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Trial record 88 of 147 for:    severe preeclampsia AND hypertensive disorders

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

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ClinicalTrials.gov Identifier: NCT02808494
Recruitment Status : Unknown
Verified February 2017 by Illumina, Inc..
Recruitment status was:  Recruiting
First Posted : June 21, 2016
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Illumina, Inc.

Brief Summary:
Sample Collection Study

Condition or disease
Preeclampsia

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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
Study Start Date : March 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Affected Group
Women with a diagnosis of preeclampsia or fetal growth restriction.
Control/Unaffected Group
Women who do not have a diagnosis of preeclampsia or fetal growth restriction.



Primary Outcome Measures :
  1. cfRNA markers associated with preterm preeclampsia [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Stored for future assay development use.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Affected Group: Pregnant women diagnosed with preterm preeclampsia or fetal growth restriction

Control group: Pregnant women matched for gestational age to the Affected group above

Criteria

Inclusion Criteria:

  1. Women 18 years of age or older at enrollment
  2. Pregnant women with a viable singleton gestation
  3. Able to provide written, informed consent
  4. Able to provide 20 mL of whole blood
  5. Diagnosis of preeclampsia with severe features and/or diagnosis of fetal growth restriction.

    1. Preeclampsia with severe features is defined as:

      Proteinuria: Execretion 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

    2. 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)

  6. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808494


Contacts
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Contact: Kevin O'Shea 6502042231 koshea@illumina.com

Locations
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United States, Delaware
Christiana Hospital Not yet recruiting
Newark, Delaware, United States, 19718
Contact: Carrie Kitto    302-733-2379    ckitto@christianacare.org   
Contact: Stephanie J Lynch    347-931-0318    sl2739@cumc.columbia.edu   
Principal Investigator: Kelly Ruhstaller         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Vidya Iyer, MBBS    617-636-0186      
Principal Investigator: Errol Norwitz, MD         
United States, New Jersey
Saint Peter's University Hospital Not yet recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Tracy Vitale    732-339-7602    tvitale@saintpetersuh.com   
Contact: Stephanie J Lynch    347-931-0318    sl2739@cumc.columbia.edu   
Principal Investigator: Angela Ranzini         
Rutgers University Not yet recruiting
Piscataway, New Jersey, United States, 08854
Contact: Shama Khan    732-235-6630    khansp@rwjms.rutgers.edu   
Contact: Stephanie J Lynch    347-931-0318    sl2739@cumc.columbia.edu   
Principal Investigator: Christina Duzyj-Buniak         
Virtua Materna-Fetal Medicine Specialists Not yet recruiting
Sewell, New Jersey, United States, 08080
Contact: Erin Obermeier    856-291-8875    eobermeier@virtua.org   
Contact: Stephanie J Lynch    347-931-0318    sl2739@cumc.columbia.edu   
Principal Investigator: Ronald Librizzi         
United States, New York
New York-Presbyterian/Queens Not yet recruiting
Flushing, New York, United States, 11355
Contact: Rosalyn Chan    718-670-1707    roc9166@nyp.org   
Contact: Stephanie J Lynch    347-931-0318    sl2739@cumc.columbia.edu   
Principal Investigator: Daniel Skupski         
New York-Presbyterian/Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Caroline Torres    212-305-2158    ct2179@cumc.columbia.edu   
Contact: Stephanie J Lynch    3479310318    sl2739@cumc.columbia.edu   
Principal Investigator: Ronald Wapner         
Winthrop University Hospital Clinical Trials Center Not yet recruiting
New York, New York, United States, 11501
Contact: Kim Byrnes    510-663-9582    kbyrnes@winthrop.org   
Contact: Stephanie J Lynch    347-931-0318    sl2739@cumc.columbia.edu   
Principal Investigator: Jolene Muscat         
United States, Pennsylvania
Drexel Medicine Not yet recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Cheryl Tocci    215-762-8582    ctocci@drexelmed.edu   
Contact: Stephanie J Lynch    347-931-0318    sl2739@cumc.columbia.edu   
Principal Investigator: Lauren Plante         
United States, Texas
The University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Ashley Salazar         
Principal Investigator: George Saade, MD         
Sponsors and Collaborators
Illumina, Inc.
Investigators
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Study Director: Amy Mueller, MD Illumina, Inc.

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Responsible Party: Illumina, Inc.
ClinicalTrials.gov Identifier: NCT02808494     History of Changes
Other Study ID Numbers: RGH-014
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Illumina, Inc.:
Preeclampsia
Fetal Growth Restriction
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications