Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy

Completed

• Conditions: Pregnancy Related; Benzodiazepines Causing Adverse Effects in Therapeutic Use; Congenital Anomaly
• Interventions: Drug: Benzodiazepine

• Registration Number: NCT04856436
• Lead Sponsor: Sungkyunkwan University

Brief 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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-23
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3094227

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women with exposure to benzodiazepines	Benzodiazepine	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).
Pregnant women without exposure to benzodiazepines	Benzodiazepine	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

Primary Outcome Measures

Name	Time	Method
Risk of congenital malformations	from the birth date until up to 8 years, death, or study end date (Dec 31, 2019)	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.

Trial Locations

Locations (1)

Sungkyunkwan University; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of