Randomised trials of alternative malaria chemoprophylaxis strategies among pregnant women in Kigoma, Tazania: I. Rationale and design

The objective of the study was to assess the effectiveness of alternative strategies of malaria chemoprophylaxis on the reduction of malaria episodes and prevalence of parasitaemia among pregnant women in Kigoma urban district in western Tanzania.Randomised antimalarial prophylactic trial.The study was conducted in an urban maternal and child health (MCH) clinic in Kigoma town.All pregnant women attending antenatal care services at Kigoma urban MCH clinic were eligible. Informed consent was sought from each pregnant woman for participation in the study. INTERVENTION MEASURES: The intervention measures were intermittent and continuous malaria chemoprophylaxis using chloroquine and proguanil.Reduction of malaria episodes and parasitaemia and haemoglobin levels among participating pregnant women in Kigoma urban district.Baseline data indicates that the overall mean haemoglobin concentrations among the primigravidae and multigravidae women were similar within the intervention and comparison groups (F-test (df = 5, N = 701) = 1.27, P = 0.27). Similarly, no significant difference was observed in the prevalence of malaria parasitaemia within the primigravidae intervention and comparison groups (chi 2 test (df = 5, N = 701) = 5.4, P = 0.4). Hence, the process of randomisation produced comparable intervention and comparison groups with balanced characteristics. Specific results of the baseline studies are presented in the companion paper.We conclude that the process of randomisation resulted in comparable intervention and comparison groups. As malaria is a common cause of considerable morbidity and mortality among pregnant women in Tanzania, the present study provided useful data for improving reproductive health in Kigoma region, western Tanzania.This randomized antimalarial prophylactic trial assessed the effectiveness of alternative malaria chemoprophylaxis strategies on the reduction of malaria episodes and prevalence of parasitemia among pregnant women in urban Kigoma, Tanzania. All pregnant women attending antenatal care services at an urban maternal and child health clinic were randomly exposed to either intermittent or continuous malaria chemoprophylaxis using chloroquine and proguanil. The main outcome measures of the study were reduction of malaria episodes and parasitemia and hemoglobin levels among pregnant women. Baseline findings suggest that the overall mean hemoglobin concentrations among primigravida and multigravida women were similar within the intervention and comparison groups (P = 0.27). Similarly, no significant difference was observed in the prevalence of malaria parasitemia within the primigravida intervention and comparison groups (P = 0.4). Hence, the process of randomization produced comparable intervention and comparison groups with balanced characteristics. As malaria is a common cause of morbidity and mortality among pregnant women in Tanzania, this study provided useful data for improving reproductive health in the Kigoma region.