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Completed

NCT Number: NCT04856436

Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy

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

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Key information

Conditions

Pregnancy Related Benzodiazepines Causing Adverse Effects in Therapeutic Use Congenital Abnormalities Congenital Anomaly Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Sungkyunkwan University

Suwon, Gyeonggi-do, 16419, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benzodiazepine

Drug

Exposure to benzodiazepine during early pregnancy

Primary outcomes

  1. Risk of congenital malformations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sungkyunkwan University

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study title

Maternal and Neonatal Outcomes Following Benzodiazepine Use During Pregnancy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2021
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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