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RecruitingNCT05485649Updated May 6, 2026

Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study

An observational study in Epilepsy, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University Health Network, Toronto · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Sex
Female
01

Study 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.

02

Conditions studied

  • Epilepsy

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Keywords

  • Pregnancy
  • Neonatal
  • Obstetrical
  • Anti-seizure medication
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In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 80 is below the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

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

    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.

    Time frame: 2 years

Secondary outcomes

  1. Clinical (neurological, obstetrical, neonatal) outcomes during pregnancy

    To determine the association between adherence with the aforementioned guidelines and pregnancy, delivery, neonatal, and neurological outcomes when adjusting for baseline possible confounders.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • University Health Network
    Toronto, Ontario M5T 2S8, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05485649
Lead sponsor
University Health Network, Toronto
Responsible party
Esther Bui (Assistant Professor, MD FRCPC, University Health Network, Toronto) — Principal investigator
First posted
Aug 3, 2022
Start date
Jul 20, 2022
Primary completion
Jun 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
May 6, 2026

Study contacts

Esther Bui, MD
Contact
Esther.Bui@uhn.ca
416-603-5320
Sharon Ng, BA
Contact
Sharon.Ng@uhnresearch.ca
416-603-5320

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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