Randomised trials of alternative malaria chemoprophylaxis strategies among pregnant women in Kigoma, Tazania: 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 wasobserved in the prevalence of malaria parasitaemia within the primigravidae intervention and comparison groups (c2 test (df=5, N = 701) = 5.4, P = 0.4). Hence, the process of randomisation produced comparable intervention and comparison groups with balancedcharacteristics. 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

Randomised trial of alternative malaria chemoprophylaxis strategies among pregnant women in Kigoma, Tanzania: II results from baseline studies

Objective: To determine baseline data among pregnant women consenting to participate in a randomised trial of alternative strategies of malaria chemoprophylaxis in Kigoma urban district, western Tanzania.Design: Cross-sectional study.Setting: The study was conducted in an urban MCH clinic in Kigoma town in western Tanzania.Subjects: All consenting pregnant women who fulfilled entry criteria were recruited into the study.Baseline studies: Baseline data were collected prior to randomisation of women to antimalarial prophylactic regimens. Baseline measurements included examination for blood depleting parasitic infections (stool and urine examinations), haemoglobin levels, haematocrit, sickling test, and blood slide for malaria parasites.Results: A total of 728 pregnant women consented to participate in the interview and of these 705 participated in baseline studies constituting a participation rate of 96.8%. The age of participating women ranged from 14 to 45 years with a mean age of 23.7 years (standarddeviation [SD] = 5.4) while the mean number of pregnancies ranged from 1 to 13 with a mean of 3.2 (SD = 2.2). The prevalence of malaria parasitaemia among the pregnant women examined was 9.4% (N = 705) while the prevalence of anaemia (defined as Hb < 8.5 gdl-1) was12.4% (N = 579). No significant difference was observed in prevalence proportions of malaria parasitaemia in relation to age, parity, marital status and use of mosquito bednets. However the prevalence of anaemia among women in the age group 31-45 years was significantly lower than that observed among women in the age group 14-20 years (2.9% versus 18.9%; crude odds ratio [OR] = 0.13; 95% confidence interval [CI], 0.02-0.55). Sickle cell disease (HbAS) was found in 2.3% (N = 564) of the pregnant women examined.Conclusion: It is concluded that the prevalence of malaria parasitaemia and anaemia was very high in this population suggesting the need for interventions directed at controlling these major causes of maternal morbidity and mortality in Tanzania