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

Study acronym: GEM
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  2. Minor Start date changed from estimate of Jan 13, 2025 to Jan 16, 2025v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06771453
Lead Sponsor Women and Infants Hospital of Rhode Island
Conditions
(from sponsor)
Aneuploidy, Genetic Counseling, Informed Consent, Decisional Conflict
Related terms Aneuploidy
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov