Trial record 18 of 103 for:    Open Studies | "Pre-Eclampsia"

Predicitve Use of Spot Urine Protein/Creatinine Ratios in Preeclampsia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by MemorialCare.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of California, Irvine
Information provided by:
MemorialCare
ClinicalTrials.gov Identifier:
NCT00870428
First received: March 26, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition
Preeclampsia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Predictive Use of Spot Urine Protein/Creatinine Ratios and Decreased Sample Collection Time in the Diagnosis of Preeclampsia

Resource links provided by NLM:


Further study details as provided by MemorialCare:

Primary Outcome Measures:
  • To determine if protein excretion determined by spot urine protein-to-creatinine ratios are equivalent to the gold standard 24-h urine protein collections. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To see if total protein excretion obtained from shorter timed urine collections of 4- and 8-hours duration or a combination of the two tests are equivalent to a 24-h urine collection. [ Time Frame: 4 hr, 8 hr, 24 hr ] [ Designated as safety issue: No ]

Estimated Enrollment: 117
Study Start Date: March 2009
Groups/Cohorts
Preeclampsia Evaluation
Patients who are admitted for the evaluation of preeclampsia

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women between 24-42 weeks who are being evaluated for preeclampsia.

Criteria

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
  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: NCT00870428

Locations
United States, California
Long Beach Memorial Womens Pavillion Recruiting
Long Beach, California, United States, 90806
Contact: Christine Preslicka, RN    562-933-2755    cpreslicka@memorialcare.org   
Sponsors and Collaborators
MemorialCare
University of California, Irvine
Investigators
Principal Investigator: Deborah Wing, MD Univeristy of California Irvine
  More Information

No publications provided

Responsible Party: Deborah A. Wing, Univeristy of California Irvine
ClinicalTrials.gov Identifier: NCT00870428     History of Changes
Other Study ID Numbers: 584-08
Study First Received: March 26, 2009
Last Updated: March 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by MemorialCare:
Preeclampsia
proteinuria

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on September 16, 2014