Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-18 @ 3:31 AM
Study NCT ID:
NCT02379351
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2015-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erin.clark@hsc.utah.edu', 'phone': '801-5818425', 'title': 'Dr. Erin Clark', 'organization': 'University of Utah, Department of Obstetrics & Gynecology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental: In-Home Non-Stress Test Device', 'description': 'Patients with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at University of Utah Hospital will be eligible for enrollment. After being taught how to use the Airstrip® Sense4Baby™ system machine, participants will use the device on a weekly basis (at home) until the time of delivery. Participants will also receive an in clinic NST once a week.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Interpretable Results (Participants Who Used the NST Device Correctly)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}, {'units': "Remote NST's Completed", 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: In-Home Non-Stress Test Device', 'description': 'Patients with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at University of Utah Hospital will be eligible for enrollment. After being taught how to use the Airstrip® Sense4Baby™ system machine, participants will use the device on a weekly basis (at home) until the time of delivery. Participants will also receive an in clinic NST once a week.'}], 'classes': [{'categories': [{'title': 'Number of Interpretable Results', 'measurements': [{'value': '107', 'groupId': 'OG000'}]}, {'title': 'Number of Non-Interpretable Results', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.1', 'groupIds': ['OG000'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Data analysis will use mostly descriptive statistics - parametric and nonparametric statistics will be used as indicated (Chi-squared)', 'nonInferiorityComment': 'This pilot study is primarily descriptive statistics'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Enrollment at 32 0/7 - 37 6/7 weeks gestation through delivery', 'description': 'Number of Interpretable Results (Participants who Used the NST Device Correctly)', 'unitOfMeasure': "Remote NST's Completed", 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': "Remote NST's Completed", 'denomUnitsSelected': "Remote NST's Completed", 'populationDescription': 'Patients with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at University of Utah Hospital. Participants were trained by clinicians at the hospital and then used the device on a weekly basis (at home) until the time of delivery. Participants will also receive an in clinic NST once a week.'}, {'type': 'SECONDARY', 'title': 'Provider Satisfaction With Remote NST Compared to On-site NST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Providers', 'description': 'Providers involved with NST testing including NST nursing staff, Ordering provider, Interpreting provider.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Data analysis will use mostly descriptive statistics: parametric and nonparametric statistics will be used as indicated.', 'nonInferiorityComment': 'Likert Scale of Provider Satisfaction', 'otherAnalysisDescription': 'Likert Scale of Provider Satisfaction'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 Years', 'description': 'Provider Satisfaction With Remote NST Compared to On-site NST', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Referring and NST Reading Providers'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: In-Home Non-Stress Test Device', 'description': 'Patients with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at University of Utah Hospital will be eligible for enrollment. After being taught how to use the Airstrip® Sense4Baby™ system machine, participants will use the device on a weekly basis (at home) until the time of delivery. Participants will also receive an in clinic NST once a week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'In-Home Non-Stress Test Device', 'description': 'Patients with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at University of Utah Hospital. Participants utilized the device on a weekly basis (at home) until the time of delivery. Participants also received an in clinic NST once a week.\n\nIn-Home Non-Stress Test Device: Airstrip® Sense4Baby™'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '49'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Patients with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at University of Utah Hospital'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-31', 'size': 380732, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-28T14:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2015-02-20', 'resultsFirstSubmitDate': '2019-03-28', 'studyFirstSubmitQcDate': '2015-02-26', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-27', 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Interpretable Results (Participants Who Used the NST Device Correctly)', 'timeFrame': 'Enrollment at 32 0/7 - 37 6/7 weeks gestation through delivery', 'description': 'Number of Interpretable Results (Participants who Used the NST Device Correctly)'}], 'secondaryOutcomes': [{'measure': 'Provider Satisfaction With Remote NST Compared to On-site NST', 'timeFrame': '2 Years', 'description': 'Provider Satisfaction With Remote NST Compared to On-site NST'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-stress Test', 'Fetal Monitoring', 'Telemedicine'], 'conditions': ['High Risk Pregnancy']}, 