Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-30 @ 6:04 AM
Study NCT ID:
NCT07197892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-10
First Post:
2025-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conversational AI Platform for Early Pregnancy Care City-wide Recruitment: A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2637}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2025-09-26', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of citywide recruitment of pregnant patients in Philadelphia.', 'timeFrame': '12 months', 'description': 'Proportion of pregnant patients in Philadelphia who sign up to use CIRCA texting platform'}], 'secondaryOutcomes': [{'measure': 'Platform engagement', 'timeFrame': 'Between platform enrollment up until 12 weeks, 6 days gestation', 'description': 'Percentage of surveys completed by participant'}, {'measure': 'Platform acceptability', 'timeFrame': 'To be completed at 1 week of use and at final study survey (up to 12 weeks 6 days gestation)', 'description': 'Net promoter score (Range 0-10, with a higher score indicating a better rating)'}, {'measure': 'Birth outcome', 'timeFrame': 'From platform enrollment up until the event of a live birth or other pregnancy outcome.', 'description': 'Early pregnancy loss, ectopic pregnancy, abortion, severe maternal morbidity, preterm birth'}, {'measure': 'Emergency Department Utilization', 'timeFrame': 'From platform enrollment until 12 weeks, 6 days gestation.', 'description': 'Emergency Department visits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early pregnancy loss', 'Miscarriage', 'Prenatal care', 'Abortion'], 'conditions': ['Early Pregnancy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nCIRCA 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Access to a working mobile phone\n* Ability to read English\n* Pregnant with a gestational age less than 12 weeks, 6 days by last menstrual period or by ultrasound, or per patient self-report\n\nExclusion Criteria: N/A'}, 'identificationModule': {'nctId': 'NCT07197892', 'acronym': 'CIRCA', 'briefTitle': 'Conversational AI Platform for Early Pregnancy Care City-wide Recruitment: A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Conversational AI Platform for Early Pregnancy Care City-wide Recruitment: A Feasibility Study', 'orgStudyIdInfo': {'id': '859274'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CIRCA Texting Platform', 'description': 'CIRCA is a two-way texting platform that uses artificial intelligence to match patient texts to clinician-vetted responses and send educational content.', 'interventionNames': ['Other: CIRCA Texting Platform']}], 'interventions': [{'name': 'CIRCA Texting Platform', 'type': 'OTHER', 'description': 'Two-way texting platform that uses artificial intelligence to match patient texts to clinician-vetted responses and send educational content', 'armGroupLabels': ['CIRCA Texting Platform']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Arden McAllister', 'role': 'CONTACT', 'email': 'arden.mcallister@pennmedicine.upenn.edu', 'phone': '267-785-8044'}], 'facility': 'Penn Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Arden McAllister, MPH', 'role': 'CONTACT', 'email': 'arden.mcallister@pennmedicine.upenn.edu', 'phone': '267-785-8044'}], 'overallOfficials': [{'name': 'Alice Abernathy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}