Conversational AI Platform for Early Pregnancy Care City-wide Recruitment: A Feasibility Study

Not Applicable

Not yet recruiting

• Conditions: Early Pregnancy

• Registration Number: NCT07197892
• Lead Sponsor: University of Pennsylvania

Brief Summary

This study seeks to determine pregnant patients in the Philadelphia area can be recruited to a conversational AI texting platform. The trial will be considered feasible if recruitment goals are met in proportion to delivery volume at the hospital.

Detailed Description

The investigators developed a conversational AI platform to improve periconception care (CIRCA) to engage individuals in their healthcare decision making, reduce barriers to care, and ultimately reduce widespread inequities in reproductive and maternal health.

CIRCA was developed to enable care from positive pregnancy test onward. After a positive test, patients scan a QR code to onboard via SMS to the program. A positive pregnancy test is confirmed, and an estimated gestational duration is calculated from last menstrual period, if known. If unknown, the patient is directed to schedule a visit at a nearby early pregnancy assessment center where they can receive routine testing and counseling to confirm the pregnancy and its gestational duration. They are then able to receive triage and scheduled educational content.

Study Timeline

• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Study First Posted: 2025-09-30
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-08
• Last Update Posted: 2025-10-10
• Study Start: 2025-12-01
• Primary Completion: 2027-02
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 2637

Inclusion Criteria

• Willing and able to provide informed consent
• Access to a working mobile phone
• Ability to read English
• Pregnant with a gestational age less than 12 weeks, 6 days by last menstrual period or by ultrasound, or per patient self-report

Exclusion Criteria

N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of citywide recruitment of pregnant patients in Philadelphia.	12 months	Proportion of pregnant patients in Philadelphia who sign up to use CIRCA texting platform

Secondary Outcome Measures

Name	Time	Method
Platform engagement	Between platform enrollment up until 12 weeks, 6 days gestation	Percentage of surveys completed by participant
Platform acceptability	To be completed at 1 week of use and at final study survey (up to 12 weeks 6 days gestation)	Net promoter score (Range 0-10, with a higher score indicating a better rating)
Birth outcome	From platform enrollment up until the event of a live birth or other pregnancy outcome.	Early pregnancy loss, ectopic pregnancy, abortion, severe maternal morbidity, preterm birth
Emergency Department Utilization	From platform enrollment until 12 weeks, 6 days gestation.	Emergency Department visits

Trial Locations

Locations (1)

Penn Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States