'descriptionModule': {'briefSummary': 'Non-stress tests (NSTs) are used to monitor the health of babies during pregnancy. These tests are currently conducted in clinics and hospitals. This requires travel to a clinic or hospital, sometimes multiple times per week, in order to receive these tests. Technology has been developed that now allows for NSTs to be done in other locations, including home or work. The Airstrip® Sense4Baby™ NST device has been FDA-approved for use by obstetricians in clinical and hospital settings. The investigators are evaluating the use of the Airstrip® Sense4Baby™ NST device in out-of-hospital settings. The investigators would like to know if this type of monitoring is feasible and acceptable to patients and physicians.', 'detailedDescription': 'Phase I of this study enrolls pregnant women with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at the University of Utah Hospital. Participants receive an in-clinic NST with the Airstrip® Sense4Baby™ device, are taught how to use the device, and asked to demonstrate their ability to use the device. Once the participant successfully demonstrates use of the monitor the device is given to the participant to use at the scheduled time each week. Patients receive educational materials, including a visuals-enhanced, short quick start guide.\n\nFor her remote NST monitoring, the patient will receive a virtual NST appointment. At the time of the scheduled appointment, the patient will apply the monitor and the NST will be read by the mid-level provider staffing the testing center after a thirty-minute strip has been recorded and transmitted to the database. The NST will also be interpreted by the maternal-fetal medicine physician, according to the established workflow. The patient will be notified of the result by a telephone call from the mid-level provider and appropriate follow-up arranged according to the NST management algorithm developed for this study. If the patient has trouble with using the device at home, the patient will be able to talk with the mid-level provider via telephone to troubleshoot issues.\n\nThe patient will also continue to receive an NST in clinic weekly. These NST schedules will be repeated on a weekly basis until delivery or until the provider discontinues the NST order.\n\nPatients will be contacted after delivery to assess overall satisfaction with the NST at home versus in clinic.\n\nPhase II of this study will enroll the same patient population (pregnant women with physician-ordered twice-weekly NSTs scheduled). Participants in Phase II may receive NSTs up to twice weekly at home. During regularly scheduled obstetric visits (every 1 to 2 weeks depending on gestational age and circumstances), NSTs will be performed on site. However, we will remove the requirement for once weekly on-site testing at the University of Utah Hospital.\n\nThe requirement to be within a 60-mile radius of University Hospital will be removed for Phase II participants. Instead, the requirement will be to be within a 60-mile radius of a hospital with an obstetric unit.\n\nPatients will be contacted after delivery to assess overall satisfaction with the NST at home versus in clinic.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Target population: The target population is high-risk pregnant women.\n\nAccessible population: The accessible population is high-risk obstetric patients receiving care throughout the University of Utah Healthcare system and who receive their NSTs at MFDC.\n\nInclusion Criteria (Phase I):\n\n* Singleton gestation\n* Estimated gestational age of 32 0/7 -37 6/7 weeks\n* Physician order for twice weekly NSTs\n* Live within 60-mile radius of the University of Utah University Hospital\n* Reliable access to and connectivity with wireless Internet\n* Reliable for communication and follow-up\n\nExclusion Criteria (Phase I:\n\n* Multifetal gestation\n* Maternal age less than 18\n* Plans to move prior to end of pregnancy\n* No or limited access to internet and/or phone\n\nInclusion Criteria (Phase II):\n\n* Singleton gestation\n* Estimated gestational age of 32 0/7 -37 6/7 weeks\n* Physician order for twice weekly NSTs\n* Live within 60-mile radius of the University of Utah University Hospital or a hospital with an obstetric inpatient unit\n* Reliable access to and connectivity with wireless Internet\n* Reliable for communication and follow-up\n\nExclusion Criteria (Phase II):\n\n* Multifetal gestation\n* Maternal age less than 18\n* Plans to move prior to end of pregnancy\n* No or limited access to internet and/or phone'}, 'identificationModule': {'nctId': 'NCT02379351', 'briefTitle': 'Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring In A Local High-Risk Obstetric Population', 'orgStudyIdInfo': {'id': '77591'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In-Home Non-Stress Test Device', 'description': 'Patients with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at University of Utah Hospital will be eligible for enrollment. After being taught how to use the Airstrip® Sense4Baby™ system machine, participants will use the device on a weekly basis (at home) until the time of delivery. Participants will also receive an in clinic NST once a week.', 'interventionNames': ['Device: In-Home Non-Stress Test Device']}], 'interventions': [{'name': 'In-Home Non-Stress Test Device', 'type': 'DEVICE', 'description': 'Airstrip® Sense4Baby™', 'armGroupLabels': ['In-Home Non-Stress Test Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Erin AS Clark, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}