Peer-reviewed article
The efficacy of a single dose of oral azithromycin in labour to prevent infections in infants and birthing parents in Fiji: secondary outcomes from a randomised controlled trial.
Hume-Nixon M, Clark S, Ratu T, Nguyen C, Neal EFG et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This randomised controlled trial tested whether giving pregnant people a single dose of azithromycin during labour reduces infections in newborns and birthing parents in Fiji. The study included 2,110 pregnant people and their infants. While the intervention did not reduce the primary outcome of skin infections in infants, it did reduce various infections in both infants and birthing parents, with the strongest effect in the first week after birth. The benefits diminished over time and did not reduce overall antibiotic prescriptions.
Key points
- At 3 months, infant infections were 13.6% in the azithromycin group versus 17.3% in the placebo group (RR 0.79, p=0.038)
- Infections in birthing parents were substantially reduced 1 week postdelivery (RR 0.31, p=0.006) with skin and soft tissue infections reduced 75% (RR 0.25, p=0.013)
- The protective effect for birthing parents diminished over the 6-month follow-up period
- Azithromycin did not reduce antibiotic prescriptions at any time point despite reducing infections
- 2,110 pregnant people were enrolled between June 2019 and January 2022 in a 1:1 randomised design
Limitations
This study was conducted only in Fiji and may not generalise to other settings with different infection epidemiology or health systems. The document does not provide data on antimicrobial resistance patterns, impacts on infant microbiome, or longer-term child health outcomes beyond 12 months, which the authors identify as needed for future research.
Abstract
Introduction Our Bulabula MaPei trial of azithromycin administered during labour in Fiji found no evidence of a reduction in the primary endpoint of infant skin and soft tissue infections (SSTIs) at 3 months of age. Here, we determine the efficacy of this intervention on several secondary outcomes. Methods This randomised controlled trial included healthy pregnant adults presenting to hospital in labour. 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. Adverse events described as proportions by group at specified time points. Results From June 2019 to January 2022, we enrolled 2110 pregnant people and their infants (n=2122; azithromycin n=1059; placebo n=1063). At 3 months, the cumulative incidence of infant infections was 13.6% in the azithromycin group compared with 17.3% in the placebo group (risk ratio (RR) 0.79; 95% CI 0.63 to 0.99; p=0.038). Infections among birthing parents, including SSTIs, were reduced with the greatest effect 1 week postdelivery (infections: RR 0.31; 95% CI 0.13 to 0.71; p=0.006, SSTIs: RR 0.25; 95% CI 0.08 to 0.75; p=0.013) but with a diminishing effect up to 6 months postdelivery. There was no effect on the prescription of antibiotics at any time point. Conclusions Intrapartum azithromycin prevents a variety of infections for birthing parents and infants up to 12 months post partum in Fiji. However, further research is required to identify target populations and better characterise potential impacts on antimicrobial resistance and the infant microbiome and resistome. Trial registration number NCT03925480.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Single oral dose of 2 g azithromycin administered to pregnant people during labour
- Population
- Healthy pregnant adults and their infants presenting to hospital in labour in Fiji (n=2,110 pregnant people, n=2,122 infants)
Key finding
Primary endpoint (infant skin and soft tissue infections at 3 months) showed no reduction
M et al. · Europe PMC · 4 Mar 2026