G40
Conditions
Interventions
Group 1: Documented pregnancies with maternal antiepileptic drug exposure at conception. Recruitment from the archive of the institute.
Sponsors
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Enrollment of pregnancies, of which neither the outcome nor pathological results of prenatal diagnostics were known at first contact to the German Embryotox Pharmacovigilance centre. Included are pregnancies with at least one antiepileptic drug exposure at conception in the study period 2000-2018.
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The use of antiepileptic drugs in pregnancy will be investigated. The aim is to evaluate the proportion of pregnant women with epilepsy who are exposed to non-recommended antiepileptic drugs at conception. In addition, the proportion of mono- and polytherapy in epilepsy treatment will be analysed. Moreover, changes in epilepsy treatments within the first trimester will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of antiepileptic drugs used for treatment of psychiatric diseases, pain and migraine in pregnant women during the study period? Furthermore, the time gap between EU marketing authorization and first request to the German Embryotox pharmacovigilance institute will be analysed. If there are sufficient data on exposure to selected newer antiepileptic drugs, the course of these pregnancies will be descriptively evaluated. | — |
Countries
Germany
Contacts
Public ContactMaria Hoeltzenbein
Pharmakovigilanz- und Beratungszentrum Embryonaltoxikologie
Outcome results
None listed