Monitoring of adverse events following praziquantel based treatment in pregnant women in Madagascar - a sub-study from the freeBILy clinical trial

Abstract

Schistosomiasis is a parasitic neglected tropical disease that is particularly associated with poverty and a lack of water, sanitation and hygiene (WASH) facilities. It poses a significant public health problem in endemic countries, mostly in Sub-Saharan-Africa. The World Health Organization (WHO) guidelines recommend to perform preventive annual chemotherapy as mass drug administrations (MDA) in endemic populations that include over two-year-old children, adults, pregnant women after their first trimester and lactating women. Despite its safe and efficient treatment, pregnant women are still often excluded from treatment programs as national policy makers and healthcare practitioners are reluctant to follow recommendations. This thesis aimed to further elucidate safety and tolerability aspects with regards to chemotherapy of pregnant women with schistosomiasis in Madagascar, where data and resources are scarce. This work also comprises evaluation of sociodemographic factors of foetal death and an evaluation of time-dependent serious adverse events (SAE), including prematurity and foetal death after chemotherapy with praziquantel.