Assessment of the Safety of Antimalarial Drug Use During Early Pregnancy (ASAP)
This prospective cohort study is addressing the need for improved methods for pharmacovigilance in early pregnancy and an urgent need for data to inform policy makers and treatment guidelines on the safety of artemisinin combination therapies (ACT) when used during early pregnancy. Considering their widespread use and the prevalence of malaria, women in malaria-endemic countries could be exposed inadvertently to ACTs at an early stage of their pregnancy. To date, little is known about their human safety profile and we presently lack the validated pharmacovigilance tools to systematically conduct active surveillance to contribute to risk-benefit assessments at the national and global level. This project is designed systematically collect observational data that is complimentary to the Malaria in Pregnancy Consortium (MiPc) trials that focus on the safety and efficacy of antimalarials in the second and third trimesters of pregnancy. The study is funded through MiPc via support from the Bill and Melinda Gates Foundation.
- Develop and field-test active surveillance tools and procedures for artemisinin-based combination therapy (ACT) exposure identification & assessment during early pregnancy and pregnancy outcomes assessment.
- Contribute safety information to the evidence database on the relationship between the use of ACTs during early pregnancy and the risk of adverse pregnancy outcomes by evaluating the relationship between the use of ACTs during early pregnancy and the risk of miscarriages and major congenital malformations.
This study is being carried out in Africa with the following key collaborators at three research sites in Africa, and the Global Medicines Program is providing centralized support and coordination. The three sites are:
- Eduardo Mondlane University, Mozambique: E. Sevene: Site PI
- Manhica Health Research Centre, Mozambique: E. Macete
- Centre for International Health, University of Barcelona, Spain: C. Menendez
- Liverpool School of Tropical Medicine, UK: F. ter Kuile* and S. Dellicour: Site PI
- Kenya Medical Research Institute, Kenya: S. Kariuki, P. Ouma and G. Bigogo
- Centers for Disease Control and Prevention, USA: L. Slutsker, K. Laserson, M. Hamel, D. Feikin and M. Desai
- IRSS/Centre Muraz, Burkina Faso: H. Tinto: Site PI
- Prince Leopold Institute of Tropical Medicine, Belgium: U. d’Alessandro
- WHO (2007) Assessment of the safety of artemisinin compounds in pregnancy: report of two joint informal consultations convened in 2006. Geneva: WHO. Full text
- Pregnancy Exposure Registries for Assessing Antimalarial Drug Safety in Pregnancy in Malaria Endemic Countries. Dellicour S, ter Kuile F, Stergachis A. PLoS Medicine. 2010. Vol. 5, No. 9, e187 doi:10.1371/journal.pmed.0050187. Full text