Comparison of Random Spot Urine Protein:Creatinine Ratio to 24-Hour Timed Urine Protein Collection in the Evaluation of Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

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.
    

Detailed description: 
      The investigators will recruit a total of 12,000 pregnant female subjects ages 18-45 that
      have a confirmed positive pregnancy test and whom are attending the new Obstetrics
      Orientation class. Subjects will be recruited from the MOFH and Eglin.

      Visit 1:

        -  Obtain signed Informed Consent document and HIPAA Authorization (research-driven)

        -  Review Medical History and record patients age, gestational age, parity and presence of
           high-risk antepartum conditions (i.e. chronic hypertension, gestational diabetes
           mellitus-all classes, and pre-existing renal disease) (standard of care)

      All participants who consent to be part of this study will be followed throughout their
      entire pregnancy (birth of child). Those who are identified by their primary obstetrics
      provider as potentially having preeclampsia will then have a P:C Ratio anytime their Primary
      Obstetrics provider orders a standard of care 24-hour urine collection (see Antepartum Visit
      Schedule Below). Those participants who are not evaluated for preeclampsia during their
      pregnancy will be dropped from the study at the end of their pregnancy (birth of child).

      Antepartum Visit:

        -  Collect 24-hour protein urine (standard of care)

        -  Collect spot random urine protein:creatinine ratio (at 0 and 24 hours) (research-driven)

        -  Perform a urinalysis to identify subjects that may have a Urinary Tract Infection (UTI)
           (if participant tests positive for a UTI, they will be excluded from this data point,
           however, they will continue in the study and data will be collected from their
           subsequent urine collections given that the UTI is no longer present) (research-driven)

      Participants will be recruited from the new Obstetrics Orientation class so that baseline
      data may be used to compare a participant's "non-pregnant" physiological state to later
      gestations (i.e. before and during the time they develop preeclampsia). Previous studies do
      not directly compare baseline and later gestational data that would show whether the
      correlation between the P:C ratio and 24 hour urine protein changes or remains unchanged.
      This data would be more clinically relevant when determining presence of preeclampsia with
      the understanding that the spot protein:creatinine ratio may or may not retain a strong
      correlation to the 24 hour urine protein during all gestational ages.

      Participants will be continually followed by their Primary Obstetric provider, who will
      provide standard of care. This includes notifying patients of worsening conditions of
      preeclampsia, laboratory results, all treatment for preeclampsia, and all teaching involved
      in the diagnosis and treatment of preeclampsia.

      The amount of urine collected for the standard of care 24-hour urine is approximately 2,000
      milliliters (mls) of urine. The amount needed in order to process a P:C Ratio is
      approximately 10mls at 0 hours and 24 hours (total of 20mls).

      Participants will follow the standard procedures for a 24-hour urine collection. During the
      first urination (0 hours) and the last urination (24 hours) participants will pour off 50 mls
      into a urine cup

      Each site's Laboratory will be responsible for analyzing urine samples obtained at their site
      for this study. Samples will be labeled as they would for standard laboratory draws. All
      Laboratories are Clinical Laboratory Improvement Amendments (CLIA) certified and will use
      these procedures when processing Laboratory specimens mentioned in this research project.

      SUBJECTS COMPLETING THE STUDY:

      Subject's participation in this study is completed at the conclusion of their pregnancy.
      Subjects will be told the results of their protein urine and spot random urine
      protein:creatinine ratio by their primary obstetrics provider after each study is completed.
      Upon completion of the study, each Associate Investigator will send the de-identified data to
      the Principal Investigator via an encrypted email for analysis. Associate Investigators are
      also responsible for sending the Principal Investigator all the Informed Consent and HIPAA
      Authorization documents via encrypted email for retention the conclusion of the study.

      WITHDRAWAL PROCEDURES:

      If at any time during the study, the subject decides to withdraw from the study, they may do
      so with no further testing required, beyond that required by standard of care.

      DEVIATIONS:

      Deviations that do not increase the risks to subjects like those listed in the "risks"
      section of this protocol are to be reported to the Principal Investigator of this study the
      1st workday of every month via the "WHMC Tracking Log for Problems Not Requiring Immediate
      Reporting". This is done to ensure ongoing monitoring and identification of trends that may
      arise.
    

Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: preeclampsia; protein; creatinine; protein:creatinine ratio