WHO ACTION RCT Outcomes: Dexamethasone and Risk of Neonatal Death in Women from Low-Income Countries at Risk for Preterm Birth
BACKGROUND AND PURPOSE:
Antenatal glucocorticoids are considered a key intervention in preventing preterm birth
2015 population study found that in low resource settings, the use of antenatal glucocorticoids was associated with an increase in adverse outcomes (e.g., stillbirth) that was thought to be related to increased risk for maternal infection
A recent WHO ACTION trial (NEJM, 2020) examined the safety and efficacy of dexamethasone for prevention of early preterm birth, in low-resource countries
Multicountry randomized trial
Bangladesh | India | Kenya | Nigeria | Pakistan
26w0d to 33w6d
At risk for preterm birth
IM dexamethasone 6 mg q12 hours
Neonatal death alone (<28 days)
Stillbirth or neonatal death
Maternal bacterial infection: Maternal fever (temperature ≥38°C) or clinically suspected or confirmed infection that required antibiotics
2852 women | 3070 offspring
Trial was stopped for benefit at the second interim analysis
Neonatal death occurred more frequently in the placebo group (P=0.03)
Relative risk (RR) 0.84 (95% CI, 0.72 to 0.97)
Stillbirth or neonatal death occurred more frequently in the placebo group (P=0.04)
RR 0.88 (95% CI, 0.78 to 0.99)
There was no significant difference in the incidence of possible maternal bacterial infection
Relative risk 0.76 (95% CI, 0.56 to 1.03)
No significant between-group difference
For women in low-income countries who were at risk for early preterm birth, the use of dexamethasone led to lower risks of neonatal death alone and stillbirth or neonatal death vs placebo
The Incidence of maternal bacterial infection was not increased
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