Non-study post-partum antibiotics use and risk of maternal and neonatal infection: A secondary analysis of the A-PLUS randomized controlled trial.
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McClure Elizabeth M, Tita Alan T N, Carlo Waldemar A, Saleem Sarah, Moore Janet L, Jessani Saleem, Tikmani Shiyam Sunder, Shivkumar Poonam, Waikar Manjushri R, Patel Archana, Mwenechanya Musaku, Chomba Elwyn, Kavi Avinash, Metgud Mrityunjay C, Goudar Shivaprasad S, Lokangaka Adrien, Tshefu Antoinette, Nyongesa Paul, Esamai Fabian, Haque Rashidul, Billah Sk Masum, Derman Richard J, Bauserman Melissa, Bose Carl L, Hibberd Patricia L, Ekhaguere Osayame Austine, Bucher Sherri, Petri William A, Mazariegos Manolo, Krebs Nancy F, Asturias Edwin J, Hemingway-Foday Jennifer J, Babineau Denise C, Koso-Thomas Marion, Goldenberg Robert L
Аннотация
METHODS: Women ≥28 weeks gestation in labor and planning a vaginal delivery at a study hospital in seven low- and middle-income countries (Bangladesh, India [two sites], Pakistan, Guatemala, Kenya, Democratic Republic of Congo, and Zambia) were eligible for inclusion. Non-study antibiotic use was collected prospectively. We estimated the interaction of non-study antibiotics with azithromycin versus placebo on maternal and newborn sepsis.
RESULTS: A total of 29 287 participants were randomized (14 590 to azithromycin; 14 688 to placebo). Maternal infection was reduced among the azithromycin group compared to placebo among those who did not receive non-study antibiotics, with estimated relative risk (RR) 0.58 (95% confidence interval [CI] 0.48, 0.70), and among those who received non-study antibiotics, with RR 0.80 (95% CI 0.70, 0.91). Similar results were observed for maternal sepsis. Neonatal infection was not significantly reduced in any group. These results were similar when stratified by African and Asian region but not statistically significant.
CONCLUSION: Our results suggest a benefit of azithromycin in reducing maternal infection or sepsis across all groups, with a larger reduction in risk among participants who had not received other antibiotics. Given the concerns of inappropriate use of antibiotics, further research is warranted to determine the most effective strategies of reducing risk of infection.