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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Verinata Health, Inc.
ClinicalTrials.gov Identifier:
NCT01708746
First received: October 15, 2012
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition
High Risk Pregnancy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Verinata Health, Inc.:

Primary Outcome Measures:
  • Invasive prenatal procedures rate measure by the occurance of chorionic villus sampling (CVS) and/or amniocentesis [ Time Frame: Enrolled women will be evaluated on or before Gestational Age: Wk 28 ] [ Designated as safety issue: No ]
    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:
  • Preferences of pregnant women on prenatal testing by completion of preference questionnaire. [ Time Frame: Evaluated at time of enrollment ] [ Designated as safety issue: No ]
    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.


Enrollment: 205
Study Start Date: November 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Enrolled subjects
Historic control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population is comprised of pregnant women at least 18 years of age, who meet the inclusion criteria but none of the exclusion criteria described below. Women who present for prenatal genetic counseling at one of the designated study clinics will be recruited.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708746

Locations
United States, California
Southern California Kaiser Permanente Medical Group
Baldwin Park, California, United States, 91706
Southern California Kaiser Permanente Medical Group
Los Angeles, California, United States, 90027
Southern California Kaiser Permanente Medical Group
Panorama City, California, United States, 94102
Southern California Kaiser Permanente Medical Center
Woodland Hills, California, United States, 91367
Sponsors and Collaborators
Verinata Health, Inc.
Investigators
Principal Investigator: George E Tiller, MD, PhD Kaiser Permanente, Dept Genetics