Tripathy 2010.
| Methods | Cluster‐randomised controlled trial conducted in Jharkhand and Orissa in India | |
| Participants | Pregnant women aged 15 to 49 years, residing in the project area, who had given birth during the study. From 36 clusters in Jharkhand and Orissa (mean cluster population 6338), 18 clusters were randomly assigned to intervention or control via stratified allocation. Total number of participants was 228,186 (n = 4672 births) | |
| Interventions | In intervention clusters (n = 2457 births), a facilitator convened 13 groups every month to support participatory action and learning for women, and facilitated the development and implementation of strategies to address maternal and newborn health problems Groups took part in a participatory learning and action cycle Control clusters (n = 2235) given standard care |
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| Outcomes | Neonatal mortality rate, maternal depression, stillbirth, maternal and perinatal deaths, uptake of antenatal and delivery services, home care practices during and after delivery, health care‐seeking behaviour | |
| Notes | Analysis was by intention‐to‐treat Funding: Health Foundation, UK Department for International Development, Wellcome Trust, and the Big Lottery Fund (UK). Funders had no role in design of the study, data collection, data analysis or interpretation, or writing up of study findings, although they made a site visit early in the study implementation |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "we assigned 18 clusters to intervention or control using stratified randomizations" 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 in this design, as all clusters are randomised at once |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "neither the intervention team nor the participants were masked to group assignment during the trial" Comment: no blinding occurred due to the nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the intervention and surveillance teams were not unaware of allocation" Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition (19%) was reported along with reasons |
| 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 |