Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-31 @ 4:47 PM
Study NCT ID:
NCT03712735
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2018-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2018-10-17', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breakthrough pain', 'timeFrame': 'Duration of labor with epidural', 'description': 'Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Labor analgesia', 'Programmed intermittent epidural bolus'], 'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'Comparison of three programmed intermittent epidural bolus (PIEB) pump settings for maintenance of labour analgesia.', 'detailedDescription': 'The optimal PIEB and patient controlled epidural administered (PCEA) bolus settings are still unknown. Therefore, in this study, the investigators aim to compare analgesia outcomes both high and low PIEB flow rate settings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton, vertex presentations at term (37-42 weeks gestational age)\n* \\</= 5cm cervical dilation at the time of epidural anesthesia request\n* ASA 2-3 patients aged 19 or over who are able to provide informed consent\n\nExclusion Criteria:\n\n* Contraindications to neuraxial analgesia or risk factors likely to affect placement or function of the epidural\n* History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids\n* Current or historical evidence of any significant medical conditions\n* Clinical settings in which continuous epidural infusion may be preferable\n* Risk factors significantly increasing the need for Cesarean delivery\n* Anticipated fetal abnormalities'}, 'identificationModule': {'nctId': 'NCT03712735', 'briefTitle': 'Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Effect of Programmed Intermittent Epidural Bolus Delivery Rate on the Quality of Labour Analgesia: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'H18-02318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings:\n\nPIEB flow rate = high; interval = 60 min', 'interventionNames': ['Drug: Bupivacaine 0.08% - fentanyl 2mcg']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min', 'interventionNames': ['Drug: Bupivacaine 0.08% - fentanyl 2mcg']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min', 'interventionNames': ['Drug: Bupivacaine 0.08% - fentanyl 2mcg']}], 'interventions': [{'name': 'Bupivacaine 0.08% - fentanyl 2mcg', 'type': 'DRUG', 'description': 'In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Women's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Anton Chau, MD MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Anthony Chau', 'investigatorAffiliation': 'University of British Columbia'}}}}