An interventional study of Video Educational Tool Regarding Prenatal Genetics in Aneuploidy, Genetic Counseling and Informed Consent, sponsored by Women and Infants Hospital of Rhode Island. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Other
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:
73 studies on the registry are indexed under Aneuploidy; 10 are open to participants now.
This study's planned enrollment of 140 is below the median of 200 across 34 interventional studies indexed under Aneuploidy.
Browse Aneuploidy studies →Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The patient will receive routine prenatal care with no video education.
The patient receives routine prenatal care plus video education on prenatal genetics.
Other: Video Educational Tool Regarding Prenatal Genetics
Video education about prenatal genetics will include content regarding aneuploidy screening and diagnostic testing options, how to make a values-based choice, and specifics of risks/benefits/limitations of each type of testing option.
Score on Decisional Conflict Scale (low health literacy version of the tool)
The investigators will assess the decisional conflict scale score around the time when patients make a decision about prenatal genetic screening options. The resulting score ranges from 0 to 100, with 0 indicating no decisional conflict (best outcome) and 100 indicating extremely high decisional conflict (worst outcome).
Time frame: After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
Perception of likelihood of having a baby affected by a genetic problem
The investigators will use a Likert scale to assess patient's perception of likelihood of having a baby affected by a genetic problem (score ranges from 1 \[not likely at all\] to 4 \[very likely\]).
Time frame: After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
Percent of patients opting to pursue genetic testing
The investigators will assess the percent of participants who decide to pursue screening or diagnostic genetic testing options
Time frame: After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
Patient-provider communication
The investigators will use a modified doctor-patient communication questionnaire to assess how patients perceived communication and comprehension of counseling with their prenatal care provider (score 0 to 8, with higher score reflecting better communication).
Time frame: Six to ten weeks from follow up survey #1
Retention of Prenatal Genetics Knowledge
The investigators will assess prenatal genetics knowledge remote from the intervention to assess retention of its content (score 0 to 12 with a higher score reflecting more knowledge). The questionnaire was created by the investigators. It is six questions that query the participants on key content highlighted in the educational intervention; the content covered is also considered standard of care to receive in counseling in routine prenatal care (for those who were not randomized to the intervention).
Time frame: Six to ten weeks from follow up survey #1
Perception of genetic data privacy
The investigators will assess on a Likert scale how important privacy of participants' own genetic data and that of their baby were in making a decision about prenatal genetic testing (score 0 to 8 with higher score reflecting more importance)
Time frame: Six to ten weeks from follow up survey #1
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Women and Infants Hospital of Rhode Island