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

Completed

• Conditions: Newborns
• Interventions: Behavioral: multifaceted program

• Registration Number: NCT02584166
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-10
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4929

Inclusion Criteria

• all newborns born between 1er october 2008 and 30 November 2010 (minimum : 22 weeks of gestation)

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Exclusion Criteria

• newborns died in context of abortion

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention group	multifaceted program	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.

Primary Outcome Measures

Name	Time	Method
the rate of non conform management of morbidity and mortality cases	at 26th month	Comparison in the two groups

Secondary Outcome Measures

Name	Time	Method
the rate of avoidable mortality and morbidity cases	at 26th month	Comparison in the two groups
the incidence of mortality and morbidity among number of births	at 26th month	Comparison in the two groups