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 recognized as associated with important adverse consequences in pregnant women, particularly in areas of high transmission. Although strategies using 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 Research Project investigation were to determine the comparative efficacy of regimens containing chloroquine (CQ) or mefloquine (MQ) antimalarial treatment and chemoprophylaxis in an area of CQ-resistant P. falciparum 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 maternal fever illness and severe anemia; and 5) the likelihood of infant acquisition of malaria infection. Although the investigation was not designed to evaluate the role of antimalarial chemoprophylaxis and treatment on infant mortality reduction, because babies born to study women were scheduled to be followed for up to two years of life, the study allowed for an examination of mortality and morbidity in this population. The sample size was insufficient to provide more than descriptive analysis of mortality and morbidity in the fetal, perinatal, neonatal, postneonatal, and infant time intervals. The study design allowed for the evaluation of two additional aspects of maternal and infant health: other determinants of the above-listed outcomes in addition to malaria prevention (e.g., maternal age, gravidity, socioeconomic status, infection with human immunodeficiency virus or syphilis) and reported cause-specific mortality in the fetal-to-infant intervals. The study design included 22 months of enrollment of pregnant women at their first antenatal clinic visit from four clinic sites in Mangochi District, Malawi, with assignment to one of four antimalarial regimens and prospective follow-up through pregnancy, at delivery, and during infancy. All drug dosing was performed under supervision by the study team, making this an evaluation of intervention efficacy (excluding the role of patient compliance).