Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-24 @ 5:16 AM
Study NCT ID:
NCT02984267
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2016-11-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tvernon@azanesthesia.net', 'phone': '480-570-7082', 'title': 'Dr. Thomas Vernon', 'organization': 'Arizona Anesthesia Consultants'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the patients current hospitalization (typically 2-3 days)', 'description': 'All study participants were evaluated during and immediately following their epidural catheter procedure, and also later followed up on in person by study personnel within 24 hours of their delivery to assess for any adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Inadvertent dural puncture', 'notes': 'Number of participants sustaining an inadvertent dural puncture during the procedure resulting in the formation of a post-dural puncture headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia', 'notes': 'Number of patients experiencing a transient paresthesia in their back or leg(s) during epidural catheter placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Time Required for Epidural Catheter Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'OG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed immediately during epidural catheter placement', 'description': 'Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Epidural Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'OG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}], 'classes': [{'categories': [{'measurements': [{'value': '4.33', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed immediately during epidural catheter placement', 'description': 'Time required to successfully place the epidural catheter', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Attempts at Epidural Catheter Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'OG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed immediately during epidural catheter placement', 'unitOfMeasure': 'Number of attempts', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'OG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed immediately during epidural catheter placement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'OG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed immediately during epidural catheter placement and within 24 hours after delivery', 'description': 'Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.', 'unitOfMeasure': 'Complications', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Epidural Failure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'OG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed within 24 hours after delivery', 'description': 'Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Epidural Catheter Placement Satisfaction Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'OG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed immediately following epidural catheter placement', 'description': 'Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Anxiety Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'OG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed immediately following epidural catheter placement', 'description': 'Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Palpation or Ultrasound Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'OG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed immediately prior to epidural catheter placement', 'description': 'The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Anesthesia Experience Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'OG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}], 'classes': [{'categories': [{'measurements': [{'value': '79.1', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '74.3', 'spread': '9.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured within 24 hours of delivery', 'description': "Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'FG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement\n\nUltrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement'}, {'id': 'BG001', 'title': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation\n\nPalpation: Using palpation only to evaluate the spine prior to epidural placement'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.3', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '29.9', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '27.9', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', '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 (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gravidity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Number of pregnancies', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Parity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Number of children born', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Estimated gestational age', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.6', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '38.7', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '122.0', 'spread': '17.1', 'groupId': 'BG000'}, {'value': '120.6', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '121.2', 'spread': '15.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '163.7', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '162.1', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '162.8', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45.6', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '45.9', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '45.8', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'American Society of Anesthesiologists (ASA) physical status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'title': 'ASA1', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'ASA2', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'ASA3', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ASA1, ASA2, and ASA3 are all categories that participants could fall into based on the status of their overall health. ASA1 indicates a normal, healthy patient. ASA2 indicates a patient with mild systemic disease (examples include but are not limited to pregnancy, current smoker, obesity with a BMI \\>30 but \\<40, and well controlled diabetes or hypertension). ASA3 indicates a patient with severe systemic disease (examples include but are not limited to poorly controlled diabetes or hypertension, chronic obstructive pulmonary disorder, morbid obesity with a BMI greater than or equal to 40).', 'unitOfMeasure': 'Participants'}, {'title': 'External landmarks visible', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The back of the patient is visually examined to determine if the outline of the spinous processes of the vertebrae can be seen through the skin.', 'unitOfMeasure': 'Participants'}, {'title': 'Palpable interspace', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A patient has "palpable interspaces" when the spinous processes of the vertebrae, and thus the interspaces between them, can easily be physically felt by the provider through the patient\'s skin.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Palpation was not performed in ultrasound group because only the ultrasound was used to asses location for epidural catheter placement in that group. The number of participants in the ultrasound group reflects only the number analyzed (i.e. 0) and the total number of participants analyzed reflects the total number analyzed (i.e. 9 participants).'}], 'populationDescription': 'Ultrasound 43.75% (7/16); Palpation 56.25% (9/16)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-01', 'size': 102137, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-07T19:50', 'hasProtocol': False}, {'date': '2016-10-01', 'size': 174068, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-07T20:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2016-11-23', 'resultsFirstSubmitDate': '2018-03-30', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-13', 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Time Required for Epidural Catheter Placement', 'timeFrame': 'Assessed immediately during epidural catheter placement', 'description': 'Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter'}], 'secondaryOutcomes': [{'measure': 'Epidural Procedure Time', 'timeFrame': 'Assessed immediately during epidural catheter placement', 'description': 'Time required to successfully place the epidural catheter'}, {'measure': 'Number of Attempts at Epidural Catheter Placement', 'timeFrame': 'Assessed immediately during epidural catheter placement'}, {'measure': 'Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt', 'timeFrame': 'Assessed immediately during epidural catheter placement'}, {'measure': 'Complications', 'timeFrame': 'Assessed immediately during epidural catheter placement and within 24 hours after delivery', 'description': 'Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.'}, {'measure': 'Epidural Failure Rate', 'timeFrame': 'Assessed within 24 hours after delivery', 'description': 'Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported'}, {'measure': 'Epidural Catheter Placement Satisfaction Level', 'timeFrame': 'Assessed immediately following epidural catheter placement', 'description': 'Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.'}, {'measure': 'Patient Anxiety Level', 'timeFrame': 'Assessed immediately following epidural catheter placement', 'description': 'Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.'}, {'measure': 'Palpation or Ultrasound Time', 'timeFrame': 'Assessed immediately prior to epidural catheter placement', 'description': 'The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion'}, {'measure': 'Overall Anesthesia Experience Satisfaction', 'timeFrame': 'Measured within 24 hours of delivery', 'description': "Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current (pregnant) BMI ≥ 40\n* Age ≥ 18\n* ASA score of 3 or less\n* Full term pregnancy (37 weeks gestational age or greater)\n\nExclusion Criteria:\n\n* Known scoliosis\n* Known contraindications to neuraxial blockade\n* Intrauterine fetal demise or non-viable fetus.'}, 'identificationModule': {'nctId': 'NCT02984267', 'briefTitle': 'Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40', 'orgStudyIdInfo': {'id': 'OBUS1123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound Group', 'description': 'The interventional group that will have their spine evaluated by ultrasound prior to epidural placement', 'interventionNames': ['Device: Ultrasound']}, {'type': 'OTHER', 'label': 'Palpation Group', 'description': 'The control group that will have their epidural placed in the usual fashion based on palpation', 'interventionNames': ['Other: Palpation']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Using ultrasound guidance to evaluate the spine prior to epidural placement', 'armGroupLabels': ['Ultrasound Group']}, {'name': 'Palpation', 'type': 'OTHER', 'description': 'Using palpation only to evaluate the spine prior to epidural placement', 'armGroupLabels': ['Palpation Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Magee Women's Hospital", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas J. Vernon', 'class': 'OTHER'}, 'collaborators': [{'name': 'West Penn Allegheny Health System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'OB Anesthesia Fellow', 'investigatorFullName': 'Thomas J. Vernon', 'investigatorAffiliation': 'University of Pittsburgh'}}}}