Health Condition 1: G409- Epilepsy, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
AIIMSDelhi
Eligibility
Inclusion criteria
Inclusion criteria: Screening Criteria For women with epilepsy[WWE] INCLUSION CRITERIA 1. Women with Epilepsy having child may or may not exposed to ASMs during their prenatal period 2.Mothers of age equal or greater than 18 years. 3.Informed consent provided willingly for participation and access to medical records. Screening Criteria For children INCLUSION CRITERIA 1.Children of WWE with or without ASMs exposure during their pre-natal period. 2.Age of 10 years 3.Assent obtained from the child and informed consent provided by the WWE[Parents].
Exclusion criteria
Exclusion criteria: Screening Criteria For WWE Exclusion criteria 1. Mothers exposed to known teratogenic drugs other than ASMs (e.g., methotrexate) during pregnancy, which may interfere with study interpretation. 2. Child exposed to drugs (like anticancer drugs, antipsychotic drugs), heavy metals, toxins (like pesticides), psychological stress, etc. after delivery which may lead to developmental and genetic anomaly. 3. Parental or family history suggestive of any chromosomal or inherited genetic syndromes. Screening Criteria for children EXCLUSION CRITERIA 1 Child exposed to drugs (like anticancer drugs, antipsychotic drugs), heavy metals, toxins (like pesticides), psychological stress, etc. after delivery which may lead to developmental and genetic anomaly. 2Parental or family history suggestive of any chromosomal or inherited genetic syndromes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the burden of developmental anomaly among children (up to 10 years) with prenatal exposure to antiseizure medications.Timepoint: 4 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate maternal and fetal outcomes in women with epilepsy on anti-seizure medication therapy during their previous pregnancy. Timepoint: 4 years;To evaluate the variation in blood levels of antiseizure medications (ASMs) such as levetiracetam, carbamazepine, phenytoin, and valproate in pregnant women with epilepsy across the first, second, and third trimesters compared with baseline (before pregnancy)/postpartum (more than 4 weeks) concentrations. Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactYatharth Goel
AIIMS, New Delhi
Outcome results
None listed