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临床试验/NCT02189265
NCT02189265已完成不适用

Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands

University of Edinburgh2 个研究点 分布在 2 个国家目标入组 2,069,695 人开始时间: 2000年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,069,695
试验地点
2
主要终点
Perinatal mortality

研究概览

简要总结

The purpose of this study is to investigate whether there has been a change in perinatal outcomes following the phased smoking ban introduction (January 2004 for workplaces; July 2008 for bars and restaurants) workplaces in the Netherlands.

详细描述

Primary research questions

  1. Is the phased introduction of smoke-free legislation in The Netherlands associated with reductions in adverse perinatal outcomes (e.g. perinatal mortality, preterm birth, small for gestational age)?
  2. How do these associations compare with those described for other European countries in comparable studies (i.e. Belgium (Cox 2013), England (Been et al under review), Scotland (Mackay 2012))?

Study design Retrospective cohort study (using prospective routinely collected health care data)

Study population All singleton births in the Netherlands between January 1st 2000 and December 31st 2011.

Intervention The intervention under study is the ban on smoking in workplaces, and in bars and restaurants implemented in the Netherlands on January 1st, 2004 and July 1st, 2008, respectively.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Retrospective

入排标准

年龄范围
— 至 1 Week(Child)
性别
All
接受健康志愿者

入选标准

  • Singleton birth occurring in the Netherlands between January 1st, 2000 and December 31st, 2011
  • Liveborn (for all outcomes other than stillbirth and congenital anomalies)

排除标准

  • No chromosomal anomalies

结局指标

主要结局

Perinatal mortality

时间窗: from 24+0 weeks gestation (for stillbirth); up to 7 days postnatally (for early neonatal mortality)

stillbirth (i.e. intrauterine death from 24+0 weeks gestation) or early neonatal mortality (i.e. death within the first 7 days postnatally)

Preterm birth

时间窗: gestational age >= 24+0 weeks and <37+0 weeks

live birth with gestational age \>= 24+0 weeks and \<37+0 weeks

Small for gestational age

时间窗: gestational age >= 24+0 weeks

live birth at gestational age \>= 24+0 weeks with birth weight below 10th centile

次要结局

  • Stillbirth(gestational age >= 24+0 weeks)
  • Early neonatal mortality(up to 7 days postnatally after live birth at gestational age >= 24+0 weeks)
  • Very preterm birth(gestational age >= 24+0 weeks and <32+0 weeks)
  • Low birth weight(gestational age >= 24+0 weeks)
  • Very low birth weight(gestational age >= 24+0 weeks)
  • Very small for gestational age(gestational age >= 24+0 weeks)
  • Major congenital anomalies(gestational age >= 24+0 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jasper Been

Dr.

University of Edinburgh

研究点 (2)

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