Search reports, ask a question, or jump to a page.
The problem
Intervention: Single oral dose of 2 g azithromycin administered to pregnant people during labour
Who it was tested with: Healthy pregnant adults and their infants presenting to hospital in labour in Fiji (n=2,110 pregnant people, n=2,122 infants).
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"Prior to delivery, participants were randomly assigned a single dose of 2 g of oral azithromycin or placebo that were identical in appearance to mask treatment allocation, in a 1:1 ratio stratified by ethnicity. Cumulative incidence of infections and antibiotic prescription was compared using an intention-to-treat analysis of complete cases." This describes a well-designed randomised controlled trial with blinding and stratification, making it appropriate for the EXPERIMENTAL tier.
The primary endpoint (infant SSTIs at 3 months) was not met, limiting the clinical significance of the secondary infection reductions. The diminishing effect over time for birthing parents raises questions about clinical utility. Potential impacts on antimicrobial resistance and infant microbiome were not measured and remain concerns for scale-up.
Across countries and designs
2 studies · 1 country
