Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study

Epilepsy Clinical Trial

Official title:

Obstetrical & Neurological Outcomes in Individuals With Epilepsy During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485649
• Other study ID #: 20-5753.2
• Status: Recruiting
• Start date: July 20, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: University Health Network, Toronto
• Contact: Esther Bui, MD
• Phone: 416-603-5320
• Email: Esther.Bui[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. In particular, we are interested in the association between following recommended epilepsy management guidelines for pregnant individuals with epilepsy and those aforementioned outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year