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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04856436
Other study ID # SKKU-2021-PREG-BZ
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date July 30, 2021

Study information

Verified date March 2022
Source Sungkyunkwan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 3094227
Est. completion date July 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 45 Years
Eligibility 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


Intervention

Drug:
Benzodiazepine
Exposure to benzodiazepine during early pregnancy

Locations

Country Name City State
Korea, Republic of Sungkyunkwan University Suwon Gyeonggi-do

Sponsors (2)

Lead Sponsor Collaborator
Sungkyunkwan University National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Bais B, Molenaar NM, Bijma HH, Hoogendijk WJG, Mulder CL, Luik AI, Lambregtse-van den Berg MP, Kamperman AM. Prevalence of benzodiazepines and benzodiazepine-related drugs exposure before, during and after pregnancy: A systematic review and meta-analysis. J Affect Disord. 2020 May 15;269:18-27. doi: 10.1016/j.jad.2020.03.014. Epub 2020 Mar 5. Review. — View Citation

Bellantuono C, Tofani S, Di Sciascio G, Santone G. Benzodiazepine exposure in pregnancy and risk of major malformations: a critical overview. Gen Hosp Psychiatry. 2013 Jan-Feb;35(1):3-8. doi: 10.1016/j.genhosppsych.2012.09.003. Epub 2012 Oct 6. Review. — View Citation

Grigoriadis S, Graves L, Peer M, Mamisashvili L, Dennis CL, Vigod SN, Steiner M, Brown C, Cheung A, Dawson H, Rector N, Guenette M, Richter M. Benzodiazepine Use During Pregnancy Alone or in Combination With an Antidepressant and Congenital Malformations: Systematic Review and Meta-Analysis. J Clin Psychiatry. 2019 Jul 9;80(4). pii: 18r12412. doi: 10.4088/JCP.18r12412. — View Citation

Iqbal MM, Sobhan T, Ryals T. Effects of commonly used benzodiazepines on the fetus, the neonate, and the nursing infant. Psychiatr Serv. 2002 Jan;53(1):39-49. Review. — View Citation

Shyken JM, Babbar S, Babbar S, Forinash A. Benzodiazepines in Pregnancy. Clin Obstet Gynecol. 2019 Mar;62(1):156-167. doi: 10.1097/GRF.0000000000000417. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. from the birth date until up to 8 years, death, or study end date (Dec 31, 2019)
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