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Australian Pregnancy Register for women on anti-epileptic medication


  Phone 1800 069 722  

PURPOSE OF THE REGISTRY:

A voluntary Australia-wide registry of patients who become pregnant while taking an antiepileptic drug has been established at the Victorian Epilepsy Centre. More information can be found at: www.victorianepilepsycentre.org.au

The purpose is to determine the incidence of birth defects resulting from pregnancies in Australian women who were taking antiepileptic drugs and whether certain drugs or drug combinations are safer than others

MEDICATIONS

Carbamazepine (Tegretol ®)

Clonazepam (Rivotril ®)

Clobazam (Frisium ®)

Diazepam (Valium ®)

Ethosuximide (Zarontin ®)

Gabapentin (Neurontin ®)

Lamotrigine (Lamictal ®)

Sodium Valproate (Epilim ®)

Phenobarbitone, Phenytoin (Dilantin ®)

Primidone (Mysoline ®)

Tiagabine (Gabitril ®)

Topiramate (Topamax ®)

Vigabatrin (Sabril ®)

Registry Staff:

Prof. Frank Vajda

Principal Investigator

Prof. Cecilie Lander

Principal Investigator

Dr. Terence O'Brien

Neurologist

Dr. Mark Cook

Neurologist

Ms Alison Hitchcock

Study Coordinator

Ms Janet Graham

Study Coordinator

BACKGROUND INFORMATION

From previous research it is believed that women with epilepsy who are taking antiepileptic medication may have a slightly higher incidence than the general population of having babies with birth defects, 2-3% for the general population versus 4-6% for women with epilepsy on medication.

There is no clear evidence available to determine whether this small increase is related directly to the drugs, the epilepsy itself, or other factors. As well there is no good information currently available to determine whether the overall risk of birth defects is lesser or greater with any one particular antiepileptic medication.

DO NOT STOP MEDICATIONS WITHOUT FIRST CONSULTING YOUR DOCTOR AS THIS MAY RESULT IN UNCONTROLLED EPILEPTIC SEIZURES WITH POTENTIALLY SERIOUS CONSEQUENCES FOR BOTH THE MOTHER AND THE UNBORN BABY.

Registry administered by:
Australian Centre for Clinical Neuropharmacology,
St Vincent's Hospital Melbourne
Phone 1800 069 722

TARGET GROUP

  • Women with epilepsy who become pregnant whether or not they are taking an antiepileptic medication.
  • Women taking an antiepileptic medication for an indication other than epilepsy.

ENROLMENT

  • All calls to the Australian Antiepileptic Drug Pregnancy Register will be answered by a Research Coordinator who is a Registered Nurse.
  • The Research Coordinator will provide information about the registry and ask questions as to the woman's eligibility.
  • If she agrees to participate, a written information sheet and consent form will be mailed to her to sign.
  • Following consent there will be four phone interviews:
    • Enrolment
    • Seven months gestation
    • Following the end of pregnancy.
    • One year following delivery.
  • At each phone interview questions regarding epilepsy, medication, pregnancy and the baby will be asked.
  • Permission will be gained from each woman so that their neurologist, obstetrician, paediatrician or family practitioner can be contacted for information about the woman's treatment and diagnosis.
  • It may be necessary to request from each woman permission to view hospital medical records.

This registry is supported by a wide range of groups including patient organisations and the pharmaceutical industry.

THE TOLL FREE NUMBER FOR THE PREGNANCY REGISTER IS 1800 069 722

PLEASE URGE YOUR PATIENTS TO CALL US. THEIR PARTICIPATION MAY HELP WOMEN LIKE THEMSELVES IN THE FUTURE. 

THIS REGISTRY HAS BEEN GENEROUSLY SUPPORTED BY:

National Epilepsy Association of Australia

Aventis Pharma

Epilepsy Foundation of Victoria Inc

Reckitt and Colman

Epilepsy Association of NSW

Sanofi Synthelabo

Epilepsy Society of Australia

Novartis Pharmaceuticals

Parke Davis

Janssen-Cilag


EMAIL epilepsy@epilepsy.asn.au    818 Burke Rd, Camberwell Victoria  3124  Australia
PHONE (03) 9805 9111    TOLL FREE 1300 852 853    FAX (03) 9882 7159

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North East Valley Division General Practice, Victoria, Australia, Disclaimer 
Level 1, Pathology Building, Repatriation Campus, A&RMC, Heidelberg West VIC 3081. .. map
Phone: 03 9496 4333, Fax: 03 9496 4349,  Email: nevdgp@nevdgp.org.au
Please note: NEVDGP does not provide an on-line consultation
Last modified: September 04, 2006