Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-01-07 @ 7:40 AM
Study NCT ID:
NCT04538261
Status:
TERMINATED
Last Update Posted:
2025-06-03
First Post:
2020-08-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Elevation of the Fetal Buttocks Prior to External Cephalic Version
Sponsor:
Organization:
Raw JSON
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Ashley Hill, MD', 'organization': 'AdventHealth Orlando'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 hour after completion of ECV procedure until discharge after delivery (average of 3.5 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Having Successful Conversion to Cephalic Presentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately upon completion of the ECV procedure', 'description': 'Successful conversion of breech fetus to cephalic presentation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately after ECV procedure or during subsequent labor and delivery', 'description': 'Presence of cesarean delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fetal Presentation at Time of Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Labor and Delivery (approximately 12 hours)', 'description': 'Cephalic presentation of the fetus during participant delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cost of ECV Procedure and Hospital Stay (Mother)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'timeFrame': 'ECV procedure and during labor, delivery, and immediate postpartum period (up to 42 days)', 'description': 'Cost of ECV procedure and hospital stay (mother)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome because of multiple changes to the electronic medical record platforms during the study period and loss of analytics team resources that preclude analysis. There is no possibility of data collection for this secondary outcome.'}, {'type': 'SECONDARY', 'title': 'Cost of ECV Procedure and Hospital Stay (Neonate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'timeFrame': 'Birth to hospital discharge (up to 42 days)', 'description': "Cost of neonate's hospitalization after delivery", 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome because of multiple changes to the electronic medical record platforms during the study period and loss of analytics team resources that preclude analysis. There is no possibility of data collection for this secondary outcome.'}, {'type': 'SECONDARY', 'title': 'Shoulder Dystocia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Labor and Delivery (approximately 12 hours)', 'description': 'Presence of shoulder dystocia during delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rupture of Membranes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 1 hour of ECV procedure', 'description': 'Presence of rupture of membranes after ECV procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Emergency Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During or within 1 hour of performing ECV procedure', 'description': 'Need for emergency cesarean delivery during or after ECV procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pelvic Hematoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During or within 1 hour of performing ECV procedure', 'description': 'Development of a pelvic hematoma within 1 hour of ECV procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedural Pain During Device Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '69'}, {'value': '59.6', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 2 minutes after insertion of balloon device.', 'description': 'Visual analogue pain score after insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after ECV procedure', 'description': 'Number of attempted ECV procedures to convert fetus from breech to cephalic presentation', 'unitOfMeasure': 'Number of attempts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cost of Hospital Stay for ECV Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the 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There is no possibility of data collection for this secondary outcome.'}, {'type': 'SECONDARY', 'title': 'Procedural Pain Prior to Device Insertion.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of balloon device'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 3 minutes prior to insertion of device.', 'description': 'Baseline visual analogue pain score prior to insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedural Pain After Inflation of Device or Sham Inflation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of balloon device'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '75'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 1 minute after device inflation or sham inflation.', 'description': 'Visual analogue pain score after inflation or sham inflation of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain After External Cephalic Version Attempt.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Non-inflation of balloon device'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '60'}, {'value': '29.