Genetic CounselingNCT07077707
Prenatal Genetics Chatbot Trial: Prenatal GENEie
A study testing Prenatal GENEie Chatbot and In-person genetic counseling in people with Genetic Counseling, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
During pregnancy, all pregnant people are offered tests to look for genetic conditions in the baby. However, there isn't a standard way of giving this information to patients. Doctors have a lot of things to discuss during the first prenatal visit and don't always have time to explain genetics in detail. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Genetic Counseling
- What is being tested?
- Prenatal GENEie Chatbot and In-person genetic counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,470 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 31 Mar 2029
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- English or Spanish speaking with ability to read and write
- Gestational age <20 weeks
- Access to smartphone or tablet (through personal use or study)
Who cannot join
- Patients who have already had genetic counseling related to current pregnancy
- h/o trisomy, major fetal anomaly. or aneuploidy in previous pregnancy
- Parent with Robertsonian translocation
- Twins, vanishing twin, multi-gestation pregnancy
- Fetal anomaly noted in early pregnancy
- In- vitro fertilization with pre-implantation genetic testing (PGT-A or PGT-M)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
Official title: A Randomized Trial of Chatbot for Prenatal Genetic Counseling
During pregnancy, all pregnant people are offered tests to look for genetic conditions in the baby. However, there isn't a standard way of giving this information to patients. Doctors have a lot of things to discuss during the first prenatal visit and don't always have time to explain genetics in detail. Also, not everyone has access to genetic counselors. Prenatal genetics can be confusing, especially for people who haven't had a lot of formal education or who speak languages other than English. There might be misunderstandings about what these tests can find and what their benefits or risks are for these tests.
Mobile apps, like chatbots, could be a helpful way to give information about prenatal genetics. Almost everyone has a cell phone, and a chatbot can let people learn at their own speed and whenever they want.
Read more
The goal of this study is to see if a chatbot app Prenatal GENEie can teach pregnant women about prenatal genetics, and compare the chatbot to talking with a genetic counselor in person. The study wants to answer these main questions:
- Does the Prenatal GENEie help pregnant patients learn about prenatal genetics the same way as a meeting with a genetic counselor?
- Can the Prenatal GENEie and in-person counseling both help people make decisions about whether they want prenatal genetic testing?
The researchers will compare the chatbot Prenatal GENEie with in-person counseling to see if the chatbot teaches people about prenatal genetics in a similar way.
Participants will:
- Take a test to check what they already know about prenatal genetics prior to the intervention
- Use the chatbot or have an in-person meeting with a genetic counselor
- Take a test after using the chatbot or meeting with a counselor to see how much their knowledge has improved
- Fill out a survey about how comfortable they feel with their decision to do or not do prenatal genetic testing
Read the detailed description
Current recommendations from the American College of Obstetricians and Gynecologists (ACOG) call for all pregnant people to be offered screening and diagnostic testing options for aneuploidy, including maternal serum screening, cell-free fetal DNA (cfDNA), chorionic villus sampling, amniocentesis, and carrier screening for cystic fibrosis and spinal muscular atrophy. As a result, the nearly 4 million pregnant people receiving prenatal care in the United States annually require access to associated, and complex, prenatal genetic counseling. Additionally, access to pregnancy terminations has radically changed in the post-Dobbs era. With these considerations and a commitment to person centered-care, informed decision-making is critical, and predicated on people having adequate knowledge of the benefits and risks of different testing options. In the context of prenatal genetics, no option is the correct choice for all persons. Instead, the ideal choice is based on an individual's beliefs and values. Obstetric care providers have the challenge of addressing an ever-increasing number of topics during the first prenatal care visit, and prenatal genetic counselors face a high number of referrals. Yet there is a national shortage of genetic counselors with an uneven geographic distribution. The resulting lack of access to standardized prenatal genetic counseling can lead to patient misinterpretation of the goals or results of prenatal genetic testing and may be contributing to socioeconomic and racial disparities in prenatal genetic screening and diagnosis. Minority patients have a lower uptake of prenatal genetic screening and higher live-birth rates of children with Down syndrome likely due to lower rates of informed choice rather than negative attitudes about testing. Language barriers further exacerbate misunderstanding of prenatal genetic testing options.
