Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'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': 'Adamsturdivant@uabmc.edu', 'phone': '205-934-4042', 'title': 'Adam Sturdivant', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 1 hour', 'eventGroups': [{'id': 'EG000', 'title': 'Palpation Group', 'description': 'The palpation group will have an epidural placed after manual palpation of the spine.\n\nPalpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ultrasound Group', 'description': 'The ultrasound group will have an epidural placed after identifying midline with the ultrasound.\n\nUltrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time for Epidural Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation Group', 'description': 'The palpation group will have an epidural placed after manual palpation of the spine.\n\nPalpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure'}, {'id': 'OG001', 'title': 'Ultrasound Group', 'description': 'The ultrasound group will have an epidural placed after identifying midline with the ultrasound.\n\nUltrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 1 hour', 'description': 'Comparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Needle Passes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation Group', 'description': 'The palpation group will have an epidural placed after manual palpation of the spine.\n\nPalpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure'}, {'id': 'OG001', 'title': 'Ultrasound Group', 'description': 'The ultrasound group will have an epidural placed after identifying midline with the ultrasound.\n\nUltrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 1 hour', 'unitOfMeasure': 'needle passes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation Group', 'description': 'The palpation group will have an epidural placed after manual palpation of the spine.\n\nPalpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure'}, {'id': 'OG001', 'title': 'Ultrasound Group', 'description': 'The ultrasound group will have an epidural placed after identifying midline with the ultrasound.\n\nUltrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 1 hour', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Identify Midline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation Group', 'description': 'The palpation group will have an epidural placed after manual palpation of the spine.\n\nPalpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure'}, {'id': 'OG001', 'title': 'Ultrasound Group', 'description': 'The ultrasound group will have an epidural placed after identifying midline with the ultrasound.\n\nUltrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '24.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 1 hour', 'description': 'Comparing the time it takes to locate midline of the back in the palpation group vs. the ultrasound group. Measured in minutes from the start of the identification process until completion of the midline identification process.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Epidural Failure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation Group', 'description': 'The palpation group will have an epidural placed after manual palpation of the spine.\n\nPalpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure'}, {'id': 'OG001', 'title': 'Ultrasound Group', 'description': 'The ultrasound group will have an epidural placed after identifying midline with the ultrasound.\n\nUltrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 1 hour', 'description': 'Comparing the number of epidural failures in the palpation vs. ultrasound group.', 'unitOfMeasure': 'failed epidurals', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Top-offs Required', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation Group', 'description': 'The palpation group will have an epidural placed after manual palpation of the spine.\n\nPalpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure'}, {'id': 'OG001', 'title': 'Ultrasound Group', 'description': 'The ultrasound group will have an epidural placed after identifying midline with the ultrasound.\n\nUltrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 1 hour', 'unitOfMeasure': 'number of topoffs required', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Palpation Group', 'description': 'The palpation group will have an epidural placed after manual palpation of the spine.\n\nPalpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure'}, {'id': 'FG001', 'title': 'Ultrasound Group', 'description': 'The ultrasound group will have an epidural placed after identifying midline with the ultrasound.\n\nUltrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Palpation Group', 'description': 'The palpation group will have an epidural placed after manual palpation of the spine.\n\nPalpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure'}, {'id': 'BG001', 'title': 'Ultrasound Group', 'description': 'The ultrasound group will have an epidural placed after identifying midline with the ultrasound.\n\nUltrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], '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': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', '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': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44.4', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '43.3', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '43.8', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '163.9', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '164.2', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '164.1', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '119.5', 'spread': '20.6', 'groupId': 'BG000'}, {'value': '116.8', 'spread': '20.2', 'groupId': 'BG001'}, {'value': '118.1', 'spread': '20.