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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-11-20

Brief Summary

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Sample Collection Study

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Detailed Description

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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.

Conditions

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Preeclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Affected Group

Women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction.

No interventions assigned to this group

Control/Unaffected Group

Women who do not have a diagnosis of preeclampsia with severe features and/or fetal growth restriction.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No