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

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• 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.

Documents

Study publications

Hurley, Eimir, Sturkenboom, Miriam, Poblador-Plou, Beatriz, Sanfelix-Gimeno, Ga…

CONSIGN community on Zenodo (includes all publications currently available with…