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

NCT02808494 | Completed

• 1 other identifier: RGH-014
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 10

Brief Summary

Sample Collection Study

Conditions

Preeclampsia

Keywords

Preeclampsia; Fetal Growth Restriction

Outcome Measures

Primary Outcomes (1)

• cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Illumina, Inc.: lead

Study Sites (10)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Rutgers University

Piscataway, New Jersey, 08854, United States

Location

Virtua Materna-Fetal Medicine Specialists

Sewell, New Jersey, 08080, United States

Location

New York-Presbyterian/Queens

Flushing, New York, 11355, United States

Location

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

Location

Winthrop University Hospital Clinical Trials Center

New York, New York, 11501, United States

Location

Drexel Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

• Munchel S, Rohrback S, Randise-Hinchliff C, Kinnings S, Deshmukh S, Alla N, Tan C, Kia A, Greene G, Leety L, Rhoa M, Yeats S, Saul M, Chou J, Bianco K, O'Shea K, Bujold E, Norwitz E, Wapner R, Saade G, Kaper F. Circulating transcripts in maternal blood reflect a molecular signature of early-onset preeclampsia. Sci Transl Med. 2020 Jul 1;12(550):eaaz0131. doi: 10.1126/scitranslmed.aaz0131.

  PMID: 32611681 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Stored for future assay development use.

MeSH Terms

Conditions

Pre-Eclampsia; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Rhoa, MD

  Illumina, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: June 21, 2016
• Study Start: March 1, 2016
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)