Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes
Conditions
Sponsors
Pt BD Sharma PGIMS Rohtak
Eligibility
Inclusion criteria
Inclusion criteria: 1) Female patients of 18 - 65 years of age. 2) Female patients of epilepsy on levetiracetam monotherapy during current and/or past pregnancy. 3) Patient willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with psychogenic/ non epileptic seizures (NES). 2) Patients with history of alcohol/ substance abuse. 3) Patient having any personality or psychiatric disorders. 4) Patient with history of non-compliance to AED therapy. 5) Patient with history of any medical condition/concomitant medication causing teratogenicity. 6) Patients having severe physical disability, thyroid, liver, or renal dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Levetiracetam monotherapy in pregnant women with epilepsy. Efficacy will be assessed by comparing change in epilepsy frequency before and during pregnancy in pregnant women with epilepsy on Levetiracetam monotherapy. Efficacy will be assessed by asking questions from case record form regarding epilepsy frequency and comparing data of before and during pregnancy period.Timepoint: No follow up for participants who are not currently pregnant, their data will be collected at baseline only once regarding past history of epilepsy before and during pregnancy as per questions from case record form. Participants who are currently pregnant, their data will be recorded in case record form at the time of enrollment and they will be followed up only once at the end of their pregnancy term period (i.e. 9 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of Levetiracetam monotherapy in pregnant women with epilepsy. Safety will be assessed by recording safety parameters like adverse drug reactions, obstetric outcomes and delivery outcomes by asking questions as per case record form. Safety will be assessed by comparing frequency of adverse outcomes before and during pregnancy period.Timepoint: No follow up for participants who are not currently pregnant, their data will be collected at baseline only once regarding safety parameters of anti epileptic drugs as per case record form during pregnancy. Participants who are currently pregnant, their data will be recorded in case record form at the time of enrollment and they will be followed up only once at the end of their pregnancy term period (i.e. 9 months) to record safety parameters data in case record form. | — |
Countries
India
Contacts
Public ContactDr Deepinder Narang
Pt B. D. Sharma PGIMS Rohtak
Outcome results
None listed