Pregnancy outcome in women exposed to dopamine agonists during pregnancy: a study in EFEMERIS database

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/16882
• EU PAS number:
  EUPAS5362
• Study ID:
  16882
• Official title and acronym:
  Pregnancy outcome in women exposed to dopamine agonists during pregnancy: a study in EFEMERIS database
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Data from EFEMERIS, a cohort of 57,408 pregnant women living in South West France were used to compare women exposed to dopamine agonists during pregnancy and unexposed women. The exposed group included women who received at least one prescription for one dopamine agonist during pregnancy. These women were individually matched with two unexposed women from the cohort for age and the month-and-year of the start of pregnancy. Pregnancy losses, birth defects, preterm births, low birth weight and psychomotor development were studied.
• 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: 01/02/2012

Study start date

Actual: 01/03/2012

Data analysis start date

Actual: 01/03/2012

Date of final study report

Actual: 01/07/2013

Sources of funding

Other

More details on funding

Agence Nationale de Sécurité des Médicaments et produits de santé (ANSM), Clinical Research Hospital Program

Regulatory

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