NCT03105492

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
553

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

April 7, 2017

Last Update Submit

April 19, 2019

Conditions

Pregnant

Keywords

Prenatal Testing

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Pregnant women

Women who are pregnant

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Study Officials

  • Benjamin E Berkman, J.D.

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 10, 2017

Study Start

June 15, 2017

Primary Completion

February 12, 2018

Study Completion

April 10, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations

US(1)