TABLE 7

Pregnant women: all outcomes

Time of outcomeDefinition of outcomesInterventionControlBetween group comparison
Exacerbations#Exacerbations: an unscheduled visit to a doctor, presentation to the emergency room or admission to hospital, or when OCS used
Events separated by 7 days or more were counted as a second event
0.288 per pregnancy (mean±sd study time 17.8±5.5 weeks)0.615 per pregnancy (mean study time 18.8±3.8 weeks)Incidence rate ratio 0.496 (95% CI 0.325–0.755), p=0.001
Mean (95% CI) OCS use0.08 (0.03–0.133)0.19 (0.08–0.31)p=0.042
Mean (95% CI) hospitalisations0 (0–0)0.03 (−0.004–0.06)p=1.0
Mean (95% CI) emergency room/labour ward visits0.04 (0.001–0.07)0.02 (−0.01–0.04)p=0.399
Mean (95% CI) unplanned or unscheduled doctors' visits0.26 (0.16–0.36)0.56 (0.40–0.72)p=0.002
ICS useDifference in means (from baseline to last visit) (read off graph):−210 µg·day−150 µg·day−1p=0.043
Median (IQR) BDP equivalent ICS dose (µg·day−1)200 (0–400)0 (0–800)p=0.079
Users76 (68.5%) out of 11146 (42.2%) out of 109p<0.0001
Other outcomesMedian (IQR) HRQoL
 SF-12 physical summary  (low 0, high 100):47.7 (40.8–52.0)46.9 (38.2–51.8)p=0.89
 SF-12 mental summary  (low 0, high 100):56.9 (50.2–59.3)54.2 (46.1–57.6)p=0.037
 AQLQ-M: total score  (good 0, poor 10):0.75 (0.38–1.25)0.81 (0.38–1.63)p=0.54
Asthma control: mean±sd ACQ0.56±0.670.72±0.80p=0.046
Median (IQR) β2-agonist use in past week0 (0–3)1 (0–5)p=0.024
LABA users45 (40.5%) out of 11119 (17.4%) out of 109p<0.0001
Adverse events, mortality, compliance and test failure ratesNRNRNR
  • OCS: oral corticosteroids; IQR: interquartile range; BDP: beclomethasone diproprionate; ICS: inhaled corticosteroid; HRQoL: health-related quality of life; SF-12: short form 12; AQLQ-M: Asthma Quality of Life Questionnaire-Marks; ACQ: Asthma Control Questionnaire; LABA: long-acting β2-agonist; NR: not reported. #: time of outcome was monthly until birth (maximum ∼30 weeks). Information from [26].