Impact of a Mobile App on Pregnant Women's Prenatal Genetic Testing Decision-making

NCT ID: NCT05055700

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2022-04-30

Brief Summary

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Determine the effect of a culturally sensitive prenatal genetic testing (PGT) education intervention delivered via a mobile application on pregnant women's perceptions, knowledge, and uptake of PGT. Our working hypothesis, based on prior studies, is that pregnant women who receive a culturally sensitive intervention to enhance their knowledge and understanding of PGT will feel more confident in their decision-making regarding PGT.

Detailed Description

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Conditions

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Pregnant Women Mobile Applications Genetic Testing Prenatal Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intervention group

This arm will review a mobile app to learn information about prenatal genetic testing before their appointment with maternal-fetal medicine specialists.

Group Type EXPERIMENTAL

Mobile app with prenatal genetic testing information

Intervention Type BEHAVIORAL

In the intervention group, participants will be asked to download, register, and review a mobile app on their own mobile phones before their appointment with maternal-fetal medicine specialists. This mobile app includes prenatal genetic testing information about amniocentesis, chorionic villus sampling, nuchal translucency screening, cell-free DNA, triple/quad/penta screening, anatomy ultrasound, and carrier screening.

Control group

This arm will only receive usual care - visit maternal-fetal medicine specialists.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile app with prenatal genetic testing information

In the intervention group, participants will be asked to download, register, and review a mobile app on their own mobile phones before their appointment with maternal-fetal medicine specialists. This mobile app includes prenatal genetic testing information about amniocentesis, chorionic villus sampling, nuchal translucency screening, cell-free DNA, triple/quad/penta screening, anatomy ultrasound, and carrier screening.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Women who:

1. age over 18 years old;
2. are able to speak, read and, write English or Spanish;
3. are currently pregnant;
4. have a smartphone with IOS or Android;
5. are current prenatal patients in one of the prenatal clinics in the Driscoll Health System;
6. were referred to the clinic because they are at high risk of having a baby with genetic conditions (e.g., advanced maternal age, family history, history of delivering affected baby, abnormal blood or ultrasound screening results).

Exclusion Criteria

Women who:

1. are unable to speak, read, and write English or Spanish;
2. do not own a smartphone with IOS or Android system.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Driscoll Children's Hospital

OTHER

Sponsor Role collaborator

Global Institute for Hispanic Health

UNKNOWN

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

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Lei-Shih Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lei-Shih Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Robin Page

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

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Driscoll Children's hospital

Corpus Christi, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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0004459

Identifier Type: -

Identifier Source: org_study_id

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