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Please use this identifier to cite or link to this item: https://hdl.handle.net/2445/69257
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
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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.
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TINTO, Halidou, et al. 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. Reproductive Health. 2015. Vol. 12, num. 112, pags. 1-9. ISSN 1742-4755. [consulted: 18 of October of 2026]. Available at: https://hdl.handle.net/2445/69257