Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 11:29 PM
Study NCT ID:
NCT05250960
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2022-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pre-epidural Sequential Compression Devices (SCDs) to Prevent Hypotension During Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Rachel_Baker2@trihealth.com', 'phone': '513-569-6191', 'title': 'Rachel Baker', 'organization': 'TriHealth'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During delivery', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention - SCD Arm', 'description': 'Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement\n\nSCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control - no SCD Arm', 'description': 'Patient will receive 1L of LR during and after epidural placement with no use of SCDs', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - SCD Arm', 'description': 'Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement\n\nSCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement'}, {'id': 'OG001', 'title': 'Control - no SCD Arm', 'description': 'Patient will receive 1L of LR during and after epidural placement with no use of SCDs'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'SBP \\<90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Category II Tracings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention - SCD Arm', 'description': 'Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement\n\nSCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement'}, {'id': 'OG001', 'title': 'Control - no SCD Arm', 'description': 'Patient will receive 1L of LR during and after epidural placement with no use of SCDs'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 hour', 'description': "Category II fetal tracings - fetal heart tracings will be reviewed by two independent nurses who will document whether Category II tracings are present or not\n\nCategory II tracings - The classification of Category II tracings includes the following:\n\nbradycardia with variability, tachycardia, minimal variability, no variability with no recurrent decelerations, marked variability, absence of induced accelerations even after fetal stimulation, recurrent variable decelerations with minimal or moderate baseline variability, prolonged decelerations lasting more than two minutes, but less than ten minutes, recurrent late decelerations with moderate variability, variable decelerations with other characteristics such as slow return to baseline, overshooting the baseline, or 'shoulders'", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention - Sequential Compression Devices (SCD) Arm', 'description': 'Patient will receive 1liter (L) of Lactated Ringers (LR) and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement\n\nSCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement'}, {'id': 'FG001', 'title': 'Control - no Sequential Compression Devices (SCD) Arm', 'description': 'Patient will receive 1L of LR during and after epidural placement with no use of SCDs'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention - SCD Arm', 'description': 'Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement\n\nSCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement'}, {'id': 'BG001', 'title': 'Control - no SCD Arm', 'description': 'Patient will receive 1L of LR during and after epidural placement with no use of SCDs'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '43'}, {'value': '28.5', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '37'}, {'value': '28.8', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '43'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', '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 and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-27', 'size': 265260, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-09T16:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2022-02-18', 'resultsFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-10', 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypotension', 'timeFrame': '1 hour', 'description': 'SBP \\<90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer)'}, {'measure': 'Category II Tracings', 'timeFrame': '1 hour', 'description': "Category II fetal tracings - fetal heart tracings will be reviewed by two independent nurses who will document whether Category II tracings are present or not\n\nCategory II tracings - The classification of Category II tracings includes the following:\n\nbradycardia with variability, tachycardia, minimal variability, no variability with no recurrent decelerations, marked variability, absence of induced accelerations even after fetal stimulation, recurrent variable decelerations with minimal or moderate baseline variability, prolonged decelerations lasting more than two minutes, but less than ten minutes, recurrent late decelerations with moderate variability, variable decelerations with other characteristics such as slow return to baseline, overshooting the baseline, or 'shoulders'"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hypotension', 'Labor Complication']}, 'descriptionModule': {'briefSummary': 'When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of SCDs in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms:\n\n* Arm 1: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement\n* Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs', 'detailedDescription': 'When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of SCDs in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms:\n\n* Arm 1: Patient will receive 1liter (L) of lactated ringers (LR) and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement\n* Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs Outcome variables include occurrence of maternal hypotension or Category II fetal tracings in the first hour after epidural placement.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Laboring women only', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laboring at Bethesda North Hospital Labor \\& Delivery Unit\n* Will receive epidural analgesia\n* 37+ weeks gestation\n* Singleton pregnancy\n* Category 1 tracings only before epidural placement\n\nExclusion Criteria:\n\n* Under 18 years old\n* Does not speak English\n* Unable to consent to involvement in the research study\n* Diagnosed with fetal demise\n* Diagnosis of pre-existing hypertension\n* Diagnosis of gestational hypertension\n* Diagnosis of pre-eclampsia\n* Diagnosis of diabetes\n* Breech presentation\n* Contraindications to lower leg compression (ex: fractured bones in leg, cellulitis, lower limb amputation, etc.)\n* Contraindications to receiving 1L of LR\n* Blood pressure on admission systolic blood pressure (SBP)\\>160 or diastolic blood pressure (DBP)\\>110\n* Fetal heart rate abnormalities before epidural'}, 'identificationModule': {'nctId': 'NCT05250960', 'briefTitle': 'Pre-epidural Sequential Compression Devices (SCDs) to Prevent Hypotension During Labor', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Evaluating the Use of Pre-epidural Placement of Sequential Compression Devices (SCD) to Prevent Hypotension', 'orgStudyIdInfo': {'id': '21-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention - SCD arm', 'description': 'Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement', 'interventionNames': ['Device: SCD']}, {'type': 'NO_INTERVENTION', 'label': 'Control - no SCD arm', 'description': 'Patient will receive 1L of LR during and after epidural placement with no use of SCDs'}], 'interventions': [{'name': 'SCD', 'type': 'DEVICE', 'description': 'Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement', 'armGroupLabels': ['Intervention - SCD arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bethesda North Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}