Using ‘real world’ data to enhance medication safety during pregnancy: towards a ‘fit-for-purpose’ registration system on maternal medication use and mother-infant outcomes (BELpREG)

Evidence on medication safety in pregnancy is lacking for most products, despite their frequent use. As randomized controlled trials cannot be performed in this population, opportunities of ‘real-world’ data collection for pharmacoepidemiologic research should be fully exploited. In 2021, a prototype of a comprehensive registration system on maternal medication use and mother-infant outcomes (BELpREG) was developed at KU Leuven, allowing data entry by women. Although the prototype was tested ‘in-house’, pilot-testing ‘in real-life’ and subsequent modifications are pivotal to result in a robust research instrument, ready for large-scale implementation. This FWO proposal will focus on the feasibility assessment and validation of the BELpREG prototype. During a pilot period, data completeness, correctness, representativeness of the sample, and women’s / healthcare professionals’ (HCPs) experiences with data entry / recruiting women will be assessed (WP 1). In WP 2, additional features to the BELpREG system will be explored, including data registration by HCPs, long-term data collection on infant development and linkage with external databases. In WP 3-4, ‘use cases’ based on BELpREG data will be performed for hypothesis-generating (‘drug utilization’) (WP 3) and hypothesis-testing purposes (‘analytic pharmacoepidemiology’) (WP 4). This will eventually result in a ‘fit-for-purpose’ system, ready to contribute to increasing the knowledge on medication safety in pregnancy.