Manandhar 2004.
| Methods | Cluster‐randomised controlled trial conducted in Makwanpur district of Nepal. Between 1998 and 2000, local community leaders and interested parties were taken into confidence | |
| Participants | Inclusion criteria included 15 to 49 years of age, married, and potential to conceive within the study period Exclusion criteria were age under 15 or over 49 years, unmarried, permanently separated or widowed, and no potential for conception within study period. A village development committee (VDC) was taken as a unit of randomisation. 42 rural VDC were matched to 21 pairs on the basis of geography, ethnicity, and population. Total number of participants was 28,931 women |
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| Interventions | Intervention (n = 2972): monthly meetings of mothers in groups to identify maternal and neonatal problems; prioritisation of problems; possible solutions, planning, implementation, and monitoring of those solutions; and sharing information with others. Primary cycle consisted of series of 10 meetings Control (n = 3303): there was no active intervention in the control area. However, benefits to control clusters were improvements in equipment and training provided at all levels of already existing government healthcare system Married women of reproductive age were identified through a door‐to‐door baseline survey. A community surveillance system was put in place. This system was responsible for monthly visits by local women for enumerations and to monitor pregnancy status of women in the cohort. After identification of pregnancy, interviews were carried out by VDC interviewer at 7 months of gestation and 1 month postpartum. All pregnancies occurring within the cohort were followed at least 6 weeks after delivery. In the first year, facilitation team's skills were developed and groundwork was laid by exploring ideas about child birth |
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| Outcomes | Primary outcomes: neonatal mortality rate, perinatal mortality rate Secondary outcomes: antenatal care services usage, perinatal illness, birth practices, health care‐seeking behaviour, newborn care practices, breastfeeding practices, infant mortality |
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| Notes | Perinatal birth attendants were available in all localities Funding: representatives of the UK Department for International Development (DFID) suggested that no healthcare activities should be carried out in parallel with existing government services and that—for sustainability reasons—no funding should be available for women’s group activities. Apart from these issues, 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) | Low risk | Quote: "pairing was based on a process of topographic stratification"; "we used a list of random numbers to select 12 pairs"; "we randomly allocated one cluster in each pair to either intervention or control on the basis of a coin toss" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | This is a cluster‐randomised controlled trail so allocation concealment is not an issue |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "because of the nature of the intervention the trial allocation was not masked" Comment: probably not done |
| 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 | Exclusion and attrition (9.5%) were described 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 |