How to classify women exposed to drug prescriptions during pregnancy in pharmaco-epidemiology studies? Method using treatment intensity and individual trajectories of exposure over time

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26677
• EU PAS number:
  EUPAS8001
• Study ID:
  26677
• Official title and acronym:
  How to classify women exposed to drug prescriptions during pregnancy in pharmaco-epidemiology studies? Method using treatment intensity and individual trajectories of exposure over time
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Pregnancy represents a situation in which the dose, the duration and the period of exposure play an essential role in the occurrence of adverse effects on the newborn. However, these parameters are often insufficiently and inconsistently addressed. Therefore, it is necessary to develop new methods in order to take into account more precisely exposure profiles to drugs during pregnancy in pharmaco-epidemiology studies. The objective of the present study is to propose a new method to classify women according to drug exposure during pregnancy taking into account treatment intensity, duration and evolution.We will apply this method to psychotropic drugs during pregnancy in EFEMERIS.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pharmacologie En Population cohorteS biobanqueS (PEPSS), Hopitaux de Toulouse

France

Study timelines

Date when funding contract was signed

Actual: 14/09/2012

Study start date

Actual: 15/11/2012

Data analysis start date

Actual: 15/01/2013

Date of final study report

Planned: 02/11/2015

Actual: 03/12/2015

Sources of funding

Other

More details on funding

ANSM - PHRC

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable