A Population-based Cohort Study of Pregabalin to Characterize Pregnancy Outcomes

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 data collection

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

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:
  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

Documents

Study results

A0081359 Pregabalin Final Study Report ABSTRACT VS1 01June2020

Study report

A0081359 Pregabalin Final Study Report VS1 01JUNE2020