Postpartum Education Via Artificial Intelligence for Recovery and Loneliness: A Randomized Controlled Trial

Conditions

• Artificial Intelligence (AI)
• Chatbot
• Depression
• Loneliness
• Mental Health
• Pelvic Floor Disorder
• Peritraumatic Distress
• Postpartum
• Women

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Generative artificial intelligence (genAI) postpartum chatbot — OTHER
  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.
• Standard of Care (SOC) — OTHER
  Access to the same postpartum care that participants would receive if they did not participate in the study.

Study Details

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.

Key Dates

Start date

Nov 10, 2025

Status verified

Oct 2025

Primary completion

Oct 1, 2026

Completion

Nov 1, 2026

Study Design

Enrollment

130 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Standard postpartum care
  Standard postpartum care
• Experimental: Generative AI Chatbot Intervention
  Generative AI Chatbot Intervention

Primary Outcome Measure

Prolapse and incontinence knowledge [ Time Frame: Will be administered to both groups at three time points: 1) at enrollment, 2) post-intervention or standard of care, 3) at 6 months postpartum. ]

Central Contacts

• Alexandra C Nutaitis, DO
  858-657-7344
  [email protected]
• Cecile Ferrando, MD, MPH
  (858) 657-1238
  [email protected]

Locations (1)

Find similar trials in La Jolla, CA

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