NCT03936335招募中不适用
Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,930
- 试验地点
- 1
- 主要终点
- Prevalence of MCMs
研究概览
简要总结
The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations [MCMs], small for gestational age [SGA]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.
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
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated LMP
- •Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy
- •Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply
排除标准
- 未提供
研究组 & 干预措施
Dupilumab cohort
Exposed to dupilumab during the relevant exposure window:
- First trimester
- Pregnancy
干预措施: dupilumab (Drug)
结局指标
主要结局
Prevalence of MCMs
时间窗: Up to 21 months
Initially identified through the presence of corresponding codes on the insurance claims, confirmed through medical record review for infant outcomes: 01 April 2017 through December 2024
次要结局
- Incidence of spontaneous abortion or miscarriage(Up to 9 months)
- Incidence of stillbirth(Up to 9 months)
- Incidence of SGA(Up to 21 months)
研究者
研究点 (1)
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