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

Study Protocol

Richard Ruffin¹  Robert Bryce²  Anil Roy³  Brian Smith³  Jeffery Bowden³  Justin Beilby⁴  Anne Wilson⁵  Jonathan Karnon⁶  Vicki L Clifton⁷  Luke E Grzeskowiak⁷  Kate Roberts-Thomson⁷  Gustaaf Dekker⁷  Karen Rivers⁷  Michael Davies⁷  Philippa Middleton⁷ 

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

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

DOI  :  10.1186/1471-2393-14-9

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

来源: Springer

【 摘 要 】

BackgroundPregnancy 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/designDesign: 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).DiscussionThe 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 registrationACTRN12613000244707

【 授权许可】

Unknown   
© Grzeskowiak et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.