Study identification

PURI

https://redirect.ema.europa.eu/resource/43410

EU PAS number

EUPAS43409

Study ID

43410

Official title and acronym

Demonstrating solutions for studying intermittent medication exposures in diseases with episodic manifestations during pregnancy: application to medication for migraine in pregnancy

DARWIN EU® study

No

Study countries

Finland
France
Germany
Italy
Norway
Spain
United Kingdom

Study description

This study will be conducted within the ConcePTION project of the Innovative Medicines Initiative under grant agreement No 821520. This study is based on electronic health care registry data from 9 health care data bases in 7 European countries between 2005 and 2019/most recent data available. The study is divided into a medication utilisation part, and a medication safety part. The objective are as follows: Medication utilisation study: to describe drug utilization patterns in women with migraine over the course of pregnancy, focusing especially on intermittent migraine medication use, using triptans as the motivating example. Medication utilisation before, during and after pregnancy will be reviewed and compared across data sources. Medication safety study: To study the association between prenatal exposure to triptans and adverse maternal and pregnancy outcomes. The potential impact of exposure misclassification on exposure-outcome associations will be assessed under a range of scenarios. Results from across data sources will be combined using meta-analytic techniques.

Study status

Planned
Research institutions and networks

Institutions

Swansea University Scotland, FISABIO, Área de Investigación en Enfermedades Raras Spain, Centre Hospitalier Universitaire France, Finnish Institute for Health and Welfare, Information Services Department Finland

Networks

ConcepTION
First published:
01/02/2024
Network

Contact details

Hedvig Nordeng

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
EU institutional research programme
Pharmaceutical company and other private sector 

More details on funding

EFPIA, Innovative Medicines Initiative (IMI), grant No 821520
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable