Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study

April 29, 2026 updated by: Esther Bui, University Health Network, Toronto

Obstetrical & Neurological Outcomes in Individuals With Epilepsy During Pregnancy

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • University Health Network
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Pregnant individuals with epilepsy seen at the Toronto Western Hospital Clinic.

Description

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.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical (neurological, obstetrical, neonatal) outcomes during pregnancy
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-5753.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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