Nordic Pregnancy drug Safety Studies - NorPreSS

Nordic pregnant women are generally healthy. Yet, about 60% are prescribed drugs during pregnancy due to chronic diseases that necessitate long-term drug therapy also during the pregnancy. At the time of marketing of new drugs, there are scarcely any data on fetal effects since the potential adverse effects of drugs in pregnancy are virtually impossible, and unethical, to study in the experimental setting of randomized clinical trials before new drugs are marketed.

Limited knowledge exists on both short and long-term outcomes in children exposed to drugs in-utero. Further, knowledge concerning the health consequences for chronically ill women, abstaining from their drugs during pregnancy is sparse. It is urgent to investigate the health impact of drugs used in pregnancy on the child as well as the consequences for the mother if she discontinues medical treatment during pregnancy. Moreover, it is imperative that such investigation is built upon solid data and research approaches. The Nordic Pregnancy drug Safety Study (NorPreSS) proposed in this application is specifically focused on the safety of antidiabetic, antiepileptic and antidepressant drugs in light of these substances rising use among pregnant women. We will utilize the Nordic nationwide registries to perform analyses combining various data sources using state-of-the-art methods in statistics and epidemiology. By comparing Nordic countries we will identify areas suitable for interventions, drugs inappropriate for use in pregnancy and suggest improvements in healthcare and welfare policies.

In order to utilize the richness of Nordic data efficiently, we will need to refine the tools for integration and analyses of data from Nordic countries in a secure and efficient manner. Experienced research teams across Denmark, Finland, Iceland, Norway and Sweden will work together and recruit young researchers and strengthen collaborative efforts in the Nordic countries and internationally.

A main goal is to use our results to suggest early life interventions which may have a long lasting impact on health throughout life. We will provide clear interpretation of our results for policy makers. Further we think it is important to facilitate information about the findings to both women in child-bearing age, pregnant women, the public in general and media.