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Thorax 63:981-987 doi:10.1136/thx.2008.098244
  • Asthma

Effect of maternal asthma, exacerbations and asthma medication use on congenital malformations in offspring: a UK population-based study

  1. L J Tata1,
  2. S A Lewis1,
  3. T M McKeever1,
  4. C J P Smith1,
  5. P Doyle2,
  6. L Smeeth2,
  7. J E Gibson1,
  8. R B Hubbard1
  1. 1
    Epidemiology & Public Health, University of Nottingham, UK
  2. 2
    Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, UK
  1. Dr L J Tata, Division of Epidemiology & Public Health, Clinical Sciences Building, City Hospital, Hucknall Road, Nottingham NG5 1PB, UK; laila.tata{at}nottingham.ac.uk
  • Received 28 February 2008
  • Accepted 6 July 2008
  • Published Online First 4 August 2008

Abstract

Background: Clinical advice to pregnant women with asthma is to maintain optimal therapeutic management; however, potential adverse effects of asthma treatments on fetal development remain uncertain. A study was undertaken to assess the association between maternal asthma and gestational exposure to asthma medications with risk of congenital malformation in offspring.

Methods: A matched case-control study was performed using The Health Improvement Network primary care database. Children with malformations were matched to control children on birth year, general practice and singleton or twin delivery.

Results: 5124 cases of liveborn children with major congenital malformations and 30 053 controls were included in the study. The risk of any malformation in children born to women with asthma was marginally higher than that in children born to women without asthma (adjusted OR 1.10, 95% CI 1.01 to 1.20). However, no association was present in children born to mothers receiving asthma treatment in the year before or during pregnancy (OR 1.06, 95% CI 0.94 to 1.20). In assessing teratogenicity of medications, no increased risk of malformation was found with gestational exposures to short- or long-acting β agonists, inhaled corticosteroids, oral corticosteroids, other bronchodilators or cromones. These findings were similar for each of 11 system-specific malformation groups, except for an increase in musculo-skeletal system malformation associated with cromone exposure.

Conclusions: Gestational exposure to commonly used asthma medications was found to be safe overall, although a moderate teratogenic risk of cromones cannot be excluded. There was some evidence of a small increased risk of congenital malformation in children born to women with asthma, but this was not explained by gestational exposure to asthma drugs.

Footnotes

  • Funding: This study was funded by a grant from Asthma UK. Asthma UK did not have any role in the design and conduct of the study; collection, management, analysis and interpretation of the data; the preparation, review or approval of the manuscript; or in the decision to submit the paper for publication. No authors work for Asthma UK and all authors are thus independent researchers from the funders.

  • Competing interests: None.

  • Ethics approval: Ethical approval for this study was obtained from the Medical Research Ethics Committee in 2004. All patient records in THIN are anonymised to ensure that researchers cannot identify individuals.

  • LJT participated in the literature review, development of the study design, data management, data analysis, writing the article and revising article drafts for publication. SAL, PD and LS participated in the development of the study design, interpretation of the data and revising article drafts for publication. TMMcK participated in the interpretation of the data and revising article drafts for publication. CJPS participated in the initial data management and revising article drafts for publication. JEG participated in the data management, interpretation of the data and revising article drafts for publication. RBH (guarantor) had the initial idea for the study and its design and participated in the initial literature review, development of the study design, interpretation of the data and revising article drafts for publication. He had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All authors have seen and approved the final version.