None listed
Conditions
Brief summary
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 (AAMS). Methods/design: Design: Multicentre, randomized controlled trial Inclusion criteria: Women with physician diagnosed asthma, which is not currently in remission, who are less than 18 weeks gestation with a singleton pregnancy and do not have a chronic medical condition. Trial entry and randomization: Eligible women with asthma, stratified by disease severity, will be randomized into one of two study groups: 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 60-90 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. In addition, 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 adapted model of an asthma education program within the antenatal clinic setting has the significant potential to improve the participation rate of pregnant women in the self-management of their asthma, reduce asthma exacerbations and improve perinatal health outcomes.
Interventions
The intervention group will receive care through the nurse-led Antenatal Asthma Management Service, based in the antenatal outpatient clinic. The Antenatal Asthma Management Service will be led by a respiratory nurse with qualifications in asthma management and education and spirometry. All asthmatic women will receive asthma education with a full assessment of their asthma at 18, 24, 30 and 36 weeks gestation conducted by a respiratory nurse. Each antenatal visit will include a 60-90 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. In addition, subjects will receive education about asthma control and management skills including trigger avoidance and smoking cessation counseling when appropriate. While it is standard antenatal care for all pregnant women to complete a smoking questionnaire at their first booking visit and be encouraged to quit smoking, an additional key component of the Antenatal Asthma Management Service will be in providing additional counseling on the importance of smoking cessation in relation to their asthma and the health of their baby. Women will be provided with information on the benefits of smoking cessation and direct referrals will be made to QuitSA for cessation support. During the first visit at 18 weeks gestation, all subjects will be provided with an individualized written asthma action plan, which has been developed according to evidence based principles by the asthma educator using a standardized template following National Asthma Council recommendations. In addition, current asthma management therapies will be evaluated and recommendations regarding optimal therapy will be made. If women are identified at their first antenatal visit as having unstable asthma, as determined by the Juniper Asthma Control Questionnaire (ACQ) score of >1.5 a recommendation will be made for step-up therapy in accordance with well-established clinical guidelines and previous studies. If inhaled corticosteroids need to be prescribed an on-call respiratory physician will be contacted. A detailed asthma management report, including asthma action plan and recommended changes in therapy if required, will be forwarded to the participant’s preferred family physician (i.e. general practitioner) who will review each action plan and assess the appropriateness of recommended changes in therapy. This preferred provider will be the lead clinician responsible for her asthma management during pregnancy. All recommendations made through the Antenatal Asthma Management Service will be recorded and followed-up to determine their outcome (i.e. acceptance of recommendation). During subsequent visits to the Antenatal Asthma Management Service, the respiratory nurse will continually review asthma control and management plans. Subjects assessed as having poor asthma control (ACQ>1.5) or experiencing a current exacerbation will be referred to their usual family physician in the community or respiratory physician in the hospital for appropriate review. During antenatal appointments urgent medical review will be available for patients with an acute exacerbation. The respiratory nurse and designated family physician and/or respiratory physician will collaborate closely on appropriate step-up therapy for the participant. Between visits, participants will be encouraged to follow their asthma action plan closely and see their family doctor if their asthma worsens. Those subjects who also attend specialist respiratory clinics will also have information forwarded to their physician for reference. Subjects will be encouraged to maintain these specialist visits. During the study, care received for asthma management from a GP, obstetrician or respiratory specialist will be noted.
Sponsors
Study design
Eligibility
Inclusion criteria
To be eligible, participants must be less than 18 weeks gestation at the time of recruitment, have asthma which has been previously diagnosed by a doctor and is not currently in remission (remission defined as no asthma symptoms and no use of asthma medications in previous year), aged 18-45 years, expected to give birth to a singleton and be able to speak English.
Exclusion criteria
Participants will be excluded from the study if they have previously participated in an Asthma study run at the hospital or have a pre-existing chronic medical condition (i.e. diabetes, hypertension, cardiac disease, HIV/hepatitis, renal disease, haematology disorder (i.e. thalassaemia, thrombophilia), thyroid disorder, psychiatric disease requiring therapy with antidepressant or antipsychotic, epilepsy).