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Dr
Esperanca Sevene

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Profile EDCTP Fellowship 1

Project Title

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

EDCTP Project

TA.2005.40203.007

EDCTP Program

EDCTP1

EDCTP Project Call

Career Development Fellowship (CDF)

Project Objectives

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

Study Design

Prospective cohort safety study

Host Organisation

Department Institution Country
Eduardo Mondlane University Mozambique

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.