Building an ecosystem for better monitoring and communicating of medication safety in pregnancy and breastfeeding

  • Period: 2019-04-30 – 2024-12-31
  • Budget: 7,397,549 SEK
  • Funder: Innovative Medicines Initiative

Safety evidence ecosystem

More than 5 million women get pregnant in the EU every year and a majority takes at least one medication during pregnancy. As few as 5% of available medications have been adequately monitored, tested and labelled with safety information for use in pregnant and breastfeeding women. The field, while inherently difficult to study, has suffered from a lack of systematically gathered insights that could lead to more effective data generation methodologies. Fragmentation and misinformation results in confusing and contradictory communication and perception of risks by both health professionals and women and their families.

ConcePTION is a public-private research project, funded by the Innovative Medicines Initiative, with the aim of increasing knowledge about drugs taken during pregnancy and lactation. Within the ConcePTION project, several studies are underway to investigate the impact of drugs both during pregnancy and during breastfeeding.

ConcePTION aims to establish a trusted ecosystem that can efficiently, systematically, and in an ethically responsible manner, generate and disseminate reliable evidence-based information regarding effects of medications used during pregnancy and breastfeeding to women and their healthcare providers. This will be achieved by generating, cataloguing, linking, collecting and analysing data from pharmacovigilance, modelling, routine healthcare, breastmilk samples through a large network.

ConcePTION in Sweden

In Sweden, in two demonstration studies, we will collect breast milk and blood samples from the mother and the baby for two drugs: metformin and prednisolone. In both cases, there is currently limited data, which is partly old from the 1970s, partly analyzed with outdated methods. The samples are transported to Uppsala Biobank for storage and analyzed with mass spectrometric methods at the Department of Pharmacy, Uppsala University.

Uppsala University is the sponsor of the studies, for more information, please contact Mats G. Hansson, senior professor. Are you currently breastfeeding and taking any of the medicines Metformin or Prednisolone? Consider participating in our study. To learn more about the study and sign up, visit the website for the Metformin study and the Prednisolone study (Swedish only). Or contact those responsible for the study via e-mail: or

Visit the ConcePTION website

ConcePTION unites 88 organisations from 22 countries

Uppsala University participates through the Centre for Research Ethics & Bioethics and the Department of Pharmacy.

People in the project