NCT07223736 · University of California, San Diego
Postpartum Education Via Artificial Intelligence for Recovery and Loneliness: A Randomized Controlled Trial
(PEARL)
What this study is about
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.
View original scientific description
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.
Interventions
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.
OTHER
Standard of Care (SOC)
Access to the same postpartum care that participants would receive if they did not participate in the study.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- La Jolla, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2026 · Source of record for eligibility and locations