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

September 24, 2014 updated by: Verinata Health, Inc.
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • 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 Group
      • Woodland Hills, California, United States, 91367
        • Southern California Kaiser Permanente Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Enrolled subjects
Historic control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preferences of pregnant women on prenatal testing by completion of preference questionnaire.
Time Frame: Evaluated at time of enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verinata Health, Inc.

Investigators

  • Principal Investigator: George E Tiller, MD, PhD, Kaiser Permanente, Dept Genetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (Estimate)

October 17, 2012

Study Record Updates

Last Update Posted (Estimate)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • VER-0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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