Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes
Conditions
Interventions
None listed
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women with confirmed diagnosis of epilepsy and on stable dose of levetiracetam throughout gestation period 2. Subject on a stable dose of one or two antiepileptic drugs during baseline. 3. Participants willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients with unstable medical conditions like renal and hepatic insufficiency and history of neuropsychiatric disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To analyze prospectively the changes in levetiracetam serum levels in women with epilepsy during pregnancy â?¢ To observe any change in f requency and number of seizure events during pregnancy compared to baseline and to correlate the fetal outcome with drug levels during pregnancyTimepoint: At the end of every trimester every 3rd monthly | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate adverse effect profile followin g treatment with levetiracetam.Timepoint: At the end of every trimester every 3rd monthly | — |
Countries
India
Contacts
Public ContactDr Bikash Medhi
PGIMER, CHANDIGARH
Outcome results
None listed