Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT06785467
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2025-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
eDoula Feasibility and Acceptability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Control group will receive routine care and will be recruited postpartum to respond to a survey on their labor and satisfaction outcomes. Once control group recruitment is complete, intervention recruitment will begin. Intervention arm participants will gain access to the eDoula app during pregnancy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-01-16', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction with eDoula app', 'timeFrame': 'Measured in the 7 days following delivery', 'description': 'Participant-reported satisfaction with the eDoula app using a 3-question Likert scale. Scores can have a value from 3 to 15, with a higher score indicating greater satisfaction.'}, {'measure': 'eDoula App Use', 'timeFrame': 'Recruitment (19-28 weeks gestation) to delivery', 'description': 'The number of days during pregnancy that the eDoula app was used'}], 'secondaryOutcomes': [{'measure': 'Labor Agentry Scale-10 (LAS-10)', 'timeFrame': 'Measured in the 7 days following delivery', 'description': 'Instrument measuring patient control during childbirth. Scores can have a value from 10 to 70, with a higher score indicating a better outcome.'}, {'measure': 'Birth Satisfaction Scale-Revised (BSS-R)', 'timeFrame': 'Measured in the 7 days following delivery', 'description': 'Instrument measuring patient satisfaction with the birth experience. Scores can have a value from 0 to 40, with higher scores representing greater birth satisfaction.'}, {'measure': 'Edinburgh Postnatal Depression Scale (EPDS)', 'timeFrame': 'Measured in the 7 days following delivery', 'description': 'Instrument measuring postnatal depression symptoms following delivery. Scores can have a falue from 0 to 30, with higher scores representing more symptoms of postnatal depression.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Labor', 'Birth'], 'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'eDoula is an app that will give patients reading material and videos to watch based on their due date. It also provides helpful postpartum guidance. First, patients without access to the app will be recruited and surveyed on their labor and satisfaction outcomes. Then, recruitment will begin for the intervention arm of the study. Participants will be recruited to use the app and complete a survey during the postpartum period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous\n* Singleton pregnancy\n* English speaking\n* Own a smart phone or other device capable of downloading and running the eDoula app\n* Delivered at 36 weeks 0 days gestation or later\n* Able to labor\n\nExclusion Criteria:\n\n* Planned cesarean delivery\n* Pregnancy complications including placenta accreta spectrum, vasa previa, intrauterine fetal demise, or known major fetal anomaly\n* Delivery planned at a location other than Oregon Health and Science University'}, 'identificationModule': {'nctId': 'NCT06785467', 'briefTitle': 'eDoula Feasibility and Acceptability', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'eDoula: The Feasibility and Acceptability of Mobile Application in Pregnancy, Labor, and Birth Support', 'orgStudyIdInfo': {'id': 'OHSU IRB 27596'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'These participants will receive routine pregnancy and delivery care.'}, {'type': 'EXPERIMENTAL', 'label': 'eDoula Intervention', 'description': 'These participants will have access to the eDoula app during pregnancy.', 'interventionNames': ['Other: eDoula App']}], 'interventions': [{'name': 'eDoula App', 'type': 'OTHER', 'description': 'eDoula is an app that will give patients reading material and videos to watch based on their due date. It also provides helpful postpartum device.', 'armGroupLabels': ['eDoula Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Women's Health Research Unit", 'role': 'CONTACT', 'email': 'whru@ohsu.edu', 'phone': '503-494-3666'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': "Women's Health Research Unit Department of Ob/Gyn", 'role': 'CONTACT', 'email': 'whru@ohsu.edu', 'phone': '503-494-3666'}], 'overallOfficials': [{'name': 'Fei Cai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fei Cai', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}