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

Verinata Health

Status: Completed

Conditions: High Risk Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT01708746

VER-0008

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age 18 years or older at enrollment
• Clinically confirmed singleton pregnancy
• Gestational age between 10 weeks, 0 days and 20 weeks, 0 days
• Referred for prenatal genetic counseling due to increased risk for fetal aneuploidy (advanced maternal age (AMA ≥ 35 years at delivery, high-risk prenatal screen result, abnormal fetal ultrasound finding consistent with fetal aneuploidy, and/or history of prior affected pregnancy for fetal aneuploidy)
• Pregnancy records accessible and available for data collection (e.g., results from screening, ultrasound examinations, invasive prenatal procedures if performed, and infant hospital discharge exam)
• Able to provide consent for participation using language-appropriate forms

Exclusion Criteria

• Invasive prenatal procedure (amniocentesis or CVS) already performed
• History of demised or vanished co-twin (spontaneous or following in vitro fertilization)

Trial design

205 participants in 2 patient groups

Enrolled subjects

Historic control