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% |
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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 |
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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 |
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Population studied |
Description: Women with a singleton pregnancy beyond 24 weeks gestation Number: Intervention 14,500 patients, control 14,157 patients |
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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 |