Clinical Trial

GEM: Impact of a Video Education Tool on Decisional Conflict Among Prenatal Patients

Study acronym: GEM
Active, Not Recruiting
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Record status
This record was last updated September 18, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this randomized clinical trial is to assess the impact of a video educational tool on patient decisional conflict at the time when making a decision about prenatal genetic testing. The control group will receive standard prenatal care. The secondary aims include assessing the impact of the video educational tool versus standard care on pregnant participants': perception of likelihood of having a baby affected by a genetic problem, intended plan for genetic testing, patient-provider communication, retention of prenatal genetics knowledge, and perception of genetic data privacy. Participants will be asked to: 1. Watch video education (if randomized to this group) and complete a baseline survey at their dating ultrasound regarding knowledge of prenatal genetics, prior experiences, and demographics 2. Complete a follow up survey after seeing their prenatal care provider regarding: decisional conflict scale with respect to prenatal genetic testing decision (primary outcome), perception of likelihood of having a baby affected by a genetic problem (secondary outcome) and the type of genetic testing chosen (secondary outcome). 3. Complete a second follow up survey six to ten weeks from the second survey to assess: Provider patient communication, retention of genetics knowledge, patient recollection of testing performed, and self-reported out of pocket cost related to genetic testing.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-01-09; most recent amendment 2025-09-17.
Status change: Recruiting → Active, Not Recruiting 2025-09-17
Status change: Not Yet Recruiting → Recruiting 2025-01-21
Trial Details
NCT Number NCT06771453
Lead Sponsor Women and Infants Hospital of Rhode Island
Conditions Aneuploidy, Genetic Counseling, Informed Consent, Decisional Conflict
Enrollment 140 participants
Start Date 2025-01-16
Primary Completion 2025-10 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-09-18