None listed
Conditions
Brief summary
Background: Uncontrolled 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/Design: A randomized controlled trial testing a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA[copyright]) which involves education and regular monitoring. Pregnant women with asthma will be recruited from antenatal clinics of one maternity hospital 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. Discussion: If 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.
Interventions
The trial tests an intervention involving a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA[copyright]). This intervention will embrace a collaborative approach involving the participants’ family physician, pharmacist and asthma educator. Asthma education, monitoring, feedback and follow-up are integral components of the monthly intervention. Every month, participants in the intervention group will be contacted for an hour session by the trial’s nominated pharmacist to assess
The trial tests an intervention involving a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA[copyright]). This intervention will embrace a collaborative approach involving the participants’ family physician, pharmacist and asthma educator. Asthma education, monitoring, feedback and follow-up are integral components of the monthly intervention. Every month, participants in the intervention group will be contacted for an hour session by the trial’s nominated pharmacist to assess their asthma control by administrating Juniper's Asthma Control Questionnaire (ACQ) and a short data collection form which inquires about oral corticosteroid use, asthma related hospital admissions and days off work and preventer to reliever use ratio. They will be followed up every month till delivery (7-9 months duration depending on when they had their first outpatient visit). The ACQ states that an increase in a score of 0.5 is a clinically significant deterioration of asthma control. The trial’s pharmacist will feedback to the participant’s nominated family physician if their ACQ score has increased by 0.5 or greater and if there has been a documented exacerbation since the last monthly visit. The pharmacist and family physician will then collaborate on appropriate step up therapy for the participant. It is anticipated that this close monthly monitoring will maintain the participant’s asthma under tight control during pregnancy. Each participant in the intervention group will be given a handheld device (PiKo-6) for home monitoring of lung function which they can use as often as they please but we will ask for their latest result at the monthly visits. They will receive a medication management review, periodic review of inhaler device technique, instruction in the use of PiKo-6, trigger avoidance and smoking cessation support (if relevant). The intervention group will also have their FEV1/FEV6 observed during the trial every month. This information will be oberservational data only as we are exploring this value as a marker for asthma control during pregnancy. We will not be using this ratio to determine medication dosage changes during the trial.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All pregnant women 18 years and older who can communicate in English and have agreed to be approached for research will be included. Participants will be included if they have had asthma symptoms in the last ten years.
Exclusion criteria
Patients who are unlikely to meet the demands of the trial will be excluded (e.g. patients who expect to relocate during the trial). Patients who were previously involved in the project titled “Qualitative in depth interviews with pregnant asthmatic women” which has the Mercy Health Human Research Ethics Committee project number - (R11/15) will also be excluded. If there is an event such as a miscarriage or termination of pregnancy during the trial, the participant will be removed from the trial. Participants who have not had asthma symptoms in the last ten years will also be excluded.
Outcome results
None listed