Impact of a video tool on prenatal decision-making
The GEM Trial - Genetics Education and Equity in Maternal Fetal Medicine: A Pilot Feasibility Randomized Controlled Trial to Assess Impact of a Video Education Tool (VET) on Decisional Conflict Among Prenatal Patients
This study tests if a video tool can help pregnant patients feel more confident and informed when making decisions about genetic testing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06771453 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates how a video educational tool influences decisional conflict among pregnant patients considering prenatal genetic testing. Participants are randomly assigned to either receive the video tool or standard prenatal care. The study measures various outcomes, including patients' understanding of genetic testing, communication with healthcare providers, and their perceptions of genetic data privacy. Surveys are conducted before and after the intervention to assess changes in knowledge and decision-making confidence.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals over 18 years old, fluent in English or Spanish, and within 24 weeks of gestation without prior genetic screening during the current pregnancy.
Not a fit: Patients with diagnosed fetal anomalies or those who have undergone genetic counseling in this pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient understanding and reduce anxiety related to prenatal genetic testing decisions.
How similar studies have performed: Other studies have shown that educational interventions can improve patient understanding and decision-making in healthcare settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient ≥ 18 years of age * Preferred language English or Spanish * Singleton pregnancy * No documentation of genetic screening results or counseling during this pregnancy * Gestational age \<24 weeks Exclusion Criteria: * Diagnosed with a fetal anomaly * Diagnosed with known abnormal nuchal translucency test * Diagnosed with fetal loss * Use of a donor oocyte (egg) this pregnancy * Prior involvement in other research study regarding prenatal genetic testing in the past two years
Where this trial is running
Providence, Rhode Island
- Women and Infants — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Margaret M Thorsen, MD
- Email: mthorsen@wihri.org
- Phone: 401-274-1122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.