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. 2014 Oct 10;2014(10):CD000169. doi: 10.1002/14651858.CD000169.pub3

Njagi 2003ii KEN.

Methods As for Njagi 2003i KEN
Participants As for Njagi 2003i KEN
Interventions
  1. IPT‐SP (2 doses)

  2. Placebo (2 doses)


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.