Maternal and Neonatal Outcomes Following Benzodiazepine Use During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,094,227
- 试验地点
- 1
- 主要终点
- Risk of congenital malformations
研究概览
简要总结
This is a nationwide cohort study to assess maternal and neonatal outcomes following exposure to benzodiazepines during pregnancy.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnancies with live birth, 2011-2018
- •Pregnancies linked to liveborn infants
- •Pregnancies aged 20-45 years at delivery
排除标准
- •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
研究组 & 干预措施
Pregnant women with exposure to benzodiazepines
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).
干预措施: Benzodiazepine (Drug)
Pregnant women without exposure to benzodiazepines
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
干预措施: Benzodiazepine (Drug)
结局指标
主要结局
Risk of congenital malformations
时间窗: 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.
次要结局
未报告次要终点
研究者
Ju-Young Shin
Associate Professor
Sungkyunkwan University