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

April 22, 2022 updated by: Illumina, Inc.

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

Sample Collection Study

Study Overview

Status

Completed

Conditions

Detailed Description

This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preeclampsia with severe features 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.

Study Type

Observational

Enrollment (Actual)

242

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
      • Piscataway, New Jersey, United States, 08854
        • Rutgers University
      • Sewell, New Jersey, United States, 08080
        • Virtua Materna-Fetal Medicine Specialists
    • New York
      • Flushing, New York, United States, 11355
        • New York-Presbyterian/Queens
      • New York, New York, United States, 10032
        • New York-Presbyterian/Columbia University Medical Center
      • New York, New York, United States, 11501
        • Winthrop University Hospital Clinical Trials Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel Medicine
    • Texas
      • Galveston, Texas, United States, 77555
        • The University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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:

  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: 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

    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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Matthew Rhoa, MD, Illumina, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

November 20, 2017

Study Completion (Actual)

November 20, 2017

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • RGH-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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