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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Renal Insufficiency; Thrombocytopenia; Headache; Pre-Eclampsia; Pulmonary Edema; Visual Impairment; Impaired Liver Function; Proteinuria in Pregnancy
• Intervention / Treatment: Other: Non-interventional study

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.

• Study Type: Observational
• Enrollment (Anticipated): 344

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • West Coast Medical Research, Inc.
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care
  • Florida
    • Boca Raton, Florida, United States, 33433
      • Women's Health Partners, LLC
    • Plantation, Florida, United States, 33324
      • Discovery Clinical Research
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Leavitt Clinical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Healthcare
  • Maryland
    • Silver Spring, Maryland, United States, 20910
      • Obstetrics and Gynecology Associates AMB
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Valley Ob-Gyn Clinic, PC
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers-RWJMS
    • New Brunswick, New Jersey, United States, 08901
      • St. Peter's University Hospital
    • Voorhees, New Jersey, United States, 08043
      • Virtua Voorhees Hospital
  • New York
    • Brooklyn, New York, United States, 11220
      • New Life Medical Esthetics and Wellness, PLLC
    • New York, New York, United States, 10032
      • Columbia University
  • North Carolina
    • Elkin, North Carolina, United States, 28621
      • Total Woman Care
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • David B. Schwartz, MD, LLC
    • Fairfield, Ohio, United States, 45014
      • Obstetrics & Gynecology Associates, Inc.
    • Franklin, Ohio, United States, 45005
      • HillTop Obstetrics & Gynecology
    • Mentor, Ohio, United States, 44060
      • Dr. Ahuja and Associates OB-GYN
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic, PA
  • Texas
    • Austin, Texas, United States, 78758
      • Aa Ob-Gyn, Pllc
    • Austin, Texas, United States, 78758
      • OB-GYN North
    • Corpus Christi, Texas, United States, 78412
      • Corpus Christi Women's Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Advanced Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive Preeclampsia group; A group with diagnosis of preeclampsia within 24 hours of testing and pre-term delivery	Other: Non-interventional study; This is an observational, non-interventional study.
Study Cohort; 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.	Other: Non-interventional study; This is an observational, non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of preeclampsia is determined by standard of care.	Observational, non-interventional sample procurement study in which participants are treated per standard of care	3 months

Collaborators and Investigators

• Sponsor: Progenity, Inc.
• Investigators: Study Director: Peter Stiegler, PhD, Progenity, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Hypertension; Renal Insufficiency; Proteinuria; Thrombocytopenia; Pulmonary Edema; Impaired Liver Function; Cerebral Symptoms; Visual Symptoms
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Lung Diseases; Kidney Diseases; Urologic Diseases; Eye Diseases; Urological Manifestations; Pain; Neurologic Manifestations; Hematologic Diseases; Urination Disorders; Pregnancy Complications; Blood Platelet Disorders; Sensation Disorders; Hypertension, Pregnancy-Induced; Hypertension; Proteinuria; Renal Insufficiency; Headache; Eclampsia; Pre-Eclampsia; Thrombocytopenia; Pulmonary Edema; Vision, Low; Vision Disorders
• Other Study ID Numbers: PRO-129-PREECLAMPSIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No