Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-02-11 @ 2:09 PM
Study NCT ID:
NCT02885350
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
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': 'D015360', 'term': 'Analgesia, Epidural'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'antti.vaananen@hus.fi', 'phone': '358504271850', 'title': 'Dr Antti Vaananen', 'organization': "Helsinki University Central hospital/Women's hospital/anaesthesia"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'No known limitations.'}}, 'adverseEventsModule': {'timeFrame': '30 minutes', 'description': 'The parturient is monitored for 30 minutes after the intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Spinal Fentanyl', 'description': '20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.\n\nSpinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 18, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Epidural Fentanyl', 'description': '100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.\n\nEpidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 8, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Spinal Sufentanil', 'description': '5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.\n\nSpinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 12, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Epidural Sufentanil', 'description': '20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.\n\nEpidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 8, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pruritus', 'notes': 'Opioid induced pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Spinal Fentanyl', 'description': '20 micrograms of intrathecally administered fentanyl in single dose. 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Total volume of epidural injection 7 ml.\n\nEpidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '74'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '47'}, {'value': '67', 'groupId': 'OG002', 'lowerLimit': '54', 'upperLimit': '81'}, {'value': '42', 'groupId': 'OG003', 'lowerLimit': '30', 'upperLimit': '55'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 minutes', 'description': 'All parturients are to have a pain visual analog scale (VAS - on a 0-100 mm scale) at 80mm or higher before the initial study drug delivery. On this scale 0 mm presents a totally pain free condition while 100 mm presents the worst imaginable pain. The change of maximum pain in millimeters on the VAS scale during the 20 minutes following the study drug delivery will be recorded.', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Spinal Fentanyl', 'description': '20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.\n\nSpinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique'}, {'id': 'OG001', 'title': 'Epidural Fentanyl', 'description': '100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.\n\nEpidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.'}, {'id': 'OG002', 'title': 'Spinal Sufentanil', 'description': '5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.\n\nSpinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique'}, {'id': 'OG003', 'title': 'Epidural Sufentanil', 'description': '20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.\n\nEpidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.'}], 'classes': [{'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000', 'lowerLimit': '121', 'upperLimit': '234'}, {'value': '112', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '143'}, {'value': '151', 'groupId': 'OG002', 'lowerLimit': '111', 'upperLimit': '192'}, {'value': '130', 'groupId': 'OG003', 'lowerLimit': '93', 'upperLimit': '168'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The data below report an average duration of time that is typically less than three hours', 'description': 'The time from the study drug dose to the administration of next epidural bolus, up to five hours. After the study drug dose all parturients wil have epidural catheters in place for subsequent analgesia.', 'unitOfMeasure': 'min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spinal Fentanyl', 'description': '20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.\n\nSpinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique'}, {'id': 'FG001', 'title': 'Epidural Fentanyl', 'description': '100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.\n\nEpidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.'}, {'id': 'FG002', 'title': 'Spinal Sufentanil', 'description': '5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.\n\nSpinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique'}, {'id': 'FG003', 'title': 'Epidural Sufentanil', 'description': '20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.\n\nEpidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Spinal Fentanyl', 'description': '20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.\n\nSpinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique'}, {'id': 'BG001', 'title': 'Epidural Fentanyl', 'description': '100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.\n\nEpidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.'}, {'id': 'BG002', 'title': 'Spinal Sufentanil', 'description': '5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.\n\nSpinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique'}, {'id': 'BG003', 'title': 'Epidural Sufentanil', 'description': '20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.\n\nEpidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain visual analog scale at 0-100 mm', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '84', 'spread': '12', 'groupId': 'BG000'}, {'value': '87', 'spread': '9', 'groupId': 'BG001'}, {'value': '86', 'spread': '8', 'groupId': 'BG002'}, {'value': '87', 'spread': '11', 'groupId': 'BG003'}, {'value': '86', 'spread': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'A 100 mm visual analog scale (VAS) is used, where 0 mm presents no pain at all and 100 mm presents the worst possible pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Parturients in active labour'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-01', 'size': 584071, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-27T02:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-27', 'studyFirstSubmitDate': '2016-08-26', 'resultsFirstSubmitDate': '2021-03-31', 'studyFirstSubmitQcDate': '2016-08-30', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-28', 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery', 'timeFrame': '20 minutes', 'description': 'All parturients are to have a pain visual analog scale (VAS - on a 0-100 mm scale) at 80mm or higher before the initial study drug delivery. On this scale 0 mm presents a totally pain free condition while 100 mm presents the worst imaginable pain. The change of maximum pain in millimeters on the VAS scale during the 20 minutes following the study drug delivery will be recorded.'}], 'secondaryOutcomes': [{'measure': 'The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid', 'timeFrame': 'The data below report an average duration of time that is typically less than three hours', 'description': 'The time from the study drug dose to the administration of next epidural bolus, up to five hours. After the study drug dose all parturients wil have epidural catheters in place for subsequent analgesia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'referencesModule': {'references': [{'pmid': '31286476', 'type': 'RESULT', 'citation': 'Vaananen A, Kuukasjarvi M, Tekay A, Ahonen J. Spinal and epidural sufentanil and fentanyl in early labour. Acta Anaesthesiol Scand. 2019 Nov;63(10):1413-1418. doi: 10.1111/aas.13450. Epub 2019 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be compared when given either intrathecally or epidurally in primiparous parturients during early phase of the labour.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primiparous parturients\n* In early phase of labour (cervical dilatation at or under 5 cm)\n* No prior opioids by any route of administration within past 120 min\n* Pain at or over 80 mm on 0-100 mm visual analog scale during contraction\n\nExclusion Criteria:\n\n* Allergy for any of the medications used\n* Contraindications for epidural/spinal analgesia\n* BMI at the time of delivery under 20 or over 35 kg/m2'}, 'identificationModule': {'nctId': 'NCT02885350', 'briefTitle': 'Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour', 'orgStudyIdInfo': {'id': 'ยง12/19.6.2016/HUS/400/2016'}, 'secondaryIdInfos': [{'id': '2016-000486-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal fentanyl', 'description': '20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.', 'interventionNames': ['Drug: Spinal analgesia for labour pain']}, {'type': 'EXPERIMENTAL', 'label': 'Epidural fentanyl', 'description': '100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.', 'interventionNames': ['Drug: Epidural analgesia for labour pain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal sufentanil', 'description': '5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.', 'interventionNames': ['Drug: Spinal analgesia for labour pain']}, {'type': 'EXPERIMENTAL', 'label': 'Epidural sufentanil', 'description': '20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.', 'interventionNames': ['Drug: Epidural analgesia for labour pain']}], 'interventions': [{'name': 'Spinal analgesia for labour pain', 'type': 'DRUG', 'description': 'Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique', 'armGroupLabels': ['Spinal fentanyl', 'Spinal sufentanil']}, {'name': 'Epidural analgesia for labour pain', 'type': 'DRUG', 'otherNames': ['labor epidural', 'labour epidural'], 'description': 'Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.', 'armGroupLabels': ['Epidural fentanyl', 'Epidural sufentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'FI-00610', 'city': 'Helsinki', 'state': 'Uusimaa', 'country': 'Finland', 'facility': 'Maternity Hospital, Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Antti J Vaananen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital (Katiloopiston sairaala)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.D.', 'investigatorFullName': 'Jouni Ahonen', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}