Postpartum Education Via Artificial Intelligence for Recovery and Loneliness: A Randomized Controlled Trial
NCT ID: NCT07223736
Last Updated: 2025-11-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
130 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-11-10
Study Completion Date
2026-11-01
Brief Summary
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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.
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.
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Detailed Description
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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 just because of the physical symptoms, but also because of the associated embarrassment, isolation, and negative stigma.Compounding this challenging recovery further, one in five women will experience a perinatal mood disorder, such as anxiety, depression, or PTSD. Despite the profound physical and psychological impacts of childbirth, postpartum care remains limited, inconsistent, and difficult to access.
It is well established that many postpartum individuals seek education, community, and emotional validation on various online platforms. When postpartum individuals are interviewed, many report feeling their postpartum health concerns are neglected and minimized, resulting in feelings of disempowerment through the help-seeking process. Further compounding these feelings, is the lack of timely or frequent postpartum care with many women having difficulty attending postpartum visits and often being only seen once postpartum. Furthermore, patients who experience a severe pelvic floor injury at delivery may not have access to specialty care clinic for peripartum pelvic floor disorders. Through qualitative interviews with postpartum individuals with obstetric anal sphincter injury (OASI), themes of seeking social support through online communities such as Facebook and Instagram were identified, though the effectiveness of these groups in meeting patients' needs is unclear. While social media platforms may serve as a support bridge for patients as they await their postpartum visit, much of the content on these platforms is anecdotal, humorous, and not produced by physicians. Furthermore, these platforms also expose recovering individuals to distressing anecdotal narratives or idyllic imagery that may further worsen mental health in this vulnerable patient population.
As postpartum individuals navigate the fourth trimester, feelings of loneliness and isolation are common. Loneliness is linked to adverse health outcomes, including cardiovascular disease, cognitive health, infectious disease, and all-cause mortality, yet its impact on pelvic floor muscle recovery remains largely unexplored.In the U.S. Surgeon General's 2023 advisory, the healing power of social connection and community was emphasized. Lunstad et al., acknowledge that despite mounting evidence healthcare has been slow to recognize that social relationships are health determinants. Postpartum individuals are not immune to loneliness, in fact in a systematic review, the prevalence of loneliness among peripartum women ranged between 32% to 100%. Identifying solutions to address the epidemic of postpartum loneliness is critical to improving the overall health of both birthing individuals and their infants.
Optimizing postpartum maternal mental and physical health is not only critical for the postpartum individual's recovery, but also profoundly influences infant development. The first weeks and months after delivery represent a sensitive window for neonatal brain development, attachment formation, and physiological regulation. When postpartum individuals experience persistent pain, incontinence, or limited mobility, it can hinder early caregiving, reduce breastfeeding success, and increase maternal-infant separation.Maternal mental health disorders have been associated with disrupted bonding, impaired infant stress regulation, and long-term cognitive, emotional, and behavioral challenges in children. Emerging research in developmental neuroscience demonstrates that early maternal-infant interactions shape the infant's stress response system and neurodevelopment trajectory through mechanisms involving cortisol regulation, oxytocin signaling, and epigenetic modifications. It is possible that through improved maternal knowledge of pelvic floor health, that postpartum individuals will experience improved self-efficacy, decreased loneliness, and possibly even improved physical recovery.
However, peripartum pelvic floor disorder knowledge is lacking. McLennan et al., evaluated the information that patients received during pregnancy, and found that the most neglected content area was education on PFDs. Furthermore, Reagan et al., found that most available patient education materials are above the reading level recommended by the National Institutes of Health for maximum patient comprehension. Numerous publications have concurred that there is a global lack of knowledge and understanding of urinary incontinence, pelvic organ prolapse, and bowel incontinence educating patients on PFDs, with many authors calling for increased emphasis of pelvic floor health and development of educational programs to inform patients.Rutledge et al., performed a randomized controlled trial assessing peripartum pelvic floor health knowledge as measured with the Prolapse and Incontinence Knowledge Questionnaire (PIKQ) among women randomized to receiving written handouts only or written handouts plus an interactive workshop. Results of this study demonstrated that both groups improved in their knowledge, but interestingly patient perspectives on preferred education was discovered. Themes surrounding the delivery of educational content were identified, such as a preference for reviewing informational materials on their own time and having the opportunity to receive real-time responses to questions. In addition, themes of preferred educational content developed, including desire to understand the etiology of PFDs, comfort with discussing PFDs, and relief in learning treatment options.
