Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 885,185
- 主要终点
- Number of Infants With Major Congenital Malformations
研究概览
简要总结
A prospective population-based cohort study to examine whether varenicline use during pregnancy is associated with an increased risk of major congenital malformations in infants above that associated with smoking during pregnancy.
详细描述
Sampling will not be employed. The data sources record nearly all (>98.6%) births in Denmark and Sweden.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All live and stillbirths between May 2007 and December 2012 in Denmark and Sweden.
排除标准
- •Births less than 22 weeks of gestation in Denmark and 28 weeks in Sweden are not recorded by the registers.
研究组 & 干预措施
Exposed
Infants exposed in utero to varenicline
干预措施: varenicline (Drug)
Unexposed
infants exposed in utero to cigarette smoke from maternal smoking
干预措施: cigarette smoke from maternal smoking (Behavioral)
Reference
infants not exposed in utero to either varenicline or cigarette smoke from maternal smoking
干预措施: Non-Exposure (Other)
结局指标
主要结局
Number of Infants With Major Congenital Malformations
时间窗: For 12 months after birth
Major congenital malformations were defined as any codes within the Q-chapter of The Tenth Revision of the International Classification of Diseases (ICD-10), excluding certain minor anomalies.
次要结局
- Number of Infants With Stillbirths(At the time of birth)
- Number of Infants Born Small for Gestational Age (SGA)(At the time of birth)
- Number of Infants Born Preterm(At the time of birth)
- Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes(At the time of birth)
- Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS)(For 12 months after birth)