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

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.

Inclusion Criteria:

- Tricare beneficiaries receiving care at Nellis AFB

- Pregnant women (Active Duty Military or DoD beneficiaries) ages 18-45

Exclusion Criteria: None