Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
NCT ID: NCT02780414
Last Updated: 2022-03-11
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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COMPLETED
1730 participants
OBSERVATIONAL
2016-01-31
2020-10-23
Brief Summary
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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.
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Detailed Description
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Collection of whole blood and urine samples will be performed at one or more clinic visits from pregnant women carrying a single fetus with no known fetal abnormalities.
Interim study visits will continue every 14 days \[+/- 3 days\] until the subject either: 1) reaches 37 0/7 weeks' gestation, 2) develops Pre-E, 3) delivers, or 4) is lost to follow-up.
In addition, a group of pregnant women diagnosed with Pre-E will be enrolled as positive control cases.
Conditions
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Study Design
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FAMILY_BASED
PROSPECTIVE
Study Groups
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Study Cohort
A group of at least 1,541 pregnant women with NO Pre-E diagnosis
No interventions assigned to this group
Positive Pre-E Control
A group of at least 250 pregnant women diagnosed with Pre-E
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 18 to 45 years of age
* Singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using the 2014 American Congress of Obstetricians and Gynecologists (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 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.
* Subject is willing to provide informed consent and comply with study procedures
* 18 to 45 years of age
* 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 diagnosed with Pre-E using 2013 ACOG guidelines
Exclusion Criteria
* 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:
* 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
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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Center of Research in Women's Health
Birmingham, Alabama, United States
University of Colorado
Aurora, Colorado, United States
Yale Medical
New Haven, Connecticut, United States
Northwestern
Chicago, Illinois, United States
Indiana University Health Physicians Women's Health
Indianapolis, Indiana, United States
Johns Hopkins Medicine
Baltimore, Maryland, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington Univ School of Medicine - Dept of OB-GYN
St Louis, Missouri, United States
Winthrop Clinical Trials Center
Mineola, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Regional Obstetrical Consultants, PC
Chattanooga, Tennessee, United States
Austin Maternal Fetal Medicine
Austin, Texas, United States
University of Texas Medical Branch, Galveston
Galveston, Texas, United States
UT Health Medical School
Houston, Texas, United States
University of Utah Hospital, OB/GYN Dept.
Salt Lake City, Utah, United States
Medical College of Wisconsin - Department of Obstetrics & Gynecology
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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PRO-104-PREECLAMPSIA
Identifier Type: -
Identifier Source: org_study_id
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