gms | German Medical Science

Context: Information on possible risks to the human embryo and fetus is usually missing at the time when new drugs receive approval. In spite of this lack of knowledge, most pregnant women in Germany receive several drug prescriptions. Thus, studies to assess drug risks in pregnancy are urgently needed.

Aim of the study: To evaluate whether data from the German statutory health insurance (SHI) system can be used to detect and measure hazards in pregnancy with respect to the outcome in the newborn using a well established risk factor.

Material and method: Coverage of children by SHIs in Germany is included in the fees paid by one parent. Similarly, spouses without earnings are included in the families’ insurance coverage. Family clusters can be established in insurance claims data. Mothers and their offspring can be identified if they are insured together in a cluster. The percentage of newborns which can be linked to their respective mothers will be determined. The database consists of claims data from four German SHI providers covering about 13 million subjects. Maternal diabetes is a known risk factor for fetal and neonatal morbidity, i.e. preterm birth and mortality. In addition the rate of congenital malformations is known to be significantly higher in the offspring of diabetic mothers. Maternal diabetes affects approximately 1% of all newborns in Germany. We will examine the association of maternal diabetes with adverse neonatal outcomes. Neonatal outcomes will be analysed using ambulatory and hospital claims data.

Results: Results will be presented at the meeting.

Conclusion: Since pregnant women are generally excluded from trials most adverse drug effects cannot be recognized in the premarketing phase and only become apparent during the postmarketing period. Examples of research questions in 2006 include SSRIs and persistent pulmonary hypertension of the newborn or ACE inhibitors and major congenital malformations.