Ensuring Patients' Informed Access to Noninvasive Prenatal Testing

Summary

Noninvasive prenatal genetic testing (NIPT) is an important new screening test option provided to pregnant women in the first trimester of pregnancy. The advantage of this screen is that is provides information about the risk of trisomy 13, trisomy 18, and trisomy 21 with greater accuracy than conventional screens. At the same time, NIPT can produce information about the risk of a cohort of other fetal genetic variants, including sex chromosome aneuploidies and microdeletion syndromes. While not yet clinically available for whole exome sequencing, the potential for this next clinical application already exists. The challenge is that, while this is an important new test, there are little data about how to best structure patient-centered decisions about NIPTs use, including decisions if to use this screen and how the information may directly inform subsequent prenatal care decisions. The purpose of this study is to gain formative data about current practice patterns with respect to how NIPT is discussed in the clinical visit and to use these data to help inform best practices for NIPTs continued use in the clinical setting.

Conditions

• Genetic Disease
• Genetic Syndrome
• Prenatal Disorder
• Prenatal Maternal Abnormality
• Pregnancy Complications

Interventions

BEHAVIORAL

NEST

This is a point-of-care shared decision-making instrument.

BEHAVIORAL

Usual care

This group will utilize usual care with respect to healthcare provider practice for education and counseling.

Sponsors & Collaborators

• Indiana University

  collaborator OTHER

• National Human Genome Research Institute (NHGRI)

  collaborator NIH

• The Cleveland Clinic

  lead OTHER

Principal Investigators

• Ruth M Farrell, M.D., M.A. · The Cleveland Clinic

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-19

Primary Completion

2022-04-30

Completion

2023-06-15

Countries

• United States

Study Locations