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '58'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 2 minutes of ECV procedure completion.', 'description': 'Visual analogue pain score after ECV procedure (100mm visual analogue scale where 0 =no pain and 100=extreme pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'FG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Non-inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'Inflation of the balloon device\n\nFetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '28.6', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '29.5', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'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': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-23', 'size': 314337, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-28T12:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Investigators and participants will not know whether participants have undergone inflation of the balloon device.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized trial using control and interventional arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Not recruiting at the rate we thought it would.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2020-08-17', 'resultsFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-29', 'studyFirstPostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Having Successful Conversion to Cephalic Presentation', 'timeFrame': 'Immediately upon completion of the ECV procedure', 'description': 'Successful conversion of breech fetus to cephalic presentation'}], 'secondaryOutcomes': [{'measure': 'Cesarean Delivery', 'timeFrame': 'Immediately after ECV procedure or during subsequent labor and delivery', 'description': 'Presence of cesarean delivery'}, {'measure': 'Fetal Presentation at Time of Delivery', 'timeFrame': 'Labor and Delivery (approximately 12 hours)', 'description': 'Cephalic presentation of the fetus during participant delivery'}, {'measure': 'Cost of ECV Procedure and Hospital Stay (Mother)', 'timeFrame': 'ECV procedure and during labor, delivery, and immediate postpartum period (up to 42 days)', 'description': 'Cost of ECV procedure and hospital stay (mother)'}, {'measure': 'Cost of ECV Procedure and Hospital Stay (Neonate)', 'timeFrame': 'Birth to hospital discharge (up to 42 days)', 'description': "Cost of neonate's hospitalization after delivery"}, {'measure': 'Shoulder Dystocia', 'timeFrame': 'Labor and Delivery (approximately 12 hours)', 'description': 'Presence of shoulder dystocia during delivery'}, {'measure': 'Rupture of Membranes', 'timeFrame': 'Within 1 hour of ECV procedure', 'description': 'Presence of rupture of membranes after ECV procedure'}, {'measure': 'Emergency Cesarean Delivery', 'timeFrame': 'During or within 1 hour of performing ECV procedure', 'description': 'Need for emergency cesarean delivery during or after ECV procedure'}, {'measure': 'Pelvic Hematoma', 'timeFrame': 'During or within 1 hour of performing ECV procedure', 'description': 'Development of a pelvic hematoma within 1 hour of ECV procedure'}, {'measure': 'Procedural Pain During Device Insertion', 'timeFrame': 'Within 2 minutes after insertion of balloon device.', 'description': 'Visual analogue pain score after insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).'}, {'measure': 'Number of Attempts', 'timeFrame': 'Immediately after ECV procedure', 'description': 'Number of attempted ECV procedures to convert fetus from breech to cephalic presentation'}, {'measure': 'Cost of Hospital Stay for ECV Procedure', 'timeFrame': 'Patient arrival to labor unit for ECV procedure and discharge home (up to 72 hours)', 'description': 'Total cost of the hospital stay for the ECV procedure'}, {'measure': 'Procedural Pain Prior to Device Insertion.', 'timeFrame': 'Within 3 minutes prior to insertion of device.', 'description': 'Baseline visual analogue pain score prior to insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).'}, {'measure': 'Procedural Pain After Inflation of Device or Sham Inflation.', 'timeFrame': 'Within 1 minute after device inflation or sham inflation.', 'description': 'Visual analogue pain score after inflation or sham inflation of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).'}, {'measure': 'Pain After External Cephalic Version Attempt.', 'timeFrame': 'Within 2 minutes of ECV procedure completion.', 'description': 'Visual analogue pain score after ECV procedure (100mm visual analogue scale where 0 =no pain and 100=extreme pain).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Breech', 'Version'], 'conditions': ['Breech Presentation', 'External Cephalic Version']}, 'referencesModule': {'references': [{'pmid': '32332415', 'type': 'BACKGROUND', 'citation': 'External Cephalic Version: ACOG Practice Bulletin, Number 221. Obstet Gynecol. 2020 May;135(5):e203-e212. doi: 10.1097/AOG.0000000000003837.'}, {'pmid': '26868074', 'type': 'RESULT', 'citation': 'Seal SL, Dey A, Barman SC, Kamilya G, Mukherji J, Onwude JL. Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilatation. Int J Gynaecol Obstet. 2016 May;133(2):178-82. doi: 10.1016/j.ijgo.2015.09.019. Epub 2016 Jan 15.'}, {'pmid': '25828903', 'type': 'RESULT', 'citation': 'Hofmeyr GJ, Kulier R, West HM. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2015 Apr 1;2015(4):CD000083. doi: 10.1002/14651858.CD000083.pub3.'}, {'pmid': '18456227', 'type': 'RESULT', 'citation': 'Kok M, Cnossen J, Gravendeel L, van der Post J, Opmeer B, Mol BW. Clinical factors to predict the outcome of external cephalic version: a metaanalysis. Am J Obstet Gynecol. 