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Clinical Trials/NCT05485649
NCT05485649
Recruiting
N/A

Obstetrical & Neurological Outcomes in Individuals With Epilepsy During Pregnancy

University Health Network, Toronto1 site in 1 country80 target enrollmentJuly 20, 2022
ConditionsEpilepsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Epilepsy
Sponsor
University Health Network, Toronto
Enrollment
80
Locations
1
Primary Endpoint
Frequency of adherence to the 2015 Ontario Task Force management of epilepsy in pregnancy
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2022
End Date
January 1, 2026
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Esther Bui

Assistant Professor, MD FRCPC

University Health Network, Toronto

Eligibility Criteria

Inclusion Criteria

  • WWE seen at the Toronto Western Hospital Epilepsy Clinic since June 1st
  • 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

  • Not provided

Outcomes

Primary Outcomes

Frequency of adherence to the 2015 Ontario Task Force management of epilepsy in pregnancy

Time Frame: 2 years

Describe the frequency of adherence to the 2015 Ontario Task Force management of epilepsy in pregnancy (i.e., AED regimen of WWE, frequency of polytherapy, adherence to serum monitoring of lamotrigine, and folic acid supplementation) and its association with year of pregnancy and type of healthcare provider.

Secondary Outcomes

  • Clinical (neurological, obstetrical, neonatal) outcomes during pregnancy(1 year)

Study Sites (1)

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