Antidepressants during pregnancy: a French drug utilisation study in EFEMERIS cohort

Study identification

• EU PAS number:
  EUPAS26684
• Study ID:
  26685
• Official title and acronym:
  Antidepressants during pregnancy: a French drug utilisation study in EFEMERIS cohort
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Previous studies have suggested that exposure to some antidepressants (AD) during pregnancy could be associated with an increased risk of congenital malformations and neurodevelopment disorders for the child. We conducted a study to describe the use of AD during pregnancy in France.We performed a drug utilisation study in EFEMERIS, a French cohort of pregnant women. At the time of the present study, 89,170 pregnant women, who were pregnant from 2005 to 2014 in Haute-Garonne were included.
• 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

Planned: 15/09/2016

Actual: 15/09/2016

Study start date

Planned: 01/10/2016

Actual: 01/10/2016

Date of final study report

Planned: 01/01/2018

Actual: 01/01/2018

Sources of funding

Other

More details on funding

ANSM

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable