Azithromycin in labor lowers clinical infections in mothers and newborns: a double-blind trial

Claire Oluwalana, Bully Camara, Christian Bottomley, Sean Goodier, Abdoulie Bojang, Beate Kampmann, Samba Ceesay, Umberto D'Alessandro, Anna Roca

    Research output: Contribution to journalA1: Web of Science-article

    Abstract

    BACKGROUND AND OBJECTIVES: We have recently completed a proof-of-concept trial showing that bacterial colonization decreased in women and newborns after the administration of azithromycin during labor. Here, we aim to assess the effect of the intervention on maternal and neonatal clinical infections.

    METHODS: This was a double-blind, placebo-controlled randomized trial. Gambian women in labor were given either an oral dose of azithromycin (2 g) or placebo. Follow-up was conducted for 8 weeks after delivery.

    RESULTS: From April 2013 to April 2014, we recruited 829 mothers and their 830 newborns. Sixteen infants died during the follow-up period (8 per arm). No maternal deaths or serious adverse events related to the intervention were reported. Maternal infections were lower in the azithromycin group (3.6% vs 9.2%; relative risk [RR], 0.40; 95% confidence interval [CI], 0.22-0.71; P = .002), as was the prevalence of mastitis (1.4% vs 5.1%; RR, 0.29; 95% CI, 0.12-0.70; P = .005) and fever (1.9% vs 5.8%; RR, 0.33; 95% CI, 0.15-0.74; P = .006). Among newborns, the overall prevalence of infections was also lower in the azithromycin group (18.1% vs 23.8%; RR, 0.76; 95% CI, 0.58-0.99; P = .052) and there was a marked difference in prevalence of skin infections (3.1% vs 6.4%; RR, 0.49; 95% CI, 0.25-0.93; P = .034).

    CONCLUSIONS: Azithromycin given to women in labor decreases infections in both women and newborns during the puerperal period. Larger studies designed to evaluate the effect of the intervention on severe morbidity and mortality are warranted.

    Original languageEnglish
    Article number20162281
    JournalPediatrics
    Volume139
    Issue number2
    Number of pages11
    ISSN0031-4005
    DOIs
    Publication statusPublished - 2017

    Keywords

    • LACTATING WOMEN
    • SEPSIS
    • PREVENTION
    • GAMBIA
    • HEALTH
    • MORTALITY
    • PROTOCOL
    • DISEASE
    • AFRICA
    • MILK

    Cite this