Mobile digital tools, including chatbots, provide an attractive alternative to in-person genetic counseling due to the near ubiquitous availability of mobile devices among patients and ability to ensure tailoring and standardization. Previous digital tools developed for prenatal genetic education showed promise, but most are more instructional than interactive, computer-based rather than mobile-based, and do not include information on carrier screening currently recommended by ACOG. Notably, most tools were developed before the clinical availability of cfDNA testing, now the most common prenatal screening modality in the U.S. To address this critical need, a multidisciplinary team of perinatologists, genetic counselors, and digital health experts developed an innovative, patient-informed, mobile chatbot (iPrenatal) to simulate a text and audio-based counseling discussion about aneuploidy screening and diagnosis . Preliminary data from the researchers' randomized trial of 258 English-speaking pregnant people showed significantly higher post-intervention knowledge scores among patients who used iPrenatal compared with those who received routine provider education (66% vs 55%, p < 0.001). The researchers propose to leverage this success by engaging users in formative work to create Prenatal GENEie, with information on aneuploidy and carrier testing, and provide all content in English and Spanish. The researchers will evaluate Prenatal GENEie in a randomized controlled trial of 1470 pregnant people in clinics serving racially and socioeconomically diverse pregnant women. The researchers will test their central hypothesis that an enhanced digital education chatbot providing standardized yet tailored prenatal genetic counseling will be comparable to in-person prenatal counseling by a genetic counselor in increasing patient knowledge and uptake of prenatal genetic tests.
The specific aims of this study are:
Aim 1: Determine the effect of Prenatal GENEie on patient knowledge and uptake of prenatal genetic testing, compared to in-person genetic counseling. The researchers hypothesize that Prenatal GENEie will result in non-inferior knowledge gain and testing uptake, compared to genetic counseling.
Aim 2: Assess ability of Prenatal GENEie to narrow the gap in knowledge and uptake of prenatal genetic screening between English- and Spanish-speaking patients, compared to in-person genetic counseling. The researchers hypothesize that Prenatal GENEie will narrow the gap in knowledge scores and uptake of prenatal genetic testing between English- and Spanish-speaking patients.
The expected outcome of this study is high-quality evidence on the ability of an educational chatbot to equitably increase patient knowledge and uptake of prenatal genetic screening and diagnostic tests. If shown to be effective, this validated chatbot interface will be adaptable and scalable to other settings, including areas of provider shortages, and languages to increase equitable access to prenatal genetic counseling.
- Conditions
- Genetic Counseling
- Being tested
- Prenatal GENEie Chatbot, In-person genetic counseling
- Keywords
- prenatal genetics, prenatal testing, mobile application, chatbot, patient education, aneuploidy, decisional conflict, genetics health literacy
- Medical subject headings
- Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal GENEie ChatbotOther
Patient Educational Phone Chatbot Application for Prenatal Genetics in English \& Spanish
In-person genetic counselingOther
Standard in-person genetic counseling for prenatal genetics education
| Study group | Role | What they receive |
|---|---|---|
| In-person genetic counseling | Active comparator | Patients in this group will be scheduled for an in-person genetic counseling visit to discuss options for aneuploidy screening, carrier screening, and prenatal diagnosis. For Spanish-speaking patients the genetic counselors will use in-person interpreters. Receives: Other: In-person genetic counseling |
| Prenatal Genetics Chatbot- Prenatal GENEie | Experimental | Patients in the intervention group will be assisted by research staff to download and interact with the chatbot Prenatal GENEie in their preferred language (English or Spanish) for a minimum of 30 minutes to learn about aneuploidy screening, carrier screening and prenatal diagnosis. Receives: Other: Prenatal GENEie Chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prenatal Knowledge Score
The prenatal knowledge score is calculated from questionnaire with 30 true/false questions. The scores range from 0 (lowest knowledge) to 30 (highest knowledge), reflecting the number of correct responses.. The change in prenatal knowledge score is then calculated from the percent answered correctly after the intervention from number of correct responses before the intervention. The highest knowledge increase is 30 and the lowest is 0.
Measured: Baseline knowledge at enrollment and within 7 days after intervention
Rate of Prenatal Screening
Proportion of patients who have had cfDNA screening during pregnancy
Measured: Assessed between enrollment and 24 weeks gestation
Secondary outcomes (3)
Rate of Any Prenatal Screening or Diagnostic Testing
Proportion of patients who have any kind of genetic testing: cfDNA, serum screening, carrier screening, diagnostic testing
Measured: Assessed between enrollment and 24 weeks gestation
Decisional-conflict scale
The Decisional-conflict scale consists of 10 items, each with 3 response categories (yes, no, unsure). Items are given a score value of (0=yes, 2=unsure, 4=no). Total score is calculated by summing items, dividing by 10 and multiplying by 25. Score ranges from 0 (no conflict) to 100 (highest decisional conflict) with higher scores indicating higher level of decisional conflict.
Measured: Within 7 days after intervention
Satisfaction Scale for Educational Intervention
Likert Scale for Satisfaction with genetic counseling or chatbot (secondary outcomes to be described in secondary manuscripts). The Likert scale is 1 to 5 with 1= not at all satisfied with the educational intervention to 5=highly satisfied with educational intervention
Measured: Within 7 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Genetic CounselingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Melissa Russo, Women and Infants Hospital of Rhode Island
- Investigators
- Method Tuuli, MD, Principal investigator, Women & Infants Hospital in Providence RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077707
- Sponsor's protocol ID
- 2164485
- Other IDs
- R01HD111426
- Status last verified
- Jul 2025
- First submitted
- 28 Feb 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocols, and metadata including participant age, sex, race and ethnicity, height, weight, socioeconomic status, and other demographic data; past and present medical, surgical and obstetric history; intervention, chatbot genetic counseling or in person genetic counseling; and pregnancy and study outcomes data.
Publications
Larion S, Warsof SL, Romary L, Mlynarczyk M, Peleg D, Abuhamad AZ. Uptake of noninvasive prenatal testing at a large academic referral center. Am J Obstet Gynecol. 2014 Dec;211(6):651.e1-7. doi: 10.1016/j.ajog.2014.06.038. Epub 2014 Jun 19.
PubMed 24954652Carlson LM, Harris S, Hardisty EE, Hocutt G, Vargo D, Campbell E, Davis E, Gilmore K, Vora NL. Use of a novel computerized decision aid for aneuploidy screening: a randomized controlled trial. Genet Med. 2019 Apr;21(4):923-929. doi: 10.1038/s41436-018-0283-2. Epub 2018 Sep 14.
PubMed 30214066Rothwell E, Johnson E, Wong B, Rose NC, Latendresse G, Altizer R, Zagal J, Smid M, Watson A, Botkin JR. The Use of a Game-Based Decision Aid to Educate Pregnant Women about Prenatal Screening: A Randomized Controlled Study. Am J Perinatol. 2019 Feb;36(3):322-328. doi: 10.1055/s-0038-1667371. Epub 2018 Aug 14.
PubMed 30107621Kuppermann M, Pena S, Bishop JT, Nakagawa S, Gregorich SE, Sit A, Vargas J, Caughey AB, Sykes S, Pierce L, Norton ME. Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: a randomized clinical trial. JAMA. 2014 Sep 24;312(12):1210-7. doi: 10.1001/jama.2014.11479.
PubMed 25247517Yee LM, Wolf M, Mullen R, Bergeron AR, Cooper Bailey S, Levine R, Grobman WA. A randomized trial of a prenatal genetic testing interactive computerized information aid. Prenat Diagn. 2014 Jun;34(6):552-7. doi: 10.1002/pd.4347. Epub 2014 Mar 18.
PubMed 24578289Bryant AS, Norton ME, Nakagawa S, Bishop JT, Pena S, Gregorich SE, Kuppermann M. Variation in Women's Understanding of Prenatal Testing. Obstet Gynecol. 2015 Jun;125(6):1306-1312. doi: 10.1097/AOG.0000000000000843.
PubMed 26000501Khoshnood B, Pryde P, Wall S, Singh J, Mittendorf R, Lee KS. Ethnic differences in the impact of advanced maternal age on birth prevalence of Down syndrome. Am J Public Health. 2000 Nov;90(11):1778-81. doi: 10.2105/ajph.90.11.1778.
PubMed 11076250Bishop J, Huether CA, Torfs C, Lorey F, Deddens J. Epidemiologic study of Down syndrome in a racially diverse California population, 1989-1991. Am J Epidemiol. 1997 Jan 15;145(2):134-47. doi: 10.1093/oxfordjournals.aje.a009084.
