Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
1 other identifier
observational
344
1 country
24
Brief Summary
Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 5, 2018
CompletedFirst Posted
Study publicly available on registry
December 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 23, 2020
January 1, 2020
2.3 years
December 5, 2018
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnosis of preeclampsia is determined by standard of care.
Observational, non-interventional sample procurement study in which participants are treated per standard of care
3 months
Study Arms (2)
Positive Preeclampsia group
A group with diagnosis of preeclampsia within 24 hours of testing and pre-term delivery
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.
Interventions
This is an observational, non-interventional study.
Eligibility Criteria
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.
You may qualify if:
- Subject is 18 to 45 years of age
- 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
- 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
You may not qualify if:
- Pregnancy is non-viable, as evidenced by absence of fetal cardiac activity
- Major fetal anomaly or chromosomal aneuploidy
- Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Progenity, Inc.lead
Study Sites (24)
West Coast Medical Research, Inc.
San Diego, California, 92123, United States
Christiana Care
Newark, Delaware, 19718, United States
Women's Health Partners, LLC
Boca Raton, Florida, 33433, United States
Discovery Clinical Research
Plantation, Florida, 33324, United States
Leavitt Clinical Research
Idaho Falls, Idaho, 83404, United States
Norton Healthcare
Louisville, Kentucky, 40202, United States
Obstetrics and Gynecology Associates AMB
Silver Spring, Maryland, 20910, United States
Valley OB-GYN Clinic, PC
Saginaw, Michigan, 48602, United States
Rutgers-RWJMS
New Brunswick, New Jersey, 08901, United States
St. Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Virtua Voorhees Hospital
Voorhees Township, New Jersey, 08043, United States
New Life Medical Esthetics and Wellness, PLLC
Brooklyn, New York, 11220, United States
Columbia University
New York, New York, 10032, United States
Total Woman Care
Elkin, North Carolina, 28621, United States
David B. Schwartz, MD, LLC
Cincinnati, Ohio, 45219, United States
Obstetrics & Gynecology Associates, Inc.
Fairfield, Ohio, 45014, United States
Hilltop Obstetrics & Gynecology
Franklin, Ohio, 45005, United States
Dr. Ahuja and Associates OB-GYN
Mentor, Ohio, 44060, United States
Drexel University
Philadelphia, Pennsylvania, 19102, United States
The Jackson Clinic, PA
Jackson, Tennessee, 38305, United States
Aa Ob-Gyn, Pllc
Austin, Texas, 78758, United States
OB-GYN North
Austin, Texas, 78758, United States
Corpus Christi Women's Clinic
Corpus Christi, Texas, 78412, United States
Advanced Clinical Research
Salt Lake City, Utah, 84107, United States
Biospecimen
This study will collect 20 mL whole blood samples from subjects at one or more study visits. The whole blood will be processed to plasma and stored for testing.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Stiegler, PhD
Progenity, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2018
First Posted
December 7, 2018
Study Start
October 1, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
January 23, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share