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

NCT01708746 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 205

Last updated 2014-09-26

No results posted yet for this study

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.

Conditions

  • High Risk Pregnancy

Sponsors & Collaborators

  • Verinata Health, Inc.

    lead INDUSTRY

Principal Investigators

  • George E Tiller, MD, PhD · Kaiser Permanente, Dept Genetics

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01708746 on ClinicalTrials.gov