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

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 institution and networks

Institutions

University of Oslo

Finnish Institute for Health and Welfare (THL)

Finland

Pharmacoepidemiology and Drug Safety Research Group (PharmaSafe), University of Oslo

Norway

Emilia-Romagna Health and Social Agency (ASSR Emilia-Romagna)

Italy

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Clinical Practice Research Datalink (CPRD)

United Kingdom

The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO)

Spain

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

Study timelines

Date when funding contract was signed

Planned: 01/04/2019

Study start date

Planned: 08/05/2021

Date of final study report

Planned: 15/03/2023

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