Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers

Eligible subjects will provide written informed consent after which demographic and baseline
clinical data will be recorded.

Collection of whole blood and urine samples will be performed at one or more clinic visits
from pregnant women carrying a single fetus with no known fetal abnormalities.

Interim study visits will continue every 14 days [+/- 3 days] until the subject either: 1)
reaches 37 0/7 weeks' gestation, 2) develops Pre-E, 3) delivers, or 4) is lost to follow-up.

In addition, a group of pregnant women diagnosed with Pre-E will be enrolled as positive
control cases.

Eligibility criteria for the STUDY COHORT (CASES and NEGATIVE PRE-E

CONTROLS):

Inclusion Criteria:

- Subject is willing to provide informed consent and comply with study procedures

- 18 to 45 years of age

- Singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using the 2014 American
Congress of Obstetricians and Gynecologists (ACOG) Dating Criteria (pregnancies
starting as twins but complicated with either vanishing twin syndrome or fetal demise
of one twin before 14 weeks, are eligible for inclusion)

- Patient presenting with clinical suspicion of Pre-E based on either: New onset
elevated blood pressure in otherwise normotensive patient, worsening hypertension in a
patient with pre-existing hypertension, new onset proteinuria or worsening of
pre-existing proteinuria, or any other clinical finding requiring a workup to rule-out
Pre-E.

Exclusion Criteria:

- Pregnancy is non-viable or absence of fetal cardiac activity

- Diagnosis of Pre-E or anticipated delivery within 24 to 48 hours because of Pre-E with
severe features including: persistent severe hypertension (systolic ≥160 or diastolic
≥110; thrombocytopenia <100,000; liver enzymes 2x above upper normal limit or >70 with
severe persistent right upper quadrant (RUQ) or epigastric pain, new development of
renal insufficiency; pulmonary edema; new-onset persistent cerebral or visual
disturbances.

- Major fetal anomaly or chromosomal aneuploidy

- Current dialysis for kidney failure, including continuous ambulatory peritoneal
dialysis

Eligibility criteria for the POSITIVE CONTROL group:

Inclusion Criteria:

- Subject is willing to provide informed consent and comply with study procedures

- 18 to 45 years of age

- Singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using 2014 ACOG Dating
Criteria (pregnancies starting as twins but complicated with either vanishing twin
syndrome or fetal demise of one twin before 14 weeks, are eligible for inclusion)

- Patient diagnosed with Pre-E using 2013 ACOG guidelines

Exclusion Criteria:

- Pregnancy is non-viable or absence of cardiac activity

- Major fetal anomaly or chromosomal aneuploidy

- Current dialysis for kidney failure, including continuous ambulatory peritoneal
dialysis