Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study

Obstetrical & Neurological Outcomes in Individuals With Epilepsy During Pregnancy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05485649

Enrollment

Registered

2022-08-03

Start date

2022-07-20

Completion date

2026-08-01

Last updated

2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Pregnancy, Neonatal, Obstetrical, Anti-seizure medication

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Frequency of adherence to the 2015 Ontario Task Force management of epilepsy in pregnancy	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

Measure	Time frame	Description
Clinical (neurological, obstetrical, neonatal) outcomes during pregnancy	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.

Countries

Canada

Contacts

CONTACTEsther Bui, MD

Esther.Bui@uhn.ca416-603-5320

CONTACTSharon Ng, BA

Sharon.Ng@uhnresearch.ca416-603-5320

Outcome results