Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
- Conditions
- Proteinuria in PregnancyImpaired Liver FunctionPre-EclampsiaHypertensionThrombocytopeniaRenal InsufficiencyPulmonary EdemaHeadacheVisual Impairment
- Interventions
- Other: Non-interventional study
- Registration Number
- NCT03767803
- Lead Sponsor
- Progenity, Inc.
- Brief Summary
Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 344
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Positive Preeclampsia group Non-interventional study A group with diagnosis of preeclampsia within 24 hours of testing and pre-term delivery Study Cohort Non-interventional study A group without diagnosis of preeclampsia. Also includes a group without diagnosis of preeclampsia within 24 hours of testing, but who have subsequent worsening or re-emergence of signs and symptoms of preeclampsia, and are later diagnosed with preeclampsia and have pre-term delivery.
- Primary Outcome Measures
Name Time Method Diagnosis of preeclampsia is determined by standard of care. 3 months Observational, non-interventional sample procurement study in which participants are treated per standard of care
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
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
Norton Healthcare
🇺🇸Louisville, Kentucky, United States
Discovery Clinical Research
🇺🇸Plantation, Florida, United States
Leavitt Clinical Research
🇺🇸Idaho Falls, Idaho, 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
Virtua Voorhees Hospital
🇺🇸Voorhees, New Jersey, United States
St. Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
New Life Medical Esthetics and Wellness, PLLC
🇺🇸Brooklyn, New York, United States
Columbia University
🇺🇸New York, New York, United States
David B. Schwartz, MD, LLC
🇺🇸Cincinnati, Ohio, United States
Total Woman Care
🇺🇸Elkin, North Carolina, 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
The Jackson Clinic, PA
🇺🇸Jackson, Tennessee, United States
Aa Ob-Gyn, Pllc
🇺🇸Austin, Texas, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Corpus Christi Women's Clinic
🇺🇸Corpus Christi, Texas, United States
OB-GYN North
🇺🇸Austin, Texas, United States
Advanced Clinical Research
🇺🇸Salt Lake City, Utah, United States