Challis 2004 MOZ.

Methods	Trial design: RCT Data collected: 2001 to 2002 Length of follow‐up: from first antenatal visit to first week after delivery Frequency of follow‐up: monthly
Participants	Parity: 0‐1 Number: 600 Inclusion criteria: nulliparous and primiparous women under 21 years Excluded: none stated
Interventions	SP (3 tablets): at enrolment and in third trimester Placebo Other: clinical malaria symptoms treated with CQ, SP or quinine and tetracycline irrespective of allotment Administration supervised: yes
Outcomes	Parasitaemia at second visit Placenta malaria Birthweight
Notes	Location: Mozambique Urban/rural: both (women from Matola ‐ town and Boane ‐ village) Malaria transmission: 20% prevalence Drug resistance: chloroquine resistance present HIV prevalence: 10% Funding: Department of Research Co‐operation with Developing countries (SAREC) at the Swedish International Development Authority (Sida) and from Mid Sweden Research and Development Centre (FoU)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"The data were analysed on an ITT basis. ITT includes a random allocation procedure producing comparable groups and an analysis of the data according to the way we intended to treat the subjects". Women were "randomly assigned" to receive SP or placebo. No sufficient information provided how the allocation sequence was generated.
Allocation concealment (selection bias)	Unclear risk	Packages of SP or placebo tablets.
Blinding (performance bias and detection bias) All outcomes	Low risk	"Three tablets (SP or placebo) were given in a double‐blind manner: either SP/SP – an initial treatment dose of SP at enrolment with a second dose at the beginning of the third trimester; or placebo/placebo…The placebo dose was three similar tablets in shape and colour as SP tablets."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details provided, except that all slides were analysed and double checked at the malaria laboratory at the Ministry of Health.
Incomplete outcome data (attrition bias) All outcomes	High risk	At second dose: 189/600 = 31.5% lost to follow‐up. At delivery: 309/600 women = 51.5% lost to the follow‐up peripheral blood analyses (153/300 = 51% from the placebo group and 156/300 = 52% from the SP group).
Selective reporting (reporting bias)	Low risk	No selective reporting observed.
Other bias	Low risk	None identified.