Pregnant Women Clinical Trial
Official title:
Assessing the Impact of a Mobile App on Pregnant Women's Perceptions, Knowledge, and Uptake of Prenatal Genetic Testing
NCT number | NCT05055700 |
Other study ID # | 0004459 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2021 |
Est. completion date | December 1, 2022 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Driscoll Children's hospital | Corpus Christi | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas A&M University | Driscoll Children's Hospital, Global Institute for Hispanic Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | Uptake of prenatal genetic testing | Participants' decisions on prenatal genetic testing by reviewing participants' medical charts. | Within one year after the intervention. | |
Secondary | Psychological symptom [Anxiety] | Measured by the 6-item sub-scale of Brief Symptom Inventory-18 about anxiety. | From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists. | |
Secondary | Decision Self-Efficacy about prenatal genetic testing | Measured by the modified 11-item Decision Self-Efficacy scale. | From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists. | |
Secondary | Preparation for Decision Making about prenatal genetic testing | Measured by the modified 7-item Preparation for Decision Making scale. | From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists. |
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