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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02808494

Enrollment

242

Registered

2016-06-21

Start date

2016-03-31

Completion date

2017-11-20

Last updated

2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Preeclampsia, Fetal Growth Restriction

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions	2 years

Countries

United States

Outcome results