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

Study Overview
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Brief Summary
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Sample Collection Study

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.

Official Title
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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

Conditions
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Preeclampsia

Participation Criteria
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Eligibility Criteria
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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 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Affected Group<br>Women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction. | |
| Control/Unaffected Group<br>Women who do not have a diagnosis of preeclampsia with severe features and/or fetal growth restriction. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preeclampsia, Fetal Growth Restriction