Lewycka 2013.
| Methods | Factorial, cluster‐randomised controlled trial in rural Mawali (Mai Mwana trial) | |
| Participants | A cohort of women that of child‐bearing age (10 to 49 years) was defined at a baseline survey (n = 43,719), and those who consented were enrolled to participate. 48 clusters were defined, with populations of approximately 3000 people, and these clusters were randomly allocated to 1 of the 4 study groups. Monitored outcomes of 26,262 births between 2005 and 2009 | |
| Interventions | Four study groups were included: (1) women's groups and volunteer peer counselling, (2) only women's groups, (3) only volunteer peer counselling, (4) no intervention Facilatator guided women's groups through a community action cycle, to tackle maternal and child health problems (n = 207 groups) Trained volunteer peer counsellors made home visits at 5 time points during pregnancy and after birth to support breastfeeding and infant care. (n = 75 female volunteer peer counsellors) |
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| Outcomes | Primary outcomes: women's groups: maternal, perinatal, neonatal, and infant mortality rates; peer counsellors: infant mortality rates, exclusive breastfeeding rates Secondary outcomes: maternal and infant morbidity; skilled antenatal, delivery, and postnatal care; tetanus toxoid immunisation; use of malaria prophylaxis; insecticide‐treated bed nets during pregnancy; PMTCT services; infant immunisations; early BF; reduced use of prelacteal feeds; neonatal mortality and infant morbidity rates; caretaker practices; timing of initiation of breastfeeding; family planning (condom use) |
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| Notes | Funding: Saving Newborn Lives, UK Department for International Development, and Wellcome Trust. There is no statement related to involvement of these funding parties in design and conduct of the study | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "clusters of villages, rather than individual villages, were used as the unit of randomisation to further reduce rates of travel across cluster boundaries and the possibility of contamination"; "allocated clusters with a random number sequence generated in Stata" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Quote: "the interventions made masking of allocation impossible at the participant level, allocation was masked for data analysis" Comment: probably done |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: the women knew their intervention allocation due to activities that they undertook |
| 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 | Comment: attrition (14.5%) was given 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 |