Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
NCT ID: NCT03767803
Last Updated: 2020-01-23
Study Results
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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UNKNOWN
344 participants
OBSERVATIONAL
2018-10-01
2020-12-31
Brief Summary
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Detailed Description
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Study population includes subjects who are pregnant, of any race or ethnicity, 18 to 45 years of age, 28 0/7 to 36 6/7 weeks' gestational age with a singleton fetus and have provided written informed consent to provide whole blood specimens at one or more study visits.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Positive Preeclampsia group
A group with diagnosis of preeclampsia within 24 hours of testing and pre-term delivery
Non-interventional study
This is an observational, non-interventional study.
Study Cohort
A group without diagnosis of preeclampsia. Also includes a group without diagnosis of preeclampsia within 24 hours of testing, but who have subsequent worsening or re-emergence of signs and symptoms of preeclampsia, and are later diagnosed with preeclampsia and have pre-term delivery.
Non-interventional study
This is an observational, non-interventional study.
Interventions
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Non-interventional study
This is an observational, non-interventional study.
Eligibility Criteria
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Inclusion Criteria
* Subject is willing to provide informed consent
* Subject enrolling at a study OB-GYN or MFM site is in the opinion of the physician able to provide 20 mL of whole blood and will comply with all study procedures
* Subject has a singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using 2014 ACOG Dating Criteria (pregnancies starting as twins but complicated with either vanishing twin syndrome or fetal demise of one twin before 14 weeks, are eligible for inclusion)
* Patient presenting with clinical suspicion of Pre-E based on one or more of the following clinical signs and symptoms of Pre-E:
* New onset increased blood pressure in otherwise normotensive patient
* Worsening hypertension in a patient with pre-existing hypertension
* New onset proteinuria or worsening of pre-existing proteinuria
* Any other clinical finding typically associated with suspicion of Pre-E and requiring workup to rule-out Pre-E
Exclusion Criteria
* Major fetal anomaly or chromosomal aneuploidy
* Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
18 Years
45 Years
FEMALE
No
Sponsors
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Progenity, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Stiegler, PhD
Role: STUDY_DIRECTOR
Progenity, Inc.
Locations
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West Coast Medical Research, Inc.
San Diego, California, United States
Christiana Care
Newark, Delaware, United States
Women's Health Partners, LLC
Boca Raton, Florida, United States
Discovery Clinical Research
Plantation, Florida, United States
Leavitt Clinical Research
Idaho Falls, Idaho, United States
Norton Healthcare
Louisville, Kentucky, United States
Obstetrics and Gynecology Associates AMB
Silver Spring, Maryland, United States
Valley OB-GYN Clinic, PC
Saginaw, Michigan, United States
Rutgers-RWJMS
New Brunswick, New Jersey, United States
St. Peter's University Hospital
New Brunswick, New Jersey, United States
Virtua Voorhees Hospital
Voorhees Township, New Jersey, United States
New Life Medical Esthetics and Wellness, PLLC
Brooklyn, New York, United States
Columbia University
New York, New York, United States
Total Woman Care
Elkin, North Carolina, United States
David B. Schwartz, MD, LLC
Cincinnati, Ohio, United States
Obstetrics & Gynecology Associates, Inc.
Fairfield, Ohio, United States
Hilltop Obstetrics & Gynecology
Franklin, Ohio, United States
Dr. Ahuja and Associates OB-GYN
Mentor, Ohio, United States
Drexel University
Philadelphia, Pennsylvania, United States
The Jackson Clinic, PA
Jackson, Tennessee, United States
Aa Ob-Gyn, Pllc
Austin, Texas, United States
OB-GYN North
Austin, Texas, United States
Corpus Christi Women's Clinic
Corpus Christi, Texas, United States
Advanced Clinical Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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PRO-129-PREECLAMPSIA
Identifier Type: -
Identifier Source: org_study_id
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