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

OBJECTIVE 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. DESIGN Randomised antimalarial prophylactic trial. SETTING The study was conducted in an urban maternal and child health (MCH) clinic in Kigoma town. SUBJECTS 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. MAIN OUTCOME MEASURES Reduction of malaria episodes and parasitaemia and haemoglobin levels among participating pregnant women in Kigoma urban district. RESULTS 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. CONCLUSION 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.