CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Medical condition to be studied:
  COVID-19

Population studied

• Age groups:
  • Paediatric Population (< 18 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)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1000000

Study design details

• Main study objective:
  To estimate prevalence of medicines use in pregnant COVID-19 patients and to describe severity of clinical outcomes as well as pregnancy and neonatal outcomes
• Outcomes:
  Use of medication Severity of COVID-19 Pregnancy and neonatal outcomes
• Data analysis plan:
  Descriptive analysis, matched analysis of cohorts and sensitivity analysis will be conducted.