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

NCT02584166 | Completed

• 1 other identifier: D50791
• Study Type: observational
• Target: 4,929
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Newborns

Keywords

Morbidity; Mortality; conferences; human science

Outcome Measures

Primary Outcomes (1)

• the rate of non conform management of morbidity and mortality cases

  Comparison in the two groups

  at 26th month

Secondary Outcomes (2)

• the rate of avoidable mortality and morbidity cases

  at 26th month

• the incidence of mortality and morbidity among number of births

  at 26th month

Study Arms (2)

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

Control group

No intervention in 57 maternity units

Interventions

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.

Intervention group

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All newborns born between 1er october 2008 and 30 November 2010 (in one of the 95 maternity units which belongs to one of the 5 perinatal networks).

You may qualify if:

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

You may not qualify if:

• newborns died in context of abortion

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Related Publications (1)

• Dupont C, Winer N, Rabilloud M, Touzet S, Branger B, Lansac J, Gaucher L, Duclos A, Huissoud C, Boutitie F, Rudigoz RC, Colin C; OPERA group. Multifaceted intervention to improve obstetric practices: The OPERA cluster-randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2017 Aug;215:206-212. doi: 10.1016/j.ejogrb.2017.06.026. Epub 2017 Jun 19.

  PMID: 28649035 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 22, 2015
• Study Start: October 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 28, 2015

Record last verified: 2015-10