While in person support groups, text based platforms, and telehealth coaches have attempted to address this unmet need for postpartum support and education, conversational agents (chatbots) have recently emerged as a promising tool for scalable, real-time health education and support in this patient population. Chatbots have the potential to deliver just-in-time adaptive intervention (JITAI), a novel intervention design that adapts the provision of support (ie type, timing, intensity) to delivery support at the moment and in the context that the user needs it most. JITAI increases user receptivity to support and is increasingly being used to help support health behavior changes, including mental health. Using natural language processing, chatbots interact with users to provide education, emotional support, and symptom guidance. Their availability on smartphones has made them a widely used tool for health information retrieval and mental wellness. Prior studies evaluating chatbots in the peripartum period have demonstrated successful engagement of individuals, improved user knowledge, and reduction in depressive symptoms. Furthermore, outside of the peripartum patient population, chatbots are known to reduce loneliness through direct companionship and social interactions. Kim et al., explored the mental health potential of AI social chatbots over four weeks and found that UCLA loneliness scores started to improve by week two among individuals interacting with the chatbot. Thus, we propose a similar study intervention time frame (4 weeks).
There is an urgent, unmet need for comprehensive, real time postpartum pelvic floor health education and support in the immediate postpartum period. To address this unmet need, we have developed a genAI postpartum chatbot to bridge the gap for patients to their providers. The chatbot was built using UCSD Health approved Large Language Models (LLMs) made available within the UCSD Health Cloud. In order to provide accurate curated information in response to patient questions in the chatbot, the chatbot implements retrieval augmented generation (RAG).
In the setting of rising maternal morbidity, coupled with limited healthcare access, understanding the impact of a postpartum educated AI chatbot on maternal loneliness, knowledge, and physical recovery is critical to improve maternal and infant health.
It is well established that many postpartum individuals seek education, community, and emotional validation on various online platforms. When postpartum individuals are interviewed, many report feeling their postpartum health concerns are neglected and minimized, resulting in feelings of disempowerment through the help-seeking process. Further compounding these feelings, is the lack of timely or frequent postpartum care with many women having difficulty attending postpartum visits and often being only seen once postpartum. Furthermore, patients who experience a severe pelvic floor injury at delivery may not have access to specialty care clinic for peripartum pelvic floor disorders. Through qualitative interviews with postpartum individuals with obstetric anal sphincter injury (OASI), themes of seeking social support through online communities such as Facebook and Instagram were identified, though the effectiveness of these groups in meeting patients' needs is unclear. While social media platforms may serve as a support bridge for patients as they await their postpartum visit, much of the content on these platforms is anecdotal, humorous, and not produced by physicians. Furthermore, these platforms also expose recovering individuals to distressing anecdotal narratives or idyllic imagery that may further worsen mental health in this vulnerable patient population.
As postpartum individuals navigate the fourth trimester, feelings of loneliness and isolation are common. Loneliness is linked to adverse health outcomes, including cardiovascular disease, cognitive health, infectious disease, and all-cause mortality, yet its impact on pelvic floor muscle recovery remains largely unexplored.In the U.S. Surgeon General's 2023 advisory, the healing power of social connection and community was emphasized. Lunstad et al., acknowledge that despite mounting evidence healthcare has been slow to recognize that social relationships are health determinants. Postpartum individuals are not immune to loneliness, in fact in a systematic review, the prevalence of loneliness among peripartum women ranged between 32% to 100%. Identifying solutions to address the epidemic of postpartum loneliness is critical to improving the overall health of both birthing individuals and their infants.
Optimizing postpartum maternal mental and physical health is not only critical for the postpartum individual's recovery, but also profoundly influences infant development. The first weeks and months after delivery represent a sensitive window for neonatal brain development, attachment formation, and physiological regulation. When postpartum individuals experience persistent pain, incontinence, or limited mobility, it can hinder early caregiving, reduce breastfeeding success, and increase maternal-infant separation.Maternal mental health disorders have been associated with disrupted bonding, impaired infant stress regulation, and long-term cognitive, emotional, and behavioral challenges in children. Emerging research in developmental neuroscience demonstrates that early maternal-infant interactions shape the infant's stress response system and neurodevelopment trajectory through mechanisms involving cortisol regulation, oxytocin signaling, and epigenetic modifications. It is possible that through improved maternal knowledge of pelvic floor health, that postpartum individuals will experience improved self-efficacy, decreased loneliness, and possibly even improved physical recovery.
