Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
1 other identifier
observational
1,730
1 country
20
Brief Summary
Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the current diagnostic paradigm have been evaluated. However, no stand-alone diagnostic method has emerged that more accurately identifies women at risk for preeclampsia, warranting improvements in diagnosing Pre-E. This sample collection study will obtain serum and urine samples from pregnant women who present with clinical signs, symptoms, or conditions contributing to the suspicion of Pre-E. Samples will be used to evaluate and validate the performance of an assay intended to aid in assessing the risk of Pre-E.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Longer than P75 for all trials
20 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
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 12, 2016
CompletedFirst Posted
Study publicly available on registry
May 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2020
CompletedMarch 11, 2022
March 1, 2022
4.7 years
May 12, 2016
March 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Suspected and Pre-E cases determined by institutional standards
about 2 years
Study Arms (2)
Study Cohort
A group of at least 1,541 pregnant women with NO Pre-E diagnosis
Positive Pre-E Control
A group of at least 250 pregnant women diagnosed with Pre-E
Eligibility Criteria
Pregnant women 18 to 45 years of age and 28 0/7 to 36 6/7 weeks gestational age with a singleton fetus presenting to clinic/triage/Labor \& Delivery for evaluation of, but not limited to, one or more of the following: * new onset elevated blood pressure * pre-existing hypertension * new onset proteinuria or worsening of pre-existing proteinuria * other organ system findings including thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, and cerebral or visual symptoms
You may qualify if:
- Subject is willing to provide informed consent and comply with study procedures
- to 45 years of age
- Patient presenting with clinical suspicion of Pre-E based on either: New onset elevated blood pressure in otherwise normotensive patient, worsening hypertension in a patient with pre-existing hypertension, new onset proteinuria or worsening of pre-existing proteinuria, or any other clinical finding requiring a workup to rule-out Pre-E.
You may not qualify if:
- Pregnancy is non-viable or absence of fetal cardiac activity
- Diagnosis of Pre-E or anticipated delivery within 24 to 48 hours because of Pre-E with severe features including: persistent severe hypertension (systolic ≥160 or diastolic ≥110; thrombocytopenia \<100,000; liver enzymes 2x above upper normal limit or \>70 with severe persistent right upper quadrant (RUQ) or epigastric pain, new development of renal insufficiency; pulmonary edema; new-onset persistent cerebral or visual disturbances.
- Major fetal anomaly or chromosomal aneuploidy
- Current dialysis for kidney failure, including continuous ambulatory peritoneal dialysis
- Eligibility criteria for the POSITIVE CONTROL group:
- Subject is willing to provide informed consent and comply with study procedures
- to 45 years of age
- Patient diagnosed with Pre-E using 2013 ACOG guidelines
- Pregnancy is non-viable or absence of 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 (20)
Center of Research in Women's Health
Birmingham, Alabama, 35294, United States
University of Colorado
Aurora, Colorado, 80045, United States
Yale Medical
New Haven, Connecticut, 06520, United States
Northwestern
Chicago, Illinois, 60611, United States
Indiana University Health Physicians Women's Health
Indianapolis, Indiana, 46202, United States
Johns Hopkins Medicine
Baltimore, Maryland, 21287, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Washington Univ School of Medicine - Dept of OB-GYN
St Louis, Missouri, 63111, United States
Winthrop Clinical Trials Center
Mineola, New York, 11501, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7516, United States
Duke University
Durham, North Carolina, 27705, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Regional Obstetrical Consultants, PC
Chattanooga, Tennessee, 37403, United States
Austin Maternal Fetal Medicine
Austin, Texas, 78758, United States
University of Texas Medical Branch, Galveston
Galveston, Texas, 77555, United States
UT Health Medical School
Houston, Texas, 77030, United States
University of Utah Hospital, OB/GYN Dept.
Salt Lake City, Utah, 84132, United States
Medical College of Wisconsin - Department of Obstetrics & Gynecology
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Costantine MM, Sibai B, Bombard AT, Sarno M, West H, Haas DM, Tita AT, Paidas MJ, Clark EAS, Boggess K, Grotegut C, Grobman W, Su EJ, Burd I, Saade G, Chavez MR, Paglia MJ, Merriam A, Torres C, Habli M, Macones G, Wen T, Bofill J, Palatnik A, Edwards RK, Haeri S, Oberoi P, Mazloom A, Cooper M, Lockton S, Hankins GD. Performance of a Multianalyte 'Rule-Out' Assay in Pregnant Individuals With Suspected Preeclampsia. Hypertension. 2022 Jul;79(7):1515-1524. doi: 10.1161/HYPERTENSIONAHA.122.19038. Epub 2022 May 12.
PMID: 35545947DERIVED
Biospecimen
This research study will collect 20 mL of whole blood and a 5 mL urine sample at one or more clinic visits from pregnant women carrying a single fetus with no known fetal abnormalities.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Stiegler, PhD
Progenity, Inc.
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2016
First Posted
May 23, 2016
Study Start
January 1, 2016
Primary Completion
September 29, 2020
Study Completion
October 23, 2020
Last Updated
March 11, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share