title: A randomized controlled trial to assess the clinical and cost effectiveness of a nurse-led Antenatal Asthma Management Service in South Australia (AAMS study).
abstract: 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.
  
  
  METHODS
  
  
  
  METHODS
  Multicentre, randomized controlled trial.
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  ACTRN12613000244707.
authors.forename: Luke E
authors.initials: LE
authors.lastname: Grzeskowiak
authors.forename: Gustaaf
authors.initials: G
authors.lastname: Dekker
authors.forename: Karen
authors.initials: K
authors.lastname: Rivers
authors.forename: Kate
authors.initials: K
authors.lastname: Roberts-Thomson
authors.forename: Anil
authors.initials: A
authors.lastname: Roy
authors.forename: Brian
authors.initials: B
authors.lastname: Smith
authors.forename: Jeffery
authors.initials: J
authors.lastname: Bowden
authors.forename: Robert
authors.initials: R
authors.lastname: Bryce
authors.forename: Michael
authors.initials: M
authors.lastname: Davies
authors.forename: Justin
authors.initials: J
authors.lastname: Beilby
authors.forename: Anne
authors.initials: A
authors.lastname: Wilson
authors.forename: Philippa
authors.initials: P
authors.lastname: Middleton
authors.forename: Richard
authors.initials: R
authors.lastname: Ruffin
authors.forename: Jonathan
authors.initials: J
authors.lastname: Karnon
authors.affiliation: The Robinson Institute, The University of Adelaide, Haydown Road, 5112 Adelaide, SA, Australia. Vicki.Clifton@adelaide.edu.au.
authors.forename: Vicki L
authors.initials: VL
authors.lastname: Clifton
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000328:Adult; D001249:Asthma / Q000517:prevention & control*; D003362:Cost-Benefit Analysis; D037001:Directive Counseling; D018450:Disease Progression; D005260:Female; D006801:Humans; D055118:Medication Adherence; D008875:Middle Aged; D010353:Patient Education as Topic; D057184:Practice Patterns, Nurses' / Q000191:economics*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control*; D011295:Prenatal Care / Q000191:economics*; D012107:Research Design; D012646:Self Administration; D012720:Severity of Illness Index; D016540:Smoking Cessation; D013021:South Australia; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones