PATIENT INFORMATION SHEET
A REGISTER IN THE UK TO DETERMINE THE SAFETY OF THE
ANTI-EPILEPTIC DRUGS IN PREGNANCY
You are being invited to take part in a research study. Before you decide it
is important for you to understand why the research is being done and what it
will involve. Please take time to read the following information carefully
and discuss it with friends, relatives and your GP if you wish. Ask us if
there is anything that is not clear if you would like more information. Take
time to decide whether or not you wish to take part.
Purpose of Study
We are conducting a study to determine which of the drugs used to treat seizures
(or epilepsy) are the safest in pregnancy. The reason for doing this is that whilst
there is some evidence that the older anti-epileptic drugs (AEDs) can rarely affect
foetal development, there is very little information on the safety of the more recently
introduced AEDs. We have therefore set up a register in the United Kingdom for
comparing the safety of all available AEDs. To do this we propose to collect
information on the outcome of all pregnancies occurring in women with seizures
(or epilepsy), whether or not AEDs are being taken. As a woman with seizures
(or epilepsy) you have therefore been chosen to take part in the study.
It is however, up to you to decide whether or not to take part. If you do decide to
take part you will be given this information sheet to keep and be asked to sign a
consent form. If you decide to take part, you are still free to withdraw at any
time and without giving a reason. This will not affect the standard of care you receive.
If you do decided to take part the information we initially need to be forwarded to
the Register includes demographic details (including name and date of birth),
details on your seizures (or epilepsy), past and present AED intake, and expected
date of delivery. We need to know your name and date of birth as at intervals after
the expected date of delivery we need to gather information on the course and
outcome of this, and any other previous pregnancies, if appropriate. This
information will be collected from your GP and any other doctors who may have
been involved in your care during this pregnancy (for example paediatricians,
clinical geneticists). All information will be sent to us at the Register, which
is based at the Department of Neurology, Royal Victoria Hospital, Belfast.
All information is strictly confidential and will not be made available by us to
anyone other than those who are directly involved with your care. In addition, any
results from the study will be presented only in a way that does not allow you, or
anyone else who takes part in the study, to be identified.
If you decide to take part, you will not be required to make any additional visits to
any clinics or to have any additional tests or procedures. If you decided to take
part we, at the Register, will also not be in direct contact with you. However, if
you wish to contact us for any further information, contact details are as given at
the bottom of this page.
Thank-you for taking the time to read this, and for considering taking part
in the study.
Contact Details: Dr James Morrow, Consultant Neurologist, Department of
Neurology, Ward 4E, Royal Victoria Hospital, Grosvenor Road, Belfast,
BT12 6BA. Tel. No: 01232 240503 Ext. 4325. Fax No: 01232 235258.
FREEPHONE TELEPHONE NUMBER: 0800 389 1248
IN CONFIDENCE REPORT OF ANTI-EPILEPTIC DRUGS
(AED'S) IN PREGNANCY - EPILEPSY FOLLOW UP