Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers

This is a limited prospective collection of whole blood samples from pregnant women with a
diagnosis of preterm preeclampsia and/or fetal growth restriction in addition to samples
from a control group to aid in the development of a Next Generation Sequencing (NGS)-based
assay to detect molecular markers associated with preterm preeclampsia.

Inclusion Criteria:

- Women 18 years of age or older at enrollment

- Pregnant women with a viable singleton gestation

- Able to provide written, informed consent

- Able to provide 20 mL of whole blood

- Diagnosis of preeclampsia and/or diagnosis of fetal growth restriction

- Preeclampsia; Diastolic Blood Pressure ≥110mmHg on at least 2 occasions 4 hours apart
while on bed rest, but before the onset of labor with Proteinuria; Excretion of
≥300mg/24hr (24 hour collection) of protein or a timed excretion that is extrapolated
to the 24 hour urine value or a protein/creatinine [both in mg/dL] ratio of at least
0.3 or the qualitative determination (urine dipstick) of ≥ 1+

- Fetal Growth Restriction; Estimated fetal weight or abdominal circumference by
ultrasound at ≥ 19 0/7 weeks gestational age < 5%ile or 5-10%ile with abnormal
umbilical artery Doppler examination (>95%ile, absent end diastolic flow or reverse
end diastolic flow)

- Gestational age between 20 to 36 weeks 6 days determined by ultrasound and/or LMP per
ACOG guidelines1

Exclusion Criteria:

- Known malignancy

- History of maternal organ or bone marrow transplant

- Maternal blood transfusion in the last 8 weeks

- Any hypertension diagnosed prior to current pregnancy

- Diabetes

- Fetal anomaly or known chromosome abnormality

- Thrombocytopenia (< 100,000 plts/mL)

- Impaired liver function (AST/ALT 2X ULN)

- Newly developed renal insufficiency (serum creatinine >1.1 mg/dL or a doubling of
serum creatinine in the absence of other renal disease)

- Pulmonary edema

- New onset cerebral disturbances or visual scotomata