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

Status unconfirmed

Conditions studied: Pre-Eclampsia, Hypertension, Proteinuria in Pregnancy, Thrombocytopenia, Renal Insufficiency, Impaired Liver Function, Pulmonary Edema, Headache, Visual Impairment

In brief

Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.

Key facts

Study ID

NCT03767803

Run by

Progenity, Inc.

People needed

344

Starts

2018-10-01

Expected to finish

2020-12-31

Last updated by the study team

2020-01-23

Who can join

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

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
• 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

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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