NCT04856436

Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy

Maternal and Neonatal Outcomes Following Benzodiazepine Use During Pregnancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,094,227 (actual)
• Sponsor: Sungkyunkwan University · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Pregnancy Related
• Benzodiazepines Causing Adverse Effects in Therapeutic Use
• Congenital Anomaly

Interventions

Type	Name	Description
DRUG	Benzodiazepine	Exposure to benzodiazepine during early pregnancy

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-06-30
• Completion: 2021-07-30
• First posted: 2021-04-23
• Last updated: 2022-03-07

Locations

1 site across 1 country: South Korea