Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT04474704
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2020-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia
Sponsor:
Organization:
Raw JSON
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'description': 'Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.\n\nCheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': '24 hours of postpartum magnesium sulfate (current arbitrary standard of care)\n\nStandard of care: 24 hours of postpartum magnesium sulfate', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cheetah® Non-invasive Cardiac Monitoring System', 'description': 'Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.\n\nCheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': '24 hours of postpartum magnesium sulfate (current arbitrary standard of care)\n\nStandard of care: 24 hours of postpartum magnesium sulfate'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '24', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours postpartum', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composite of Postpartum Adverse Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cheetah® Non-invasive Cardiac Monitoring System', 'description': 'Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.\n\nCheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': '24 hours of postpartum magnesium sulfate (current arbitrary standard of care)\n\nStandard of care: 24 hours of postpartum magnesium sulfate'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 4 weeks after delivery', 'description': 'any of the following: use of acute anti-hypertensive medications for persistently severe range blood pressure (defined as \\>160/110 persistent after 15 min), need for more than one dose of acute anti-hypertensive medications, need to restart Mg (for persistent neurological symptoms), postpartum readmission for PE, as well as the development of pulmonary edema, HELLP, or eclampsia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluating Incidence of Need to Restart Magnesium Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cheetah® Non-invasive Cardiac Monitoring System', 'description': 'Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.\n\nCheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': '24 hours of postpartum magnesium sulfate (current arbitrary standard of care)\n\nStandard of care: 24 hours of postpartum magnesium sulfate'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 week postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluating Number of Participants With Hospital Readmission for Preeclampsia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cheetah® Non-invasive Cardiac Monitoring System', 'description': 'Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.\n\nCheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': '24 hours of postpartum magnesium sulfate (current arbitrary standard of care)\n\nStandard of care: 24 hours of postpartum magnesium sulfate'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 4 weeks postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Acute Anti-hypertensive Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cheetah® Non-invasive Cardiac Monitoring System', 'description': 'Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.\n\nCheetah® 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Monitoring System', 'description': 'Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.\n\nCheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': '24 hours of postpartum magnesium sulfate (current arbitrary standard of care)\n\nStandard of care: 24 hours of postpartum magnesium sulfate'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 days after delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cheetah® Non-invasive Cardiac Monitoring System', 'description': 'Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.\n\nCheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': '24 hours of postpartum magnesium sulfate (current arbitrary standard of care)\n\nStandard of care: 24 hours of postpartum magnesium sulfate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cheetah® Non-invasive Cardiac Monitoring System', 'description': 'Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.\n\nCheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': '24 hours of postpartum magnesium sulfate (current arbitrary standard of care)\n\nStandard of care: 24 hours of postpartum magnesium sulfate'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '30', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '30.4', 'spread': '5.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black race', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'White race', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic ethnicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Nulliparity', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI at delivery', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '39.1', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '38.3', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gestational age at delivery', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '37'}, {'value': '36', 'groupId': 'BG001', 'lowerLimit': '34', 'upperLimit': '38'}, {'value': '36', 'groupId': 'BG002', 'lowerLimit': '33.5', 'upperLimit': '37.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-31', 'size': 1421948, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-10T08:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2020-07-08', 'resultsFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-07', 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.', 'timeFrame': 'up to 24 hours postpartum'}], 'secondaryOutcomes': [{'measure': 'Composite of Postpartum Adverse Outcomes', 'timeFrame': 'up to 4 weeks after delivery', 'description': 'any of the following: use of acute anti-hypertensive medications for persistently severe range blood pressure (defined as \\>160/110 persistent after 15 min), need for more than one dose of acute anti-hypertensive medications, need to restart Mg (for persistent neurological symptoms), postpartum readmission for PE, as well as the development of pulmonary edema, HELLP, or eclampsia'}, {'measure': 'Evaluating Incidence of Need to Restart Magnesium Sulfate', 'timeFrame': 'up to 1 week postpartum'}, {'measure': 'Evaluating Number of Participants With Hospital Readmission for Preeclampsia', 'timeFrame': 'up to 4 weeks postpartum'}, {'measure': 'Use of Acute Anti-hypertensive Medications', 'timeFrame': 'Up to 5 days after delivery'}, {'measure': 'Need for More Than 1 Dose of Anti-hypertensive Medication', 'timeFrame': 'Up to 5 days after delivery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['preeclampsia with severe features', 'magnesium sulfate', 'Systemic Vascular Resistance', 'non-invasive cardiac monitoring'], 'conditions': ['Preeclampsia With Severe Features']}, 'descriptionModule': {'briefSummary': 'This is a single site pilot randomized, controlled, trial randomizing patients with PE with severe features to one of 2 groups:\n\n* 24 hours of postpartum magnesium sulfate (current arbitrary standard of care)\n* Using the Cheetah® device to aid in an individualized duration of magnesium sulfate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preeclampsia with severe features, diagnosed using the American Congress of Obstetricians and Gynecologists (ACOG) standard criteria 4 requiring magnesium sulfate\n* Females older than 18 years of age\n* Singleton pregnancy\n* Gestational age greater than 24 0/7 weeks\n* The patient is physically and mentally able to understand the informed consent and is willing to participate in this study\n* Able to speak English or Spanish\n\nExclusion Criteria:\n\n* Multiple gestation\n* Prisoners\n* Patients with chronic renal insufficiency or epilepsy\n* Known cardiovascular disease\n* Patients with contraindications to magnesium sulfate use (e.g. myasthenia gravis)\n* Patients with eclampsia or HELLP syndrome\n* Contraindications for magnesium sulfate'}, 'identificationModule': {'nctId': 'NCT04474704', 'briefTitle': 'Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Use of Cheetah® Non-invasive Cardiac Monitoring System to Guide Discontinuation of Postpartum Magnesium Sulfate in Women With Severe Preeclampsia: A Pilot Randomized Control Trial', 'orgStudyIdInfo': {'id': '2020H0264'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cheetah® non-invasive cardiac monitoring system', 'description': 'Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.', 'interventionNames': ['Device: Cheetah® non-invasive cardiac monitoring system']}, {'type': 'OTHER', 'label': 'Standard of care', 'description': '24 hours of postpartum magnesium sulfate (current arbitrary standard of care)', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'Cheetah® non-invasive cardiac monitoring system', 'type': 'DEVICE', 'description': 'Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))', 'armGroupLabels': ['Cheetah® non-invasive cardiac monitoring system']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': '24 hours of postpartum magnesium sulfate', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Maged Costantine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor', 'investigatorFullName': 'Maged Costantine', 'investigatorAffiliation': 'Ohio State University'}}}}