Priority Research Centre Grow Up Well, University of Newcastle, and Hunter Medical Research Institute, Newcastle, Australia
School of Medicine and Public Health, Faculty of Health, University of Newcastle, and Hunter Medical Research Institute, Newcastle, Australia.
Eur Respir J. 2022 Nov 17;60(5). doi: 10.1183/13993003.00298-2022. Print 2022 Nov.
Asthma exacerbations in pregnancy are associated with adverse perinatal outcomes. We aimed to determine whether fractional exhaled nitric oxide ( )-based asthma management improves perinatal outcomes compared to usual care.
The Breathing for Life Trial was a multicentre, parallel-group, randomised controlled trial conducted in six hospital antenatal clinics, which compared asthma management guided by (adjustment of asthma treatment according to exhaled nitric oxide and symptoms each 6-12 weeks) to usual care (no treatment adjustment as part of the trial). The primary outcome was a composite of adverse perinatal events (preterm birth, small for gestational age (SGA), perinatal mortality or neonatal hospitalisation) assessed using hospital records. Secondary outcomes included maternal asthma exacerbations. Concealed random allocation, stratified by study site and self-reported smoking status was used, with blinded outcome assessment and statistical analysis (intention to treat).
Pregnant women with current asthma were recruited; 599 to the control group (608 infants) and 601 to the intervention (615 infants). There were no significant group differences for the primary composite perinatal outcome (152 (25.6%) out of 594 control, 177 (29.4%) out of 603 intervention; OR 1.21, 95% CI 0.94-1.56; p=0.15), preterm birth (OR 1.14, 95% CI 0.78-1.68), SGA (OR 1.06, 95% CI 0.78-1.68), perinatal mortality (OR 3.62, 95% CI 0.80-16.5), neonatal hospitalisation (OR 1.24, 95% CI 0.89-1.72) or maternal asthma exacerbations requiring hospital admission or emergency department presentation (OR 1.19, 95% CI 0.69-2.05).
-guided asthma pharmacotherapy delivered by a nurse or midwife in the antenatal clinic setting did not improve perinatal outcomes.
妊娠期间哮喘加重与围产期不良结局相关。我们旨在确定基于呼出气一氧化氮( )的哮喘管理是否比常规护理更能改善围产期结局。
呼吸生命试验是一项多中心、平行组、随机对照试验,在六个医院产前诊所进行,比较了根据 (根据呼气一氧化氮和症状每 6-12 周调整哮喘治疗)进行的哮喘管理与常规护理(作为试验的一部分不进行治疗调整)。主要结局是通过医院记录评估的不良围产事件(早产、小于胎龄儿(SGA)、围产儿死亡或新生儿住院)的综合指标。次要结局包括孕产妇哮喘加重。使用隐蔽随机分组,按研究地点和自我报告的吸烟状况分层,进行盲法结局评估和统计分析(意向治疗)。
招募了当前患有哮喘的孕妇;对照组 599 例(608 例婴儿),干预组 601 例(615 例婴儿)。主要复合围产结局(对照组 594 例中有 152 例(25.6%),干预组 603 例中有 177 例(29.4%);比值比 1.21,95%置信区间 0.94-1.56;p=0.15)、早产(比值比 1.14,95%置信区间 0.78-1.68)、SGA(比值比 1.06,95%置信区间 0.78-1.68)、围产儿死亡率(比值比 3.62,95%置信区间 0.80-16.5)、新生儿住院率(比值比 1.24,95%置信区间 0.89-1.72)或需要住院或急诊就诊的孕产妇哮喘加重(比值比 1.19,95%置信区间 0.69-2.05)无显著差异。
在产前诊所环境中由护士或助产士提供的基于呼出气一氧化氮的哮喘药物治疗并未改善围产期结局。