Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-27 @ 4:33 PM
Study NCT ID:
NCT00977769
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2009-09-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carbetocin Versus Oxytocin and Hemodynamic Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C020731', 'term': 'carbetocin'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lrossela@ous-hf.no', 'phone': '+4723070000', 'title': 'Professor Leiv Arne Rosseland', 'organization': 'Oslo University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Carbetocin 100 µg', 'description': 'carbetocin 100 µg : Hemodynamic effect of', 'otherNumAtRisk': 25, 'otherNumAffected': 9, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oxytocin 5 u', 'description': 'oxytocin 5 u : Hemodynamic effect of', 'otherNumAtRisk': 26, 'otherNumAffected': 9, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo (NaCl)', 'description': 'placebo (NaCl) : Hemodynamic effect of', 'otherNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Feeling of warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Xerostomia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Metallic taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cardiac Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Carbetocin 100 µg', 'description': 'carbetocin 100 µg : Hemodynamic effect of'}, {'id': 'OG001', 'title': 'Oxytocin 5 u', 'description': 'oxytocin 5 u : Hemodynamic effect of'}, {'id': 'OG002', 'title': 'Placebo (NaCl)', 'description': 'placebo (NaCl) : Hemodynamic effect of'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '111'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '100'}, {'value': '43', 'groupId': 'OG002', 'lowerLimit': '35', 'upperLimit': '51'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2.5 minutes', 'description': 'The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.', 'unitOfMeasure': 'percentage change in cardiac output', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Arterial Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Carbetocin 100 µg', 'description': 'carbetocin 100 µg : Hemodynamic effect of'}, {'id': 'OG001', 'title': 'Oxytocin 5 u', 'description': 'oxytocin 5 u : Hemodynamic effect of'}, {'id': 'OG002', 'title': 'Placebo (NaCl)', 'description': 'placebo (NaCl) : Hemodynamic effect of'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '31'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '34'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '22'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2.5 min', 'description': 'The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.', 'unitOfMeasure': 'percentage change in arterial blood pres', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Carbetocin 100 µg', 'description': 'carbetocin 100 µg : Hemodynamic effect of'}, {'id': 'OG001', 'title': 'Oxytocin 5 u', 'description': 'oxytocin 5 u : Hemodynamic effect of'}, {'id': 'OG002', 'title': 'Placebo (NaCl)', 'description': 'placebo (NaCl) : Hemodynamic effect of'}], 'classes': [{'categories': [{'measurements': [{'value': '579', 'spread': '623', 'groupId': 'OG000'}, {'value': '841', 'spread': '556', 'groupId': 'OG001'}, {'value': '853', 'spread': '518', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'The calculated estimated blood loss from delivery until 2 h after intervention', 'unitOfMeasure': 'ml blood loss', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carbetocin 100 µg', 'description': 'carbetocin 100 µg : Hemodynamic effect of'}, {'id': 'FG001', 'title': 'Oxytocin 5 u', 'description': 'oxytocin 5 u : Hemodynamic effect of'}, {'id': 'FG002', 'title': 'Placebo (NaCl)', 'description': 'placebo (NaCl) : Hemodynamic effect of'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Carbetocin 100 µg', 'description': 'carbetocin 100 µg : Hemodynamic effect of'}, {'id': 'BG001', 'title': 'Oxytocin 5 u', 'description': 'oxytocin 5 u : Hemodynamic effect of'}, {'id': 'BG002', 'title': 'Placebo (NaCl)', 'description': 'placebo (NaCl) : Hemodynamic effect of'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '34.8', 'spread': '4.0', 'groupId': 'BG002'}, {'value': '34.5', 'spread': '4.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Norway', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-04', 'studyFirstSubmitDate': '2009-09-15', 'resultsFirstSubmitDate': '2013-04-24', 'studyFirstSubmitQcDate': '2009-09-15', 'lastUpdatePostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-04', 'studyFirstPostDateStruct': {'date': '2009-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Output', 'timeFrame': '2.5 minutes', 'description': 'The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.'}, {'measure': 'Arterial Blood Pressure', 'timeFrame': '2.5 min', 'description': 'The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.'}], 'secondaryOutcomes': [{'measure': 'Bleeding', 'timeFrame': '120 minutes', 'description': 'The calculated estimated blood loss from delivery until 2 h after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cesarean delivery', 'blood pressure', 'cardiac output'], 'conditions': ['Effects of; Anesthesia, in Pregnancy']}, 'referencesModule': {'references': [{'pmid': '23598289', 'type': 'RESULT', 'citation': 'Rosseland LA, Hauge TH, Grindheim G, Stubhaug A, Langesaeter E. Changes in blood pressure and cardiac output during cesarean delivery: the effects of oxytocin and carbetocin compared with placebo. Anesthesiology. 2013 Sep;119(3):541-51. doi: 10.1097/ALN.0b013e31829416dd.'}, {'pmid': '34127491', 'type': 'DERIVED', 'citation': 'Michelsen TM, Tronstad C, Rosseland LA. Blood pressure and cardiac output during caesarean delivery under spinal anaesthesia: a prospective cohort study. BMJ Open. 2021 Jun 14;11(6):e046102. doi: 10.1136/bmjopen-2020-046102.'}]}, 'descriptionModule': {'briefSummary': 'A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.', 'detailedDescription': 'Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy pregnant women for planned cesarean section\n\nExclusion Criteria:\n\n* Bleeding disorders\n* Placenta disorders'}, 'identificationModule': {'nctId': 'NCT00977769', 'briefTitle': 'Carbetocin Versus Oxytocin and Hemodynamic Effects', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.', 'orgStudyIdInfo': {'id': '2009carb'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'carbetocin 100 µg', 'description': 'Carbetocin injection, 100µg, single injection', 'interventionNames': ['Drug: carbetocin 100 µg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'oxytocin 5 u', 'description': 'Oxytocin 5U, injection, single injection', 'interventionNames': ['Drug: oxytocin 5 u']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo (NaCl)', 'description': 'Saline single injection', 'interventionNames': ['Drug: placebo (NaCl)']}], 'interventions': [{'name': 'carbetocin 100 µg', 'type': 'DRUG', 'otherNames': ['Pabal, injection'], 'description': 'Hemodynamic effect of', 'armGroupLabels': ['carbetocin 100 µg']}, {'name': 'oxytocin 5 u', 'type': 'DRUG', 'otherNames': ['Syntocinon, injection'], 'description': 'Hemodynamic effect of', 'armGroupLabels': ['oxytocin 5 u']}, {'name': 'placebo (NaCl)', 'type': 'DRUG', 'otherNames': ['Saline, injection'], 'description': 'Hemodynamic effect of', 'armGroupLabels': ['placebo (NaCl)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Division of Anesthesia and Intensive Care Medicine', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Leiv Arne Rosseland, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Leiv Arne Rosseland', 'investigatorAffiliation': 'Oslo University Hospital'}}}}