Status:
COMPLETED
Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy
Lead Sponsor:
Sungkyunkwan University
Collaborating Sponsors:
National Research Foundation of Korea
Conditions:
Pregnancy Related
Benzodiazepines Causing Adverse Effects in Therapeutic Use
Eligibility:
FEMALE
20-45 years
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 benzodiazepi...
Eligibility Criteria
Inclusion
- Pregnancies with live birth, 2011-2018
- Pregnancies linked to liveborn infants
- Pregnancies aged 20-45 years at delivery
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
3094227 Patients enrolled
Trial Details
Trial ID
NCT04856436
Start Date
December 1 2020
End Date
July 30 2021
Last Update
March 7 2022
Active Locations (1)
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1
Sungkyunkwan University
Suwon, Gyeonggi-do, South Korea, 16419