PubMed 9006310Dormandy E, Michie S, Hooper R, Marteau TM. Low uptake of prenatal screening for Down syndrome in minority ethnic groups and socially deprived groups: a reflection of women's attitudes or a failure to facilitate informed choices? Int J Epidemiol. 2005 Apr;34(2):346-52. doi: 10.1093/ije/dyi021. Epub 2005 Feb 28.
PubMed 15737971
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Chatbot for Prenatal Genetic Counseling
- ClinicalTrials.gov ID
- NCT07077707
- Acronym / sponsor ID
- 2164485
- Conditions
- Genetic Counseling
- Keywords
- prenatal genetics, prenatal testing, mobile application, chatbot, patient education, aneuploidy, decisional conflict, genetics health literacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,470 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 22 Jul 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.
During pregnancy, all pregnant people are offered tests to look for genetic conditions in the baby. However, there isn't a standard way of giving this information to patients. Doctors have a lot of things to discuss during the first prenatal visit and don't always have time to explain genetics in detail. Also, not everyone has access to genetic counselors. Prenatal genetics can be confusing, especially for people who haven't had a lot of formal education or who speak languages other than English. There might be misunderstandings about what these tests can find and what their benefits or risks are for these tests.
Mobile apps, like chatbots, could be a helpful way to give information about prenatal genetics. Almost everyone has a cell phone, and a chatbot can let people learn at their own speed and whenever they want.
The goal of this study is to see if a chatbot app Prenatal GENEie can teach pregnant women about prenatal genetics, and compare the chatbot to talking with a genetic counselor in person. The study wants to answer these main questions:
- Does the Prenatal GENEie help pregnant patients learn about prenatal genetics the same way as a meeting with a genetic counselor?
- Can the Prenatal GENEie and in-person counseling both help people make decisions about whether they want prenatal genetic testing?
The researchers will compare the chatbot Prenatal GENEie with in-person counseling to see if the chatbot teaches people about prenatal genetics in a similar way.
Participants will:
- Take a test to check what they already know about prenatal genetics prior to the intervention
- Use the chatbot or have an in-person meeting with a genetic counselor
- Take a test after using the chatbot or meeting with a counselor to see how much their knowledge has improved
- Fill out a survey about how comfortable they feel with their decision to do or not do prenatal genetic testing
Detailed description
Current recommendations from the American College of Obstetricians and Gynecologists (ACOG) call for all pregnant people to be offered screening and diagnostic testing options for aneuploidy, including maternal serum screening, cell-free fetal DNA (cfDNA), chorionic villus sampling, amniocentesis, and carrier screening for cystic fibrosis and spinal muscular atrophy. As a result, the nearly 4 million pregnant people receiving prenatal care in the United States annually require access to associated, and complex, prenatal genetic counseling. Additionally, access to pregnancy terminations has radically changed in the post-Dobbs era. With these considerations and a commitment to person centered-care, informed decision-making is critical, and predicated on people having adequate knowledge of the benefits and risks of different testing options. In the context of prenatal genetics, no option is the correct choice for all persons. Instead, the ideal choice is based on an individual's beliefs and values. Obstetric care providers have the challenge of addressing an ever-increasing number of topics during the first prenatal care visit, and prenatal genetic counselors face a high number of referrals. Yet there is a national shortage of genetic counselors with an uneven geographic distribution. The resulting lack of access to standardized prenatal genetic counseling can lead to patient misinterpretation of the goals or results of prenatal genetic testing and may be contributing to socioeconomic and racial disparities in prenatal genetic screening and diagnosis. Minority patients have a lower uptake of prenatal genetic screening and higher live-birth rates of children with Down syndrome likely due to lower rates of informed choice rather than negative attitudes about testing. Language barriers further exacerbate misunderstanding of prenatal genetic testing options.
