Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers
Status: | Recruiting |
---|---|
Conditions: | Women's Studies, Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/2/2017 |
Start Date: | March 2016 |
End Date: | December 2017 |
Contact: | Kevin O'Shea |
Email: | koshea@illumina.com |
Phone: | 6502042231 |
Prospective Collection of Whole Blood Specimens of Subjects Diagnosed With Preterm Preeclampsia and/or Fetal Growth Restriction in Support of a Molecular Assay Development
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.
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:
- 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 and/or diagnosis of fetal growth restriction
- Preeclampsia; Diastolic Blood Pressure ≥110mmHg on at least 2 occasions 4 hours apart
while on bed rest, but before the onset of labor with 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 the qualitative determination (urine dipstick) of ≥ 1+
- Fetal Growth Restriction; Estimated fetal weight or abdominal circumference by
ultrasound at ≥ 19 0/7 weeks gestational age < 5%ile or 5-10%ile with abnormal
umbilical artery Doppler examination (>95%ile, absent end diastolic flow or reverse
end diastolic flow)
- Gestational age between 20 to 36 weeks 6 days determined by ultrasound and/or LMP per
ACOG guidelines1
Exclusion Criteria:
- Known malignancy
- History of maternal organ or bone marrow transplant
- Maternal blood transfusion in the last 8 weeks
- Any hypertension diagnosed prior to current pregnancy
- Diabetes
- Fetal anomaly or known chromosome abnormality
- Thrombocytopenia (< 100,000 plts/mL)
- Impaired liver function (AST/ALT 2X ULN)
- Newly developed renal insufficiency (serum creatinine >1.1 mg/dL or a doubling of
serum creatinine in the absence of other renal disease)
- Pulmonary edema
- New onset cerebral disturbances or visual scotomata
We found this trial at
10
sites
Flushing, New York 11355
Principal Investigator: Daniel Skupski
Phone: 718-670-1707
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800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Errol Norwitz, MD
Phone: 617-636-0186
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: George Saade, MD
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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254 Easton Ave
New Brunswick, New Jersey 08901
New Brunswick, New Jersey 08901
(732) 745-8600
Principal Investigator: Angela Ranzini
Phone: 732-339-7602
Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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New York, New York 10065
Principal Investigator: Ronald Wapner
Phone: 212-305-2158
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259 1st Street
New York, New York 11501
New York, New York 11501
Principal Investigator: Jolene Muscat
Phone: 510-663-9582
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Newark, Delaware 19718
Principal Investigator: Kelly Ruhstaller
Phone: 302-733-2379
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1427 Vine Street
Philadelphia, Pennsylvania 19102
Philadelphia, Pennsylvania 19102
Principal Investigator: Lauren Plante
Phone: 215-762-8582
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Piscataway, New Jersey 08854
Principal Investigator: Christina Duzyj-Buniak
Phone: 732-235-6630
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239 Hurffville Crosskeys Road
Sewell, New Jersey 08080
Sewell, New Jersey 08080
Principal Investigator: Ronald Librizzi
Phone: 856-291-8875
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