Ensuring Patients' Informed Access to Noninvasive Prenatal Testing
United States691 participantsStarted 2018-02-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age or older
✓. Present for their initial prenatal visit care with one of the providers enrolled in the study
✓. Able to provide consent to participate in the study
✓. Available for a follow up in the 1st or 2nd trimester of pregnancy
✓. Have a viable intrauterine pregnancy
✓. Present for care between 7-12 weeks estimated gestation age (EGA)
Exclusion criteria
✕. Less than 18 years of age
✕. Not currently pregnant or an intrauterine pregnancy has not yet been established
✕. Inability to provide informed consent for research participation
✕. 18 years of age or older
✕. The male or female partner (such as partner or mother/aunt/grandmother serving in the role of primary collaborative decision-maker in place of a partner) of a pregnant woman who has participated in the research