Location Contact: |
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Long Beach, California 90806
United States
Christine Preslicka, RN
Phone: 562-933-2755
Email: cpreslicka@memorialcare.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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