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Clinical Trial Summary

This is a nationwide cohort study to assess maternal and neonatal outcomes following exposure to benzodiazepines during pregnancy.


Clinical Trial 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 nationwide cohort study using the Health Insurance Review and Assessment (HIRA) database of South Korea, which covers the entire South Korean population. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04856436
Study type Observational
Source Sungkyunkwan University
Contact Yunha Noh, PharmD
Phone +82-31-299-4377
Email [email protected]
Status Recruiting
Phase
Start date December 1, 2020
Completion date December 31, 2022

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