Admin. Supplement to: Ensuring Patients' Informed Access to Noninvasive Prenatal Testing

  • Funded by National Institutes of Health (NIH)
  • Total publications:0 publications

Grant number: 3R01HG010092-04S1

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2017
    2021
  • Known Financial Commitments (USD)

    $223,677
  • Funder

    National Institutes of Health (NIH)
  • Principal Investigator

    Ruth Farrell
  • Research Location

    United States of America
  • Lead Research Institution

    Cleveland Clinic Lerner Com-Cwru
  • Research Priority Alignment

    N/A
  • Research Category

    Clinical characterisation and management

  • Research Subcategory

    Supportive care, processes of care and management

  • Special Interest Tags

    N/A

  • Study Type

    Non-Clinical

  • Clinical Trial Details

    N/A

  • Broad Policy Alignment

    Pending

  • Age Group

    Adults (18 and older)

  • Vulnerable Population

    Pregnant women

  • Occupations of Interest

    Unspecified

Abstract

PROJECT Abstract: Prenatal genetic screening tests and diagnostic tests (referred to as prenatal genetic tests) are a fundamental component of the delivery of high-quality, evidence-based prenatal care. Current guidelines recommend that prenatal genetic tests should be offered to all pregnant patients to optimize obstetric outcomes, ideally offered early in pregnancy so that patients can make formative decisions about their prenatal care. Delay in access and utilization of prenatal genetic tests can have significant implications for pregnancy outcomes. The COVID-19 pandemic is an urgent clinical problem that has emerged with the potential to jeopardize women's access to genetic tests. Currently, it is not known how COVID-19 may impact pregnant women's access to and utilization of these critical tests. This includes concern not just for those pregnant women who become severely ill with COVID-19 but also those who fear exposure to SARS-CoV-2 by presenting to a healthcare facility have genetic testing by means of a blood draw or ultrasound-based procedure. The goal of this study is to study the effect of COVID-19 on prenatal healthcare delivery, specifically patients' ability to access prenatal genetic screen-ing and diagnostic tests in an informed and evidence-based fashion. By doing so, we will identify serious short term health issues for women, children, and families resulting from this pandemic and readily-deployable and scalable solutions to ensure women's informed access to high-quality prenatal care during future public health crises. This study is significant as its findings will lead to system-level improvements to support pregnant patients' informed access to prenatal genetic tests for the duration of the pandemic and future public health emergencies of similar magnitude. Additionally, this study will increase the impact of theNEST R01, providing an in-depth understanding of how COVID-19 affects shared decision-making, informed consent, and patient satisfaction regarding prenatal genetic testing decisions. In doing so, this proposal dove-tails with the objectives of the parent R01 to ensure that patients have informed access to advances in prenatal genetic technologies as crucial metrics of prenatal healthcare safety, access, and quality.