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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Purpose
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 |
|---|
|
Preeclampsia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Comparison of Random Spot Urine Protein:Creatinine Ratio to 24-Hour Timed Urine Protein Collection in the Evaluation of Preeclampsia |
- Number of participants diagnosed with preeclampsia with the protein:creatinine ratio test [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12000 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Women being evaluated for preeclampsia |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
18-45 year-old pregnant women (Active Duty Military or DoD beneficiaries) attending the new Obstetrics Orientation class.
Inclusion Criteria:
- Tricare beneficiaries receiving care at Nellis AFB
- Pregnant women (Active Duty Military or DoD beneficiaries) ages 18-45
Exclusion Criteria: None
Contacts and Locations| Contact: Matthew Snyder, D.O, Maj | 702-653-2989 | matthew.snyder@nellis.af.mil |
| United States, Nevada | |
| Mike O'Callaghan Federal Hospital | Not yet recruiting |
| Nellis AFB, Nevada, United States, 89191 | |
| Contact: Matthew Snyder, D.O., Maj 702-653-2989 matthew.snyder@nellis.af.mil | |
| Principal Investigator: | Matthew Snyder, D.O., Maj | Mike O'Callaghan Federal Hospital |
More Information
No publications provided
| Responsible Party: | Mike O'Callaghan Federal Hospital |
| ClinicalTrials.gov Identifier: | NCT01447290 History of Changes |
| Other Study ID Numbers: | FWH20110165H |
| Study First Received: | October 4, 2011 |
| Last Updated: | April 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mike O'Callaghan Federal Hospital:
|
preeclampsia protein creatinine protein:creatinine ratio |
Additional relevant MeSH terms:
|
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications |
ClinicalTrials.gov processed this record on May 21, 2013