Postpartum Education Via Artificial Intelligence for Recovery and Loneliness: A Randomized Controlled Trial
NCT07223736 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2025-11-03
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.
Conditions
- Pelvic Floor Disorder
- Loneliness
- Postpartum
- Mental Health
- Depression
- Peritraumatic Distress
- Women
- Artificial Intelligence (AI)
- Chatbot
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.
Sponsors & Collaborators
-
University of California, San Diego
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-10
- Primary Completion
- 2026-10-01
- Completion
- 2026-11-01
Countries
- United States
Study Locations
More Related Trials
-
Brief Psycho-educational Intervention to Enhance Maternal Reflective Functioning in the Early Postpartum Among Primiparous: Pilot Study
NCT07318168 ·Status: COMPLETED ·Phase: NA
-
Patient Centered Postpartum Contraception App
NCT03402217 ·Status: COMPLETED
-
The Effects of Pregnancy Classes and Contributing Factors to Postpartum Depression
NCT03763435 ·Status: UNKNOWN
-
Remote Peer Support in Prevention of Postpartum Depression
NCT04639752 ·Status: UNKNOWN ·Phase: NA
-
Clinical and Cost-effectiveness of an Online Self-help Intervention and a Face-to-face Intervention Versus Usual Care in Mothers at Moderate Risk for Perinatal Depression
NCT07027761 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Feasibility of M-health Version of "What Were We Thinking" Intervention to Promote Maternal Postpartum Mental Health
NCT04847076 ·Status: COMPLETED ·Phase: NA
-
Online Collaborative Learning Intervention to Prevent Perinatal Depression
NCT02121015 ·Status: COMPLETED ·Phase: NA
-
Effect of 'Parentbot - a Digital Healthcare Assistant (PDA)' in Improving Parenting Outcomes During the Perinatal Period
NCT05463926 ·Status: COMPLETED ·Phase: NA
-
PREVENTION OF PERINATAL DEPRESSION BY EPDS DURING THE FIRST PRENATAL CONSULTATION AT MATERNITY DEPARTMENT
NCT05632510 ·Status: UNKNOWN ·Phase: NA
-
PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be
NCT07302165 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)
NCT06640907 ·Status: RECRUITING ·Phase: NA
-
Risk of Maternal Depression From 1 Year to 4 Years Postpartum in Yvelines
NCT06042972 ·Status: RECRUITING
-
Salutogenesis and Self-efficacy-based Childbirth Education Programme for Preventing Postpartum Depression
NCT06698107 ·Status: RECRUITING ·Phase: NA
-
Effectiveness of a Web-based Prevention Program for Postpartum Depression
NCT00816725 ·Status: COMPLETED ·Phase: NA
-
Preventing Perinatal Depression with an App-Based CBT Program
NCT06672432 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Maternal Well-being in the Perinatal Period
NCT06473935 ·Status: RECRUITING
-
Maternal Mental Health Access - MaMa
NCT06049433 ·Status: RECRUITING ·Phase: NA
-
LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression
NCT06366035 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Mother-Infant Intervention for Postpartum Depression and Associated Mother-Infant Relationship Dysfunction
NCT02057627 ·Status: COMPLETED ·Phase: NA
-
EMA and mHealth in Preventing Postpartum Depression
NCT06777563 ·Status: RECRUITING ·Phase: NA
-
Preventing Postpartum Depression in Prenatal Care
NCT02741206 ·Status: WITHDRAWN ·Phase: NA
-
Impact of Earlier Postpartum Contact on Postpartum Visit Compliance and Maternal Wellbeing
NCT04226807 ·Status: TERMINATED ·Phase: NA
-
Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression
NCT02979444 ·Status: COMPLETED ·Phase: NA
-
"Thinking Healthy Programme" for Perinatal Depression in Nepal
NCT05393479 ·Status: UNKNOWN ·Phase: NA
-
Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk
NCT06276647 ·Status: COMPLETED ·Phase: NA