Follow-up study on medicines used during pregnancy

Almost all medicines are transmitted through the placenta and are transferred to the fetus. However, for most medicines, there is not enough research data to make a reliable assessment of safety and risks. Fortunately, however, only few drugs are known to be clearly detrimental to fetal development.

Pregnant women are not included in clinical trials for ethical reasons. Information on new medicines is collected mainly during use, i.e. when a pregnancy begins in an unplanned manner or when medication is considered to be necessary for the mother. Pharmacovigilance research during pregnancy is also challenging because there may be few mothers taking an individual medicine and the risk cannot therefore be assessed. 

You will be eligible for a follow-up study if you are in the early stages of pregnancy (first trimester) or if you are taking a new medicine of which we only have little experience on use during pregnancy. When you call us for advice at the Medication for Mothers (Äidin lääkeneuvonta), we will ask you if you want to participate in the follow-up. We will send you a follow-up form in a couple of months after your due date. The follow-up form asks for basic information about medication used during pregnancy, the course of your pregnancy and childbirth, and information about the baby. The form does not contain any personally identifiable information. We collect follow-up information confidentially, and any personal information collected during a call will be removed from the electronic database upon return of the form. Participation in the follow-up is completely voluntary.

By participating in the monitoring study and returning the follow-up form, you can help gather important information about the safety of your medication during pregnancy. This is not a pharmaceutical trial, we only collect information in general about the normal medication the mother is using during pregnancy. We also need a control group of mothers who do not use any medication or who use medication that has been assessed safe with enough researched information. 

Anonymous data are used in statistical studies in collaboration with other teratological information services in Europe and North America. We have participated in studies involving antidepressants, antirheumatics, and antiepileptics, among others. The studies have provided important additional information on the safety of medicines and have been published in renowned international medical journals.