The preliminary results from this study were presented at the workshop of the AGENS group [Working group for the use of secondary data of the German Epidemiological Society], 22.03.–23.05.2012 in Bremen.
Evaluation of pregnancy outcome records in the German Pharmacoepidemiological Research Database (GePaRD)†
Article first published online: 3 JUN 2013
Copyright © 2013 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 22, Issue 8, pages 873–880, August 2013
How to Cite
Mikolajczyk, R., Kraut, A. and Garbe, E. (2013), Evaluation of pregnancy outcome records in the German Pharmacoepidemiological Research Database (GePaRD). Pharmacoepidem. Drug Safe., 22: 873–880. doi: 10.1002/pds.3467
- Issue published online: 21 JUL 2013
- Article first published online: 3 JUN 2013
- Manuscript Accepted: 29 APR 2013
- Manuscript Revised: 19 MAR 2013
- Manuscript Received: 15 AUG 2012
- health insurance database;
- pregnancy outcomes;
- pregnancy markers;
- claims database;
Routine health care data are a valuable source for the assessment of risks of drugs during pregnancy. Therefore, the aim of the current analysis was the evaluation of pregnancy outcome records in German health insurance data.
We used the German Pharmacoepidemiologic Research Database including data of more than 15 million insurants (about 18% of the German population). Among 10–49 year-old women, we identified six categories of pregnancy outcomes: term births, preterm births, stillbirths, induced abortions, spontaneous abortions and ectopic pregnancies. In order to assess the validity of these records, we have set our results in relation to representative data for the corresponding outcomes in Germany. We also investigated whether pregnancy markers (diagnoses, procedures or medical services which indicate an existing pregnancy) can be used to identify pregnancies.
In total, we identified 94 261 pregnancy outcomes in 2005. The percentage of births outside hospital (1.2%) and of preterm births (11.6%), the rate of stillbirths (3 per 1000 live births) and the rate of ectopic pregnancies (20 per 1000 live births) agreed well with representative data for Germany. Compared to epidemiological data, the occurrence of spontaneous abortions was underestimated (5.4% of all pregnancies). There were 4.1 induced abortions per 100 live births, compared to 18.1 in national data. Positive predictive values and sensitivities of markers varied across marker categories and for different pregnancy outcomes.
Completeness of pregnancy outcomes recorded in the database varied by pregnancy outcome. This should be taken into account in studies of drug safety in pregnancy. Copyright © 2013 John Wiley & Sons, Ltd.