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Comparison of Random Spot Urine Protein:Creatinine Ratio to 24-Hour Timed Urine Protein Collection in the Evaluation of Preeclampsia (P:C Ratio)

This study has been completed.
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital Identifier:
First received: October 4, 2011
Last updated: October 10, 2014
Last verified: October 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.


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

Resource links provided by NLM:

Further study details as provided by Mike O'Callaghan Federal Hospital:

Primary Outcome Measures:
  • Number of participants diagnosed with preeclampsia with the protein:creatinine ratio test [ Time Frame: 24 months ]

Enrollment: 100
Study Start Date: May 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Women being evaluated for preeclampsia

  Show Detailed Description


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
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Please refer to this study by its identifier: NCT01447290

United States, Nevada
Michael O'Callaghan Federal Hospital/Nellis Air Force Base
Nellis AFB, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
Principal Investigator: Matthew Snyder, D.O., Maj Mike O'Callaghan Federal Hospital
  More Information

Responsible Party: Mike O'Callaghan Federal Hospital Identifier: NCT01447290     History of Changes
Other Study ID Numbers: FWH20110165H
Study First Received: October 4, 2011
Last Updated: October 10, 2014

Keywords provided by Mike O'Callaghan Federal Hospital:
protein:creatinine ratio

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications processed this record on May 22, 2017