Njagi 2003ii KEN.
Methods | As for Njagi 2003i KEN | |
Participants | As for Njagi 2003i KEN | |
Interventions |
Other: Folic acid and iron given to all women |
|
Outcomes | As for Njagi 2003i KEN | |
Notes | As for Njagi 2003i KEN | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated random number sequences in blocks of 12. |
Allocation concealment (selection bias) | Unclear risk | No details provided. |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Placebo and active drug tablets were of equal size, colour and shape. The investigators had no knowledge of the assigned groups until after data collection, editing and data analysis were completed." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition rate 17.4% (168/963): 114 lost due to migration, 35 – home delivery, 19 – refused to continue. Attrition rate in ITN and SP group 35/242 (14.5%), in ITN and placebo group 32/238 (13.4%), in SP group 52/245 (21.2%), in placebo group 49/238 (20.6%). Together with the exclusions, 211/963 (21.9%) women with no treatment outcome. |
Selective reporting (reporting bias) | Unclear risk | Mentioned that mode of delivery, birthweight and baby's Hb were recorded but they were never reported. The trial report fails to include results for a key outcome that would be expected to have been reported for such a trial. |
Other bias | Low risk | None identified. |