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

Newborns Clinical Trial

— OPERA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584166
• Other study ID #: D50791
• Status: Completed
• Phase: N/A
• First received: October 20, 2015
• Last updated: October 27, 2015
• Start date: October 2009
• Est. completion date: March 2014

Study information

• Verified date: October 2015
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4929
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Newborns

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of non conform management of morbidity and mortality cases	Comparison in the two groups	at 26th month	Yes
Secondary	the rate of avoidable mortality and morbidity cases	Comparison in the two groups	at 26th month	Yes
Secondary	the incidence of mortality and morbidity among number of births	Comparison in the two groups	at 26th month	Yes