NewbornsOPERANCT02584166
Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences (OPERA)
An observational study of Newborns, run by Hospices Civils de Lyon.
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. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Newborns
- What is being tested?
- multifaceted program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,929 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- all newborns born between 1er october 2008 and 30 November 2010 (minimum : 22 weeks of gestation)
Who cannot join
- newborns died in context of abortion
About this study
Official title: Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences
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
- Being tested
- multifaceted program
- Keywords
- Morbidity, Mortality, conferences, human science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multifaceted programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: multifaceted program | |
| Control group | No intervention in 57 maternity units |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of non conform management of morbidity and mortality cases
Comparison in the two groups
Measured: at 26th month
Secondary outcomes (2)
the rate of avoidable mortality and morbidity cases
Comparison in the two groups
Measured: at 26th month
the incidence of mortality and morbidity among number of births
Comparison in the two groups
Measured: at 26th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startOct 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NewbornsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,929 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584166
- Sponsor's protocol ID
- D50791
- Acronym
- OPERA
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28649035
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences
- ClinicalTrials.gov ID
- NCT02584166
- Acronym / sponsor ID
- OPERA / D50791
- Conditions
- Newborns
- Keywords
- Morbidity, Mortality, conferences, human science
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,929 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Behavioral: multifaceted program38 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. |
| Control group | – | –No intervention in 57 maternity units |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (1 listed)
- all newborns born between 1er october 2008 and 30 November 2010 (minimum : 22 weeks of gestation)
Key exclusion criteria (1 listed)
- newborns died in context of abortion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multifaceted programThis 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. | Behavioural | Intervention group |
Primary outcome
the rate of non conform management of morbidity and mortality cases
Time frame: at 26th month
Comparison in the two groups
2 secondary outcomes
the rate of avoidable mortality and morbidity cases
Time frame: at 26th month
the incidence of mortality and morbidity among number of births
Time frame: at 26th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Derived from this study: PubMed 28649035Dupont 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborns, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of non conform management of morbidity and mortality cases (time frame: at 26th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02584166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.