Assessing the safety of oseltamivir exposure in pregnant women

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
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  OSELTAMIVIR
• Medical condition to be studied:
  Influenza

Population studied

• Short description of the study population:
  Pregnant women in Denmark whose pregnancies were starting and ending between 01 January 2002 and 31 December 2013 and were prescribed oseltamivir during pregnancy.
• 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:
  0

Study design details

• Main study objective:
  To assess the association of exposure to oseltamivir during pregnancy and birth defects in the offspring, particularly those of the circulatory system.
• Outcomes:
  -Babies with birth defects: EUROCAT classification, diagnosed up to one year postnatal among live born babies -Pregnancy outcomes: Live birth, preterm delivery, ’small for gestational age’ Apgar score at 5 minutes, stillbirth, induced and spontaneous abortions -Maternal outcomes: treatment-emergent hospital diagnoses in the mother occurring within 28 days of receipt of oseltamivir
• Data analysis plan:
  Cohort Study (Part 1)Matched and non-matched comparisons between exposed and unexposed pregnancies for all outcomes of interest will be performed. Exposed and unexposed cohorts will be characterised descriptively for the distribution of covariates (only before matching) and potential confounders before and after matching.Case-control Study (Part 2)Conditional multivariate logistic regression for matched case-controls will be used to estimate odds ratios for the association between first trimester exposure to oseltamivir and malformations. Distributions of potential confounders among the exposed and unexposed will be presented. The calculation will be conducted for the category of overall malformations and malformations of special interest, such as those of the circulatory system.