Briand 2009 BEN

Methods	Trial design: open‐label, randomized, 2‐arm trial of 2 doses of IPTp Follow‐up: the second IPTp dose was administered from 30 weeks of gestation and at least 1 month after administration of the first dose. Women were visited at home, at delivery, and until 6 weeks after the end of pregnancy. Adverse event (AE) monitoring: AEs were recorded via an open‐labelled questionnaire during visits at home occurring within 1 week after each IPTp intake.
Participants	Numbers of participants randomized: 802 (IPTp‐mefloquine), 799 (IPTp‐sulfadoxine‐pyrimethamine) Inclusion criteria: HIV‐uninfected women of all gravidities at 16 to 28 weeks of gestation who had no history of a neurological or psychiatric disorder and who had not previously used sulfadoxine‐pyrimethamine or mefloquine nor reported having adverse reactions to medications containing sulfa. Exclusion criteria: pregnant women not meeting inclusion criteria.
Interventions	Two doses of IPTp with sulfadoxine‐pyrimethamine (1500 mg of sulfadoxine and 75 mg of pyrimethamine per dose) Two doses of IPTp with mefloquine (15 mg/kg per dose; Mepha)
Outcomes	Maternal peripheral parasitaemia at delivery Placental malaria (presence of asexual stage parasites in blood smear) Maternal anaemia at delivery (defined by haemoglobin < 10 g/dL) Mean haemoglobin at delivery Clinical malaria episodes during pregnancy Cord blood parasitaemia Mean birth weight Low birth weight rates Prematurity rates Spontaneous abortion (expulsion of a foetus at < 28 weeks of gestation) rates Stillbirth rates (delivery of a dead child at < 28 weeks of gestation) Congenital malformation rates Maternal mortality Neonatal mortality Frequency of adverse events: vomiting, headache, weakness, and dizziness
Notes	Country: Benin Setting: antenatal care clinics from Ouidah,a semi‐rural town Transmission: perennial with seasonal peaks Resistance: in 2005, rates of sulfadoxine‐pyrimethamine and mefloquine resistance in vivo in children < 5 years of age were estimated to be 50% and 2.5% by day 28 of treatment, respectively. Dates: 2005 to 2008 Funding: Fonds de Solidarité Prioritaire (French Ministry of Foreign Affairs; project no. 2006–22); Institut de Recherche pour le Développement; Fondation pour la Recherche Médicale (grant FDM20060907976 to V.B.); Fondation de France; and Fondation Mérieux
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "Randomization of subjects was stratified according to maternity clinic and gravidity".
Allocation concealment (selection bias)	High risk	Allocation was not concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding was reported, and safety outcomes are likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Efficacy	Low risk	No blinding of outcome assessment was reported, but the review authors judge that the efficacy outcome measurement is not likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Safety	High risk	No blinding of outcome assessment was reported; thus the review authors judge that the safety outcome measurement is likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing outcome data were balanced in numbers across intervention groups, and similar reasons for missing data were reported across groups.
Selective reporting (reporting bias)	Low risk	The study protocol is not available, but it is clear that published reports describe all expected outcomes, including those that were prespecified.
Other bias	Low risk	The study appears to be free of other sources of bias.