Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Post-Authorisation Safety Study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N03AX16) pregabalin
pregabalin
Population studied

Short description of the study population

The study population consists of all pregnancies identified in the respective administrative registries from 1 January 2005 to 31 December 2015 in Denmark, Finland, and Norway and all pregnancies identified from 1 July 2006 to 31 December 2013 in Sweden.
Patients meeting any of the following criteria will not be included in the study:
1. Pregnancies with exposure to known teratogenic medications during the first trimester;
2. Pregnancies carrying a foetus with a chromosomal abnormality diagnosis.

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)
    • Children (2 to < 12 years)

Special population of interest

Pregnant women

Estimated number of subjects

900000
Study design details

Main study objective

The study objectives are to describe the use of pregabalin exposure in pregnancy and to estimate the risk of major congenital malformations, birth outcomes other than congenital malformations and neurodevelopmental outcomes with the use of pregabalin.

Outcomes

major congenital abnormalities, Neurodevelopmental outcomes

Data analysis plan

Prevalence of each birth outcome will be computed as number of newborns with a given outcome divided by the total number of newborns at risk. For the outcomes of congenital malformations and stillbirth in the analysis not including pregnancies ending in 2nd trimester abortion the number of newborns at risk will be the total number of live or stillborn children. Incidence rate of each postnatal outcome will be computed as the number of first-recorded events during the follow-up divided by the total person-time at risk contributed by each liveborn infant. The follow-up for each newborn will begin on the date of birth and will end on the date of a given postnatal outcome, emigration, death, or the end of the observation period.Crude and adjusted prevalence ratios and 95% Wald confidence intervals (CIs) for each birth outcome and a given population/contrast will be estimated using log-binomial regression.Crude and adjusted incidence rate ratios and 95% Wald CIs will be estimated