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

October 31, 2025 updated by: Cecile Ferrando, University of California, San Diego

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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 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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
        • Principal Investigator:
          • Cecile Ferrando, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard postpartum care
Other: Standard of Care (SOC)
Access to the same postpartum care that participants would receive if they did not participate in the study.
Other Names:
  • Standard postpartum care
  • Routine postpartum care
Experimental: Generative AI Chatbot Intervention
Other: Standard of Care (SOC)
Access to the same postpartum care that participants would receive if they did not participate in the study.
Other Names:
  • Standard postpartum care
  • Routine postpartum care
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loneliness scores
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.
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.
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.
Pelvic Floor Distress
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.
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.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient global impression of improvement (PGI-I)
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.
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.
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.
Mother to Infant Bonding Scale (MIBS)
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.
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.
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.
Peritraumatic Distress Inventory (PDI)
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.
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.
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.
Edinburgh Postnatal Depression Scale (EPDS)
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.
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.
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.
Multidimensional Scale of Perceived Social Support (MSPSS)
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.
The Multidimensional Scale of Perceived Social Support (MSPSS) is 12 item scale on perception of perceived adequacy of social support from friends, family and significant other. There are 4 items per sub-scale and items are scores on a 7-point Likert Scale (1 = very strongly disagree to 7 = very strongly agree). Higher scores indicate greater perceived social support.
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.
Adverse Childhood Experience (ACE) Questionnaire
Time Frame: Will be administered to both groups at a single time point: at enrollment.
The Adverse Childhood Experience (ACE) Questionnaire consists of 10 items covering three domains: abuse (emotional, physical, sexual), neglect (emotional, physical), and household challenges (parental separation/divorce, domestic violence, substance abuse, mental illness, incarceration). Respondents answer yes/no to each item, and the total ACE score reflects the number of categories experienced. Higher scores are associated with increased risk for a range of adverse health outcomes in adulthood, including mental illness, substance use, and chronic diseases.
Will be administered to both groups at a single time point: at enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 10, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 31, 2025

First Submitted That Met QC Criteria

October 31, 2025

First Posted (Estimated)

November 3, 2025

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 31, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 812859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Single site location and current IRB approval is for no data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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