Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-25 @ 11:48 PM
Study NCT ID:
NCT01932060
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2013-08-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ajbut@stanford.edu', 'phone': '(650) 736-8513', 'title': 'Dr. Alexander Butwick', 'organization': 'Stanford University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'during period of hospitalization - max 7 days', 'eventGroups': [{'id': 'EG000', 'title': 'Oxytocin Infusion 1', 'description': 'Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.\n\nOxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oxytocin Infusion 2', 'description': 'Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.\n\nOxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Estimated Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Infusion 1', 'description': 'Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.\n\nOxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.'}, {'id': 'OG001', 'title': 'Oxytocin Infusion 2', 'description': 'Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.\n\nOxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.'}], 'classes': [{'categories': [{'measurements': [{'value': '512', 'groupId': 'OG000', 'lowerLimit': '405', 'upperLimit': '740'}, {'value': '634', 'groupId': 'OG001', 'lowerLimit': '340', 'upperLimit': '886'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'immediately at end of surgery', 'description': 'Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).', 'unitOfMeasure': 'ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hemoglobin Indices After Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Infusion 1', 'description': 'Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.\n\nOxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.'}, {'id': 'OG001', 'title': 'Oxytocin Infusion 2', 'description': 'Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.\n\nOxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '11.8'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '12.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hr after cesarean delivery', 'description': 'Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery', 'unitOfMeasure': 'g/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxytocin Infusion 1', 'description': 'Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.\n\nOxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.'}, {'id': 'FG001', 'title': 'Oxytocin Infusion 2', 'description': 'Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.\n\nOxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxytocin Infusion 1', 'description': 'Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.\n\nOxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.'}, {'id': 'BG001', 'title': 'Oxytocin Infusion 2', 'description': 'Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.\n\nOxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '6', 'groupId': 'BG000'}, {'value': '32', 'spread': '5', 'groupId': 'BG001'}, {'value': '33', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-07', 'studyFirstSubmitDate': '2013-08-21', 'resultsFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2013-08-28', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-12-07', 'studyFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Estimated Blood Loss', 'timeFrame': 'immediately at end of surgery', 'description': 'Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin Indices After Cesarean Delivery', 'timeFrame': '24 hr after cesarean delivery', 'description': 'Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oxytocin', 'blood loss', 'Cesarean delivery'], 'conditions': ['Postpartum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to maintain adequate uterine tone after delivery. The study investigators aim to compare two different infusion rates of oxytocin to assess the optimal infusion regimen for reducing blood loss in women undergoing elective Cesarean delivery.', 'detailedDescription': 'Oxytocin (pitocin) is a drug commonly used in obstetric practice, and the drug effect is to increase the muscular tone of the uterus to reduce uterine bleeding after neonatal delivery. Pregnant patients undergoing elective (scheduled)Cesarean delivery routinely receive oxytocin after delivery of the baby. Post-delivery, oxytocin is commonly administered as an IV bolus and/or infusion. No previous studies have accurately assessed differences in oxytocin infusions after delivery in patients undergoing elective cesarean delivery. Thus the study aim is to investigate which infusion rate can optimally provide adequate maintenance of uterine tone during Cesarean delivery while being associated with minimal or no maternal side-effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy pregnant patients with uncomplicated pregnancies:\n* ASA (American Association of Anesthesiologists) class 1 or 2 patients.\n* Singleton pregnancies.\n\nExclusion Criteria:\n\n* ASA class 3 or 4 patients.\n* Known drug allergy to intravenous oxytocin.\n* Significant medical or obstetric disease.\n* Known uterine abnormality.\n* Known placental abnormality.'}, 'identificationModule': {'nctId': 'NCT01932060', 'briefTitle': 'Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Effects of Different Oxytocin Infusions on Blood Loss and Postpartum Hemoglobin Values in Patients Undergoing Elective Cesarean Delivery', 'orgStudyIdInfo': {'id': '28015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin Infusion 1', 'description': 'Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.', 'interventionNames': ['Drug: Oxytocin Infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin Infusion 2', 'description': 'Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.', 'interventionNames': ['Drug: Oxytocin Infusion']}], 'interventions': [{'name': 'Oxytocin Infusion', 'type': 'DRUG', 'otherNames': ['Oxytocin; Pitocin'], 'description': 'Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.', 'armGroupLabels': ['Oxytocin Infusion 1', 'Oxytocin Infusion 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital, Stanford University", 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Alexander J Butwick, F.R.C.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alex James Butwick', 'investigatorAffiliation': 'Stanford University'}}}}