• WHO ACTION Trial Collaborators (Lancet eClinicalMedicine, 2022) assessed the safety and efficacy of dexamethasone when given to women at risk of late preterm birth in hospitals in low-resource countries 

• Double-blind, randomized trial 
  • 4 hospitals in India (December 2017 to May 2020) 
• Participants 
  • Pregnant women at risk of preterm birth between 34w0d and 36w0d  
  • Birth planned or expected in the next 48 hours  
• Interventions  
  • Dexamethasone IM 6 mg injection every 12 hours with a maximum of four doses or until hospital discharge or birth (whichever came first) 
  • Placebo 
• Primary outcomes 
  • Neonatal death 
  • Any baby death (stillbirth or neonatal death) 
  • Severe neonatal respiratory distress 
  • Possible maternal bacterial infection 

• Dexamethasone: 391 participants | Placebo: 391 participants
• Between the two groups, there was no difference in risk of  
  • Neonatal death  
    • Dexamethasone: 2.7% 
    • Placebo: 2.8%  
    • RR 0.95 (95% CI, 0.42 to 2.12) 
  • Any baby death 
    • Dexamethasone: 3.8% 
    • Placebo: 4.4% 
    • RR 0.87 (95% CI, 0.45 to 1.67) 
• There was also no difference in  
  • Severe neonatal respiratory distress 
    • Dexamethasone: 0.8% 
    • Placebo: 0.5% 
    • RR 1.56 (95% CI, 0.26 to 9.29) 
  • Possible maternal bacterial infection 
    • Dexamethasone: 2.3% 
    • Placebo: 3.8%  
    • RR 0.60 (95% CI, 0.27 to 1.35) 
• Fewer neonates in the dexamethasone group required resuscitation at birth 
  • RR 0.38 (95% CI, 0.15 to 0.97) 
• The trial was stopped due to lower-than-expected prevalence of primary outcomes and slow recruitment 
  • Planned on 8% neonatal mortality | Actual mortality 2.7% 

• There was no difference in risk of neonatal death or respiratory distress with dexamethasone in this setting 
• Reason for lack of benefit compared to ALPS study aside from sample size may be related to dosing 
  • ALPS regimen was 12 mg betamethasone or placebo 24 hours apart  
  • In both trials, a substantial proportion of women only received a single dose  
• The authors state 

…the use of major resuscitation at birth for newborns was significantly lower with dexamethasone 

the overall trend of effects suggests that potential benefit of dexamethasone in late preterm cannot be excluded, and further trials are required 

Antenatal dexamethasone for late preterm birth: A multi-centre, two-arm, parallel, double-blind, placebo-controlled, randomized trial 

Related ObG Topics:

WHO ACTION RCT Outcomes: Dexamethasone and Risk of Neonatal Death in Women from Low-Income Countries at Risk for Preterm Birth

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