Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:24 PM
Study NCT ID:
NCT00356434
Status:
TERMINATED
Last Update Posted:
2017-08-18
First Post:
2006-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019851', 'term': 'Thrombophilia'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aaina1@jhmi.edu', 'phone': '410-955-8496', 'title': 'Abimbola Aina', 'organization': 'Johns Hopkins Univ'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Foot Pump', 'description': 'Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT\n\nKendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sequential Compression Device', 'description': 'Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT\n\nKendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot Pump', 'description': 'Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT\n\nKendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use'}, {'id': 'OG001', 'title': 'Sequential Compression Device', 'description': 'Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT\n\nKendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'once during first 7 days of hospitalization', 'description': 'Scale of 1-10 (1 being very uncomfortable and 10 being very uncomfortable) describing level of comfort during the time of device use (composite score of heat, softness, discomfort).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot Pump', 'description': 'Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT)\n\nKendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use'}, {'id': 'OG001', 'title': 'Sequential Compression Device', 'description': 'Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT\n\nKendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use'}], 'timeFrame': 'for 1-7 days during hospitalization', 'description': 'Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for this outcome measure, as the study was terminated prematurely.'}, {'type': 'SECONDARY', 'title': 'DVT Prevention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot Pump', 'description': 'Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT)\n\nKendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use'}, {'id': 'OG001', 'title': 'Sequential Compression Device', 'description': 'Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT\n\nKendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use'}], 'timeFrame': 'up to 3 months', 'description': 'positive DVT on ultrasound', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for this outcome measure, as the study was terminated prematurely.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Foot Pump', 'description': 'Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT)\n\nKendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use'}, {'id': 'FG001', 'title': 'Sequential Compression Device', 'description': 'Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT\n\nKendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Foot Pump', 'description': 'Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT\n\nKendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use'}, {'id': 'BG001', 'title': 'Sequential Compression Device', 'description': 'Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT\n\nKendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'PI assigned to a different hospital;difficulty recruiting patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2006-07-24', 'resultsFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2006-07-24', 'lastUpdatePostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-20', 'studyFirstPostDateStruct': {'date': '2006-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort Level', 'timeFrame': 'once during first 7 days of hospitalization', 'description': 'Scale of 1-10 (1 being very uncomfortable and 10 being very uncomfortable) describing level of comfort during the time of device use (composite score of heat, softness, discomfort).'}, {'measure': 'Patient Compliance', 'timeFrame': 'for 1-7 days during hospitalization', 'description': 'Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded'}], 'secondaryOutcomes': [{'measure': 'DVT Prevention', 'timeFrame': 'up to 3 months', 'description': 'positive DVT on ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['deep vein thrombosis', 'thrombophilia', 'pregnancy', 'thromboprophylaxis', 'decreased mobility', 'hospitalization'], 'conditions': ['Thrombophilia']}, 'referencesModule': {'references': [{'pmid': '33779986', 'type': 'DERIVED', 'citation': 'Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The researchers at Johns Hopkins University believe that the foot pump will be superior to sequential compression devices in comfort and patient compliance which may increase provider efforts to prevent deep vein thrombosis (DVT) in pregnancy.', 'detailedDescription': "The investigators will be comparing sequential compression devices (SCDs) to foot pumps to determine if foot pumps will be better tolerated by obstetric patients, both antepartum and intrapartum. Patients in whom thromboembolic prophylaxis is deemed necessary and ordered by the treating physician, who agree to participate in the study will be randomly assigned to receive SCDs or the foot pump as part of their thromboembolic prophylaxis regimen. The investigators will administer a questionnaire to assess patients' satisfaction and comfort with each device and they will be asked to complete a log of hours they wore their assigned device for a 7 day period (or as long as they are prescribed). Random spot checks to verify compliance will be performed."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant\n* Bedrest\n* Thrombophilia\n* Prescribed DVT prophylaxis\n\nExclusion Criteria:\n\n* Active DVT'}, 'identificationModule': {'nctId': 'NCT00356434', 'briefTitle': 'A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Study of Patient Compliance and Comfort Using Sequential Compression Devices and Foot Pumps for DVT Prevention', 'orgStudyIdInfo': {'id': 'foot pump vs SCD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT', 'interventionNames': ['Device: Kendall A-V foot impulse pump, model 6060']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT', 'interventionNames': ['Device: Kendall sequential compression device, model 9525']}], 'interventions': [{'name': 'Kendall A-V foot impulse pump, model 6060', 'type': 'DEVICE', 'description': 'Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use', 'armGroupLabels': ['1']}, {'name': 'Kendall sequential compression device, model 9525', 'type': 'DEVICE', 'description': 'Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Abimbola Aina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}