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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Delaware
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Newark, Delaware, Forenede Stater, 19718
- Christiana Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Tufts Medical Center
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New Jersey
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New Brunswick, New Jersey, Forenede Stater, 08901
- Saint Peter's University Hospital
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Piscataway, New Jersey, Forenede Stater, 08854
- Rutgers University
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Sewell, New Jersey, Forenede Stater, 08080
- Virtua Materna-Fetal Medicine Specialists
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New York
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Flushing, New York, Forenede Stater, 11355
- New York-Presbyterian/Queens
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New York, New York, Forenede Stater, 10032
- New York-Presbyterian/Columbia University Medical Center
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New York, New York, Forenede Stater, 11501
- Winthrop University Hospital Clinical Trials Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19102
- Drexel Medicine
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Texas
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Galveston, Texas, Forenede Stater, 77555
- The University of Texas Medical Branch
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Matthew Rhoa, MD, Illumina, Inc.
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RGH-014
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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