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

Illumina, Inc.10 sites in 1 country242 target enrollmentMarch 2016

ConditionsPreeclampsia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Preeclampsia
Sponsor: Illumina, Inc.
Enrollment: 242
Locations: 10
Primary Endpoint: cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

November 20, 2017

Last Updated

4 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Illumina, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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 guidelines