Safety of rectal artesunate in pregnancy - an assessment of pregnancy outcomes in a randomised controlled trial in Bangladesh

INTERVENTION: A single dose of either 400 mg artesunate suppository or an identical placebo suppository is given. CONDITION: Artesunate use in pregnancy ; Infections and Infestations ; Malaria PRIMARY OUTCOME: As this study is a sub‐study within a larger trial that has mortality as the main outcome, this should be considered as the same outcome for this trial. SECONDARY OUTCOME: 1. Proportion of anomalies in live‐born, proportion of stillborn and late foetal deaths (artesunate versus placebo); 2. Determination of effect on foetal viability in second and third trimester and inadvertent exposures in first trimester (artesunate and placebo); 3. Determination of neonatal and maternal mortality (artesunate versus placebo); 4. Assessment of developmental delays (artesunate versus placebo); 5. Determination of proportion of children with low birth weight (artesunate versus placebo) in the subgroup of patients assessed prospectively INCLUSION CRITERIA: 1. Pregnant women 2. Consent of patient or parent/guardian 3. Participation in survival benefit of early treatment with rectal artesunate