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Assessing the effects of maternal seizures during pregnancy on the brain development of children

Neurodevelopment After Prenatal Exposure to Seizures study: a cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN76169309
Enrollment
180
Registered
2019-01-09
Start date
2019-01-14
Completion date
Unknown
Last updated
2020-07-20

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

Conditions

Epilepsy Nervous System Diseases Epilepsy

Interventions

Participants are recruited from their local participating hospital. Following recruitment information will be taken from participants regarding their background, such as their education, health and oc

Sponsors

University of Manchester
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. They have a diagnosis of epilepsy and are either: 1.1. Trying to conceive 1.2. They are pregnant and before 21 weeks gestation 1.2.1. They have an expected date of delivery prior to the recruitment closure date (30th November 2019). 2. They are taking either: 2.1. Monotherapy lamotrigine or levetiracetam 2.2. Polytherapy combinations including lamotrigine and levetiracetam and other antiepileptic drugs; with the exception of valproate and carbamazepine. 3. They are receiving their care through one of the participating centres 4. They are willing to complete prospectively recorded seizure diaries

Exclusion criteria

Exclusion criteria: 1. Significant learning disability, requiring support to live independently 2. Experience or history of non-epileptic attacks (also known as NEAD or psychogenic seizures) 3. Taking non-antiepileptic medications which are known to be teratogenic (e.g. warfarin, mycophenolate) 4. English is not the first language in the home

Design outcomes

Primary

MeasureTime frame
1. Cognitive development is measured using Bayley Scales of Infant and Toddler Development at 12- 15 months of age. 2. Language development is measured using Bayley Scales of Infant and Toddler Development at 12- 15 months of age. 3. Motor development is measured using Bayley Scales of Infant and Toddler Development at 12- 15 months of age.

Secondary

MeasureTime frame
1. Social and behavioural development is measured using Bayley Scales of Infant and Toddler Development at 12- 15 months of age. 2. Maternal experiences of participating in the study is measured using questionnaires when the child is 12- 15 months of age.

Countries

United Kingdom

Contacts

Public ContactMyfanwy Rawson
myfanwy.rawson@mft.nhs.uk0161 701 2788

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026