Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands
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ClinicalTrials.gov Identifier: NCT02189265 |
Recruitment Status :
Completed
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
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Condition or disease | Intervention/treatment |
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Premature Birth Perinatal Mortality Infant, Low Birth Weight Stillbirth Infant Mortality Sudden Infant Death Infant, Very Low Birth Weight Infant, Small for Gestational Age | Other: Smoke-free legislation |

Study Type : | Observational |
Actual Enrollment : | 2069695 participants |
Observational Model: | Ecologic or Community |
Time Perspective: | Retrospective |
Official Title: | Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands |
Study Start Date : | January 2000 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | July 2014 |

Group/Cohort | Intervention/treatment |
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Full cohort
All singleton births in the Netherlands. Stillbirths are excluded from the denominator for all outcomes other than perinatal mortality, stillbirth and congenital anomalies.
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Other: Smoke-free legislation
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. |
- Perinatal mortality [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: gestational age >= 24+0 weeks ]live birth at gestational age >= 24+0 weeks with birth weight below 10th centile
- Stillbirth [ Time Frame: gestational age >= 24+0 weeks ]born dead from 24+0 weeks of gestation
- Early neonatal mortality [ Time Frame: up to 7 days postnatally after live birth at gestational age >= 24+0 weeks ]death within first 7 days after live birth at gestational age >= 24+0 weeks
- Very preterm birth [ Time Frame: gestational age >= 24+0 weeks and <32+0 weeks ]live birth with gestational age >= 24+0 weeks and <32+0 weeks
- Low birth weight [ Time Frame: gestational age >= 24+0 weeks ]live birth at gestational age >= 24+0 weeks with birth weight <2500 grams
- Very low birth weight [ Time Frame: gestational age >= 24+0 weeks ]live birth at gestational age >= 24+0 weeks with birth weight <1500 grams
- Very small for gestational age [ Time Frame: gestational age >= 24+0 weeks ]live birth at gestational age >= 24+0 weeks with birth weight below 2.3rd centile
- Major congenital anomalies [ Time Frame: gestational age >= 24+0 weeks ]birth at >= 24+0 weeks of gestation with a major birth defect (birth defects known to be influenced by antenatal smoke exposure based on recent systematic review (Hackshaw 2011))
Biospecimen Description:

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Ages Eligible for Study: | up to 1 Week (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Data are obtained via The Netherlands Perinatal Registry (PRN) (6). All registered stillbirths and livebirths occurring in the Netherlands between 1 January 2000 and 31 December 2011 are included.
Inclusion Criteria:
- Singleton birth occurring in the Netherlands between January 1st, 2000 and December 31st, 2011
- Liveborn (for all outcomes other than stillbirth and congenital anomalies)
Exclusion Criteria:
- No chromosomal anomalies

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189265
Netherlands | |
Academic Medical Centre | |
Amsterdam, Noord Holland, Netherlands | |
United Kingdom | |
Centre for Population Health Sciences, The University of Edinburgh | |
Edinburgh, Midlothian, United Kingdom, EH8 9AG |
Principal Investigator: | Jasper V Been, MD MPH PhD | Allergy and Respiratory Research Group, Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jasper Been, Dr., University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT02189265 |
Other Study ID Numbers: |
TRF NR-0166-1.3 |
First Posted: | July 14, 2014 Key Record Dates |
Last Update Posted: | July 14, 2014 |
Last Verified: | July 2014 |
Live birth [MeSH] Infant [MeSH] Infant, newborn [MeSH] Second-hand smoke |
Tobacco smoke pollution [MeSH] Smoke-free Smoke-free policy [MeSH] |
Premature Birth Stillbirth Perinatal Death Body Weight Birth Weight Infant Death Sudden Infant Death |
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Fetal Death Death Pathologic Processes Death, Sudden |