RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether an AI chatbot can help new mothers learn about pelvic floor health, feel less lonely, and improve symptoms after birth. The pelvic floor is the group of muscles that supports the bladder, bowel, and womb. People over age 18 who gave birth for the first time 2–6 weeks ago will be assigned by chance to usual care alone or usual care plus a chatbot for 4 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can understand the study and agree to take part.
  • Willing to follow all study steps and available for the whole study.
  • Are older than 18.
  • Gave birth for the first time.
  • Had a vaginal birth or C-section.
  • Gave birth 2–6 weeks ago.
  • Speak English.
  • Have a smartphone and internet access, and know how to use the internet.

Who can't join

  • Have given birth more than once.
  • Your baby has a major birth defect or unexpectedly needed the newborn intensive care unit (NICU).
  • Gave birth before 34 weeks of pregnancy.
  • Your baby died in the womb, or you went home from the hospital without a living baby.
  • Are in another study that could interfere with this one.
  • Carried the baby for someone else, or your baby was placed for adoption.
  • Are currently pregnant.
  • Needed a hospital stay for mental health care before delivery, or have another mental health condition that the study or care team says needs help right away.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA

  • University of California San Diego · La Jolla, CA 92093Cecile Ferrando, MD, MPH · Principal investigatorMore trials in La Jolla