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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT02584166

Collaborator

(none)

4,929

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Newborns	Behavioral: multifaceted program

Study Design

Study Type:

Observational

Actual Enrollment :

4929 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Intervention group 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 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.
Control group No intervention in 57 maternity units

Arm

Intervention/Treatment

Intervention group

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

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.

Control group

No intervention in 57 maternity units

Outcome Measures

Primary Outcome Measures

the rate of non conform management of morbidity and mortality cases [at 26th month]
Comparison in the two groups

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Month

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT02584166

Other Study ID Numbers:

D50791

First Posted:

Oct 22, 2015

Last Update Posted:

Oct 28, 2015

Last Verified:

Oct 1, 2015

Keywords provided by Hospices Civils de Lyon

Study Results

No Results Posted as of Oct 28, 2015