Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT07083167
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anesthesia Clinical Practice During Labour Neuraxial Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Informed consent', 'timeFrame': 'From the first contact with the patient before labour neuraxial analgesia until the procedure is finished.', 'description': 'Incidence of key elements (such as technique desciption, alternatives, risks, complications, and expected effects) during the consent process before the labour neuraxial analgesia procedure. This will be assessed using a structured observation checklist with dichotomous variables (yes/no).'}], 'secondaryOutcomes': [{'measure': 'Procedure description', 'timeFrame': 'During the standard clinical consent process provided to patients prior to the administration of labour neuraxial anesthesia.', 'description': 'Proportion of consent discussions in which the staff anesthesiologist described specific steps involved in administering labour neuraxial analgesia.\n\nUnit of measure: Percentage of specific consent discussions including each pre-defined procedural element using the data collection sheet (Appendix 3) during the observation of the consent process.'}, {'measure': 'Additional labour analgesia options', 'timeFrame': 'During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.', 'description': 'Proportion of specific consent discussions in which the staff anesthesiologist offered additional labour analgesia options. Unit of measure: percentage of specific consent discussions in which alternative analgesia options were offered using the data collection sheet (Appendix 3) to document whether alternatives were discussed and which options (if any) were offered.'}, {'measure': 'Risks and complications', 'timeFrame': 'During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.', 'description': 'Proportion of specific consent discussion in which specific risks and complications of labour neuraxial analgesia were mentioned and described to the patient in further detail. Unit of measure: percentage of specific consent discussions mentioning each risk; proportion thoroughly described versus briefly mentioned using the data collection sheet (Appendix 3).'}, {'measure': 'Anticipated effects', 'timeFrame': 'During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.', 'description': 'Proportion of specific consent discussions that included discussion of what the patient should expect after the labour neuraxial anesthesia procedure. Unit of measure: percentage of specific consent discussions where each anticipated effect was mentioned (pre- and/or post-procedure) using the data collection sheet (Appendix 3).'}, {'measure': 'Patient information sheets', 'timeFrame': 'During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.', 'description': 'Proportion of specific consent discussion in which the staff anesthesiologist being observed mentioned or offered the use of patient information sheets on labour neuraxial analgesia. Unit of measure: percentage of specific consent discussion involving the use or mention of an information sheet, which will be noted on the data collection sheet (Appendix 3) throughout the observed consent process.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Analgesia']}, 'referencesModule': {'references': [{'pmid': '27988961', 'type': 'BACKGROUND', 'citation': 'Yentis SM, Hartle AJ, Barker IR, Barker P, Bogod DG, Clutton-Brock TH, Ruck Keene A, Leifer S, Naughton A, Plunkett E. AAGBI: Consent for anaesthesia 2017: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2017 Jan;72(1):93-105. doi: 10.1111/anae.13762.'}, {'pmid': '24898765', 'type': 'BACKGROUND', 'citation': 'Tait AR, Teig MK, Voepel-Lewis T. Informed consent for anesthesia: a review of practice and strategies for optimizing the consent process. Can J Anaesth. 2014 Sep;61(9):832-42. doi: 10.1007/s12630-014-0188-8. Epub 2014 Jun 5.'}, {'pmid': '9305553', 'type': 'BACKGROUND', 'citation': 'Pattee C, Ballantyne M, Milne B. Epidural analgesia for labour and delivery: informed consent issues. Can J Anaesth. 1997 Sep;44(9):918-23. doi: 10.1007/BF03011961.'}, {'pmid': '29781504', 'type': 'BACKGROUND', 'citation': 'Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the communication between the anesthesiologist and the patient prior the initiation and during the administration of the labor neuraxial analgesia.\n\nThe investigators hypothesize that there will be differences among anesthesiologists during the informed consent process and communication during the procedure, specifically, how the anesthesiologists describe the technical aspects of the procedure, alternatives, risks, complications, and expected effects of labour neuraxial analgesia.\n\nThe anesthesiologists will be observed during a routine labor neuraxial analgesia procedure for healthy uncomplicated patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All obstetric anesthesiologists working in maternity unit', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all obstetric anesthesiologists working in maternity unit\n\nExclusion Criteria:\n\n* any comorbidity of the patient that would necessitate deviation from a routine practice for the initiation of labor neuraxial analgesia'}, 'identificationModule': {'nctId': 'NCT07083167', 'acronym': 'ACP-LNA', 'briefTitle': 'Anesthesia Clinical Practice During Labour Neuraxial Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Anesthesia Clinical Practice During Labour Neuraxial Analgesia: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'H24-03381 ACP-LNA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anesthesiologists', 'description': 'All anesthesiologists providing labor neuraxial analgesia', 'interventionNames': ['Other: No Interventions.']}], 'interventions': [{'name': 'No Interventions.', 'type': 'OTHER', 'description': 'No interventions.', 'armGroupLabels': ['Anesthesiologists']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Vit B Gunka, MD', 'role': 'CONTACT', 'email': 'vgunka@cw.bc.ca', 'phone': '604-875-6078'}, {'name': 'Juliana Barrera, MD', 'role': 'CONTACT', 'email': 'juliana.barrera@cw.bc.ca', 'phone': '604-875-6076'}, {'name': 'Vit B Gunka, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Juliana Barrera, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maisa Samiee, BSc candidate', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aislynn Sharrock, BA (Hons.)', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Simon Massey, MB BCh', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Department of Anesthesia at BC Women's Hospital, University of British Columbia.", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Vit B Gunka, MD', 'role': 'CONTACT', 'email': 'vgunka@cw.bc.ca', 'phone': '604-875-6078'}, {'name': 'Juliana Barrera, MD', 'role': 'CONTACT', 'email': 'juliana.barrera@cw.bc.ca', 'phone': '604-875-6076'}], 'overallOfficials': [{'name': 'Vit B Gunka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Anesthesia at BC Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Site Principal Investigator', 'investigatorFullName': 'Vit Gunka', 'investigatorAffiliation': 'University of British Columbia'}}}}