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

Tinto, Halidou, Sevene, Esperança, Dellicour, Stephanie, Calip, Gregory S, d'Alessandro, Umberto, Macete, Eusébio, Nakanabo-Diallo, Seydou, Kazienga, Adama, Valea, Innocent, Sorgho, Hermann, Valá, Anifa, Augusto, Orvalho, Ruperez, Maria, Menendez, Clara, Ouma, Peter, Desai, Meghna, terKuile, Feiko ORCID: https://orcid.org/0000-0003-3663-5617 and Stergachis, Andy (2015) '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, Vol 12, Issue 112.

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Abstract

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

Item Type:	Article
Uncontrolled Keywords:	Pregnancy; Malaria; ACTs
Subjects:	QV Pharmacology > Anti-Inflammatory Agents. Anti-Infective Agents. Antineoplastic Agents > QV 256 Antimalarials QV Pharmacology > Drug Standardization. Pharmacognosy. Medicinal Plants > QV 771 Standardization and evaluation of drugs WA Public Health > Health Problems of Special Population Groups > WA 395 Health in developing countries WQ Obstetrics > Pregnancy > WQ 200 General works
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1186/s12978-015-0101-0
Depositing User:	Jessica Jones
Date Deposited:	28 Jan 2016 10:25
Last Modified:	06 Feb 2018 13:11
URI:	https://archive.lstmed.ac.uk/id/eprint/5551

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