Bhutta 2009a.
Methods | This cluster‐randomised trial was conducted in urban and rural areas in Pakistan. Dates of study: not reported |
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Participants | Pregnant women with gestational age < 16 weeks were eligible for enrolment. MMN group (n = 1148), IFA group (n = 1230) | |
Interventions |
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Outcomes | Size at birth, gestational age at birth, perinatal mortality, maternal anaemia (Hb < 11 g/dl), mode of delivery (caesarean section) It should be noted that the data for SGA were obtained from a separate report (Food and Nutrition Bulletin 2009) and not from the individual trial report. |
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Notes | MMN and MMN + nutritional education groups were compared with IFA and IFA + nutritional education group. IFA given to all participants. Maternal malnutrition, vitamin A deficiency, anaemia and iron deficiency were common. 2 methods of community outreach were implemented that is, basic nutrition along with antenatal care messages and quarterly community‐based group sessions conducted by CHWs and social scientist. There was no significant difference in baseline characteristics between 2 groups. Data for caesarean section were presented (intervention 18/743; control 22/832). Data were not included in the analysis as this was a cluster‐RCT. Declarations of interest: not reported Funding sources: United Nations Children's Fund (UNICEF) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "a cluster‐based allocation strategy of supplements (either IF or MMN supplementation) by respective CHWs was implemented". Comment: probably done |
Allocation concealment (selection bias) | Low risk | Comment: "allocated to either the IF or MMN supplements according to their respective location and allocation by the AKU Pharmacy". Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Both tablets were identical in colour, shape and packaging" and "field staff (medical officers, CHWs, social scientists and data collection team) remained completely blinded as to the supplements allocation. All pregnant women were allocated a unique code and allocated a uniquely labelled and numerically coded specific supplement supply". Comment: participants and caregivers were probably blinded to the treatment assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Both tablets were identical in colour, shape and packaging" and "field staff (medical officers, CHWs, social scientists and data collection team) remained completely blinded as to the supplements allocation". Comment: outcome assessors were probably blinded to the treatment assignment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition (15.8%) and exclusion (around 1%) along with their reasons were reported. Attrition and exclusions were balanced across the treatment arms. |
Selective reporting (reporting bias) | Low risk | Comment: results of all outcomes mentioned in methods section were presented in the paper |
Other bias | Low risk | Comment: no other bias was identified, including cluster‐design specific biases (recruitment bias, baseline imbalance, loss of clusters, incorrect analysis, and comparability with individually randomised trials) |