A Population-based Study of the Safety of Gabapentin Use During Pregnancy

Study type

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

  Safety study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-authorisation safety study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N03AX12) gabapentin

Population studied

• Short description of the study population:
  The study population involved all births identified in the administrative registries from four Nordic countries including Denmark, Finland, Norway, and Sweden from 1 January 2005 to 31 December 2015.; Inclusion criteria:; 1. All births from 1 January 2005 through 31 December 2015 (both dates inclusive) in Denmark, Finland, and Norway and all births identified from 1 July 2006 through 31 December 2016 (both dates inclusive) in Sweden.; ; Exclusion criteria:; 1. Births with exposure to known teratogenic medications during the first trimester;; 2. Births 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:
  1700

Study design details

• Main study objective:
  This non-interventional study is being conducted to characterize the use and safety of gabapentin during pregnancy
• Outcomes:
  The primary study outcomes are: Major congenital malformations (overall and specific), Stillbirth, Low birth weight, Small for gestational age, Preterm birth, Low Apgar score at 5 minutes, Microcephaly, The secondary study outcomes are: Attention-deficit hyperactivity disorders, Pervasive developmental disorders, Learning disorders and intellectual disabilities.
• Data analysis plan:
  Descriptive statistics (ie, frequency, percent, mean, median, standard deviation as appropriate depending on data type) will be used to summarize demographic and baseline clinical characteristics of patients accrued in the study. Prevalence of each birth outcome will be computed as the number of newborns with a given outcome divided by the total number of newborns at risk.

Documents

Study report

A9451182_GABAPENTIN NON-INTERVENTIONAL STUDY ABSTRACT_08 SEPT 2022

A9451182_GABAPENTIN NON-INTERVENTIONAL STUDY REPORT_08 SEPT 2022

Study, other information

A9451182_GABAPENTIN NON-INTERVENTIONAL STUDY ABSTRACT_08 SEPT 2022.pdf