Study identification

EU PAS number

EUPAS19129

Study ID

26083

Official title and acronym

Utilisation of antiepileptic medicines in girls and women of childbearing potential - a study in three European countries

DARWIN EU® study

No

Study countries

France
Italy
United Kingdom

Study description

The use of certain antiepileptic drugs (AEDs) is known to increase the risk of both physical and neurodevelopmental abnormalities in the foetus and child. The European Medicines Agency recently carried out a review of the evidence relating to the use of the AED sodium valproate during pregnancy. Following this review, the guidelines for prescribing sodium valproate to women of childbearing age were changed in January 2015.This study will use electronic healthcare data from databases in the United Kingdom, France and Italy (Tuscany and Emilia Romagna). The study will calculate the prevalence of AED prescribing in all females of childbearing age and in females during pregnancy, stratified by calendar year, age at prescription and indication for prescribing. It will also look at the incidence of prescribing of each of the different AEDs among new users stratified by calendar year, age at prescription and indication for prescribing and evaluate the extent to which women switch AED products, particularly in relation to pregnancy.

Study status

Finalised
Research institutions and networks

Institutions

Centre for Environmental and Preventive Medicine, Queen Mary University of London United Kingdom, Drug Policy Service, Emilia Romagna Region Health Authority Italy

Contact details

Charlton Rachel

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable