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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03767803
• Other study ID #: PRO-129-PREECLAMPSIA
• Status: Active, not recruiting
• Start date: October 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2020
• Source: Progenity, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 344
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Headache
• Hypertension
• Impaired Liver Function
• Pre-Eclampsia
• Proteinuria
• Proteinuria in Pregnancy
• Pulmonary Edema
• Renal Insufficiency
• Thrombocytopenia
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Other:
• Non-interventional study
This is an observational, non-interventional study.

Locations

Country	Name	City	State
United States	Aa Ob-Gyn, Pllc	Austin	Texas
United States	OB-GYN North	Austin	Texas
United States	Women's Health Partners, LLC	Boca Raton	Florida
United States	New Life Medical Esthetics and Wellness, PLLC	Brooklyn	New York
United States	David B. Schwartz, MD, LLC	Cincinnati	Ohio
United States	Corpus Christi Women's Clinic	Corpus Christi	Texas
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	Leavitt Clinical Research	Idaho Falls	Idaho
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	Norton Healthcare	Louisville	Kentucky
United States	Dr. Ahuja and Associates OB-GYN	Mentor	Ohio
United States	Rutgers-RWJMS	New Brunswick	New Jersey
United States	St. Peter's University Hospital	New Brunswick	New Jersey
United States	Columbia University	New York	New York
United States	Christiana Care	Newark	Delaware
United States	Drexel University	Philadelphia	Pennsylvania
United States	Discovery Clinical Research	Plantation	Florida
United States	Valley OB-GYN Clinic, PC	Saginaw	Michigan
United States	Advanced Clinical Research	Salt Lake City	Utah
United States	West Coast Medical Research, Inc.	San Diego	California
United States	Obstetrics and Gynecology Associates AMB	Silver Spring	Maryland
United States	Virtua Voorhees Hospital	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Progenity, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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