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

High Risk Pregnancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708746
• Other study ID #: VER-0008
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: September 24, 2014
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2014
• Source: Verinata Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• High Risk Pregnancy

Locations

Country	Name	City	State
United States	Southern California Kaiser Permanente Medical Group	Baldwin Park	California
United States	Southern California Kaiser Permanente Medical Group	Los Angeles	California
United States	Southern California Kaiser Permanente Medical Group	Panorama City	California
United States	Southern California Kaiser Permanente Medical Center	Woodland Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Verinata Health, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012 May — View Citation

Sehnert AJ, Rhees B, Comstock D, de Feo E, Heilek G, Burke J, Rava RP. Optimal detection of fetal chromosomal abnormalities by massively parallel DNA sequencing of cell-free fetal DNA from maternal blood. Clin Chem. 2011 Jul;57(7):1042-9. doi: 10.1373/cli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive prenatal procedures rate measure by the occurance of chorionic villus sampling (CVS) and/or amniocentesis	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.	Enrolled women will be evaluated on or before Gestational Age: Wk 28	No
Secondary	Preferences of pregnant women on prenatal testing by completion of preference questionnaire.	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.	Evaluated at time of enrollment	No