Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers

Completed

Conditions studied: Preeclampsia, Hypertension, Proteinuria, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function, Pulmonary Edema

In brief

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.

Key facts

Study ID: NCT02780414
Run by: Progenity, Inc.
People needed: 1730
Starts: 2016-01-01
Expected to finish: 2020-10-23
Last updated by the study team: 2022-03-11

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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 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.

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:
Inclusion Criteria:
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:
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

Where it is running

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

Full record on ClinicalTrials.gov

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