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

Completed

Conditions studied: Preeclampsia

In brief

Sample Collection Study

Key facts

Study ID

NCT02808494

Run by

Illumina, Inc.

People needed

242

Starts

2016-03-01

Expected to finish

2017-11-20

Last updated by the study team

2022-04-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 with severe features and/or diagnosis of fetal growth restriction.
• 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
• 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)
• 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.

You may not qualify if…

• Known malignancy
• History of maternal organ or bone marrow transplant
• Maternal blood transfusion in the last 8 weeks
• Chronic hypertension diagnosed prior to current pregnancy
• Type I, II or gestational diabetes
• Fetal anomaly or known chromosome abnormality
• Active labor

Where it is running

• Christiana Hospital — Newark, Delaware, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Saint Peter's University Hospital — New Brunswick, New Jersey, United States
• Rutgers University — Piscataway, New Jersey, United States
• Virtua Materna-Fetal Medicine Specialists — Sewell, New Jersey, United States
• New York-Presbyterian/Queens — Flushing, New York, United States
• New York-Presbyterian/Columbia University Medical Center — New York, New York, United States
• Winthrop University Hospital Clinical Trials Center — New York, New York, United States
• Drexel Medicine — Philadelphia, Pennsylvania, United States
• The University of Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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