Postpartum Education Via Artificial Intelligence for Recovery and Loneliness (PEARL): A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Prolapse and incontinence knowledge
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Vaginal or cesarean delivery
- •English Speaking
- •Internet access and proficiency of internet access
- •Access to a smartphone
- •Postpartum 2-6 weeks
Exclusion Criteria
- •Multiparous
- •Major neonatal anomaly
- •Delivery < 34 weeks gestational age
- •Intrauterine fetal demise (IUFD)
- •Enrollment in any interfering studies
- •Unanticipated NICU admission
- •Discharge home without live baby
- •Surrogates/gestational carrier
- •Birthing individuals with baby placed for adoption
- •Currently pregnant
- •Psychiatric history requiring psychiatric hospitalization prior to delivery
- •Other psychiatric conditions needing immediate attention and intervention as determined by study team and/or treatment team
Arms & Interventions
Standard postpartum care
Standard postpartum care
Intervention: Standard of Care (SOC) (Other)
Generative AI Chatbot Intervention
Generative AI Chatbot Intervention
Intervention: Generative artificial intelligence (genAI) postpartum chatbot (Other)
Generative AI Chatbot Intervention
Generative AI Chatbot Intervention
Intervention: Standard of Care (SOC) (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Loneliness scores(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 administered to both groups at three time points: 1) at enrollment, 2) post-intervention or standard of care, 3) at 6 months postpartum.)
Investigators
Cecile Ferrando
Professor OBGYN & Reproductive Sciences
University of California, San Diego
