Azad 2010.
| Methods | Cluster‐randomised controlled trial conducted in Bangladesh | |
| Participants | Target population included women aged 15 to 49 years residing in the project area who gave birth during the study period, adolescents, and mothers‐in‐law. 18 clusters in 3 districts were randomly assigned to either intervention or control. There were 36,139 births in an overall population of 478,611 during 3 years | |
| Interventions | Intervention clusters: a facilitator convened 18 groups every month to support participatory action and learning for women, and to develop and implement strategies to address maternal and neonatal health problems. Other intervention involved training traditional birth attendants in bag‐valve‐mask resuscitation of neonates with symptoms of birth asphyxia Facilitators received 5 training sessions that covered participatory modes of communication and maternal and neonatal health issues There were 3162 live births in the intervention arm Control group: received the usual care provided in the area (n = 3227 total births, n = 3069 live births) |
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| Outcomes | Primary outcomes: neonatal mortality rate, maternal deaths, stillbirths Secondary outcomes: uptake of antenatal and delivery services, home care practices during and after delivery, infant mortality, health care‐seeking behaviour, perinatal mortality |
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| Notes | In all clusters (intervention and control), health services were strengthened and traditional birth attendants were trained Sponsors of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "unions were randomly allocated to either intervention or control groups by district in the presence of four project staff and two external individuals" Comment: insufficient information to permit judgement |
| Allocation concealment (selection bias) | Low risk | Comment: since this was a cluster‐randomised trial, allocation concealment should not be an issue, as in this design, all clusters are randomised at once Comment: probably done |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "neither the study investigators nor the participants were masked to group allocation" Comment: probably not done |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to permit judgment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Exclusion (0%) and attrition (14.3%) were reported along with reasons |
| Selective reporting (reporting bias) | Low risk | Comment: this is a registered trial, and this study has reported all outcomes mentioned in the protocol |
| Other bias | High risk | Quote: "the purposive selection of districts and upazilas, and the stratification of sampling, together with the restricted number of clusters, might have limited the effectiveness of randomisation procedures" Comment: probably not done |