Zanamivir 10mg/ml solution for infusion pregnancy registry: an observational study of the safety of zanamivir 10mg/ml solution for infusion exposure in pregnant women with complicated influenza and their offspring (208140)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  DECTOVA
• Study drug International non-proprietary name (INN) or common name:
  ZANAMIVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AH01) zanamivir

  zanamivir
• Medical condition to be studied:
  Influenza

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
  • 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:
  100

Study design details

• Main study objective:
  To evaluate pregnancy outcomes among women with complicated influenza exposed to zanamivir 10mg/mL solution for infusion at any time during pregnancy.
• Outcomes:
  - Number of Maternal deaths ; - Number of pregnant women with Live birth ; - Number of participants with Spontaneous abortion; - Number of participants with stillbirth; - Number of participants with Induced Abortion; - Number of premature births; - Number of small gestational age infants; - Number of low birth weight (LBW) infants; - Number of neonatal deaths; - Number of births with major congenital malformation
• Data analysis plan:
  The registry is primarily descriptive aiming to determine a signal for substantial increase in risk. Therefore, comparisons will be descriptive. Primary comparisons will be against external comparators reflecting population-based surveillance of pregnancy outcomes and literature based disease based cohorts. If it is feasible, descriptive comparisons between the registry and an appropriate internal comparator will be examined.