Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study

Recruiting

• Conditions: Epilepsy

• Registration Number: NCT05485649
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-20
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of adherence to the 2015 Ontario Task Force management of epilepsy in pregnancy	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 Outcome Measures

Name	Time	Method
Clinical (neurological, obstetrical, neonatal) outcomes during pregnancy	1 year	To determine the association between adherence with the aforementioned guidelines and pregnancy, delivery, neonatal, and neurological outcomes when adjusting for baseline possible confounders.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada