DARWIN EU® - Prescription of Common Drugs Before and During Pregnancy in Europe

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  The study population will consist of individuals with a recorded pregnancy.
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  A retrospective cohort study
• Main study objective:
  The specific objectives of this study are: ; 1. To estimate the proportion of individuals prescribed commonly prescribed drugs, overall and by pregnancy trimester. ; 2. To estimate the proportion of individuals prescribed commonly prescribed drugs before pregnancy which: ; a) are discontinued before pregnancy start; ; b) continued into the first trimester of pregnancy but not into the second trimester; ; c) continued into the first and second trimesters but not into the third trimester; or ; d) continued into the first, second, and third trimesters of pregnancy. ; 3. To estimate the proportion of individuals prescribed commonly prescribed drugs initiated during pregnancy, overall and by pregnancy trimester. ; 4. To describe the dose and treatment duration during pregnancy for the most commonly prescribed drugs ongoing at pregnancy start.
• Setting:
  4 primary care data sources in the DARWIN EU® Network of Data Partners from 4 European countries