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

Inclusion Criteria

• •1. Women 18 years of age or older at enrollment
• •2. Pregnant women with a viable singleton gestation
• •3. Able to provide written, informed consent
• •4. Able to provide 20 mL of whole blood
• •5. Diagnosis of preeclampsia with severe features and/or diagnosis of fetal growth restriction.
• •1. Preeclampsia with severe features is defined as:
• •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 a qualitative determination of (urine dipstick) of ≥1+ WITH Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on at least 2 occasions 4 hours apart while on bedrest but before the onset of labor OR Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on 1 occasion but before the onset of labor, if antihypertensive therapy is initiated due to severe hypertension OR New onset hypertension defined as: Systolic BP ≥140 mmHg or diastolic ≥90 mmHg with one or more of the following features: Thrombocytopenia (\<100,000 plts/mL); impaired liver function (AST/ALT 2X ULN); newly developed renal insufficiency (serum creatinine \>1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease); pulmonary edema; new onset cerebral disturbances or scotomata
• •2. Fetal Growth Restriction defined as:
• •Estimated fetal weight by ultrasound at ≥ 19 0/7 weeks gestational age \< 5%ile or 5-10%ile with abnormal umbilical artery Doppler examination (S/D ratio \>95%ile for gestational age, absent end diastolic flow or reverse end diastolic flow)
• •6. Gestational age between 20 0/7 and 33 6/7 weeks determined by ultrasound and/or LMP per ACOG guidelines1. A subject diagnosed with preeclampsia without severe features prior to 33 6/7 weeks gestation and who is managed expectantly and develops severe features after 34 weeks may be included.