Clinical trial NCT03767803: Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
Official title: Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Hypertension
Proteinuria in Pregnancy
Thrombocytopenia
Renal Insufficiency
Impaired Liver Function
Pulmonary Edema
Headache
Visual Impairment
Keywords: Hypertension
Proteinuria
Thrombocytopenia
Renal Insufficiency
Impaired Liver Function
Pulmonary Edema
Cerebral Symptoms
Visual Symptoms
Lead sponsor: Progenity, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 344
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of preeclampsia is determined by standard of care.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: West Coast Medical Research, Inc.
state: California
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Boca Raton
country: United States
facility: Women's Health Partners, LLC
state: Florida
city: Plantation
country: United States
facility: Discovery Clinical Research
state: Florida
city: Idaho Falls
country: United States
facility: Leavitt Clinical Research
state: Idaho
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Silver Spring
country: United States
facility: Obstetrics and Gynecology Associates AMB
state: Maryland
city: Saginaw
country: United States
facility: Valley OB-GYN Clinic, PC
state: Michigan
city: New Brunswick
country: United States
facility: Rutgers-RWJMS
state: New Jersey
city: New Brunswick
country: United States
facility: St. Peter's University Hospital
state: New Jersey
city: Voorhees
country: United States
facility: Virtua Voorhees Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: New Life Medical Esthetics and Wellness, PLLC
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Elkin
country: United States
facility: Total Woman Care
state: North Carolina
city: Cincinnati
country: United States
facility: David B. Schwartz, MD, LLC
state: Ohio
city: Fairfield
country: United States
facility: Obstetrics & Gynecology Associates, Inc.
state: Ohio
city: Franklin
country: United States
facility: Hilltop Obstetrics & Gynecology
state: Ohio
city: Mentor
country: United States
facility: Dr. Ahuja and Associates OB-GYN
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
city: Austin
country: United States
facility: Aa Ob-Gyn, Pllc
state: Texas
city: Austin
country: United States
facility: OB-GYN North
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Women's Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Advanced Clinical Research
state: Utah
Study officials:
affiliation: Progenity, Inc.
name: Peter Stiegler, PhD
role: STUDY_DIRECTOR
References: