Investigation of the Impact of Noninvasive Prenatal Testing for Fetal Aneuploidy on Utilization of Prenatal Diagnostic Procedures and Pregnant Women's Views
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/16/2013 |
| Start Date: | November 2012 |
| Contact: | Amy Sehnert, MD |
| Email: | asehnert@verinata.com |
| Phone: | 650-503-5213 |
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.
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)
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