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-19', 'size': 8528935, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-19T12:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Upon enrollment into the study, participants will be randomized 1:1 to either ultrasound or palpation. Randomization will be performed via random drawing: the provider will randomly select a card assigning the method of midline identification (i.e., ultrasound or palpation). Anesthesia providers will not be randomized. Any qualified provider available to place the epidural will be the person to perform the procedure.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2017-03-25', 'resultsFirstSubmitDate': '2019-08-21', 'studyFirstSubmitQcDate': '2017-03-29', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-16', 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time for Epidural Placement', 'timeFrame': 'Baseline up to 1 hour', 'description': 'Comparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose.'}, {'measure': 'Number of Needle Passes', 'timeFrame': 'Baseline up to 1 hour'}, {'measure': 'Total Time', 'timeFrame': 'Baseline up to 1 hour'}], 'secondaryOutcomes': [{'measure': 'Time to Identify Midline', 'timeFrame': 'Baseline up to 1 hour', 'description': 'Comparing the time it takes to locate midline of the back in the palpation group vs. the ultrasound group. Measured in minutes from the start of the identification process until completion of the midline identification process.'}, {'measure': 'Epidural Failure Rate', 'timeFrame': 'Baseline up to 1 hour', 'description': 'Comparing the number of epidural failures in the palpation vs. ultrasound group.'}, {'measure': 'Number of Top-offs Required', 'timeFrame': 'Baseline up to 1 hour'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Epidural Anesthesia', 'Spinal Ultrasound', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This study will address the utility of ultrasound in the placement of an epidural catheter in severely obese parturients. Identification of midline can often be difficult using the standard method of palpation in obese patients. The Investigator will determine if the use of ultrasound decreases the amount of time and number of attempts required to place the epidural.', 'detailedDescription': 'The use of ultrasound has expanded into many areas of medicine including the identification of bony landmarks to facilitate epidural placement in obstetric anesthesia. Using ultrasound for epidural placement has become popular over the last decade with several studies being published on the topic. The likely increase in popularity for ultrasound use in the obstetric population is the need to more reliably locate bony landmarks as the traditional palpation technique has been shown to be an inaccurate way to accomplish this. Given the fact that the long-taught palpation technique can be inaccurate and studies have validated the use of ultrasound for epidural placement, ultrasound technique is routinely taught by the obstetric anesthesiologists to the anesthesiology residents at the University of Alabama at Birmingham (UAB). Also, since both techniques are considered standard practice at UAB, anesthesia providers (residents, fellows, and faculty) are free to choose either technique to locate bony structures of the back prior to epidural placement. Since no current study has specifically addressed its use in the obese pregnant patient, the investigators would like to validate its use in this population.\n\nIn this study, investigators will evaluate the use of ultrasound in the obese population to determine if its use will decrease the time it takes to place the epidural and number of attempts required when compared to the traditional palpation technique. The study will also determine the success rate of epidural placement in both the palpation and ultrasound groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'All female parturients in active labor', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient request for a labor epidural\n* BMI≥35\n\nExclusion Criteria:\n\n* BMI\\<35\n* patient refusal of a labor epidural\n* coagulopathy\n* platelets\\<80,000\n* prior spine procedure or instrumentation\n* a diagnosis of scoliosis\n* an intracranial or spinal mass'}, 'identificationModule': {'nctId': 'NCT03100968', 'briefTitle': 'Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients: A Randomized, Prospective Study', 'orgStudyIdInfo': {'id': 'F150402002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Palpation Group', 'description': 'The palpation group will have an epidural placed after manual palpation of the spine.', 'interventionNames': ['Procedure: Palpation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound Group', 'description': 'The ultrasound group will have an epidural placed after identifying midline with the ultrasound.', 'interventionNames': ['Device: Ultrasound']}], 'interventions': [{'name': 'Palpation', 'type': 'PROCEDURE', 'description': 'Traditional epidural methods used for the identification of the midline using palpation prior to procedure', 'armGroupLabels': ['Palpation Group']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Lumbar spinal ultrasound performed for identification of the midline prior to procedure.', 'armGroupLabels': ['Ultrasound Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Department of Anesthesiology and Perioperative Medicine', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Mark F Powell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mark Powell', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}