Last updated on February 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pre-Eclampsia
  • Age: Between 18 - 100 Years
  • Gender: Female

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.
  6. 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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