However, peripartum pelvic floor disorder knowledge is lacking. McLennan et al., evaluated the information that patients received during pregnancy, and found that the most neglected content area was education on PFDs. Furthermore, Reagan et al., found that most available patient education materials are above the reading level recommended by the National Institutes of Health for maximum patient comprehension. Numerous publications have concurred that there is a global lack of knowledge and understanding of urinary incontinence, pelvic organ prolapse, and bowel incontinence educating patients on PFDs, with many authors calling for increased emphasis of pelvic floor health and development of educational programs to inform patients.Rutledge et al., performed a randomized controlled trial assessing peripartum pelvic floor health knowledge as measured with the Prolapse and Incontinence Knowledge Questionnaire (PIKQ) among women randomized to receiving written handouts only or written handouts plus an interactive workshop. Results of this study demonstrated that both groups improved in their knowledge, but interestingly patient perspectives on preferred education was discovered. Themes surrounding the delivery of educational content were identified, such as a preference for reviewing informational materials on their own time and having the opportunity to receive real-time responses to questions. In addition, themes of preferred educational content developed, including desire to understand the etiology of PFDs, comfort with discussing PFDs, and relief in learning treatment options.
While in person support groups, text based platforms, and telehealth coaches have attempted to address this unmet need for postpartum support and education, conversational agents (chatbots) have recently emerged as a promising tool for scalable, real-time health education and support in this patient population. Chatbots have the potential to deliver just-in-time adaptive intervention (JITAI), a novel intervention design that adapts the provision of support (ie type, timing, intensity) to delivery support at the moment and in the context that the user needs it most. JITAI increases user receptivity to support and is increasingly being used to help support health behavior changes, including mental health. Using natural language processing, chatbots interact with users to provide education, emotional support, and symptom guidance. Their availability on smartphones has made them a widely used tool for health information retrieval and mental wellness. Prior studies evaluating chatbots in the peripartum period have demonstrated successful engagement of individuals, improved user knowledge, and reduction in depressive symptoms. Furthermore, outside of the peripartum patient population, chatbots are known to reduce loneliness through direct companionship and social interactions. Kim et al., explored the mental health potential of AI social chatbots over four weeks and found that UCLA loneliness scores started to improve by week two among individuals interacting with the chatbot. Thus, we propose a similar study intervention time frame (4 weeks).
There is an urgent, unmet need for comprehensive, real time postpartum pelvic floor health education and support in the immediate postpartum period. To address this unmet need, we have developed a genAI postpartum chatbot to bridge the gap for patients to their providers. The chatbot was built using UCSD Health approved Large Language Models (LLMs) made available within the UCSD Health Cloud. In order to provide accurate curated information in response to patient questions in the chatbot, the chatbot implements retrieval augmented generation (RAG).
In the setting of rising maternal morbidity, coupled with limited healthcare access, understanding the impact of a postpartum educated AI chatbot on maternal loneliness, knowledge, and physical recovery is critical to improve maternal and infant health.
Conditions
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Pelvic Floor Disorder
Loneliness
Postpartum
Mental Health
Depression
Peritraumatic Distress
Women
Artificial Intelligence (AI)
Chatbot
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Participants will be randomly assigned in a 1:1 ratio to receive either standard postpartum care alone or the chatbot intervention in addition to standard postpartum care. The intervention group will have access to the chatbot for a 4-week period. No crossover between groups will occur. Outcomes will be assessed at baseline, post-intervention, and at 6 months postpartum for both groups.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Standard postpartum care
Standard postpartum care
Group Type
ACTIVE_COMPARATOR
Standard of Care (SOC)
Intervention Type
OTHER
Access to the same postpartum care that participants would receive if they did not participate in the study.
Generative AI Chatbot Intervention
Generative AI Chatbot Intervention
Group Type
EXPERIMENTAL
Generative artificial intelligence (genAI) postpartum chatbot
Intervention Type
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)
Intervention Type
OTHER
Access to the same postpartum care that participants would receive if they did not participate in the study.
Interventions
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Generative 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.
Intervention Type
OTHER
Standard of Care (SOC)
Access to the same postpartum care that participants would receive if they did not participate in the study.
Intervention Type
OTHER
Other Intervention Names
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Standard postpartum care
Routine postpartum care
Eligibility Criteria
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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
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
7. Discharge home without live baby
8. Surrogates/gestational carrier
9. Birthing individuals with baby placed for adoption
10. Currently pregnant
11. Psychiatric history requiring psychiatric hospitalization prior to delivery
12. Other psychiatric conditions needing immediate attention and intervention as determined by study team and/or treatment team
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
7. Discharge home without live baby
8. Surrogates/gestational carrier
9. Birthing individuals with baby placed for adoption
10. Currently pregnant
11. Psychiatric history requiring psychiatric hospitalization prior to delivery
12. Other psychiatric conditions needing immediate attention and intervention as determined by study team and/or treatment team
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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University of California, San Diego
OTHER
Sponsor Role
lead
Responsible Party
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Cecile Ferrando
Professor OBGYN & Reproductive Sciences
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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University of California San Diego
La Jolla, California, United States
Site Status
Countries
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United States
Central Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
812859
Identifier Type: -
Identifier Source: org_study_id
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