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

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.

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Key information

Conditions

Newborns

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multifaceted program

Behavioral

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.

Primary outcomes

the rate of non conform management of morbidity and mortality cases

Time frame: at 26th month

Comparison in the two groups

Secondary outcomes

the rate of avoidable mortality and morbidity cases

Time frame: at 26th month

Comparison in the two groups
the incidence of mortality and morbidity among number of births

Time frame: at 26th month

Comparison in the two groups

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: OPERA

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Oct 22, 2015
Registry last updated: Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed