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

NCT01447290 | Completed

• 1 other identifier: FWH20110165H
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia

Keywords

preeclampsia; protein; creatinine; protein:creatinine ratio

Outcome Measures

Primary Outcomes (1)

• Number of participants diagnosed with preeclampsia with the protein:creatinine ratio test

  24 months

Study Arms (1)

Women being evaluated for preeclampsia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Tricare beneficiaries receiving care at Nellis AFB
• Pregnant women (Active Duty Military or DoD beneficiaries) ages 18-45

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Michael O'Callaghan Federal Hospital/Nellis Air Force Base

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Matthew Snyder, D.O., Maj

  Mike O'Callaghan Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 6, 2011
• Study Start: May 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 13, 2014

Record last verified: 2014-10

Locations

US (1)