Tripathy 2016.
| Methods | Cluster‐randomised controlled trial conducted in rural eastern India (Jharkhand and Odisha) | |
| Participants | Study participants were women of reproductive age (15 to 49 years) who gave birth during the study period. From 30 clusters in Jharkhan and Odisha (estimated population 156,519), 15 clusters were randomly assigned to intervention or control. In the intervention group, 3700 births were identified compared to 3519 births in the control group. A total of 152 Accredited Social Health Activists (ASHA) helped facilitate the women's groups | |
| Interventions | Intervention: a cycle of women's groups led by ASHA, which involved participatory learning and action with a 4‐phase structure. The first phase involved identifying and prioritising maternal and newborn health problems (picture cards and participatory voting utilised). The second phase involved listening to stories of the identified areas to consider causes and possible solutions. The third phase involved implementation of the chosen strategy and learning about other practical actions that could be taken. The final phase involved evaluation of the meeting cycle and progress against strategies (n = 1635 mothers at baseline) Control: this group did not have participatory women's groups facilitated by ASHAs (n = 1609 mothers at baseline) Village health sanitation and nutrition committees were another aspect of this study in both intervention and control areas, attempting to carrying out at least 1 village health sanitation and nutrition committee meeting about rights and entitlements per village |
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| Outcomes | Primary outcome: neonatal mortality Secondary outcomes: stillbirths, perinatal mortality, maternal mortality, home care, care‐seeking practices |
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| Notes | Intention‐to‐treat Funding: Big Lottery Fund (UK). The funding agency had no role in designing the study, data collection and analysis, the decision to publish, or preparation of this manuscript |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomisation was stratified by district, with six clusters in each district allocated to either control or intervention in a public randomisation meeting ....public randomisation technique used with small plastic balls (e.g. "...allocated a number to each cluster, wrote these numbers on small plastic balls, and placed balls in a dark bag")" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Comment: since this is a cluster‐randomised trial, allocation concealment should not be an issue, as in this design, all clusters are randomised at once |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "because of the nature of the intervention being tested, the intervention team could not be masked to allocation" Comment: probably done |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the data collection team was masked to allocation, both at the cluster and at the individual level" Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "one cluster in the intervention group was lost to follow‐up due to law and order problems"; "Loss to follow‐up as a result of migration or refusal to be interviewed was 35 (< 1%) of 3735 births in the intervention clusters and 28 (< 1%) of 3547 births in the control clusters" Comment: reasons were given, and attrition rate was 0.9% |
| Selective reporting (reporting bias) | Low risk | Comment: this is not a registered trial, but outcomes mentioned in the methods are reported in the results |
| Other bias | Low risk | Study seems to be free from other biases |