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All Profiles
Call Career Development Fellowship (CDF)
Programme EDCTP1
Start Date 2005-04-23
End Date 2010-02-27
Project Code TA.2005.40203.007
Status Completed


Intensive safety monitoring of antimalarial and anti-retroviral drugs used during pregnancy in Manhiça


To measure the incidence of these adverse drug reactions and to determine risk factors that may contribute to the development of adverse drug reactions to anti-retroviral and antimalarial drugs in the pregnant women

Host Organisation

Institution Country
Eduardo Mondlane University Mozambique

Study Design

Prospective cohort safety study

Results & Outcomes

A total of 2041 pregnant woman were recruited in the study. Of these 1608 delivered at the hospital. After delivery, 1473 and 877 mothers presented their babies for assessment at second and twelfth month respectively. Fifteen pregnant women presented adverse drug reactions to drugs used during pregnancy but all recovered without sequelae. The study team attended four courses on pharmacovigilance and data management during the course of the projects.


Sevene E, Bardají A, Mariano A, Machevo S, Ayala E, Sigaúque B, Alonso P, Carné X, Menendez C. Drug exposure and pregnancy outcomes in Mozambique. Paediatr Drugs. 2012 Feb 1;14(1):43-9. doi: 10.2165/11591270
Sevene E, González R, Menéndez C. Current knowledge and challenges of antimalarial drugs for treatment and prevention in pregnancy. Expert Opin Pharmacother. 2010 Jun;11(8):1277- 93

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