Mobile digital tools, including chatbots, provide an attractive alternative to in-person genetic counseling due to the near ubiquitous availability of mobile devices among patients and ability to ensure tailoring and standardization. Previous digital tools developed for prenatal genetic education showed promise, but most are more instructional than interactive, computer-based rather than mobile-based, and do not include information on carrier screening currently recommended by ACOG. Notably, most tools were developed before the clinical availability of cfDNA testing, now the most common prenatal screening modality in the U.S. To address this critical need, a multidisciplinary team of perinatologists, genetic counselors, and digital health experts developed an innovative, patient-informed, mobile chatbot (iPrenatal) to simulate a text and audio-based counseling discussion about aneuploidy screening and diagnosis . Preliminary data from the researchers' randomized trial of 258 English-speaking pregnant people showed significantly higher post-intervention knowledge scores among patients who used iPrenatal compared with those who received routine provider education (66% vs 55%, p < 0.001). The researchers propose to leverage this success by engaging users in formative work to create Prenatal GENEie, with information on aneuploidy and carrier testing, and provide all content in English and Spanish. The researchers will evaluate Prenatal GENEie in a randomized controlled trial of 1470 pregnant people in clinics serving racially and socioeconomically diverse pregnant women. The researchers will test their central hypothesis that an enhanced digital education chatbot providing standardized yet tailored prenatal genetic counseling will be comparable to in-person prenatal counseling by a genetic counselor in increasing patient knowledge and uptake of prenatal genetic tests.
The specific aims of this study are:
Aim 1: Determine the effect of Prenatal GENEie on patient knowledge and uptake of prenatal genetic testing, compared to in-person genetic counseling. The researchers hypothesize that Prenatal GENEie will result in non-inferior knowledge gain and testing uptake, compared to genetic counseling.
Aim 2: Assess ability of Prenatal GENEie to narrow the gap in knowledge and uptake of prenatal genetic screening between English- and Spanish-speaking patients, compared to in-person genetic counseling. The researchers hypothesize that Prenatal GENEie will narrow the gap in knowledge scores and uptake of prenatal genetic testing between English- and Spanish-speaking patients.
The expected outcome of this study is high-quality evidence on the ability of an educational chatbot to equitably increase patient knowledge and uptake of prenatal genetic screening and diagnostic tests. If shown to be effective, this validated chatbot interface will be adaptable and scalable to other settings, including areas of provider shortages, and languages to increase equitable access to prenatal genetic counseling.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person genetic counseling | Active comparator | Other: In-person genetic counselingPatients in this group will be scheduled for an in-person genetic counseling visit to discuss options for aneuploidy screening, carrier screening, and prenatal diagnosis. For Spanish-speaking patients the genetic counselors will use in-person interpreters. |
| Prenatal Genetics Chatbot- Prenatal GENEie | Experimental | Other: Prenatal GENEie ChatbotPatients in the intervention group will be assisted by research staff to download and interact with the chatbot Prenatal GENEie in their preferred language (English or Spanish) for a minimum of 30 minutes to learn about aneuploidy screening, carrier screening and prenatal diagnosis. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English or Spanish speaking with ability to read and write
- Gestational age <20 weeks
- Access to smartphone or tablet (through personal use or study)
Key exclusion criteria (6 listed)
- Patients who have already had genetic counseling related to current pregnancy
- h/o trisomy, major fetal anomaly. or aneuploidy in previous pregnancy
- Parent with Robertsonian translocation
- Twins, vanishing twin, multi-gestation pregnancy
- Fetal anomaly noted in early pregnancy
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 |
|---|---|---|
| Prenatal GENEie ChatbotPatient Educational Phone Chatbot Application for Prenatal Genetics in English \& Spanish | Other | Prenatal Genetics Chatbot- Prenatal GENEie |
| In-person genetic counselingStandard in-person genetic counseling for prenatal genetics education | Other | In-person genetic counseling |
Primary outcome
Change in Prenatal Knowledge Score
Time frame: Baseline knowledge at enrollment and within 7 days after intervention
The prenatal knowledge score is calculated from questionnaire with 30 true/false questions. The scores range from 0 (lowest knowledge) to 30 (highest knowledge), reflecting the number of correct responses.. The change in prenatal knowledge score is then calculated from the percent answered correctly after the intervention from number of correct responses before the intervention. The highest knowledge increase is 30 and the lowest is 0.
