Investigation of the Impact of Noninvasive Prenatal Testing for Fetal Aneuploidy on Utilization of Prenatal Diagnostic Procedures and Pregnant Women's Views

Completed

• Conditions: High Risk Pregnancy

• Registration Number: NCT01708746
• Lead Sponsor: Verinata Health, Inc.

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 his/her 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 and/or 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

Not available

Study Timeline

• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-17
• Study Start: 2012-11
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 205

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Invasive prenatal procedures rate measure by the occurance of chorionic villus sampling (CVS) and/or amniocentesis	Enrolled women will be evaluated on or before Gestational Age: Wk 28	The primary objective of this study is to compare the rate of uptake of invasive prenatal procedures (chorionic villus sampling (CVS) or amniocentesis) between a prospectively enrolled cohort of pregnant women at high-risk for fetal aneuploidy who are offered noninvasive prenatal testing (NIPT; verifi® prenatal test) and a historical cohort matched for demographics and pre-test risk indications. The prospective group will include both those who accept NIPT and those who decline NIPT, but are willing to consent and complete a brief questionnaire.

Secondary Outcome Measures

Name	Time	Method
Preferences of pregnant women on prenatal testing by completion of preference questionnaire.	Evaluated at time of enrollment	The secondary objective is to collect views/preferences of pregnant women on prenatal testing for fetal chromosomal abnormalities and compare results of eligible women who accept versus those who decline NIPT during the enrollment period.

Trial Locations

Locations (2)

Southern California Kaiser Permanente Medical Group; 🇺🇸 Panorama City, California, United States

Southern California Kaiser Permanente Medical Center; 🇺🇸 Woodland Hills, California, United States