Malaria Prevention in Pregnant Women

Women were encouraged to attend the ANC clinic whenever they had any health complaint. Health care was free of charge and in general there was little availability of antimalarial drugs over the counter at all sites. A health facility-based passive surveillance system was established at each site to capture unscheduled visits of the study participants during the study follow-up. At each unscheduled visit, a standardized questionnaire was completed documenting signs and symptoms. Blood smears were prepared for malaria parasite examination and hemoglobin was measured if there were current or reported symptoms and/or signs suggestive of malaria. Clinical malaria episodes were treated with oral quinine or artemether-lumefantrine in the first and subsequent trimesters, respectively, for uncomplicated malaria, and with parenteral quinine for severe malaria. Solicited and unsolicited adverse events (AEs) were assessed. The former was done by directed questioning of malaria related signs and symptoms during unscheduled visits, whereas the latter were assessed through open questioning during scheduled visits. Women who were withdrawn from the study received routine ANC treatment.
At delivery, women's peripheral blood, cord blood, and placental (biopsy and impression smears) samples were collected for hematological and parasitological evaluation. Newborns were weighed (weekly calibrated scales, either digital or three beam balances), and their gestational age at birth evaluated using the Ballard's score [27] (link). Newborn weights not captured at birth but within the first week of life were estimated using a linear regression model (Figure S1) [28] (link). One month after the end of pregnancy, a capillary blood sample from the mother was collected for malaria parasite determination. LLITN use was assessed at each study visit by questions about use the preceding night.