Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-25 @ 6:57 PM
Study NCT ID:
NCT03065569
Status:
COMPLETED
Last Update Posted:
2018-05-24
First Post:
2017-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Epidural Techniques for Labour Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-23', 'studyFirstSubmitDate': '2017-01-19', 'studyFirstSubmitQcDate': '2017-02-22', 'lastUpdatePostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bupivacaine requirement for analgesia', 'timeFrame': 'From randomization until delivery', 'description': 'milligram of bupivacaine used per hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labour Analgesia']}, 'descriptionModule': {'briefSummary': 'A trial comparing outcomes for different epidural techniques in labour analgesia', 'detailedDescription': 'Epidurals are the most common form of pain relief in labour. There are two techniques in use at the moment to place the epidural: epidural or combined spinal epidural (CSE). CSE has been shown to work faster and provide better pain relief than epidural alone. The investigators aim to show that CSE also requires less medication over the course of labour as this may mean it has fewer side effects. The amount of medication needed during labour between the two different techniques given in a standardized way will be compared.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, singleton presentation at term\n\nExclusion Criteria:\n\n* Significant comorbidities likely to alter outcome of labour'}, 'identificationModule': {'nctId': 'NCT03065569', 'briefTitle': 'A Comparison of Epidural Techniques for Labour Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'A Comparison of Epidural Techniques for Labour Analgesia', 'orgStudyIdInfo': {'id': 'H16-03380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Epidural Technique', 'description': 'Epidural will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered.', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Spinal Epidural Technique', 'description': 'CSE will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered.', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': '16 mL of 0.125% bupivacaine', 'armGroupLabels': ['Combined Spinal Epidural Technique', 'Standard Epidural Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Women's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "British Columbia's Women's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Anton Chau, MD MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UBC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Anton Chau', 'investigatorAffiliation': 'University of British Columbia'}}}}