Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-02-13 @ 2:17 AM
Study NCT ID:
NCT01812304
Status:
COMPLETED
Last Update Posted:
2022-07-08
First Post:
2013-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Theoretical Compared With hands-on Training of Vaginal Breech Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2013-03-08', 'studyFirstSubmitQcDate': '2013-03-13', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'confidence, speed, self assessment', 'timeFrame': 'immediately after training and 72 hours later'}], 'primaryOutcomes': [{'measure': 'OSATS Score', 'timeFrame': 'probands are tested after training within an hour', 'description': 'OSATS Scores are assessed on a pelvic model by a blinded assessor immediately after training (1 arm hands-on, 1 arm forntal teaching)'}], 'secondaryOutcomes': [{'measure': 'OSATS Scores', 'timeFrame': '72 Hours after training', 'description': 'identical to primary outcome, but 72 hours later'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vaginal Abnormality - Baby Delivered']}, 'referencesModule': {'references': [{'pmid': '24103530', 'type': 'RESULT', 'citation': 'Buerkle B, Rueter K, Hefler LA, Tempfer-Bentz EK, Tempfer CB. Objective Structured Assessment of Technical Skills (OSATS) evaluation of theoretical versus hands-on training of vaginal breech delivery management: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):252-6. doi: 10.1016/j.ejogrb.2013.09.015. Epub 2013 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'This trial aims to assess the hypothesis that hands-on training of vaginal breech delivery on a pelvic model is significantly better in terms of a technical skills scoring system compared to frontal teaching.', 'detailedDescription': 'Primary endpoint is a score describing technical proficiency, ie the OSATS score, consisting of 25 items. Each item, if done correctly, is awarded one point. The maximum OSATS score is 25.\n\nSecondary endpoints are performance time in seconds, cinfidence using a scale from 1-5 with one being very confident and 5 having no confidence when performing the procedures, and self-assessment using a scale of 1-5 with 1 being the optimal grade.\n\nThis is a two-arm study. The experimental arm uses a hands-on training and the control arm a frontal teaching approach. The allocation is randomized and single-blinded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* able to understand German\n* Medical student\n\nExclusion criteria:\n\n* significant language barrier\n* previous experience with vaginal breech training'}, 'identificationModule': {'nctId': 'NCT01812304', 'briefTitle': 'Theoretical Compared With hands-on Training of Vaginal Breech Management', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Objective Structured Assessment of Technical Skills Evaluation of Theoretical Compared With hands-on Training of Shoulder Dystocia Management: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'VB-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hands-on training', 'description': 'probands perform predefined maneuvers to manage a vaginal breech hands-on after one instruction', 'interventionNames': ['Other: hands-on training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'frontal teaching', 'description': 'Probands perform predefined maneuvers to resolve a vaginal breech after forntal teaching', 'interventionNames': ['Other: frontal teaching']}], 'interventions': [{'name': 'hands-on training', 'type': 'OTHER', 'description': 'the intervention consists of a predefined hands-on training program including 25 technical steps to manage a vaginal breech', 'armGroupLabels': ['hands-on training']}, {'name': 'frontal teaching', 'type': 'OTHER', 'description': 'one teacher demonstrates all 25 items listed in the OSATS checklist. Probands listen and watch.', 'armGroupLabels': ['frontal teaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44623', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Ruhr University Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}], 'overallOfficials': [{'name': 'Clemens Tempfer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruhr University Bochum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Clemens Tempfer, MBA', 'investigatorFullName': 'Clemens Tempfer', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}