Q89.9 O03
Conditions
Interventions
Group 1: Documented pregnancies with maternal levetiracetam exposure during first trimester of pregnancy. Data stem from our institute's patient registry.
Group 2: Comparison cohort: Documented pregna
Sponsors
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: For both cohorts: Enrollment of pregnancies, of which neither the outcome nor pathological results of prenatal diagnostics are known at the first contact. An analysis of these prospectively ascertained pregnancies can therefore be used for risk quantification of the defined endpoints.
Exclusion criteria
Exclusion criteria: Exclusion Criteria comparison cohort: cases with levetiracetam exposure during pregnancy. Exclusion criteria (applies for the exposed and comparison groups): therapy of maternal malignancies during pregnancy and cases with maternal exposure considered as potent teratogens or fetotoxicants: i.e. valproate, topiramate and carbamazepine as well as acenocoumarol, ACE-inhibitors and AT1-antagonists (exposure in 2nd and 3rd trimester), lenalidomide, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide and warfarin.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To estimate the risk of low birth weight, gestational age at delivery (preterm birth) and pregnancy complications (i.e. preeclampsia, gestational diabetes, stillbirth). Descriptive evaluation of dose adjustment during pregnancy. To describe the risk of major congenital malformation or spontaneous abortions after first trimester exposure to levetiracetam combined with e.g. lamotrigine or other antiepileptic drugs. In case of significantly increased risks of major congenital birth defects or spontaneous abortions in the exposed cohort, a subsequent sensitivity analysis will be performed using a disease comparison group to account for a possible influence of the underlying treatment indication ‘epilepsy’. The subgroup of pregnancies exposed only to levetiracetam (monotherapy, indication epilepsy) will be compared with a group of women with epilepsy who received a lamotrigine monotherapy. | — |
Primary
| Measure | Time frame |
|---|---|
| Risk quantification of congenital major birth defects after maternal exposure to levetiracetam during first trimester in comparison to a non-exposed control cohort. Is there an increased rate of spontaneous abortions after maternal exposure to levetiracetam during first trimester in comparison to a non-exposed control cohort? First ascertainment of data takes places in early pregnancy with informed consent of the patients when outcome or pathological prenatal diagnosis is unknown. Approximately eight weeks after the estimated date of birth a structured questionnaire is send to collect data about the pregnancy outcome. | — |
Countries
Germany
Contacts
Public ContactInsa Dirk
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
Outcome results
None listed