NCT05485649

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jul 2022Aug 2026

Study Start

First participant enrolled

July 20, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

August 1, 2022

Last Update Submit

April 29, 2026

Conditions

Epilepsy

Keywords

PregnancyNeonatalObstetricalAnti-seizure medication

Outcome Measures

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.

    2 years

Secondary Outcomes (1)

  • Clinical (neurological, obstetrical, neonatal) outcomes during pregnancy

    1 year

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Esther Bui, MD

CONTACT

416-603-5320Esther.Bui@uhn.ca

Sharon Ng, BA

CONTACT

416-603-5320Sharon.Ng@uhnresearch.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, MD FRCPC

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 3, 2022

Study Start

July 20, 2022

Primary Completion

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)