Njagi 2003i KEN.

Methods	RCT
Participants	Low parity (0‐1) Number: 963 Inclusion criteria: gestational age of between 12 and 24 weeks Exclusion criteria: HIV/AIDS, severe systemic diseases
Interventions	ITN + IPT‐SP (2 doses) ITN + placebo (2 doses) Other: Folic acid and iron given to all women Administration supervised: yes
Outcomes	Maternal anaemia Maternal mortality Birth outcomes: abortions Length of follow‐up: From 1st antenatal visit to 1 week after delivery Frequency of follow‐up: monthly antenatal clinic visits
Notes	Location: Western Kenya Malaria transmission: intense Drug resistance: unknown
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.