Asthma, Rhinitis, Other Respiratory Diseases
Normal pregnancy outcomes in a population-based study including 2968 pregnant women exposed to budesonide,☆☆

https://doi.org/10.1067/mai.2003.1340Get rights and content

Abstract

Background: Inhaled corticosteroids are recommended as first-line therapy for pregnant women with moderate to severe asthma, although the effects on pregnancy outcome are uncertain. A low compliance with the recommendations might lead to inadequate control of asthma, which has been associated with adverse outcomes both for the mother and the infant. Objective: To investigate whether the reported use of inhaled budesonide (Pulmicort) during pregnancy influences birth outcome. Methods: Data were derived from the Swedish Medical Birth Register, which includes 99% of births in Sweden. During 1995 to 1998, 293,948 newborn infants were identified. Pregnancy outcomes were compared for mothers in Sweden reporting asthma medication usage with those reporting no asthma medication usage. Results: The 2968 mothers who reported use of inhaled budesonide during early pregnancy gave birth to infants of normal gestational age, birth weight, and length, with no increased rate of stillbirths or multiple births. The rate of caesarean births was higher among mothers who used asthma medication during their pregnancy than among the control group. Conclusions: The use of inhaled budesonide in Sweden is not linked with any clinically relevant effects associated with pregnancy outcome.

Section snippets

Methods

Information comprising asthma medication during pregnancy and pregnancy outcomes was derived from the Swedish Medical Birth Register, which was founded in 1973. This register contains detailed information on 99% of all births in Sweden (approximately 100,000 per year), including data on newborn infants. The register encompasses case sheet and record data from maternity clinics listing care received during parturition and examination of the newborn infant. This presupposes a similar system of

Study population

The total number of newborn infants in the Swedish Medical Birth Register for 1995 to 1998 was 298,880, after the number of multiple births (n = 4510) and stillbirths (n = 999) were excluded. Information regarding birth weight and length was obtained for 293,948 of these births (study population). Mothers recorded their use of asthma medication during early pregnancy (record form 1). Some 7719 (group A) used asthma medicines other than inhaled or oral glucocorticoids (adrenergics, xanthine

Discussion

Practitioners have been reluctant to prescribe inhaled glucocorticoids to pregnant women because of the general fear of prescribing any medication during pregnancy and because of concerns raised by the labels warning that maternal side effects and adverse perinatal outcomes may result from any type of steroid administration. In addition, some patients are reluctant to take their medication even when prescribed for fear of potential negative effects on the fetus. This may in turn increase the

Acknowledgements

The authors thank Max Köster (Centre for Epidemiology, National Board of Health and Welfare, Stockholm, Sweden) and Jonas Ranstam (Erdeven Medical Statistics Kb, Lund, Sweden) for advice and help with interpretation of the data.

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    This study was funded by AstraZeneca R&D, Lund, Sweden.

    ☆☆

    Reprint requests: Dr Ensio Norjavaara, AstraZeneca Mölndal, SE-43183 Mölndal, Sweden.

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