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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BROMOCRIPTINE

  CABERGOLINE

  LISURIDE

  QUINAGOLIDE

  APOMORPHINE

  PERGOLIDE

  PIRIBEDIL

  PRAMIPEXOLE

  ROPINIROLE

  LEVODOPA

Population studied

• Short description of the study population:
  Pregnant women in EFEMERIS database who were either exposed or unexposed to dopamine agonists and living in South West France.
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  549

Study design details

• Main study objective:
  The aim of the study was to describe pregnancy outcomes in women exposed to prescription of dopamine agonists in EFEMERIS, and to compare with unexposed women.
• Outcomes:
  Pregnancy losses, birth defects, preterm births, low birth weight, psychomotor development.
• Data analysis plan:
  Maternal characteristics and adverse fetal outcomes in the two groups (“exposed” and “unexposed”) were described and compared by simple conditional logistic regression. Then, we used conditional logistic regression to analyze risks for each outcome associated with dispensation of dopamine agonists. To identify confounders, we used simple conditional logistic regression to evaluate the association between each potential confounder (dispensation of folic acid and progesterone during organogenesis, multiple births, preterm birth, gender, mother’s occupation, number of ultrasound scans during pregnancy, pathologies during pregnancy) and each outcome. For psychomotor development, the small sample sizes led us to use exact conditional logistic regression. For analysis of the risk of pregnancy loss, survival analysis was also used, as a sensitivity analysis, to take the time–dependant characteristics of exposure into account. Cox proportional hazard regression was applied.