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



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Migraine Headaches, Renal Impairment / Chronic Kidney Disease, Ocular, Women's Studies, Endocrine, Pulmonary, Hematology
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Hematology, Nephrology / Urology, Neurology, Ophthalmology, Pulmonary / Respiratory Diseases, Reproductive
Healthy:No
Age Range:18 - 45
Updated:12/9/2018
Start Date:October 1, 2018
End Date:December 31, 2020
Contact:Alanna Menez
Email:alanna.menez@progenity.com
Phone:858-260-5216

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

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

This multicenter non-interventional observational sample acquisition study is designed to
acquire whole-blood samples from pregnant women who present with signs and symptoms of Pre-E
and are in the care at an OB-GYN and/or Maternal Fetal Medicine (MFM) site, defined as
outpatient centers, clinic sites, and medical offices.

Study population includes 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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
24
sites
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
Principal Investigator: Damien Croft, MD
Phone: 215-762-8582
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Ronald Wapner, MD
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Austin, Texas 78758
Principal Investigator: Mark Akin, MD
Phone: 737-931-0927
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Austin, Texas 78758
Principal Investigator: Christina Sebeysten, MD
Phone: 512-633-7364
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Boca Raton, Florida 33433
Principal Investigator: Stewart Newman, MD
Phone: 561-945-9303
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Boca Raton, FL
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Brooklyn, New York 11220
Principal Investigator: Lisa Eng, DO
Phone: 212-219-2723
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Cincinnati, Ohio 45219
Principal Investigator: David Schwartz, MD
Phone: 513-241-4223
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Cincinnati, OH
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Corpus Christi, Texas 78412
Principal Investigator: Charles Kirkham, MD
Phone: 214-609-0146
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Elkin, North Carolina 28621
Principal Investigator: Peter McIlveen, MD
Phone: 336-526-3500
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Elkin, NC
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Fairfield, Ohio 45014
Principal Investigator: Kimberly Bonar, MD
Phone: 513-878-1003
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Fairfield, OH
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200 Medical Center Drive
Franklin, Ohio 45005
Principal Investigator: Juan Reina, MD
Phone: 513-878-1003
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Idaho Falls, Idaho 83404
Principal Investigator: Glenn Leavitt, MD
Phone: 208-709-3097
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Jackson, Tennessee 38301
Principal Investigator: Lolly Eldridge, MD
Phone: 731-660-8396
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Louisville, Kentucky 40207
Principal Investigator: Helen How, MD
Phone: 502-629-3396
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Mentor, Ohio 44060
Principal Investigator: Samir Ahuja, MD
Phone: 440-205-5870
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New Brunswick, New Jersey 08901
Principal Investigator: Todd Rosen, MD
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New Brunswick, New Jersey
Principal Investigator: Edwin Guzman, MD
Phone: 732-745-8600
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Newark, Delaware 19718
Principal Investigator: Anthony Sciscione, MD
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Plantation, Florida 33324
Principal Investigator: Jay Cohen, MD
Phone: 954-939-6479
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Saginaw, Michigan 48602
Principal Investigator: Jacquelyn Robinson, MD
Phone: 810-356-5170
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Salt Lake City, Utah 84088
Principal Investigator: James Roth, MD
Phone: 801-542-8190
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San Diego, California 92123
Principal Investigator: Craig Saffer, MD
Phone: 858-939-1504
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Silver Spring, Maryland 20910
Principal Investigator: Nihar Ganju, MD
Phone: 240-638-9150
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Voorhees, New Jersey 08043
Principal Investigator: Ronald Librizzi, DO
Phone: 856-341-8300
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