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

NCT05055700 | Completed

• 1 other identifier: 0004459
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnant Women; Mobile Applications; Genetic Testing; Prenatal Care

Outcome Measures

Primary Outcomes (4)

• Attitudes toward prenatal genetic testing

  Measured by a 4-item scale that asks participants how they feel about prenatal genetic testing.

  From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.

• Knowledge about prenatal genetic testing

  Measured by 27 knowledge questions about prenatal genetic testing options' timing, procedures, and purposes.

  From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.

• Decisional conflicts about prenatal genetic testing

  Measured by the modified 5-item SURE Decisional Conflicts scale.

  From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.

• Uptake of prenatal genetic testing

  Participants' decisions on prenatal genetic testing by reviewing participants' medical charts.

  Within one year after the intervention.

Secondary Outcomes (3)

• Psychological symptom [Anxiety]

  From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.

• Decision Self-Efficacy about prenatal genetic testing

  From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.

• Preparation for Decision Making about prenatal genetic testing

  From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Mobile app with prenatal genetic testing information

Control group

NO INTERVENTION

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

Interventions

Mobile app with prenatal genetic testing information 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who:
• age over 18 years old;
• are able to speak, read and, write English or Spanish;
• are currently pregnant;
• have a smartphone with IOS or Android;
• are current prenatal patients in one of the prenatal clinics in the Driscoll Health System;
• 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).

You may not qualify if:

• Women who:
• are unable to speak, read, and write English or Spanish;
• do not own a smartphone with IOS or Android system.

Sponsors & Collaborators

• Texas A&M University: lead
• Driscoll Children's Hospital: collaborator
• Global Institute for Hispanic Health: collaborator

Study Sites (1)

Driscoll Children's hospital

Corpus Christi, Texas, 78412, United States

Location

Study Officials

• Lei-Shih Chen, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

• Robin Page

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: March 29, 2021
• Primary Completion: January 30, 2022
• Study Completion: April 30, 2022
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)