Condition category
Nervous System Diseases
Date applied
14/12/2018
Date assigned
09/01/2019
Last edited
11/01/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Ms Myfanwy Rawson

ORCID ID

Contact details

Genomic Medicine Research Office
St Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
0161 701 2788
myfanwy.rawson@mft.nhs.uk

Type

Scientific

Additional contact

Dr Rebecca Bromley

ORCID ID

http://orcid.org/0000-0003-4008-0917

Contact details

School of Biological Sciences
University of Manchester
Manchester
M13 9WL
United Kingdom
0161 701 4514
rebecca.bromley@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS 232507

Study information

Scientific title

Neurodevelopment After Prenatal Exposure to Seizures study: a cohort study

Acronym

NAPES

Study hypothesis

Children exposed to frequent seizures in the womb will have poorer development at 12 months of age.

Ethics approval

Greater Manchester Central Regional Ethics Committee, 17/05/2018, ref. 18/NW/0261.

Study design

Multi-centre prospective observational cohort study.

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format. Please request via email rebecca.bromley@manchester.ac.uk

Condition

Epilepsy

Intervention

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 occupation. From this point they record their seizures on a daily basis using either a paper seizure diary or an app. Each month their local research team will contact them to collect that months seizure information. In the third trimester (after 32 weeks) the participant will be contacted to provide information about their current health and medications which they are taking. Following the birth of the child information is recorded about the delivery method and the health of the child at birth. After the child's first birthday, an appointment will be arranged to see the child and parent at home where a play-based assessment will be completed. Whilst this is fun for the child it provides the assessor with important information about where the child is up to in terms of their cognitive (reasoning), language and motor development. Following the assessment of development a questionnaire will be posted to participants which will ask them about their experience of taking part in the study.

Intervention type

Other

Phase

Drug names

Primary outcome measure

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 outcome measures

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.

Overall trial start date

18/05/2018

Overall trial end date

30/11/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

180

Participant 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

Recruitment start date

14/01/2019

Recruitment end date

30/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester University NHS Foundation Trust
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Belfast Health and Social Care Trust
Royal Hospitals Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Trial participating centre

Lancashire Teaching Hospitals NHS Foundation Trust
Royal Preston Hospital Sharoe Green Lane
Preston
PR2 9HT
United Kingdom

Trial participating centre

Liverpool Women’s Hospital NHS Foundation Trust
Crown Street
Liverpool
L8 7SS
United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom

Trial participating centre

City Hospitals Sunderland NHS Foundation Trust
Sunderland Royal Hospital Kayla Road
Sunderland
SR4 7TR
United Kingdom

Trial participating centre

Newcastle Upon Tyne Hospitals NHS Foundation Trust
Royal Victoria Hospital Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

South Tees Hospitals NHS Foundation Trust
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

Walton Centre for Neurology and Neurosurgery NHS Foundation Trust
Lower Lane
Liverpool
L9 7LJ
United Kingdom

Trial participating centre

University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster Royal Infirmary Ashton Road
Lancaster
LA1 4RP
United Kingdom

Trial participating centre

Warrington and Halton Hospitals NHS Foundation Trust
Lovely Lane
Warrington
WA5 1QG
United Kingdom

Trial participating centre

Countess of Chester Hospital NHS Foundation Trust
The Countess Of Chester Health Park Liverpool Road
Chester
CH2 1UL
United Kingdom

Trial participating centre

East Lancashire Hospitals NHS Foundation Trust
Royal Blackburn Hospital Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

Mid Cheshire Hospitals NHS Foundation Trust
Leighton Hospital
Crewe
CW1 4QJ
United Kingdom

Trial participating centre

York Teaching Hospitals NHS Foundation Trust
Wigginton Road
York
YO31 8HE
United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Foundation Trust
St James Hospital Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital Birmingham Mindelsohn Way
Birmingham
B15 2GW
United Kingdom

Trial participating centre

County Durham and Darlington NHS Foundation Trust
North Road
Durham
DH1 5TW
United Kingdom

Trial participating centre

Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool Victoria Hospital Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom

Trial participating centre

Stockport NHS Foundation Trust
Stepping Hill Hospital
Stockport
SK2 7JE
United Kingdom

Trial participating centre

The Mid Yorks Hospital NHS Foundation Trust
Pinderfields Hospital
Wakefield
WF1 4DG
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom
0161306 0677
FBMHethics@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Epilepsy Research UK

Alternative name(s)

ERUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results will be shared with participants and will be written up for formal scientific publication. We will also undertake a number of local, national and international talks to share the research findings.

IPD sharing statement: the datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rebecca Bromley, rebecca.bromley@manchester.ac.uk, in electronic format, within a year of the study end for utilisation in studies with similar aims and where the participant has consented.

Intention to publish date

01/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/01/2019: Internal review.