An inventory of European data sources to support pharmacoepidemiologic research on neurodevelopmental outcomes in children following medication exposure in pregnancy: A contribution from the ConcePTION project

PLoS One. 2022 Oct 14;17(10):e0275979. doi: 10.1371/journal.pone.0275979. eCollection 2022.


Background: Studies on medication safety in pregnancy are increasingly focusing on child neurodevelopmental outcomes. Establishing neurodevelopmental safety is complex due to the range of neurodevelopmental outcomes and the length of follow-up needed for accurate assessment. The aim of this study was to provide an inventory of European data sources for use in pharmacoepidemiologic studies investigating neurodevelopment following maternal medication exposure.

Method: The EUROmediSAFE inventory of data sources in Europe for evaluating perinatal and long-term childhood risks associated with in-utero exposure to medication was updated by contacting colleagues across 31 European countries, literature review and internet searches. Included data sources must record at least one neurodevelopmental outcome and maternal medication use in pregnancy must be available, either in the data source itself or through linkage with another data source. Information on the domain of neurodevelopment, measure/scale used and the approach to measurement were recorded for each data source.

Results: Ninety data sources were identified across 14 countries. The majority (63.3%) were created for health surveillance and research with the remaining serving administrative purposes (21.1% healthcare databases,15.6% other administrative databases). Five domains of neurodevelopment were identified-infant development (36 data sources,13 countries), child behaviour (27 data sources, 10 countries), cognition (29 data sources, 12 countries), educational achievement (20 data sources, 7 countries), and diagnostic codes for neurodevelopmental disorders (42 data sources, 11 countries). Thirty-nine data sources, in 12 countries, had information on more than one domain of neurodevelopment.

Conclusion: This inventory is invaluable to future studies planning to investigate the neurodevelopmental impact of medication exposures during pregnancy. Caution must be used when combining varied approaches to neurodevelopment outcome measurement, the age of children in the data source, and the sensitivity and specificity of the outcome measure selected should be borne in mind.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child
  • Child Development*
  • Cognition
  • Female
  • Humans
  • Infant
  • Information Storage and Retrieval
  • Maternal Exposure / adverse effects
  • Neurodevelopmental Disorders* / chemically induced
  • Neurodevelopmental Disorders* / epidemiology
  • Pregnancy

Grants and funding

The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 821520 (authors JG, ML, FC and RB). This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.