Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study

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.

Recruiting

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

Female

Study type

Observational

Primary location

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location status: Recruiting

Location contact

Esther Bui, MD

CONTACT

[email protected]

416-603-5320

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Bui, MD

CONTACT

[email protected]

416-603-5320

Sharon Ng, BA

CONTACT

[email protected]

416-603-5320

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Obstetrical & Neurological Outcomes in Individuals With Epilepsy During Pregnancy

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Aug 3, 2022
Registry last updated: May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting