Intrapartum azithromycin reduces maternal infection risk regardless of time to delivery
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Key Takeaway
Consider intrapartum azithromycin for maternal infection prevention regardless of delivery timing, but note no neonatal benefit.
This secondary analysis of a randomized controlled trial examined whether the efficacy of intrapartum azithromycin for preventing infections varied by time from administration to delivery. The study included 29,236 pregnant patients at ≥28 weeks gestation presenting in labor for planned vaginal delivery across multiple international centers. Patients received either a single 2g oral dose of azithromycin or placebo during labor.
The analysis found that azithromycin reduced the risk of any maternal infection regardless of time to delivery, with a relative risk of 0.71 (95% CI 0.64-0.79) for administration ≤12 hours before delivery and 0.71 (95% CI 0.54-0.94) for >12 hours. However, in a Sub-Saharan Africa subgroup, greater benefit was observed with administration >12 hours before delivery (RR 0.21, 95% CI 0.08-0.54) compared to ≤12 hours (RR 0.52, 95% CI 0.41-0.66), with an interaction p-value of 0.03. For neonatal infection, azithromycin showed no benefit regardless of timing (RR 1.00, 95% CI 0.95-1.06 for ≤9h; RR 1.01, 95% CI 0.88-1.15 for >9h).
Safety and tolerability data were not reported in this analysis. Key limitations include its nature as a secondary analysis, which increases the risk of false-positive findings, particularly for subgroup analyses. The Sub-Saharan Africa finding requires cautious interpretation as it represents a subgroup analysis with potential confounding factors. While the analysis suggests intrapartum azithromycin benefits maternal infection prevention regardless of anticipated delivery time, clinicians should note the absence of neonatal infection benefit and consider these findings as hypothesis-generating rather than definitive practice guidance.
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View Original Abstract ↓
OBJECTIVE: A multi-centre international trial (A-PLUS), demonstrated that a single dose of 2 g oral azithromycin in labour reduced the risk of maternal sepsis or death, but not neonatal mortality. We aimed to determine whether the efficacy of azithromycin in prevention of any maternal infection or neonatal infection varied by time interval from azithromycin administration to delivery.
DESIGN: This is a secondary analysis of a randomized controlled trial.
SETTING: Multi-centre international randomized controlled trial.
POPULATION: Pregnant patients ≥ 28 weeks gestation (singleton or multiple gestation) presenting in labour for planned vaginal delivery.
OUTCOMES: The primary outcome for this secondary analysis was maternal infection and the secondary outcome was any neonatal infection.
METHODS: The estimated relative risks (and 95% confidence interval) of any maternal or neonatal infection comparing azithromycin to placebo were obtained by fitting a Poisson model adjusting for site, treatment arm, hours between drug administration and delivery (as continuous measure, and ≤ 12 or > 12 h for maternal and ≤ 9 or > 9 h for neonatal), and the two-way interaction between treatment arm and hours between drug administration and delivery.
RESULTS: Included in the analysis were n = 14 569 randomized to azithromycin and n = 14 667 to placebo. There was no evidence that the benefit of azithromycin on reducing the risk of any maternal infection varied by time from dose to delivery (RR 0.71 (0.64-0.79) and RR 0.71 (0.54-0.94) for ≤ 12 and > 12 h respectively, interaction p = 0.987), although there was an observed interaction in Sub-Saharan Africa subgroup with reduced risk observed with administration > 12 vs. ≤ 12 (RR 0.21 (0.08-0.54) vs. RR 0.52 (0.41-0.66), interaction p = 0.03). There was no benefit observed in prevention of infant infection regardless of time from dose to delivery (≤ 9 or > 9 h) (RR 1.00 (0.95-1.06) and RR 1.01 (0.88-1.15) interaction p = 0.997).
CONCLUSION: The benefit observed with a single intrapartum dose of azithromycin for prevention of any maternal infection in the setting of planned vaginal delivery was not observed to vary by time interval from azithromycin administration to delivery, although in some populations there may be greater benefit with delivery > 12 h from administration. Pregnant patients presenting for planned vaginal birth benefit from a single dose of 2 g azithromycin regardless of how soon delivery is anticipated.
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