Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy

Sungkyunkwan University

Status: Completed

Conditions: Congenital Anomaly; Benzodiazepines Causing Adverse Effects in Therapeutic Use; Pregnancy Related

Treatments: Drug: Benzodiazepine

Study type: Observational

Funder types: Other

Identifiers

NCT04856436

SKKU-2021-PREG-BZ

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,094,227 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnancies with live birth, 2011-2018
• Pregnancies linked to liveborn infants
• Pregnancies aged 20-45 years at delivery

Exclusion criteria

• Pregnancies with a chromosomal abnormality
• Pregnancies with exposure to known teratogenic drugs (e.g. antineoplastic agent, warfarin, lithium, isotretinoin, misoprostol, thalidomide) during the first trimester
• Pregnancies with no benzodiazepine prescription during the first trimester, but with at least one benzodiazepine prescription during the 3 months before the pregnancy onset

Trial design

3,094,227 participants in 2 patient groups

Pregnant women with exposure to benzodiazepines

Description:

Women who gave birth during 2011-2018, were aged 20-45 years and were filled at least one benzodiazepine prescription during the first trimester (first 90 days of pregnancy).

Treatment:

Drug: Benzodiazepine

Pregnant women without exposure to benzodiazepines

Description:

Women who gave birth during 2011-2018, were aged 20-45 years and did not fill a benzodiazepine prescription during the 3 months before the pregnancy onset through the end of the first trimester

Treatment:

Drug: Benzodiazepine