Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-30 @ 2:52 PM
Study NCT ID:
NCT03767803
Status:
UNKNOWN
Last Update Posted:
2020-01-23
First Post:
2018-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
Sponsor:
Progenity, Inc.
Organization:
Study Overview
Official Title:
Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: