Healthcare Claims Database Study to Provide Safety Information on Maternal, Fetal and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,095
- 试验地点
- 1
- 主要终点
- Prevalence of major congenital malformations (MCMs)
研究概览
简要总结
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
详细描述
This is a longitudinal observational cohort study using an electronic database of healthcare claims data. Safety information will be retrospectively collected from the database and pre-specified diagnostic codes will be used to identify pregnancy and infant outcomes. The study will include two phases, a patient accrual phase (Phase 1) and an analysis phase (Phase 2).
Descriptive statistics will be conducted to characterize the patient population and to support the interpretation of comparative analyses. Comparative analyses will be performed to estimate the effect of QUVIVIQ exposure during pregnancy on the study outcomes. Approximately 419 mother-infant pairs with exposure to QUVIVIQ and 1676 mother-infant pairs with exposure to non-orexin receptor antagonist insomnia medication are expected with a 1:4 ratio of exposed:active comparator patients.
Analysis of the prevalence of each specific pregnancy or infant outcome will comprise: (1) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia exposed to any non-orexin receptor antagonist insomnia medication during or shortly prior to pregnancy (active comparator group); (2) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia unexposed to any insomnia medication during or shortly prior to pregnancy (unexposed comparator group).
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
QUVIVIQ-exposed group
Pregnant women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to date of conception.
干预措施: Daridorexant (Drug)
Active comparator group
Pregnant women with insomnia exposed to non-orexin receptor antagonist insomnia medications during pregnancy or within 5 half-lives of the respective insomnia medication prior to date of conception.
干预措施: Non-orexin receptor antagonist insomnia medication (Drug)
Unexposed comparator group
Pregnant women with insomnia unexposed to insomnia medications during pregnancy and within 5 half-lives of any insomnia medication taken prior to date of conception.
干预措施: No insomnia medication (Other)
结局指标
主要结局
Prevalence of major congenital malformations (MCMs)
时间窗: From May 2022 to April 2028 (6 years)
MCMs will be identified as pre-specified diagnostic codes for malformations included in the National Birth Defects Prevention Network's birth defects descriptions (identified through maternal and infant claims). MCMs with etiologies presumed not to be associated with drug exposure, such as chromosomal abnormalities, genetic syndromes, prematurity-related defects, and positional effects, will be excluded from the definition of MCMs.
次要结局
- Prevalence of spontaneous abortions (SABs)(From May 2022 to April 2028 (6 years))
- Prevalence of stillbirths (SBs)(From May 2022 to April 2028 (6 years))
- Prevalence of small for gestational age infants (SGAs)(From May 2022 to April 2028 (6 years))
- Prevalence of preterm births (PTBs)(From May 2022 to April 2028 (6 years))
- Prevalence of induced abortions (IABs)(From May 2022 to April 2028 (6 years))