Peer Review Report For: Azithromycin in labour to reduce maternal and newborn sepsis and associated deaths: the need for a harmonized approach [version 1; peer review: 1 approved, 1 approved with reservations]

Maternal and newborn infections are a major contributor to mortality and morbidity globally. Lost-cost, effective and safe interventions are needed to address these. Based on promising findings, azithromycin has been identified as potentially effective antibiotic to reduce maternal and newborn infections in low- and middle-income countries (LMICs). However, robust randomized clinical trials in a range of settings are needed to confirm these findings as well as to understand the implications for antimicrobial resistance. To better understand the impact of azithromycin on maternal and newborn health, at least three clinical trials are being conducted to evaluate azithromycin in LMICs. We describe these trials, the importance of harmonizing study measures and the potential public health impact of azithromycin in LMICs.