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Completed

NCT Number: NCT05055700

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

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.

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Key information

Conditions

Pregnant Women Genetic Testing Mobile Applications Prenatal Care

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Driscoll Children's hospital

Corpus Christi, Texas, 78412, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

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).

Exclusion criteria

-

Women who:

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

Treatment and study plan

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.

Primary outcomes

  1. Attitudes toward prenatal genetic testing

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

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

  2. Knowledge about prenatal genetic testing

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

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

  3. Decisional conflicts about prenatal genetic testing

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

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

  4. Uptake of prenatal genetic testing

    Time frame: Within one year after the intervention.

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

Secondary outcomes

  1. Psychological symptom [Anxiety]

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

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

  2. Decision Self-Efficacy about prenatal genetic testing

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

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

  3. Preparation for Decision Making about prenatal genetic testing

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

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

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Driscoll Children's Hospital
  • Global Institute for Hispanic Health

Registry information

Official study title

Assessing the Impact of a Mobile App on Pregnant Women's Perceptions, Knowledge, and Uptake of Prenatal Genetic Testing

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2021
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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