Pregnant Women s Views About the Ethics of Prenatal Whole Genome Sequencing

Background:

Prenatal whole genome sequencing (PWGS) will give expecting parents large amounts of genetic data about their baby. This raises ethical concerns. Researchers want to find out if women want access to the kind of data PWGS provides. They want to know why and under what circumstances women would or would not want the data.

Objective:

To explore the views of pregnant women about possible use of PWGS. To find out whether they would want different categories of genetic data, and how they would use such findings.

Eligibility:

Women ages 18 and older who pregnant and speak English or Spanish

Design:

Participants will be recruited by their doctors.

Participants will take a survey about their views of PWGQ. They may take it online or on paper.

Study Overview

• Status: Completed
• Conditions: Pregnant

Detailed Description

The impending implementation of prenatal whole genome sequencing (PWGS) raises a host of ethical concerns given the massive amounts of genetic information that expecting parents will be able to learn about their baby. This project involves a cross-sectional quantitative survey of pregnant women to explore whether they want access to the kinds of information provided by PWGS, why and under what circumstances. The survey will address questions such as: What sorts of information do pregnant women want to know about their baby, and why? What, if anything, would they do with the information? What kind of guidance would pregnant women like from their medical team regarding fetal genetic testing? Given the range of practical and ethical challenges posed by PWGS, our data will inform practitioners approaches towards PWGS as the technology develops and becomes more widely available. It is imperative that government regulators and professional societies take into account the views of people directly affected by any policies that are created - including patients themselves - before crafting rules for whether, when and how to utilize PWGS.

• Study Type: Observational
• Enrollment (Actual): 553

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women.

Description

• INCLUSION CRITERIA:
• Participants must be 18 years of age
• Participants must be pregnant
• Participants must speak English or Spanish

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pregnant women; Women who are pregnant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Views of pregnant women	This study seeks to explore the views of pregnant women about the hypothetical utility of PWGS, whether they would want different categories of genetic information, and how they would anticipate using such findings.	at baseline

Collaborators and Investigators

• Sponsor: National Human Genome Research Institute (NHGRI)
• Investigators: Principal Investigator: Benjamin E Berkman, J.D., National Human Genome Research Institute (NHGRI)

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): February 12, 2018
• Study Completion (Actual): April 10, 2019

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Prenatal Testing
• Other Study ID Numbers: 999917080; 17-HG-N080