Comparison of Random Spot Urine Protein:Creatinine Ratio to 24-Hour Timed Urine Protein Collection in the Evaluation of Preeclampsia (P:C Ratio)
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|ClinicalTrials.gov Identifier: NCT01447290|
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : October 13, 2014
This is a non-inferiority, prospective study of the relationship between the 24-hour urine protein collection and spot protein:creatinine ratio in the diagnosis of preeclampsia involving a sample of 18-45 year-old pregnant women attending the new Obstetrics orientation. The investigators will follow all participants who consent to be part of this study throughout their entire pregnancy. Those who get evaluated for preeclampsia will then have a P:C ratio anytime their Primary Obstetrics provider orders a standard of care 24-hour urine collection (standard of care). Those participants who are not evaluated for preeclampsia during their pregnancy will be dropped from the study.
Participants evaluated for preeclampsia during the prenatal period will be asked to provide a random spot clean-catch urine sample at intervals of approximately 0 and 24 hours following the initiation of the 24-hour urine collection. The patient's demographic and clinical data, as well as the spot protein:creatinine ratio and 24-hour urine protein will be collected and analyzed at the conclusion of the study period.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Comparison of Random Spot Urine Protein:Creatinine Ratio to 24-Hour Timed Urine Protein Collection in the Evaluation of Preeclampsia|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
|Women being evaluated for preeclampsia|
- Number of participants diagnosed with preeclampsia with the protein:creatinine ratio test [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447290
|United States, Nevada|
|Michael O'Callaghan Federal Hospital/Nellis Air Force Base|
|Nellis AFB, Nevada, United States, 89191|
|Principal Investigator:||Matthew Snyder, D.O., Maj||Mike O'Callaghan Military Hospital|