The development and validation of a prototype of a Belgian data registration system on medication use during pregnancy and lactation (BELpREG-project)

Information on risks caused by medication use during pregnancy and lactation is currently lacking for most substances. This creates uncertainty and anxiety among women and healthcare professionals, which in turn might lead to unnecessary pregnancy terminations, medication reluctance and early cessation of breastfeeding. As RCTs are generally not feasible during pregnancy and lactation, opportunities to conduct observational research should be maximally exploited. However, systematic data registration is currently lacking in Belgium. Therefore, this project aims to develop and test a prototype of a robust, evidence-based data registration system on medication use during pregnancy and lactation and maternal-infant health outcomes that will be of utmost value for researchers and pharmaceutical industry.

Keywords:Pharmaco-epidemiology, Pharmacovigilance, Drug safety, Teratology, Drug information

Disciplines:Foetal development, Health information systems of medical informatics, Development of bioinformatics software, tools and databases, Obstetrics, Paediatrics, Pharmaco-epidemiology