2008 Dec;199(6):630.e1-7; discussion e1-5. doi: 10.1016/j.ajog.2008.03.008. Epub 2008 May 23.'}, {'pmid': '18055730', 'type': 'RESULT', 'citation': 'Weiniger CF, Ginosar Y, Elchalal U, Sharon E, Nokrian M, Ezra Y. External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1343-50. doi: 10.1097/01.AOG.0000295605.38175.7b.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized double-blind clinical trial evaluating the effect of a balloon device (Fetal Pillow) to elevate the fetal buttocks during external cephalic version procedures. Eligible study population: nulliparous pregnant women between 37-40 weeks estimated gestational age with a breech presenting fetus and no contraindications to external cephalic version.', 'detailedDescription': "Patients meeting inclusion criteria will be offered participation in this study. After performing an obstetric sonogram to determine fetal position, amniotic fluid status, fetal weight and placental location, the patient will be randomized to either placement of the Fetal Pillow balloon device with sham inflation (control arm) or placement of the device with inflation (study arm).\n\nThe researcher will show the patient the device, open the sterile container, and insert the device into the vagina per manufacturer's guidelines for all patients in the study. All patients will mark a line on a 100mm VAS to assess pre-insertion and post-insertion pain. The study physician will then obtain the assistance of a certified nurse midwife to inflate the device or perform a sham inflation. In order for the physician investigator to remain blinded, the physician will leave the room during the time of the inflation/sham inflation. A certified nurse midwife previously trained to inflate the device will perform the inflation or sham inflation per randomization. The assisting midwife will inflate the device with 180 mL of saline for those patients randomized to inflation. This will occur under a sheet so that the patient is blinded to the randomization scheme. If the patient is randomized to no inflation, the midwife will perform a sham inflation, also under a sheet. All patients will mark a line on a 100mm VAS to assess post-inflation/sham inflation pain. The assisting midwife then leaves the room, and the study physician reenters the room and proceeds with the external cephalic version (ECV) procedure.\n\nRegardless of randomization, at this point the ECV procedure proceeds using normal routine. The ECV will be attempted up to four times and VAS will be assessed after each attempt. Once completed, all patients will also mark a line on a 100mm VAS to assess post-ECV pain.\n\nThe research physician will then remove the Fetal Pillow. Regardless of randomization, the procedure is completed per the usual routine of fetal monitoring, assessing for rupture of membranes, labor or bleeding, discussing post-procedure care, then discharge home (or, less likely, admitting for either observation or delivery).\n\nThe researcher will fill out the ECV portion of the data collection form. Data are collected later for delivery outcomes and costs for the mother and neonate."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women delivering at AdventHealth Orlando campus.\n2. Breech presenting part as diagnosed by bedside sonography.\n3. No prior deliveries \\>/= 20 weeks gestational age.\n4. Pregnancy is between 37-40 weeks gestational age.\n5. Live fetus.\n6. Patient is \\>/= age 18.\n7. Patient speaks English or Spanish as primary language.\n8. Patient able to understand verbal and written consent\n\nExclusion Criteria:\n\n1. Non-breech presentation (cephalic, transverse, oblique).\n2. More than 1 fetus.\n3. Cervical dilation of \\>/= 1cm.\n4. Prior uterine incision.\n5. Congenital uterine anomaly.\n6. Body mass index more than 40 kg/m2.\n7. Uterine fibroids causing soft tissue dystocia.\n8. Extended fetal neck.\n9. Oligohydramnios (4-quadrant amniotic fluid index \\</= 5cm).\n10. Spontaneous rupture of membranes.\n11. Any contraindication to vaginal delivery.\n12. Intrauterine growth restriction (estimated fetal weight \\</= 10%ile).\n13. Estimated fetal weight \\> /= 5,000 grams for non-diabetic patient or \\>/= 4,500 grams for patient with pre-existing or gestational diabetes, confirmed by ultrasound.\n14. Fetal gastroschisis.\n15. Fetal neural tube defect.\n16. Severe-range preeclampsia.\n17. Patient had regional anesthesia immediately prior to ECV.'}, 'identificationModule': {'nctId': 'NCT04538261', 'briefTitle': 'Elevation of the Fetal Buttocks Prior to External Cephalic Version', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Elevation of the Fetal Buttocks Prior to External Cephalic Version', 'orgStudyIdInfo': {'id': '1379199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Non-inflation of the balloon device', 'interventionNames': ['Device: Fetal Pillow insertion']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Inflation of the balloon device', 'interventionNames': ['Device: Fetal Pillow insertion']}], 'interventions': [{'name': 'Fetal Pillow insertion', 'type': 'DEVICE', 'description': 'Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'David A Hill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}, {'name': 'Ariana Mora', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared outside of research team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}