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

Preeclampsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808494
• Other study ID #: RGH-014
• Status: Completed
• Start date: March 2016
• Est. completion date: November 20, 2017

Study information

• Verified date: April 2022
• Source: Illumina, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sample Collection Study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: November 20, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	New York-Presbyterian/Queens	Flushing	New York
United States	The University of Texas Medical Branch	Galveston	Texas
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	New York-Presbyterian/Columbia University Medical Center	New York	New York
United States	Winthrop University Hospital Clinical Trials Center	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	Drexel Medicine	Philadelphia	Pennsylvania
United States	Rutgers University	Piscataway	New Jersey
United States	Virtua Materna-Fetal Medicine Specialists	Sewell	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Illumina, Inc.

Country where clinical trial is conducted

United States, 

References & 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 re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions		2 years