Multidisciplinary approach to management of maternal asthma (MAMMA [copyright]): the PROTOCOL for a randomized controlled trial

BMC Public Health

Study Protocol

Angelina Lim¹  Kay Stewart¹  Johnson George¹  Michael J Abramson²  Susan P Walker³ 

[1] Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, VIC, Australia;Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Hospital, Melbourne, VIC, Australia;Department of Perinatal Medicine, Mercy Hospital for Women, Melbourne, Victoria, Australia and University of Melbourne, Victoria, Australia;

关键词: Asthma;    Pregnancy;    Inhaled corticosteroids;    Randomized controlled trial;    Antenatal care;    Intervention;    Lung function tests;    Multidisciplinary care;   

DOI  :  10.1186/1471-2458-12-1094

 received in 2012-06-28, accepted in 2012-11-29,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundUncontrolled asthma during pregnancy is associated with the maternal hazards of disease exacerbation, and perinatal hazards including intrauterine growth restriction and preterm birth. Interventions directed at achieving better asthma control during pregnancy should be considered a high priority in order to optimise both maternal and perinatal outcomes. Poor compliance with prescribed asthma medications during pregnancy and suboptimal prescribing patterns to pregnant women have both been shown to be contributing factors that jeopardise asthma control. The aim is to design and evaluate an intervention involving multidisciplinary care for women experiencing asthma in pregnancy.Methods/designA pilot single-blinded parallel-group randomized controlled trial testing a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA©) which involves education and regular monitoring. Pregnant women with asthma will be recruited from antenatal clinics in Victoria, Australia. Recruited participants, stratified by disease severity, will be allocated to the intervention or the usual care group in a 1:1 ratio. Both groups will be followed prospectively throughout pregnancy and outcomes will be compared between groups at three and six months after recruitment to evaluate the effectiveness of this intervention. Outcome measures include Asthma Control Questionnaire (ACQ) scores, oral corticosteroid use, asthma exacerbations and asthma related hospital admissions, and days off work, preventer to reliever ratio, along with pregnancy and neonatal adverse events at delivery. The use of FEV1/FEV6 will be also investigated during this trial as a marker for asthma control.DiscussionIf successful, this model of care could be widely implemented in clinical practice and justify more funding for support services and resources for these women. This intervention will also promote awareness of the risks of poorly controlled asthma and the need for a collaborative, multidisciplinary approach to asthma management during pregnancy. This is also the first study to investigate the use of FEV1/FEV6 as a marker for asthma control during pregnancy.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12612000681853)

【 授权许可】

Unknown   
© Lim et al.; licensee BioMed Central Ltd. 2012. 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.