Phase 3 Trial of Azithromycin Added to Standard Antibiotics to Prevent Infections After Scheduled or Prelabor Cesarean Delivery

What this Trial Is About

Researchers are studying whether adding azithromycin to the usual antibiotics given before a scheduled or prelabor cesarean delivery can reduce infections after surgery. This phase III trial involves 8,000 individuals and compares azithromycin with a placebo while all participants receive standard antibiotics. The main goal is to see if azithromycin lowers the risk of infections such as wound infections, sepsis, pneumonia, and breast infections up to six weeks after delivery. Participants are randomly assigned to receive either 500mg of intravenous azithromycin or a placebo normal saline about one hour before the cesarean incision. Both groups also get the standard antibiotic treatment before surgery, excluding azithromycin. Blood samples from the mother and baby may be collected in some cases. Researchers will track health outcomes related to infections and other complications during delivery and hospital stay. Participants will have one follow-up visit between 4 and 8 weeks after giving birth to assess both maternal and newborn health. During the study, medical records will be reviewed to monitor outcomes. The trial will measure infection rates, wound complications, hospital stay length, neonatal intensive care admissions, use of healthcare resources, and presence of antibiotic-resistant infections. The total study period for each participant lasts up to six weeks postpartum.

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial