6/29/23, 1:44 AM PregnAnZI-2 Pathway Feedback Search Clinical Topics Home Studies PregnAnZI 2 PregnAnZI 2 Trial question What is the effect of intrapartum azithromycin on neonatal sepsis and death? Study design Multi-center Double blinded RCT Population 11625 female patients Inclusion criteria: birthing parents and their newborns Key exclusion criteria: human immunodeficiency virus infection, chronic or acute condition, planned cesarean delivery or known required referral, severe congenital malformation, allergy to macrolides, use in the last 2 weeks of drugs known to prolong the QT interval Interventions N=5802 azithromycin (an oral 2 g dose during labor) N=5823 placebo (matching placebo during labor) Primary outcome Neonatal sepsis or death 2.0 % 2 1.9 1.5 % 1.0 % 0.5 % No significant difference 0.0 % Azithromycin Placebo No significant difference in neonatal sepsis or death (2% vs. 1.9%; OR 1.06, 95% CI 0.8 to 1.38) Secondary outcomes No significant difference in neonatal death (0.8% vs. 0.8%; OR 1.05, 95% CI 0.7 to 1.6) Significant decrease in neonatal skin infections (0.8% vs. 1.7%; OR 0.48, 95% CI 0.34 to 0.67) https://web.pathway.md/studies/recILsV8NeS3IUYC0 1/2 6/29/23, 1:44 AM PregnAnZI-2 Pathway Significant decrease in mastitis among postpartum parents (0.3% vs. 0.5%; OR 0.53, 95% CI 0.29 to 0.98) Safety outcomes No significant difference in death and hospitalization for both parents and newborns. Significant differences in dizziness (4.4% vs. 5.3%), reported fever (0.8% vs. 1.3%), vomiting (10.1% vs. 6.1%), edema (4.2% vs. 3.2%) in birthing parents. Conclusion In birthing parents and their newborns, azithromycin was not superior to placebo with respect to neonatal sepsis or death. Reference Anna Roca, Bully Camara, Joel D Bognini et al. Effect of Intrapartum Azithromycin vs Placebo on Neonatal Sepsis and Death: A Randomized Clinical Trial. JAMA. 2023 Mar 7;329(9):716-724. Open reference URL https://web.pathway.md/studies/recILsV8NeS3IUYC0 2/2