Fottrell 2013.
| Methods | Cluster‐randomised controlled trial in Bangladesh to assess the effect of participatory women's group intervention with higher population coverage on neonatal mortality | |
| Participants | Women who were permanently residing in 18 unions, in 3 districts, and accounting for 19,301 births during the final 24 months of the intervention. In intervention areas, 648 new women's groups were formed in addition to 162 women's groups set up as a part of an earlier trial (combined women's groups: n = 810). All unions, regardless of allocation, received health system‐strengthening initiatives | |
| Interventions | Women's group utilising participatory learning and action cycle, where they prioritise issues that affected maternal and neonatal health, and design and implement strategies to address said issues Control: both intervention and control clusters received health system‐strengthening activities. A small number of women from control areas participated in the women's group meetings; however contamination is fairly limited due to the geographical location of the clusters |
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| Outcomes | Primary outcome: neonatal mortality rates Secondary outcomes: facility deliveries, birth attendant home delivery practices (e.g. washed hands with soap), thermal care of newborns, early infant‐feeding practices, health service utilisation (antepartum, intrapartum, postpartum) |
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| Notes | Funding: implementation and evaluation of women’s groups was funded by a Big Lottery Fund International Strategic Grant. This study was supported with funds from a Wellcome Trust Strategic Award (085417ma /Z/08/Z). Sponsors did not participate in design and conduct of the study; in collection, analysis, and interpretation of data; or in preparation, review, or approval of the manuscript | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "6 unions (clusters) in each district (stratum) were randomly allocated to either intervention or control by blindly pulling pieces of paper, each representing 1 union, from a bottle. The allocation sequence had been decided on before drawing the papers" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Quote: "the nature of the intervention means that allocation was not masked" 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 | Comment: blinding of participants not possible due to nature of study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the board, as well as the implementation and in country monitoring and evaluation teams, were blind to the allocation arm on both occasions" Comment: probably yes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition was 1% and reasons were reported |
| Selective reporting (reporting bias) | Low risk | Comment: this is a registered trial, and the study has reported all outcomes mentioned in the protocol |
| Other bias | Low risk | Comment: study seems to be free from other biases |