- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02808494
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Delaware
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Newark, Delaware, United States, 19718
- Christiana Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Saint Peter's University Hospital
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Piscataway, New Jersey, United States, 08854
- Rutgers University
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Sewell, New Jersey, United States, 08080
- Virtua Materna-Fetal Medicine Specialists
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New York
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Flushing, New York, United States, 11355
- New York-Presbyterian/Queens
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New York, New York, United States, 10032
- New York-Presbyterian/Columbia University Medical Center
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New York, New York, United States, 11501
- Winthrop University Hospital Clinical Trials Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19102
- Drexel Medicine
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Texas
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Galveston, Texas, United States, 77555
- The University of Texas Medical Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Matthew Rhoa, MD, Illumina, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RGH-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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