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.
Has the capacity to provide informed consent
Stated willingness to comply with all study procedures and availability for the duration of the study
Postpartum persons, aged >18 years old
Primiparous
Multiparous
Major neonatal anomaly
Delivery < 34 weeks gestational age
Intrauterine fetal demise (IUFD)
Parallel
Generative artificial intelligence (genAI) postpartum chatbot
Other interventionParticipants 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 interventionAccess to the same postpartum care that participants would receive if they did not participate in the study.
Prolapse and incontinence knowledge
Prolapse and incontinence knowledge will be assessed via the validated prolapse and incontinence knowledge questionnaire (PIKQ). This is a validated, self-administered instrument designed to assess women's knowledge about the epidemiology, pathogenesis, diagnosis, and treatment of pelvic organ prolapse and urinary incontinence. The PIKQ has been used in the postpartum population.This questionnaire consists of two 12 item sub-scales (total of 24 questions) with answer options of "agree", "disagree", or "don't know". Correct answers receive 1 point, while incorrect answers receive 0 points. Sub-scale score ranges from 0-12 and total score ranges from 0-24. Higher scores indicate more knowledge. We aim to detect a clinically meaningful difference of 4 points between the control and intervention group. This 4-point difference represents approximately a 17% increase in knowledge and is considered a reasonable effect based on prior literature and the nature of the educational intervention.
Loneliness scores
Loneliness will be assessed via the revised UCLA loneliness scale. The revised UCLA loneliness scale provides a robust, sensitive measure of loneliness with high internal consistency and validity, and has been used in the postpartum population.This 20 question scale measures subjective feelings of loneliness and social isolation. Responses are rated on a 4 point scale; "1=never", "2=rarely", "3=sometimes", "4=often" with total score ranges from 20 to 80. Higher scores indicate worse loneliness.
Pelvic Floor Distress
Pelvic floor distress will be assessed via the Pelvic Floor Distress Inventory-20 (PFDI-20). This is a validated questionnaire that assesses the presence and impact of PFD symptoms in women. It is divided into 3 validated sub-scales to assess pelvic organ prolapse distress (POPDI-6), colorectal-anal distress (CRADI-8), and urinary distress (UDI-6). Each item is scored from 0 (not at all) to 4 (quite a bit) and the mean of each sub-scale is multiplied by 25 to obtain a sub-scale range from 0 to 100 and a total PFD-20 scores of 0 to 300.
Patient global impression of improvement (PGI-I)
PGI-I asks patients to rate their overall improvement after an intervention compared to their baseline state, using a 7-point Likert scale from "very much better" to "very much worse." It is designed to capture the patient's perception of change specifically attributable to an intervention, making it highly relevant for assessing treatment outcomes in urogynecology.
Mother to Infant Bonding Scale (MIBS)
The Mother to Infant Bonding Scale (MIBS) is 8 question scale designed to measure maternal emotion towards their infant. Each item is scores on a 4-point Likert scale (0 = Not at all, 1 = A little, 2 = Quite a lot, 3 = Very much). Scores range 0 to 24, with higher scores indicating greater difficulties in mother-infant bonding.
Peritraumatic Distress Inventory (PDI)
The Peritraumatic Distress Inventory (PDI) is a validated, self-report questionnaire designed to assess emotional and physiological distress experienced during or immediately after a traumatic event. This 13-item self-report questionnaire uses a 5-point Likert scale (0 = Not at All True, 1 = Slightly True, 2 = Somewhat True, 3 = Very True, and 4 = Extremely True to assess responses). The items are summed to achieve total scores in the range 0 to 52. The PDI has been evaluated in the postpartum setting and a score of 15+ on the modified PDI (exclusion of item 4 "I felt afraid for my own safety") produced high sensitivity and specificity: 88% with a positive CB-PTSD screen in the first postpartum months and 93% with a negative screen.
Edinburgh Postnatal Depression Scale (EPDS)
The Edinburgh Postnatal Depression Scale (EPDS) screens for symptoms of postpartum depression and anxiety over the past 2 weeks and has a score range of 0 to 30, with a score of \> 10 indicating possible depression. It is a validated survey in antenatal populations as well.
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