Scheduled screening versus preventative treatment for the control of malaria in pregnancy in Malawi: a randomised controlled trial

INTERVENTION: IPTp, ISTp-DP CONDITION: ; Malaria ; Pregnancy and Childbirth Malaria Pregnancy and Childbirth PRIMARY OUTCOME: 1. In women in their first or second pregnancy (G1‐2): Small for gestational age, LBW or preterm birth 2. Multigravidae (G3+): Malaria infection at term and delivery SECONDARY OUTCOME: Birth Weight Composite endpoint of primary endpoint plus fetal loss Foetal haemoglobin and anaemia Gestational age Immunology outcome Incidence and prevalence of clinical malaria in infants Incidence of documented clinical malaria episodes Incidence of other illness episodes Incidence of other illness episodes in infants Infant Death Malaria infection of the newborn Maternal haemoglobin and anaemia Maternal malaria infection (peripheral blood) Miscarriage Peripheral malaria infection Placental malaria (any species) Presence of any evidence of malaria infection at term Prevalence of symptomatic infant anaemia SAFETY: Congenital malformation SAFETY: Lab test results SAFETY: Neonatal jaundice SAFETY: other serious adverse events SAFETY: severe cutaneous skin reaction in mothers Small for gestational age Stillbirth Tolerability outcomes INCLUSION CRITERIA: 1. Viable singleton pregnancy 2. Gestational age 16 to 28 weeks (inclusive) by LMP (if available) or fundal height 3. No history of IPTp use during this pregnancy 4. Willing to participate and complete the study schedule 5. Has provided written informed consent 6. Resident of study area and intending to stay in the area for the duration of the follow‐up 7. Willing to deliver in the labour ward of the study clinic or hospital