Angelina S Lim1, Kay Stewart1, Michael J Abramson2, Susan P Walker3, Catherine L Smith2, Johnson George4. 1. Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville. 2. Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Hospital, Melbourne. 3. Department of Perinatal Medicine, Mercy Hospital for Women, Heidelberg; University of Melbourne, Melbourne, VIC, Australia. 4. Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville. Electronic address: Johnson.George@monash.edu.
Abstract
BACKGROUND: Uncontrolled asthma during pregnancy is associated with maternal and perinatal hazards. A pharmacist-led intervention directed at improving maternal asthma control, involving multidisciplinary care, education, and regular monitoring to help reduce these risks, was developed and evaluated. METHODS: A randomized controlled trial was carried out in the antenatal clinics of two major Australian maternity hospitals. Sixty pregnant women < 20 weeks gestation who had used asthma medications in the previous year were recruited. Participants were randomized to either an intervention or a usual care group and followed prospectively throughout pregnancy. The primary outcome was Asthma Control Questionnaire (ACQ) score. Mean changes in ACQ scores from baseline were compared between groups at 3 and 6 months to evaluate intervention efficacy. RESULTS: The ACQ score in the intervention group (n = 29) decreased by a mean ± SD of 0.46 ± 1.05 at 3 months and 0.89 ± 0.98 at 6 months. The control group (n = 29) had a mean decrease of 0.15 ± 0.63 at 3 months and 0.18 ± 0.73 at 6 months. The difference between groups, adjusting for baseline, was -0.22 (95% CI, -0.54 to 0.10) at 3 months and -0.60 (95% CI, -0.85 to -0.36) at 6 months. The difference at 6 months was statistically significant (P < .001) and clinically significant (> 0.5). No asthma-related oral corticosteroid use, hospital admissions, emergency visits, or days off from work were reported during the trial. CONCLUSIONS: A multidisciplinary model of care for asthma management involving education and regular monitoring could potentially improve maternal asthma outcomes and be widely implemented in clinical practice. TRIAL REGISTRY: Australian and New Zealand Clinical Trials Registry; No.: ACTRN12612000681853; URL: www.anzctr.org.au.
RCT Entities:
BACKGROUND: Uncontrolled asthma during pregnancy is associated with maternal and perinatal hazards. A pharmacist-led intervention directed at improving maternal asthma control, involving multidisciplinary care, education, and regular monitoring to help reduce these risks, was developed and evaluated. METHODS: A randomized controlled trial was carried out in the antenatal clinics of two major Australian maternity hospitals. Sixty pregnant women &lt; 20 weeks gestation who had used asthma medications in the previous year were recruited. Participants were randomized to either an intervention or a usual care group and followed prospectively throughout pregnancy. The primary outcome was Asthma Control Questionnaire (ACQ) score. Mean changes in ACQ scores from baseline were compared between groups at 3 and 6 months to evaluate intervention efficacy. RESULTS: The ACQ score in the intervention group (n = 29) decreased by a mean ± SD of 0.46 ± 1.05 at 3 months and 0.89 ± 0.98 at 6 months. The control group (n = 29) had a mean decrease of 0.15 ± 0.63 at 3 months and 0.18 ± 0.73 at 6 months. The difference between groups, adjusting for baseline, was -0.22 (95% CI, -0.54 to 0.10) at 3 months and -0.60 (95% CI, -0.85 to -0.36) at 6 months. The difference at 6 months was statistically significant (P &lt; .001) and clinically significant (&gt; 0.5). No asthma-related oral corticosteroid use, hospital admissions, emergency visits, or days off from work were reported during the trial. CONCLUSIONS: A multidisciplinary model of care for asthma management involving education and regular monitoring could potentially improve maternal asthma outcomes and be widely implemented in clinical practice. TRIAL REGISTRY: Australian and New Zealand Clinical Trials Registry; No.: ACTRN12612000681853; URL: www.anzctr.org.au.
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