Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy

Sungkyunkwan University3,094,227 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

3,094,227

Conditions

Interventions

BenzodiazepineDRUG

Exposure to benzodiazepine during early pregnancy

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sungkyunkwan University

Suwon, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Risk of congenital malformations

Overall congenital malformations and organ-specific congenital malformations in infants, which are confirmed by diagnostic records in the HIRA database. All infants were followed up for at least 1 year.

Time frame: from the birth date until up to 8 years, death, or study end date (Dec 31, 2019)

Data from ClinicalTrials.gov

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