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临床试验/NCT01787435
NCT01787435已完成不适用

A Cohort Study on the Association Between Acid-suppressing Drugs in Pregnancy and Asthma in the Offspring

AstraZeneca1 个研究点 分布在 1 个国家目标入组 10,116 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
10,116
试验地点
1
主要终点
Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors

研究概览

简要总结

The purpose of this study is

  1. To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood.
  2. To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.

详细描述

A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Females aged 18-45 years with at least one pregnancy between 1 January 1995 - 31 December 2010 (see study population description)

排除标准

  • Males, females below age 18 and 45 years and above (see study population description)

研究组 & 干预措施

All women exposed to PPI at any time during pregnancy

Exposure to PPI defined as presence of at least one prescription of a PPI any time between last menstrual period and delievry date

干预措施: Risk of asthma in offspring (Drug)

All women exposed to H2RA at any time during pregnancy

Exposure to H2RA defined as presence of at least one prescription of H2RA any time between last menstrual period and delivery date

干预措施: Risk of asthma in offspring (Drug)

结局指标

主要结局

Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors

时间窗: From 1 January 2005 till 31 December 2010, an expected average of 5 years.

Relative risk of first asthma diagnosis associated with prenatal exposure to histamine-2 receptor antagonists

时间窗: From 1 January 2005 till 31 December 2010, an expected average of 5 years

次要结局

未报告次要终点

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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