Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT06127706
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2023-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recognition of Second Twin. Second Training vs Naive Performer. PROMPT Mannequin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'the two groups are invited for a lecture and are exposed to training skills'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two groups randomized One with previous lecture and training, one without'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-06', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-11-06', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to identify foot', 'timeFrame': '6 weeks after lecture', 'description': 'time needed to identify foot'}, {'measure': 'number of attempt to identify foot', 'timeFrame': '6 weeks after lecture', 'description': 'number of attempt'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Twin Vaginal Delivery Skills']}, 'referencesModule': {'references': [{'pmid': '35768063', 'type': 'BACKGROUND', 'citation': 'Gauthier S, Jeanneteau P, Legendre G, Boulvais E, Collin R, Malo L, Rolland D, Courtin O, Thubert T, Winer N, Dochez V. Vaginal delivery of the second twin: A simulation program for residents in obstetrics and gynecology in a type III university maternity hospital. J Gynecol Obstet Hum Reprod. 2022 Oct;51(8):102434. doi: 10.1016/j.jogoh.2022.102434. Epub 2022 Jun 26.'}, {'pmid': '35691221', 'type': 'BACKGROUND', 'citation': 'Desseauve D, Daelemans C, Farin A, Jauvion IBM, Ceccaldi PF; Prise en charge des Accouchements a Risque eT des Urgences Maternelles PARTUM teaching program. Internal podalic version of second twin: Improving feet identification using a simulation model. Eur J Obstet Gynecol Reprod Biol. 2022 Aug;275:9-11. doi: 10.1016/j.ejogrb.2022.05.036. Epub 2022 Jun 6.'}, {'pmid': '37776704', 'type': 'BACKGROUND', 'citation': 'Celentano C, Prefumo F, Matarrelli B, Mastracchio J, Mauri S, Rosati M. Comparison of practice vs theory model training for vacuum-assisted delivery: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2023 Nov;290:109-114. doi: 10.1016/j.ejogrb.2023.09.024. Epub 2023 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'Anterior foot identification in second twin delivery Two different population of resident in ObGyn Group 1 previous formal lecture on twin vaginal delivery followed by PROMPT mannequin scenario.\n\nGroup 2 naive residents', 'detailedDescription': 'The present study is addressed to evidential skills in residents with and without previous specific didactical approach to twin vaginal delivery in identification of anterior fetal foot.\n\nThe two group are randomized by age, sex, seniority. Both the naive and the previous lecture groups are invited to scenario without knowing the intention to test their skills.\n\nThe time to reach, the number of attempts are recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residents in Ob Gyn\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06127706', 'acronym': 'twin', 'briefTitle': 'Recognition of Second Twin. Second Training vs Naive Performer. PROMPT Mannequin', 'organization': {'class': 'OTHER', 'fullName': "G. d'Annunzio University"}, 'officialTitle': 'Second Training vs Naive Performer on Second Twin Delivery on Mannequin', 'orgStudyIdInfo': {'id': 'ObGynEASC003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Formal lecture and training', 'description': 'exposure to single test of skills', 'interventionNames': ['Device: twin vaginal delivery simulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Digital learning only', 'description': 'exposure to single test of skill', 'interventionNames': ['Device: twin vaginal delivery simulation']}], 'interventions': [{'name': 'twin vaginal delivery simulation', 'type': 'DEVICE', 'otherNames': ['formal lecture', 'digital learning'], 'description': 'skill test after formal lecture and simulation in group 1 and after digital learning only', 'armGroupLabels': ['Digital learning only', 'Formal lecture and training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65100', 'city': 'Pescara', 'state': 'Italia', 'country': 'Italy', 'facility': 'Claudio Celentano', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data record are available in Cloud to investigators only due to privacy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "G. d'Annunzio University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Claudio Celentano', 'investigatorAffiliation': "Università degli Studi 'G. d'Annunzio' Chieti e Pescara"}}}}