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 is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Mike O'Callaghan Federal Hospital
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01447290
First received: October 4, 2011
Last updated: December 30, 2013
Last verified: December 2013
  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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12000
Study Start Date: May 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (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
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
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: NCT01447290

Contacts
Contact: Jill M Clark, MBA/HCM, CCRP, CCRC (702) 653-3298 matthew.snyder@nellis.af.mil

Locations
United States, Nevada
Michael O'Callaghan Federal Hospital/Nellis Air Force Base Recruiting
Nellis AFB, Nevada, United States, 89191
Contact: Jill Clark, MBA/HCM, CCRP    7026533298    jill.clark.3.ctr@us.af.mil   
Principal Investigator: Matthew Snyder, DO         
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
Investigators
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: December 30, 2013
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 July 29, 2014