Study design and participants
malaria, allergy, heart ailment
MALARIA, ALLERGY, NAIROBI
This three-arm, individually randomised, double-blind, partly placebo-controlled, trial was done in 12 antenatal clinics in southern Malawi (n=5), northeastern Tanzania (n=3), and western Kenya (n=4) in areas with high-grade sulfadoxine–pyrimethamine resistance and perennial malaria transmission. Women of any age with a viable singleton pregnancy between 16 weeks and 28 weeks gestation confirmed by ultrasound were eligible for inclusion if they were residents of the study area and were willing to adhere to the follow-up schedule and give birth in a study clinic. Women with multiple pregnancies, a known heart ailment, a history of receiving IPTp with sulfadoxine–pyrimethamine during the current pregnancy, a known allergy or contraindication to any of the study drugs, or women living with HIV were excluded. All study participants provided written informed consent. The study was approved by the ethics committees of the Kenya Medical Research Institute, Nairobi, Kenya; the College of Medicine, Blantyre, Malawi; the Medical Research Coordinating Committee, Dar Es Salaam, Tanzania; and the Liverpool School of Tropical Medicine (LSTM), Liverpool, UK.