# name
Assessment of the safety of antimalarial drug use during early pregnancy (ASAP): protocol for a multicenter prospective cohort study in Burkina Faso, Kenya and Mozambique

# metadata.dc.description.abstract[].value
BACKGROUND: A major unresolved safety concern for malaria case
                management is the use of artemisinin combination therapies
                (ACTs) in the first trimester of pregnancy. There is a need for
                human data to inform policy makers and treatment guidelines on
                the safety of artemisinin combination therapies (ACT) when used
                during early pregnancy. METHODS: The overall goal of this paper
                is to describe the methods and implementation of a study aimed
                at developing surveillance systems for identifying exposures to
                antimalarials during early pregnancy and for monitoring
                pregnancy outcomes using health and demographic surveillance
                platforms. This was a multi-center prospective observational
                cohort study involving women at health and demographic
                surveillance sites in three countries in Africa: Burkina Faso,
                Kenya and Mozambique [(ClinicalTrials.gov Identifier:
                NCT01232530)]. The study was designed to identify pregnant women
                with artemisinin exposure in the first trimester and compare
                them to: 1) pregnant women without malaria, 2) pregnant women
                treated for malaria, but exposed to other antimalarials, and 3)
                pregnant women with malaria and treated with artemisinins in the
                2nd or 3rd trimesters from the same settings. Pregnant women
                were recruited through community-based surveys and attendance at
                health facilities, including antenatal care clinics and followed
                until delivery. Data from the three sites will be pooled for
                analysis at the end of the study. Results are forthcoming.
                DISCUSSION: Despite few limitations, the methods described here
                are relevant to the development of sustainable pharmacovigilance
                systems for drugs used by pregnant women in the tropics using
                health and demographic surveillance sites to prospectively
                ascertain drug safety in early pregnancy. TRIAL REGISTRATION:
                NCT01232530.

# metadata.dc.source[].value
Articles publicats en revistes (ISGlobal)

# metadata.dc.title[].value
Assessment of the safety of antimalarial drug use during early pregnancy (ASAP): protocol for a multicenter prospective cohort study in Burkina Faso, Kenya and Mozambique