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

 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: Execretion 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.

 Exclusion Criteria:

 1. Known malignancy

 2. History of maternal organ or bone marrow transplant

 3. Maternal blood transfusion in the last 8 weeks

 4. Chronic hypertension diagnosed prior to current pregnancy

 5. Type I, II or gestational diabetes

 6. Fetal anomaly or known chromosome abnormality

 7. Active labor