Pregnant WomenNCT05055700

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

A study testing Mobile app with prenatal genetic testing information in people with Pregnant Women and Mobile Applications, run by Texas A&M University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pregnant Women, Mobile Applications, Genetic Testing
What is being tested?: Mobile app with prenatal genetic testing information
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 178 participants
Where: 1 siteUnited States
Study dates: 29 Mar 2021to 30 Apr 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Driscoll Children's hospital
Corpus Christi, Texas, 78412

Other trials in United States

About this study

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

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
Being tested: Mobile app with prenatal genetic testing information

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mobile app with prenatal genetic testing informationBehavioural
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.

Study groups in NCT05055700
Study group	Role	What they receive
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. Receives: Behavioral: Mobile app with prenatal genetic testing information
Control group	No intervention	This arm will only receive usual care - visit maternal-fetal medicine specialists.

What is being measured

The primary outcome is the main question the study is designed to answer.

Attitudes toward prenatal genetic testing
Measured by a 4-item scale that asks participants how they feel about prenatal genetic testing.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within one year after the intervention.

Secondary outcomes (3)

Psychological symptom [Anxiety]
Measured by the 6-item sub-scale of Brief Symptom Inventory-18 about anxiety.
Measured: From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.
Decision Self-Efficacy about prenatal genetic testing
Measured by the modified 11-item Decision Self-Efficacy scale.
Measured: 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
Measured by the modified 7-item Preparation for Decision Making scale.
Measured: From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 202130 Apr 2022

First posted24 Sep 2021
Study start29 Mar 2021
Primary completion30 Jan 2022
Study completion30 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pregnant WomenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 178 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05055700
Sponsor's protocol ID: 0004459
Status last verified: Sep 2025
First submitted: 14 Sep 2021
Last updated: 29 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge

All Pregnant Women trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Impact of a Mobile App on Pregnant Women's Perceptions, Knowledge, and Uptake of Prenatal Genetic Testing
ClinicalTrials.gov ID: NCT05055700
Acronym / sponsor ID: 0004459
Conditions: Pregnant Women, Mobile Applications, Genetic Testing, Prenatal Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 178 participants (actual)
Lead sponsor: Texas A&M UniversityUniversity, hospital or other
Collaborators: Driscoll Children's Hospital, Global Institute for Hispanic Health
Study start: 29 Mar 2021 (actual)
Primary completion: 30 Jan 2022 (actual)
Study completion: 30 Apr 2022 (actual)
First posted: 24 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Intervention group	Experimental	Behavioral: Mobile app with prenatal genetic testing informationThis arm will review a mobile app to learn information about prenatal genetic testing before their appointment with maternal-fetal medicine specialists.
Control group	No intervention	–This arm will only receive usual care - visit maternal-fetal medicine specialists.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mobile app with prenatal genetic testing informationIn 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.	Behavioural	Intervention group

Primary outcome

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.
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.
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.
Uptake of prenatal genetic testing
Time frame: Within one year after the intervention.
Participants' decisions on prenatal genetic testing by reviewing participants' medical charts.

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Pregnant Women

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lei-Shih Chen, PhD principal investigator

Texas A&M University

Robin Page principal investigator

Texas A&M University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mobile app with prenatal genetic testing information in people with Pregnant Women and Mobile Applications, run by Texas A&M University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attitudes toward prenatal genetic testing (time frame: From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05055700.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.