| Study characteristics |
| Methods |
Cross‐sectional stepped‐wedge cluster‐randomised controlled superiority trial. |
| Participants |
All maternity staff (unknown number of trained staff). In the intervention group there were 94,262 babies (beyond 37 weeks of gestation) studied, and in the control group 29,681. Exclusion of babies that were born preterm, at home, at other hospital, intra‐uterine death, and elective caesarean section. |
| Interventions |
PROMPT training package (second edition): 2‐day PROMPT Train‐the‐trainers programme, with subsequent unit‐level implementation of local PROMPT courses (post partum haemorrhage, sepsis, shoulder dystocia, fetal monitoring, and team‐working) |
| Outcomes |
Apgar score measured at 5 minutes after birth |
| Notes |
Multicentre trial including 15 hospitals, Scotland |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computerised randomisation with an allocation sequence list (balanced for units size). Independent statistician. |
| Allocation concealment (selection bias) |
High risk |
As there was 1 eligible maternity unit, who had attended T3 training, but no in house training, primary allocated to period 1. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Pregnant women were not made aware of maternity unit participation in the study. Staff were not blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Research teams were not blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Use of a national database. Missing Apgar scores in 0.7% of cases. |
| Selective reporting (reporting bias) |
Low risk |
Only 1 outcome measures was described in the protocol. |
| Other bias |
High risk |
High risk on recruitment bias as participants were recruited after the clusters had been randomised. Study period: 2013‐2016. |