Rate of Prenatal Screening
Time frame: Assessed between enrollment and 24 weeks gestation
Proportion of patients who have had cfDNA screening during pregnancy
3 secondary outcomes
Rate of Any Prenatal Screening or Diagnostic Testing
Time frame: Assessed between enrollment and 24 weeks gestation
Decisional-conflict scale
Time frame: Within 7 days after intervention
Satisfaction Scale for Educational Intervention
Time frame: Within 7 days after intervention
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 28 Jul 2025.
- Background: PubMed 24954652Larion S, Warsof SL, Romary L, Mlynarczyk M, Peleg D, Abuhamad AZ. Uptake of noninvasive prenatal testing at a large academic referral center. Am J Obstet Gynecol. 2014 Dec;211(6):651.e1-7. doi: 10.1016/j.ajog.2014.06.038. Epub 2014 Jun 19.
- Background: PubMed 30214066Carlson LM, Harris S, Hardisty EE, Hocutt G, Vargo D, Campbell E, Davis E, Gilmore K, Vora NL. Use of a novel computerized decision aid for aneuploidy screening: a randomized controlled trial. Genet Med. 2019 Apr;21(4):923-929. doi: 10.1038/s41436-018-0283-2. Epub 2018 Sep 14.
- Background: PubMed 30107621Rothwell E, Johnson E, Wong B, Rose NC, Latendresse G, Altizer R, Zagal J, Smid M, Watson A, Botkin JR. The Use of a Game-Based Decision Aid to Educate Pregnant Women about Prenatal Screening: A Randomized Controlled Study. Am J Perinatol. 2019 Feb;36(3):322-328. doi: 10.1055/s-0038-1667371. Epub 2018 Aug 14.
- Background: PubMed 25247517Kuppermann M, Pena S, Bishop JT, Nakagawa S, Gregorich SE, Sit A, Vargas J, Caughey AB, Sykes S, Pierce L, Norton ME. Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: a randomized clinical trial. JAMA. 2014 Sep 24;312(12):1210-7. doi: 10.1001/jama.2014.11479.
- Background: PubMed 24578289Yee LM, Wolf M, Mullen R, Bergeron AR, Cooper Bailey S, Levine R, Grobman WA. A randomized trial of a prenatal genetic testing interactive computerized information aid. Prenat Diagn. 2014 Jun;34(6):552-7. doi: 10.1002/pd.4347. Epub 2014 Mar 18.
- Background: PubMed 26000501Bryant AS, Norton ME, Nakagawa S, Bishop JT, Pena S, Gregorich SE, Kuppermann M. Variation in Women's Understanding of Prenatal Testing. Obstet Gynecol. 2015 Jun;125(6):1306-1312. doi: 10.1097/AOG.0000000000000843.
- Background: PubMed 11076250Khoshnood B, Pryde P, Wall S, Singh J, Mittendorf R, Lee KS. Ethnic differences in the impact of advanced maternal age on birth prevalence of Down syndrome. Am J Public Health. 2000 Nov;90(11):1778-81. doi: 10.2105/ajph.90.11.1778.
- Background: PubMed 9006310Bishop J, Huether CA, Torfs C, Lorey F, Deddens J. Epidemiologic study of Down syndrome in a racially diverse California population, 1989-1991. Am J Epidemiol. 1997 Jan 15;145(2):134-47. doi: 10.1093/oxfordjournals.aje.a009084.
- Background: PubMed 15737971Dormandy E, Michie S, Hooper R, Marteau TM. Low uptake of prenatal screening for Down syndrome in minority ethnic groups and socially deprived groups: a reflection of women's attitudes or a failure to facilitate informed choices? Int J Epidemiol. 2005 Apr;34(2):346-52. doi: 10.1093/ije/dyi021. Epub 2005 Feb 28.
- Individual participant dataSharing planned: Yes. Study protocols, and metadata including participant age, sex, race and ethnicity, height, weight, socioeconomic status, and other demographic data; past and present medical, surgical and obstetric history; intervention, chatbot genetic counseling or in person genetic counseling; and pregnancy and study outcomes data.
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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.
Method Tuuli, MD principal investigator
Women & Infants Hospital in Providence RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal GENEie Chatbot and In-person genetic counseling in people with 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 28 Jul 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?
Contact Melissa L Russo, MD (2022360080, mlrusso@wihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prenatal Knowledge Score (time frame: Baseline knowledge at enrollment and within 7 days after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07077707, which also lists 9 linked publications.
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 28 Jul 2025.