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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01447290
First Posted: October 6, 2011
Last Update Posted: October 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
  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

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)
Groups/Cohorts
Women being evaluated for preeclampsia

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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
Information from the National Library of Medicine

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


Locations
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
Investigators
Principal Investigator: Matthew Snyder, D.O., Maj Mike O'Callaghan Federal Hospital
  More Information

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01447290     History of Changes
Other Study ID Numbers: FWH20110165H
First Submitted: October 4, 2011
First Posted: October 6, 2011
Last Update Posted: October 13, 2014
Last Verified: October 2014

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