Pregnancy Related, Benzodiazepines Causing Adverse Effects in Therapeutic Use, Congenital Anomaly
Conditions
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.
Interventions
DRUGBenzodiazepine
Exposure to benzodiazepine during early pregnancy
Sponsors
National Research Foundation of Korea
Sungkyunkwan University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed