Prenatal GENEie Chatbot Trial for Genetic Counseling

This study is looking at new ways to provide information about genetic conditions during pregnancy. It compares a phone chatbot application called "Prenatal GENEie Chatbot" to standard in-person genetic counseling. The goal is to see if the chatbot can help pregnant individuals understand prenatal genetics better and if it affects how many people choose to get prenatal screening tests. You can join if you are a woman between 18 and 55 years old, are less than 20 weeks pregnant, can read and write in English or Spanish, and have access to a smartphone or tablet. You cannot join if you've already had genetic counseling for your current pregnancy or have a history of certain genetic conditions. The study aims to enroll 1470 participants.

Study design
This is an interventional study comparing a chatbot to in-person counseling, with a planned enrollment of 1470 participants.
What's involved
You would complete a knowledge assessment at the beginning and again within 7 days after receiving either the chatbot or in-person counseling. Your rate of prenatal screening will be assessed between enrollment and 24 weeks gestation.
Compensation
Not stated in the trial record.
Follow-up
Your prenatal knowledge will be measured within 7 days after the intervention, and prenatal screening rates will be assessed up to 24 weeks gestation.

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NCT07077707

Prenatal Genetics Chatbot Trial: Prenatal GENEie

Not Yet Recruiting
NAAges 18–55InterventionalHealth services
Women and Infants Hospital of Rhode Island
~1,470 participants
Updated 2025-07-28 on ClinicalTrials.gov
What's tested:Prenatal GENEie ChatbotIn-person genetic counseling

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Prenatal Knowledge Score
Measured over Baseline knowledge at enrollment and within 7 days after intervention
+1 more outcome measured
Genetic Counseling
1 sites across 1 states
Rhode Island1
  • Method Tuuli, MD · PRINCIPAL_INVESTIGATOR · Women & Infants Hospital in Providence RI

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Eligibility criteria

Inclusion

English or Spanish speaking with ability to read and write
Gestational age \<20 weeks
Access to smartphone or tablet (through personal use or study)

Exclusion

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)
  • Change in Prenatal Knowledge ScoreBaseline 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 ScreeningAssessed between enrollment and 24 weeks gestation

    Proportion of patients who have had cfDNA screening during pregnancy