Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Non-interventional study

Non-interventional study design

Case-control
Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N03AX12) gabapentin
gabapentin
(N03AX16) pregabalin
pregabalin

Medical condition to be studied

Neuralgia
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)

Special population of interest

Pregnant women

Estimated number of subjects

6800000
Study design details

Main study objective

1. to develop a general conceptual framework to disentangle the different indications of medications in large healthcare data sources. 2.to characterize the prescription pattern of medications used to treat neuropathic pain among women of childbearing age and pregnant women 3.to assess the association between prenatal exposure to neuropathic pain medications and adverse pregnancy outcomes.

Outcomes

major congenital anomalies, stillbirth, preterm birth, low birth weight, small for gestational age, long-term neurodevelopmental outcomes

Data analysis plan

Drug utilisation study: prevalence of medications of interest prescribed among women of childbearing age and among pregnant women, stratified by age, calendar year, data sources, and indication for prescribing Drug safety study: - cohort study : comparing “exposed” and “comparison” women. The analyses will be carried out using multivariate logistic regression, and survival analysis, depending on the outcome of interest to calculate unadjusted and adjusted odds ratios (ORs) and hazard ratios (HRs), along with 95% confidence intervals (CI). Advanced confounder adjustment methods (such as propensity score methods) might be used when appropriate to further mitigate measured confounding. - case-malformed control study using data from EUROmediCAT. We will conduct an exploratory analysis in which, for each analysis, we will consider a single EUROCAT subgroup of congenital anomaly to be the “case” group, excluding those with chromosomal conditions. Logistic regression will be used.