Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers
- Conditions
- Preeclampsia
- Registration Number
- NCT02808494
- Lead Sponsor
- Illumina, Inc.
- Brief Summary
Sample Collection Study
- Detailed Description
This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preeclampsia with severe features 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 242
-
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
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Diagnosis of preeclampsia with severe features and/or diagnosis of fetal growth restriction.
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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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
The University of Texas Medical Branch
🇺🇸Galveston, Texas, 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
Christiana Hospital
🇺🇸Newark, Delaware, United States
Drexel Medicine
🇺🇸Philadelphia, Pennsylvania, 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
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States