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

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