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Recruiting NCT05485649

Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study

Observational Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Obstetrical & Neurological Outcomes in Individuals With Epilepsy During Pregnancy

Overview

The aim of this study is to investigate the pregnancy, delivery, neonatal, and epilepsy outcomes in individuals with epilepsy undergoing pregnancy at the Maternal and Infant Health Programs at the University Health Network - Sinai Health and followed for epilepsy at the Toronto Western Hospital Epilepsy Clinic. In particular, we are interested in the association between following recommended epilepsy management guidelines for pregnant individuals with epilepsy and those aforementioned outcomes.

Primary outcome measures

  • Frequency of adherence to the 2015 Ontario Task Force management of epilepsy in pregnancy [Time frame: 2 years]
Secondary outcome measures (1)
  • Clinical (neurological, obstetrical, neonatal) outcomes during pregnancy [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • WWE seen at the Toronto Western Hospital Epilepsy Clinic since June 1st 2022.
  • Pregnant at any point between June 1st 2022 and June 1st 2024 (period of enrolment).
  • Diagnosed with epilepsy as per the International League Against Epilepsy (ILAE) 2014 definition of epilepsy.

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • University Health Network — Toronto

Identifiers

NCT: NCT05485649 · 20-5753.2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