RCT | Intrapartum azithromycin fails to reduce neonatal sepsis and death

Summary: This randomized controlled trial aimed to evaluate the effectiveness of administering azithromycin during labor to reduce neonatal sepsis and mortality. The randomized trial involved 11,983 birthing parents and their infants in West Africa.

The study found no significant difference in the incidence of neonatal sepsis or mortality between the azithromycin and placebo groups. On the other hand, the rate of non-invasive infections, including skin infections in newborns, and mastitis and puerperal fever in parents, was lower in the azithromycin group in the following four weeks.

The authors concluded that these results do not support the routine introduction of oral intrapartum azithromycin to reduce neonatal sepsis or mortality. However, it is important to notice that a recent large study published in the New England Journal of Medicine showed conflicting results.

Article: Effect of Intrapartum Azithromycin vs Placebo on Neonatal Sepsis and Death: A Randomized Clinical Trial – JAMA (link to abstract – $ for full-text)

Commentaries:

Azithromycin during labor doesn’t reduce sepsis, mortality in newborns – CIDRAP

Effect of antibiotics during pregnancy on neonatal sepsis and mortality – MedicalResearch.com

Related study with conflicting results: Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Single-dose antibiotic prevents maternal sepsis and death – NIH News

Commentaries:

In large study, a single antibiotic dose slashed rate of sepsis in childbirth – STAT

Dose of azithromycin found to cut risk of maternal death, sepsis in childbirth – CIDRAP

Commentary on Twitter

Study results do not support routine introduction of oral intrapartum azithromycin to reduce neonatal sepsis or mortality. https://t.co/yDpg1CCGa2 pic.twitter.com/5Oc4HqZ4sX

— JAMA (@JAMA_current) March 7, 2023