EpilepsyNCT05485649
Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study
An observational study of Epilepsy, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Epilepsy
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jul 2022to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant individuals with epilepsy seen at the Toronto Western Hospital Clinic.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5T 2S8
Esther Bui, MD, 416-603-5320, Esther.Bui@uhn.ca
About this study
Official title: 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.
- Conditions
- Epilepsy
- Keywords
- Pregnancy, Neonatal, Obstetrical, Anti-seizure medication
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start20 Jul 2022
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Bui, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485649
- Sponsor's protocol ID
- 20-5753.2
- Status last verified
- Apr 2026
- First submitted
- 1 Aug 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetrical & Neurological Outcomes in Individuals With Epilepsy During Pregnancy
- ClinicalTrials.gov ID
- NCT05485649
- Acronym / sponsor ID
- 20-5753.2
- Conditions
- Epilepsy
- Keywords
- Pregnancy, Neonatal, Obstetrical, Anti-seizure medication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant individuals with epilepsy seen at the Toronto Western Hospital Clinic.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Clinical (neurological, obstetrical, neonatal) outcomes during pregnancy
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esther Bui, MD (416-603-5320, Esther.Bui@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adherence to the 2015 Ontario Task Force management of epilepsy in pregnancy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.