Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers
Prospective Collection of Whole Blood Specimens of Subjects Diagnosed With Preeclampsia With Severe Features and/or Fetal Growth Restriction in Support of a Molecular Assay Development
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Delaware
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Newark, Delaware, Forente stater, 19718
- Christiana Hospital
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Massachusetts
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Boston, Massachusetts, Forente stater, 02111
- Tufts Medical Center
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New Jersey
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New Brunswick, New Jersey, Forente stater, 08901
- Saint Peter's University Hospital
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Piscataway, New Jersey, Forente stater, 08854
- Rutgers University
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Sewell, New Jersey, Forente stater, 08080
- Virtua Materna-Fetal Medicine Specialists
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New York
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Flushing, New York, Forente stater, 11355
- New York-Presbyterian/Queens
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New York, New York, Forente stater, 10032
- New York-Presbyterian/Columbia University Medical Center
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New York, New York, Forente stater, 11501
- Winthrop University Hospital Clinical Trials Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19102
- Drexel Medicine
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Texas
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Galveston, Texas, Forente stater, 77555
- The University of Texas Medical Branch
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Affected Group: Pregnant women diagnosed with preeclampsia with severe features or fetal growth restriction
Control group: Pregnant women matched for gestational age to the Affected group above
Beskrivelse
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 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.
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Affected Group
Women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction.
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Control/Unaffected Group
Women who do not have a diagnosis of preeclampsia with severe features and/or fetal growth restriction.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions
Tidsramme: 2 years
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2 years
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Matthew Rhoa, MD, Illumina, Inc.
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RGH-014
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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