Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Benzodiazepines Causing Adverse Effects in Therapeutic Use
  • Congenital Anomaly
  • Pregnancy Related
Type
Observational
Design
Observational Model: CohortTime Perspective: Retrospective

Participation Requirements

Age
Between 20 years and 45 years
Gender
Only males

Description

Benzodiazepines are widely used in pregnant women; however, their safety on congenital malformations in a real-world setting is still uncertain. We aimed to assess the association between benzodiazepine use in early pregnancy and the risk of congenital malformations. We will conduct a retrospective ...

Benzodiazepines are widely used in pregnant women; however, their safety on congenital malformations in a real-world setting is still uncertain. We aimed to assess the association between benzodiazepine use in early pregnancy and the risk of congenital malformations. We will conduct a retrospective nationwide cohort study using the Health Insurance Review and Assessment (HIRA) database of South Korea, which covers the entire South Korean population.

Tracking Information

NCT #
NCT04856436
Collaborators
National Research Foundation of Korea
Investigators
Principal Investigator: Ju-Young Shin, PhD Sungkyunkwan University