AneuploidyGEMNCT06771453
GEM: Impact of a Video Education Tool on Decisional Conflict Among Prenatal Patients
A study testing Video Educational Tool Regarding Prenatal Genetics in people with Aneuploidy and Genetic Counseling, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aneuploidy, Genetic Counseling, Informed Consent
- What is being tested?
- Video Educational Tool Regarding Prenatal Genetics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
Participants will be asked to:
- 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
- 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).
- 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.
- Conditions
- Aneuploidy, Genetic Counseling, Informed Consent, Decisional Conflict
- Being tested
- Video Educational Tool Regarding Prenatal Genetics
- Medical subject headings
- Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Educational Tool Regarding Prenatal GeneticsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Prenatal Care | No intervention | The patient will receive routine prenatal care with no video education. |
| Video Educational Tool Arm | Experimental | The patient receives routine prenatal care plus video education on prenatal genetics. Receives: Other: Video Educational Tool Regarding Prenatal Genetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
Secondary outcomes (5)
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]).
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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)
Measured: Six to ten weeks from follow up survey #1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start16 Jan 2025
- Primary completionOct 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneuploidyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771453
- Sponsor's protocol ID
- 1721550
- Acronym
- GEM
- Status last verified
- Sep 2025
- First submitted
- 27 Nov 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06771453
- Acronym / sponsor ID
- GEM / 1721550
- Conditions
- Aneuploidy, Genetic Counseling, Informed Consent, Decisional Conflict
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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).
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Prenatal Care | No intervention | –The patient will receive routine prenatal care with no video education. |
| Video Educational Tool Arm | Experimental | Other: Video Educational Tool Regarding Prenatal GeneticsThe patient receives routine prenatal care plus video education on prenatal genetics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Educational Tool Regarding Prenatal GeneticsVideo 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. | Other | Video Educational Tool Arm |
Primary outcome
Score on Decisional Conflict Scale (low health literacy version of the tool)
Time frame: After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
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).
5 secondary outcomes
Perception of likelihood of having a baby affected by a genetic problem
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
Time frame: After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
Patient-provider communication
Time frame: Six to ten weeks from follow up survey #1
Retention of Prenatal Genetics Knowledge
Time frame: Six to ten weeks from follow up survey #1
Perception of genetic data privacy
Time frame: Six to ten weeks from follow up survey #1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Educational Tool Regarding Prenatal Genetics in people with Aneuploidy and Genetic Counseling, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Decisional Conflict Scale (low health literacy version of the tool) (time frame: After enrollment and up to 14 days after their first obstetric appointment in that pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.