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Key Points: Question: Does azithromycin administered orally during labor reduce neonatal sepsis and mortality? Findings: This randomized trial in West Africa included 11 983 birthing parents and their infants. The incidence of the composite end point of neonatal sepsis or neonatal mortality was similar in the azithromycin (2.0%) and placebo (1.9%) groups. However, the incidence of noninvasive infections during the subsequent 4 weeks was reduced for newborns (skin infections) and parents (puerperal fever and mastitis) in the azithromycin group. Meaning: These results do not support routine introduction of oral intrapartum azithromycin to reduce neonatal sepsis or mortality. Importance: Neonatal sepsis is a leading cause of neonatal mortality. New interventions are needed to decrease neonatal sepsis and mortality in regions with highest burden. Objective: To evaluate the efficacy of intrapartum azithromycin to reduce neonatal sepsis or mortality, as well as neonatal and maternal infections. Design, Setting, and Participants: This double-blind, placebo-controlled, randomized clinical trial enrolled and followed up birthing parents and their infants at 10 health facilities in The Gambia and Burkina Faso, West Africa, between October 2017 and May 2021. Interventions: Participants were assigned at random to receive oral azithromycin (2 g) or placebo (ratio 1:1) during labor. Main Outcomes and Measures: The primary outcome was a composite of neonatal sepsis or mortality, with the former defined based on microbiologic or clinical criteria. Secondary outcomes were neonatal infections (skin, umbilical, eye and ear infections), malaria, and fever; postpartum infections (puerperal sepsis, mastitis), fever, and malaria; and use of antibiotics during 4-week follow-up. Results: The trial randomized 11 983 persons in labor (median age, 29.9 years). Overall, 225 newborns (1.9% of 11 783 live births) met the primary end point. The incidence of neonatal mortality or sepsis was similar in the azithromycin and placebo groups (2.0% [115/5889] vs 1.9% [110/5894]; risk difference [RD], 0.09 [95% CI, −0.39 to 0.57]), as was the incidence of neonatal mortality (0.8% vs 0.8%; RD, 0.04 [95% CI, −0.27 to 0.35]) and neonatal sepsis (1.3% vs 1.3%; RD, 0.02 [95% CI, −0.38 to 0.43]). Newborns in the azithromycin group compared with the placebo group had lower incidence of skin infections (0.8% vs 1.7%; RD, −0.90 [95% CI, −1.30 to −0.49]) and need for antibiotics (6.2% vs 7.8%; RD, −1.58 [95% CI, −2.49 to −0.67]). Postpartum parents in the azithromycin group had lower incidence of mastitis (0.3% vs 0.5%; RD, −0.24 [95% CI, −0.47 to −0.01]) and puerperal fever (0.1% vs 0.3%; RD, −0.19 [95% CI, −0.36 to −0.01]). Conclusions and Relevance: Azithromycin administered orally during labor did not reduce neonatal sepsis or mortality. These results do not support routine introduction of oral intrapartum azithromycin for this purpose. Trial Registration: ClinicalTrials.gov Identifier: NCT03199547 This randomized trial compares the efficacy of intrapartum azithromycin vs placebo to reduce neonatal sepsis or mortality, as well as neonatal and maternal infections, among birthing parents and their infants in West Africa. [ABSTRACT FROM AUTHOR]