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

NCT07223736 | Not Yet Recruiting

• 1 other identifier: 812859
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorder; Loneliness; Postpartum; Mental Health; Depression; Peritraumatic Distress; Women; Artificial Intelligence (AI); Chatbot

Keywords

loneliness; postpartum; pelvic floor disorder; mental health; depression; peritraumatic distress; artificial intelligence; AI; chatbot; LLM; women; large language model

Outcome Measures

Primary Outcomes (1)

• Prolapse and incontinence knowledge

  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 Outcomes (2)

• 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.

Other Outcomes (6)

• Patient global impression of improvement (PGI-I)

  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)

  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)

  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.

Study Arms (2)

Standard postpartum care

ACTIVE COMPARATOR

Standard postpartum care

Other: Standard of Care (SOC)

Generative AI Chatbot Intervention

EXPERIMENTAL

Generative AI Chatbot Intervention

Other: Generative artificial intelligence (genAI) postpartum chatbot; Other: Standard of Care (SOC)

Interventions

Generative artificial intelligence (genAI) postpartum chatbot OTHER

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.

Generative AI Chatbot Intervention

Standard of Care (SOC) OTHER

Access to the same postpartum care that participants would receive if they did not participate in the study.

Also known as: Standard postpartum care, Routine postpartum care

Generative AI Chatbot Intervention; Standard postpartum care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

Related Publications (58)

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MeSH Terms

Conditions

Pelvic Floor Disorders; Psychological Well-Being; Depression

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Personal Satisfaction; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Alexandra C Nutaitis, DO

CONTACT

858-657-7344; anutaitis@health.ucsd.edu

Cecile Ferrando, MD, MPH

CONTACT

(858) 657-1238; cferrando@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor OBGYN & Reproductive Sciences

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either standard postpartum care alone or the chatbot intervention in addition to standard postpartum care. The intervention group will have access to the chatbot for a 4-week period. No crossover between groups will occur. Outcomes will be assessed at baseline, post-intervention, and at 6 months postpartum for both groups.

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 3, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)