Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences (OPERA)

Study Overview
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Brief Summary
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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.

Official Title
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Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences

Conditions
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Newborns

Intervention / Treatment
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* Behavioral: multifaceted program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all newborns born between 1er october 2008 and 30 November 2010 (minimum : 22 weeks of gestation) Exclusion Criteria: newborns died in context of abortion

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention group<br>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. | Behavioral: multifaceted program<br>* 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.<br>|
| Control group<br>No intervention in 57 maternity units | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of non conform management of morbidity and mortality cases | Comparison in the two groups | at 26th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of avoidable mortality and morbidity cases | Comparison in the two groups | at 26th month | 
| the incidence of mortality and morbidity among number of births | Comparison in the two groups | at 26th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbidity, Mortality, conferences, human science