Azithromycin and Ampicillin for Late Preterm Premature Rupture of Membranes

What this Trial Is About

This research aims to find out if adding azithromycin to the standard antibiotic treatment with ampicillin improves outcomes for newborns when women experience preterm premature rupture of membranes (PPROM) between 34.0 and 36.6 weeks of pregnancy. The main goal is to see whether the combination lowers the risk of serious health problems for the newborn compared to ampicillin alone. PPROM is linked to risks such as infections and respiratory issues, and while treatments before 34 weeks are well studied, the best approach for later preterm periods is still uncertain. The study compares two antibiotic treatments for women with late PPROM: one group receives the standard regimen of intravenous ampicillin for 48 hours followed by oral amoxicillin for 5 days, while the other group gets the same regimen plus a single oral dose of azithromycin at the start. Women will remain hospitalized from diagnosis until delivery, with labor induced at 37 weeks or earlier if needed. The trial also monitors maternal and newborn health outcomes related to infections and complications. During the study, participants will be carefully monitored with regular checks of maternal vital signs, fetal heart rates twice daily, and ultrasound assessments. Researchers will track the time from membrane rupture to delivery, infections, and the need for neonatal intensive care. Placental tissue will be examined after delivery. The main outcome measured is a combination of serious newborn health issues within 72 hours after birth. Participants will be followed until delivery and through the postpartum period, with data kept confidential and used under strict ethical guidelines.

Azithromycin and Ampicillin for Late PPROM