Prenatal Genetics Chatbot Trial: Prenatal GENEie

NCT07077707 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1470

Last updated 2025-07-28

No results posted yet for this study

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. 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

Conditions

  • Genetic Counseling

Interventions

OTHER

Prenatal GENEie Chatbot

Patient Educational Phone Chatbot Application for Prenatal Genetics in English \& Spanish

OTHER

In-person genetic counseling

Standard in-person genetic counseling for prenatal genetics education

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Method Tuuli, MD · Women & Infants Hospital in Providence RI

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07077707 on ClinicalTrials.gov