Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT02584166
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2015-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences (OPERA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4929}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-27', 'studyFirstSubmitDate': '2015-10-20', 'studyFirstSubmitQcDate': '2015-10-21', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of non conform management of morbidity and mortality cases', 'timeFrame': 'at 26th month', 'description': 'Comparison in the two groups'}], 'secondaryOutcomes': [{'measure': 'the rate of avoidable mortality and morbidity cases', 'timeFrame': 'at 26th month', 'description': 'Comparison in the two groups'}, {'measure': 'the incidence of mortality and morbidity among number of births', 'timeFrame': 'at 26th month', 'description': 'Comparison in the two groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Morbidity', 'Mortality', 'conferences', 'human science'], 'conditions': ['Newborns']}, 'referencesModule': {'references': [{'pmid': '28649035', 'type': 'DERIVED', 'citation': 'Dupont C, Winer N, Rabilloud M, Touzet S, Branger B, Lansac J, Gaucher L, Duclos A, Huissoud C, Boutitie F, Rudigoz RC, Colin C; OPERA group. Multifaceted intervention to improve obstetric practices: The OPERA cluster-randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2017 Aug;215:206-212. doi: 10.1016/j.ejogrb.2017.06.026. Epub 2017 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'This cluster-randomised controlled trial will test the hypothesis that a multifaceted program with psychological intervention in morbidity mortality conferences (MMC) improve care quality and reduce the rate of morbidity mortality perinatal in diverse obstetric care settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All newborns born between 1er october 2008 and 30 November 2010 (in one of the 95 maternity units which belongs to one of the 5 perinatal networks).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all newborns born between 1er october 2008 and 30 November 2010 (minimum : 22 weeks of gestation)\n\nExclusion Criteria:\n\n* newborns died in context of abortion'}, 'identificationModule': {'nctId': 'NCT02584166', 'acronym': 'OPERA', 'briefTitle': 'Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences (OPERA)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences', 'orgStudyIdInfo': {'id': 'D50791'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention group', 'description': '38 maternity units with allocated to the intervention group: coordinating team disseminated protocols related to the management of cases, and organized mortality morbidity conferences (MMC) in each unit with staff concerned. These MMC were realized by the same outside medical binomial composed of a midwife and an obstetrician (outreach visit with a leader ship). Among the 38 maternity units, MMC were performed with the medical binomial and professionals of human science in 20 units to identify the defense mechanisms manifested by medical staff which could disturb the decision making. In the others 18 units, MMC were performed with only the outside medical binomial. Coordinating team defined with teams the area of improvement before each MMC. 3 or 4 MMC were performed according to their activity.', 'interventionNames': ['Behavioral: multifaceted program']}, {'label': 'Control group', 'description': 'No intervention in 57 maternity units'}], 'interventions': [{'name': 'multifaceted program', 'type': 'BEHAVIORAL', 'description': 'This program present two steps : a first step to revise protocols related to the management of cases (between M5 and M8) and a second step after M8 et M 26, with morbimortality conferences organized every trimester to analyze management with the staff.', 'armGroupLabels': ['Intervention group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}