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

• Sponsor: Progenity, Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03767803
• Collaborator: (none)
• Enrollment: 344
• Locations: 24
• Anticipated Duration (Months): 27
• Patients Per Site: 14.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pre-Eclampsia; Hypertension; Proteinuria in Pregnancy; Thrombocytopenia; Renal Insufficiency; Impaired Liver Function; Pulmonary Edema; Headache; Visual Impairment	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 Design

• Study Type: Observational
• Anticipated Enrollment: 344 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers
• Actual Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Progenity, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Progenity, Inc.
• ClinicalTrials.gov Identifier: NCT03767803
• Other Study ID Numbers: PRO-129-PREECLAMPSIA
• First Posted: Dec 7, 2018
• Last Update Posted: Jan 23, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Progenity, Inc.: Hypertension; Proteinuria; Thrombocytopenia; Renal Insufficiency; Impaired Liver Function; Pulmonary Edema; Cerebral Symptoms; Visual Symptoms
• Additional relevant MeSH terms: Pulmonary Edema; Vision Disorders; Vision, Low; Pre-Eclampsia; Renal Insufficiency; Eclampsia; Proteinuria; Hypertension; Thrombocytopenia; Headache

Study Results

No Results Posted as of Jan 23, 2020