Clinical trial NCT02808494: Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: Preeclampsia
Fetal Growth Restriction
Lead sponsor: Illumina, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 242
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: Sample Collection Study

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.

Eligibility 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: 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

Primary outcomes:
measure: cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
city: Sewell
country: United States
facility: Virtua Materna-Fetal Medicine Specialists
state: New Jersey
city: Flushing
country: United States
facility: New York-Presbyterian/Queens
state: New York
city: New York
country: United States
facility: New York-Presbyterian/Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Winthrop University Hospital Clinical Trials Center
state: New York
city: Philadelphia
country: United States
facility: Drexel Medicine
state: Pennsylvania
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Illumina, Inc.
name: Matthew Rhoa, MD
role: STUDY_DIRECTOR
References:
citation: 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.