Valproate: survey on awareness of teratogenicity risk and impact of risk minimisation measures in women of childbearing age.

Study type

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name, other:
  Brands of valproate‑containing medicines marketed in Belgium
• Study drug International non-proprietary name (INN) or common name:
  SODIUM VALPROATE

  VALPROIC ACID
• Anatomical Therapeutic Chemical (ATC) code:
  (N03AG01) valproic acid

  valproic acid

Population studied

• Short description of the study population:
  Adult women of childbearing age (18-49 years) registered with a mutual insurance company in Belgium and who have received at least one dispensation for valproate during 2024.
• Age groups:
  • Adults (18 to < 46 years)
• Special population of interest:
  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception
• Estimated number of subjects:
  665

Study design details

• Study design:
  Cross-sectional survey. Potential participants randomly sampled from mutual insurance company databases. Data will be collected through mailed self-administered questionnaires.
• Main study objective:
  The objective of this survey is to assess the effectiveness of RMMs in preventing valproate exposure during pregnancy. Specific objectives include evaluating patients’ awareness of the developmental toxicity risks, identifying the main sources of information about these risks, describing the distribution of valproate use across indications among women of childbearing age, and assessing the receipt of risk minimization tools.
• Setting:
  Adult women of childbearing age registered with a mutual insurance company in Belgium and who have received at least one dispensation for valproate during 2024.
• Data analysis plan:
  The statistical analysis will be purely descriptive. Analyses will be performed stratified by age group and presented in the form of frequency and percentage tables. The participation rate will be calculated dividing the number of returned questionnaires by the number of invitations sent.;