A randomized controlled trial to assess the clinical and cost effectiveness of a nurse-led Antenatal Asthma Management Service in South Australia (AAMS study)

BMC Pregnancy and Childbirth

Vicki L Clifton⁴  Jonathan Karnon⁵  Richard Ruffin¹  Philippa Middleton⁴  Anne Wilson³  Justin Beilby²  Michael Davies⁴  Robert Bryce⁷  Jeffery Bowden⁶  Brian Smith⁶  Anil Roy⁶  Kate Roberts-Thomson⁴  Karen Rivers⁴  Gustaaf Dekker⁴  Luke E Grzeskowiak⁴ 

[1] Department of Medicine, The University of Adelaide, Adelaide, Australia;Faculty of Health Sciences, The University of Adelaide, Adelaide, SA, Australia;School of Medicine, University of New South Wales, NSW, Australia;The Robinson Institute, The University of Adelaide, Haydown Road, 5112 Adelaide, SA, Australia;School of Population Health and Clinical Practice, The University of Adelaide, Adelaide, SA, Australia;Department of Respiratory Medicine, Lyell McEwin Hospital, Adelaide, SA, Australia;Department of Obstetrics and Gynaecology, Flinders Medical Centre, Adelaide, SA, Australia

关键词: Intervention;    Antenatal care;    Randomized controlled trial;    Inhaled corticosteroids;    Pregnancy;    Asthma;   

Others  :  1131802
DOI  :  10.1186/1471-2393-14-9

 received in 2013-03-05, accepted in 2013-12-11,  发布年份 2014

【 摘 要 】

Background

Pregnancy presents a unique situation for the management of asthma as it can alter the course of asthma severity and its treatment, which in turn can affect pregnancy outcomes. Despite awareness of the substantial adverse effects associated with asthma during pregnancy, little has been done to improve its management and reduce associated perinatal morbidity and mortality. The aim of this randomized controlled trial is to evaluate the clinical and cost effectiveness of an Antenatal Asthma Management Service.

Methods/design

Design: Multicentre, randomized controlled trial.

Inclusion criteria: Women with physician diagnosed asthma, which is not currently in remission, who are less than 20 weeks gestation with a singleton pregnancy and do not have a chronic medical condition.

Trial entry and randomization: Eligible women with asthma, stratified by treatment site, disease severity and parity, will be randomized into either the ‘Standard Care Group’ or the ‘Intervention Group’.

Study groups: Both groups will be followed prospectively throughout pregnancy. Women in the ‘Standard Care Group’ will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the ‘Intervention Group’ will receive additional care through the nurse-led Antenatal Asthma Management Service, based in the antenatal outpatient clinic. Women will receive asthma education with a full assessment of their asthma at 18, 24, 30 and 36 weeks gestation. Each antenatal visit will include a 60 min session where asthma management skills are assessed including: medication adherence and knowledge, inhaler device technique, recognition of asthma deterioration and possession of a written asthma action plan. Furthermore, subjects will receive education about asthma control and management skills including trigger avoidance and smoking cessation counseling when appropriate.

Primary study outcome: Asthma exacerbations during pregnancy.

Sample size: A sample size of 378 women will be sufficient to show an absolute reduction in asthma exacerbations during pregnancy of 20% (alpha 0.05 two-tailed, 90% power, 5% loss to follow-up).

Discussion

The integration of an asthma education program within the antenatal clinic setting has the significant potential to improve the participation of pregnant women in the self-management of their asthma, reduce asthma exacerbations and improve perinatal health outcomes.

Trial registration

ACTRN12613000244707

【 授权许可】

   
2014 Grzeskowiak et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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