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

Civil Hospices of Lyon

Status: Completed

Conditions: Newborns

Treatments: Behavioral: multifaceted program

Study type: Observational

Funder types: Other

Identifiers

NCT02584166

D50791

Details and patient eligibility

About

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.

Enrollment: 4,929 patients

Sex: All

Ages: Under 1 month old

Volunteers: No 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

Trial design

4,929 participants in 2 patient groups

Intervention group

Description:

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.

Treatment:

Behavioral: multifaceted program

Control group

Description:

No intervention in 57 maternity units