Postpartum Education Via Artificial Intelligence for Recovery and Loneliness (PEARL): A Randomized Controlled Trial
University of California, San Diego
Summary
The goal of this clinical trial is to learn whether a postpartum chatbot powered by generative artificial intelligence (genAI) can help new mothers get better pelvic floor health information and feel less lonely after childbirth. The main questions this study aims to answer are: * Does using the chatbot improve postpartum pelvic floor health knowledge? * Does using the chatbot help reduce feelings of loneliness during the postpartum period? * Does using the chatbot impact pelvic floor symptoms? Researchers will compare standard postpartum care to standard care plus the chatbot. Participants will: Be assigned by chance (like flipping a coin) to standard postpartum care with or without access to the chatbot. If in the chatbot group, participants will receive education and support via the chatbot over a 4-week period. Both groups will complete questionnaires to measure their pelvic floor knowledge, pelvic floor symptoms, feelings of loneliness, depression, infant bonding, perceived social support, adverse childhood experiences, and peri-traumatic distress. The chatbot was created by urogynecology experts in collaboration with UC San Diego computer science and biomedical informatics researchers. The chatbot is designed to give new mothers personalized, evidence-based information and support in real time.
Description
Pelvic floor disorders (PFDs)-including urinary incontinence, fecal incontinence, and pelvic organ prolapse-are highly prevalent and debilitating conditions affecting approximately 25% of women in the United States.Pregnancy and childbirth are known risk factors for developing PFDs. Recent imaging studies show that injuries to the levator ani muscle, perineal body, and perineal membrane occur in up to 19% of first-time mothers. Urogynecologic conditions, such as urinary and bowel incontinence, are common after pregnancy and often result in a catastrophic impact on maternal quality of life not…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Has the capacity to provide informed consent 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Postpartum persons, aged \>18 years old 4. Primiparous 5. Vaginal or cesarean delivery 6. English Speaking 7. Internet access and proficiency of internet access 8. Access to a smartphone 9. Postpartum 2-6 weeks Exclusion Criteria: 1. Multiparous 2. Major neonatal anomaly 3. Delivery \< 34 weeks gestational age 4. Intrauterine fetal demise (IUFD) 5. Enrollment in any interfering studies 6. Unanticipated NICU admission…
Interventions
- OtherGenerative artificial intelligence (genAI) postpartum chatbot
Participants randomly assigned to the chatbot intervention will be provided a URL to a secure, HIPAA-compliant web application hosted by UC San Diego (https://knolohealth.org/). This application features a generative AI-powered chatbot designed to deliver postpartum pelvic floor education and support. The chatbot is available for a 4-week period following enrollment and can be accessed at any time during that window. The chatbot's educational content is grounded in reputable, evidence-based resources, including national and international urogynecology patient education materials, as well as postpartum recovery guidelines. Participants can interact with the chatbot to ask questions and will receive tailored educational responses related to pelvic floor health. No additional in-person study visits are required for the intervention. Chatbot usage data (e.g., frequency, timing and content of chatbot interactions) will be collected to assess engagement and user needs.
- OtherStandard of Care (SOC)
Access to the same postpartum care that participants would receive if they did not participate in the study.
Location
- University of California San DiegoLa Jolla, California