Ignite Creation Date:
2024-05-06 @ 12:59 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01708746
Status:
COMPLETED
Last Update Posted:
2014-09-26
First Post:
2012-10-15
Brief Title:
Investigation of the Impact of Noninvasive Prenatal Testing for Fetal Aneuploidy on Utilization of Prenatal Diagnostic Procedures and Pregnant Womens Views
Sponsor:
Verinata Health Inc
Organization:
Verinata Health Inc
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
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:
This is a prospective single-institution observational study to be conducted at 4 clinics within the Southern California Permanente Medical Group Pregnant women who present for prenatal genetic counseling at the designated clinics and who meet study eligibility criteria will be offered the option of the verifi prenatal test by a trained licensed and certified genetic counselor GC Women who elect the verifi prenatal test will have a blood sample drawn by peripheral venipuncture that will be sent to the Verinata Health CAP-accredited clinical laboratory Redwood City CA Results will be reported to the ordering health care provider by the laboratory within 8-10 business days and will be shared with the subject by their provider Subject care and decision-making following NIPT result will be clinically managed by the provider with hisher subject and is not dictated by the study protocol All eligible women who provide informed consent whether they elect or decline NIPT will be asked to complete a short questionnaire on their views of prenatal testing The uptake of invasive prenatal procedures CVS andor amniocentesis by the total prospective cohort will be collected through review of electronic medical records EMR A historical cohort with matched demographic and pre-test indications to the prospective cohort will be identified from the EMR for comparison in the primary analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None