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

Gomez 2018.

Methods Cluster‐randomised trial with implementation waves
Participants Who: All skilled birth attendants at 40 hospitals, all midwives
Number: 403
Proportion of eligible staff participating: Not reported
Interventions Intervention description: A low‐dose, high‐frequency training model consisting of sessions for all staff followed by regular practice sessions run by peer co‐ordinators on simulators. The simulators were provided to each unit. Mentoring calls were arranged to support the team. There was also training of data collectors to monitor the outcomes.
Control: Control period in each site pre‐intervention
Location: Delivered locally
Delivered by: Skilled birth attendants (midwives) who were either master trained or locally trained and supported by mentors to be peer co‐ordinators
Length: 2, 4‐day sessions at facilities, 1‐day peer co‐ordinator session followed by regular simulation sessions
Duration: Low‐dose, high‐frequency sessions for 12 months
Outcomes Outcomes: 24‐hour newborn mortality and intrapartum stillbirth
Follow‐up: For 12 months after start of intervention, baseline measured for 6 months prior
Population studied Description: Institutional deliveries at the study sites during the time period
Number: 105,850 (38,192 in pre‐intervention, 67,658 in postintervention)
Funding Source Bill and Melinda Gates Foundation
Study Setting 40 public and mission hospital in Uppper West, Central, and Western Regions of Ghana
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The authors explain that study was randomised and how it was stratified, but not how the sequence was generated.
Allocation concealment (selection bias) Unclear risk No mention of how this was concealed
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not possible to blind the facilities or the participants due to the nature of the intervention
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Data collection performed by trained health staff and health information officers based at the sites.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Attrition was discussed for the number of healthcare workers, but not in relation to the collection of our outcomes of interest (stillbirth and neonatal death).
Selective reporting (reporting bias) Low risk Reported on planned outcomes from the trial registry and methods
Other bias High risk Due to movement of healthcare workers, there is potential for cross‐over during the waves of implementation.