Drug use assessment and risk evaluation in pregnancy--the PEGASUS-project

Since the thalidomide tragedy it is well accepted that drugs can have adverse effects on the unborn child. Although numerous studies show that drug use during pregnancy is widespread, there still is a serious lack of comprehensive and valid data on the risks of drug use during pregnancy. One objective of the PEGASUS-project, which focuses on Munich, is to enlarge the knowledge on embryo- and fetotoxic properties of drugs by prospectively recording information on drug exposure during pregnancy and analysing these data with regard to untoward fetal outcome. First results of PEGASUS confirm that drug utilization during pregnancy is rather common-85% of women use at least one preparation. The most frequent groups are haematologicals, minerals, iodide, and vitamins. Randomized studies have shown that periconceptional folic acid supplementation considerably reduces the risk of neural tube defects. However, only very few women in the PEGASUS-project recorded folic acid intake during the critical period or in sufficient dosage.