CClinicalTrials.gg
CompletedNCT05055700Updated Sep 29, 2025

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

An interventional study of Mobile app with prenatal genetic testing information in Pregnant Women, Mobile Applications and Genetic Testing, sponsored by Texas A&M University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Texas A&M University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2021, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
178
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Pregnant Women
  • Mobile Applications
  • Genetic Testing
  • Prenatal Care
03

In context

Lead sponsor

Texas A&M University is the lead sponsor of 123 studies on the registry; 23 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
178 participants (actual)

Study arms

  • Experimental
    Intervention group

    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

  • No intervention
    Control group

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

Interventions

  • BehavioralMobile 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.

06

What researchers measure

Primary outcomes

  1. Attitudes toward prenatal genetic testing

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

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

  2. Knowledge about prenatal genetic testing

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

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

  3. Decisional conflicts about prenatal genetic testing

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

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

  4. Uptake of prenatal genetic testing

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

    Time frame: Within one year after the intervention.

Secondary outcomes

  1. Psychological symptom [Anxiety]

    Measured by the 6-item sub-scale of Brief Symptom Inventory-18 about anxiety.

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

  2. Decision Self-Efficacy about prenatal genetic testing

    Measured by the modified 11-item Decision Self-Efficacy scale.

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

  3. Preparation for Decision Making about prenatal genetic testing

    Measured by the modified 7-item Preparation for Decision Making scale.

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

07

Study locations

1 site
  • Driscoll Children's hospital
    Corpus Christi, Texas 78412, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05055700
Lead sponsor
Texas A&M University
Collaborators
Driscoll Children's Hospital, Global Institute for Hispanic Health
Responsible party
Lei-Shih Chen (Professor, Texas A&M University) — Principal investigator
First posted
Sep 24, 2021
Start date
Mar 29, 2021
Primary completion
Jan 30, 2022
Completion
Apr 30, 2022
Last update
Sep 29, 2025

Study contacts

Lei-Shih Chen, PhD
principal investigator · Texas A&M University
Robin Page
principal investigator · Texas A&M University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion