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. 2019 Sep 24;2019(9):CD012177. doi: 10.1002/14651858.CD012177.pub2

Fransen 2017.

Methods Multicentre, open, cluster‐randomised trial
Participants Who: All multiprofessional obstetric staff from 24 units (12 intervention and 12 control)
Number: 471 staff
Proportion of eligible staff participating: 95%
Interventions Intervention description: Multiprofessional obstetric team training focusing on crew resource management
Control: No training
Location: Simulation centre
Delivered by: An obstetrician and communication expert drawn from the group of 10 experienced facilitators
Length: 1 day
Duration: Single session
Outcomes Outcomes: Composite of obstetric complications, low Apgar, severe postpartum haemorrhage, large blood transfusion, embolisation, hysterectomy, trauma due to shoulder dystocia, eclampsia, hypoxic ischaemic encephalopathy, low Apgar and pH < 7.05, maternal mortality
Follow‐up: 1 year
Population studied Description: Women with a singleton pregnancy beyond 24 weeks gestation
Number: Intervention 14,500 patients, control 14,157 patients
Funding Source ZonMw, the Netherlands Organisation for Health Research and Development
Study Setting Obstetric units in the Netherlands
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Units were randomly allocated by an independent researcher using a computer‐generated list.
Allocation concealment (selection bias) Low risk As above
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open trial
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No specific mention
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Not mentioned specifically, but methods to minimise missing data discussed in detail
Selective reporting (reporting bias) Low risk Reported outcomes as per protocol
Other bias Low risk Addressed issues such as staff receiving existing training at the control sites in the protocol in an attempt to minimise bias