OBJECTIVES AND METHODOLOGY IN A STUDY OF MALARIA TREATMENT AND PREVENTION IN PREGNANCY IN RURAL MALAWI - THE MANGOCHI MALARIA RESEARCH-PROJECT

Malaria infection due to Plasmodium falciparum has been widely recogni zed as associated with important adverse consequences in pregnant wome n, particularly in areas of high transmission. Although strategies usi ng antimalarial drugs for prevention had been recommended, even by the late 1980s, few studies had been carried out to examine the efficacy of these prevention efforts. The objectives of the Mangochi Malaria Re search Project investigation were to determine the comparative efficac y of regimens containing chloroquine (CQ) or mefloquine (MQ) antimalar ial treatment and chemoprophylaxis in an area of CQ-resistant P. falci parum on the following outcomes: 1) the frequency of placental malaria infection; 2) the frequency of low birth weight; 3) the frequency of prematurity or intrauterine growth retardation; 4) the frequency of ma ternal fever illness and severe anemia; and 5) the likelihood of infan t acquisition of malaria infection. Although the investigation was not designed to evaluate the role of antimalarial chemoprophylaxis and tr eatment on infant mortality reduction, because babies born to study wo men were scheduled to be followed for up to two years of life, the stu dy allowed for an examination of mortality and morbidity in this popul ation. The sample size was insufficient to provide more than descripti ve analysis of mortality and morbidity in the fetal, perinatal, neonat al, postneonatal, and infant time intervals. The study design allowed for the evaluation of two additional aspects of maternal and infant he alth: other determinants of the above-listed outcomes in addition to m alaria prevention (e.g., maternal age, gravidity, socioeconomic status , infection with human immunodeficiency virus or syphilis) and reporte d cause-specific mortality in the fetal-to-infant intervals. The study design included 22 months of enrollment of pregnant women at their fi rst antenatal clinic visit from four clinic sites in Mangochi District , Malawi, with assignment to one of four antimalarial regimens and pro spective follow-up through pregnancy, at delivery, and during infancy. All drug dosing was performed under supervision by the study team, ma king this an evaluation of intervention efficacy (excluding the role o f patient compliance).