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 |
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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 |
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Outcomes |
Outcomes: 24‐hour newborn mortality and intrapartum stillbirth Follow‐up: For 12 months after start of intervention, baseline measured for 6 months prior |
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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) |
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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. |