Parise 1998i KEN.

Methods	Trial design: Quasi‐RCT Data collected:1994 to 1996 Length of follow‐up: from first antenatal visit to delivery; for infants: follow‐up at 3‐7 days of life and at 6 weeks of age Frequency of follow‐up: at two and four weeks after enrolment and then monthly until delivery
Participants	Parity: para 0‐1 Number: 2077 Inclusion criteria: antenatal clinic attendees; first or second pregnancy Excluded: prior ADRs to sulfa‐containing or other antimalarial medications
Interventions	SP: treatment dose, repeated in late pregnancy (2 doses); not administered at intervals of less than 1 month No intermittent preventive treatment, SP given with recent history of fever or parasitaemia Other: 200 mg ferrous sulphate and 5 mg folic acid daily Administration supervised: Yes
Outcomes	Maternal anaemia Mean haemoglobin Placental infection Birthweight Preterm birth Stillbirth Neonatal death
Notes	Location: Kenya Urban/rural: urban Malaria transmission: hyperendemic area Drug resistance: chloroquine HIV seroprevalence : 2SP ‐ 26.9% (53/196); Case management ‐ 26.9% (57/212) Funding: UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (ID No. 940060); the US Agency for International Development through the Health and Human Resources Analysis for Africa (HHRAA) Project through a Participating Agency Service Agreement (PASA number AOT‐0483‐P‐HI‐2171)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	"Women were systematically assigned to receive one of three regimens using a rotating assignment based on day of clinic visit." Comment: allocation was not random.
Allocation concealment (selection bias)	High risk	Allocation schedule not concealed.
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding. Women were systematically assigned to receive either two‐dose SP with treatment doses at enrolment and again early in the third trimester, or case management (CM).
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details provided.
Incomplete outcome data (attrition bias) All outcomes	High risk	"Six hundred ninety‐nine women (34%) were lost to follow‐up during pregnancy because they moved out of the study area or failed to return for follow‐up and the study team was unable to locate their houses." Data was not available for 36.5% (248/680) women in the 2 SP and 35.9% (264/736) women in the case management group.
Selective reporting (reporting bias)	Low risk	The trial protocol was available. No selective reporting observed.
Other bias	Low risk	No apparent risk.