NCT02189265

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,069,695

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
Last Updated

July 14, 2014

Status Verified

July 1, 2014

Enrollment Period

11.9 years

First QC Date

July 3, 2014

Last Update Submit

July 11, 2014

Conditions

Premature BirthPerinatal MortalityInfant, Low Birth WeightStillbirthInfant MortalitySudden Infant DeathInfant, Very Low Birth WeightInfant, Small for Gestational Age

Keywords

Live birth [MeSH]Infant [MeSH]Infant, newborn [MeSH]Second-hand smokeTobacco smoke pollution [MeSH]Smoke-freeSmoke-free policy [MeSH]

Outcome Measures

Primary Outcomes (3)

  • Perinatal mortality

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

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

  • Preterm birth

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

    gestational age >= 24+0 weeks and <37+0 weeks

  • Small for gestational age

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

    gestational age >= 24+0 weeks

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

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.

Other: Smoke-free legislation

Interventions

Smoke-free legislationOTHER

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.

Full cohort

Eligibility Criteria

AgeUp to 1 Week
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

All singleton births in the Netherlands. Stillbirths are excluded from the denominator for all outcomes other than stillbirths and congenital anomalies.

You may qualify if:

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

You may not qualify if:

  • No chromosomal anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Academic Medical Centre

Amsterdam, North Holland, Netherlands

Location

Centre for Population Health Sciences, The University of Edinburgh

Edinburgh, Midlothian, EH8 9AG, United Kingdom

Location

Related Publications (8)

  • Cox B, Martens E, Nemery B, Vangronsveld J, Nawrot TS. Impact of a stepwise introduction of smoke-free legislation on the rate of preterm births: analysis of routinely collected birth data. BMJ. 2013 Feb 14;346:f441. doi: 10.1136/bmj.f441.

    PMID: 23412829BACKGROUND

  • Mackay DF, Nelson SM, Haw SJ, Pell JP. Impact of Scotland's smoke-free legislation on pregnancy complications: retrospective cohort study. PLoS Med. 2012;9(3):e1001175. doi: 10.1371/journal.pmed.1001175. Epub 2012 Mar 6.

    PMID: 22412353BACKGROUND

  • Page RL 2nd, Slejko JF, Libby AM. A citywide smoking ban reduced maternal smoking and risk for preterm births: a Colorado natural experiment. J Womens Health (Larchmt). 2012 Jun;21(6):621-7. doi: 10.1089/jwh.2011.3305. Epub 2012 Mar 8.

    PMID: 22401497BACKGROUND

  • Kabir Z, Daly S, Clarke V, Keogan S, Clancy L. Smoking ban and small-for-gestational age births in Ireland. PLoS One. 2013;8(3):e57441. doi: 10.1371/journal.pone.0057441. Epub 2013 Mar 26.

    PMID: 23555561BACKGROUND

  • Hackshaw A, Rodeck C, Boniface S. Maternal smoking in pregnancy and birth defects: a systematic review based on 173 687 malformed cases and 11.7 million controls. Hum Reprod Update. 2011 Sep-Oct;17(5):589-604. doi: 10.1093/humupd/dmr022. Epub 2011 Jul 11.

    PMID: 21747128BACKGROUND

  • de Laat MW, Wiegerinck MM, Walther FJ, Boluyt N, Mol BW, van der Post JA, van Lith JM, Offringa M; Nederlandse Vereniging voor Kindergeneeskunde; Nederlandse Vereniging voor Obstetrie en Gynaecologie. [Practice guideline 'Perinatal management of extremely preterm delivery']. Ned Tijdschr Geneeskd. 2010;154:A2701. Dutch.

    PMID: 21429260BACKGROUND

  • Peelen MJ, Sheikh A, Kok M, Hajenius P, Zimmermann LJ, Kramer BW, Hukkelhoven CW, Reiss IK, Mol BW, Been JV. [Tobacco control policies and perinatal health]. Ned Tijdschr Geneeskd. 2017;161:D563. Dutch.

    PMID: 28120730DERIVED

  • Peelen MJ, Sheikh A, Kok M, Hajenius P, Zimmermann LJ, Kramer BW, Hukkelhoven CW, Reiss IK, Mol BW, Been JV. Tobacco control policies and perinatal health: a national quasi-experimental study. Sci Rep. 2016 Apr 22;6:23907. doi: 10.1038/srep23907.

    PMID: 27103591DERIVED

Biospecimen

None Retained

MeSH Terms

Conditions

Premature BirthPerinatal DeathStillbirthInfant DeathSudden Infant Death

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsFetal DeathDeath, Sudden

Study Officials

  • Jasper V Been, MD MPH PhD

    Allergy and Respiratory Research Group, Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 14, 2014

Study Start

January 1, 2000

Primary Completion

December 1, 2011

Study Completion

July 1, 2014

Last Updated

July 14, 2014

Record last verified: 2014-07

Locations

NL(1)GB(1)