Kumar 2008.
| Methods | Three‐arm cluster‐randomised trial done in Shivgarh, a rural area in Uttar Pradesh, India | |
| Participants | Pregnant women, mothers‐in‐law, other female members who played supportive role, male members including fathers‐in‐law and husbands, family's immediate support group including neighbours and relatives who influenced family behaviours and helped with delivery (n = 3762 births) | |
| Interventions | Intervention 1 (n = 1537): essential newborn care only Control (n = 1115): usual services of governmental and non‐governmental organisations in the area Essential preventive newborn care includes home visits and group meetings of stakeholders about birth preparedness, hygienic delivery, and immediate newborn care, including clean umbilical cord, and skin care and thermal care including skin‐to‐skin care, breastfeeding, and care‐seeking from trained providers. The second intervention group received essential newborn care plus use of a liquid crystal sticker that indicates hypothermia by changing colour. All messages were designed to promote newborn care practices to align with existing cultural values and traditions of the local area. Saksham Sahayak (community health worker) were recruited and received classroom‐based and apprenticeship‐based field training on knowledge, attitudes, and practices about essential newborn care, behaviour change management, and trust building. Saksham Sahayaks first engaged with community stakeholders in community meetings to seek their approval, sensitise them toward the importance of their role in newborn survival, encourage shared learning, and create a supportive environment in community. Pregnant women were identified by Saksham Sahayak, self‐reporting of pregnant women, and other community health workers. Intervention was delivered by 2 antenatal visits (60 days and 30 days before expected delivery) and 2 postnatal visits (first within 24 hours of birth and second on day 3). No treatment was offered to sick neonates; however, they were advised to seek care at nearest health facility |
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| Outcomes | Primary outcomes: miscarriages, stillbirths, live births, neonatal deaths Secondary outcomes: other pregnancy outcomes, neonatal care outcomes |
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| Notes | We included in this analysis data for Intervention 1 (i.e. essential newborn care) vs control Funding: study was funded by the United States Agency for International Development, Delhi Mission, and the Saving Newborn Lives program of Save the Children US through a grant from the Bill and Melinda Gates Foundation. There is no statement about the influence these funding sources had on design and cohort of the study |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "stratified cluster randomisation was done at Johns Hopkins University using Stata 7.0 (StataCorp, College Station, TX, USA) to allocate the 39 cluster units randomly to the three study groups, yielding three allocation sequences of 13 clusters each" 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 | Unclear risk | Comment: because of the nature of the intervention, blinding did not occur |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition (3.9%) was given 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 | Low risk | Study seems to be free from other biases |