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

Plain English summary of protocol

Background and study aims
The treatment of epilepsy during pregnancy is a balance between treating the seizures and reducing, as far as possible, the risks presented to the developing child by medication. This study will investigate whether seizures which the mother has during pregnancy alters the brain development of the developing child.

Who can participate?
Women with epilepsy who are either pregnant (and not yet 21 weeks) or women who are trying for a baby currently. Women must be taking the medications lamotrigine (lamictal) or levetiracetam (keppra) alone or alongside other antiepileptic medications (but not if they are taking sodium valproate (epilim) or carbamazepine (tegtretol)). The study is looking for volunteers both who are having seizures and those who are not having seizures.

What does the study involve?
All participants will be asked to sign a consent form indicating that they understand the study and are happy for themselves and their baby to participate. They will then be asked to provide some information about their health, education, occupation and to record on a daily basis whether or not they have had seizure. Women can do this either in a paper seizure diary or using an app. When the women’s pregnancy has passed 32 weeks they will be asked about their general health and the medications they are taking again. When the baby is born researchers at the local hospital will record information about the babies birth from medical records. Shortly after the child’s first birthday a home visit will be completed where a play-based assessment will be completed with the child. This involves playing a number of games with the child, which in turn provides information on their development in areas such as reasoning, language and motor abilities. Their mothers will also be asked to complete a questionnaire about their early social development and about the mothers own mood. Mother’s will also be asked to complete two brief tasks (e.g. one puzzle and one language task) to inform on their reasoning abilities.

What are the possible benefits and risks of participating?
There may be no direct benefits personally to taking part. However, following the assessment of the child feedback would be provided to parents and a letter be sent the child’s GP and kept their medical record. If the person who completed the assessment had concerns about specific areas of the child’s development they would discuss it with the parents and then send a letter to the child’s GP. In the longer term, the findings of this study will be of benefit to both women with epilepsy and their doctors by providing information about how seizures in pregnancy may or may not impact on how the child develops in their first year of life. This may be directly relevant to participants in the study if they were planning another pregnancy in the future.

If the participant does not already record her seizures it might seem a big task to record them everyday, however only a few details are needed and on most days the participant may simply be ticking ‘no’ if they did not have any seizures. A further possible disadvantage of this study is that the developmental assessment may reveal that the child is experiencing some difficulties in one or more areas of their development. In this situation, with parental permission, we would share this information with the child’s GP to make sure that they can arrange the necessary support for the child.

Where is the study run from?
The study is being led by researchers at the University of Manchester and Manchester University Hospitals NHS Foundation Trust but involves doctors and nurses from 21 hospitals around the UK.

When is the study starting and how long is it expected to run for?
Set up for the study started in May 2018 and it will open to recruitment on the 14th January 2018. Women will be able to opt into the study until May 2020 and after this time no new participants will be able to opt into the study. The follow-ups after the child’s first birthday will run until August 2021. The study will close on 30th October 2021 with the results being available shortly after that.

Who is funding the study?
Epilepsy Research UK

Who is the main contact?
Myfanwy Rawson
Myfanwy.rawson@mft.nhs.uk

Contact information

Ms Myfanwy Rawson
Public

Genomic Medicine Research Office
St Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Phone	0161 701 2788
Email	myfanwy.rawson@mft.nhs.uk

Dr Rebecca Bromley
Scientific

School of Biological Sciences
University of Manchester
Manchester
M13 9WL
United Kingdom

ORCID ID	0000-0003-4008-0917
Phone	0161 701 4514
Email	rebecca.bromley@manchester.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• United Kingdom

Study participating centres

Sponsor information

University of Manchester
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Phone	0161306 0677
Email	FBMHethics@manchester.ac.uk
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Charity

Results and Publications

Study outputs

Editorial Notes

09/07/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2020 to 30/03/2021.
2. The overall trial end date was changed from 30/11/2021 to 30/04/2022.
3. The intention to publish date was changed from 01/01/2021 to 30/10/2022.
11/01/2019: Internal review.