Azithromycin and Ampicillin for Late PPROM

The goal of this clinical trial is to learn whether adding azithromycin to the standard antibiotic treatment (ampicillin) improves newborn outcomes in women with preterm premature rupture of membranes (PPROM) between 34.0 and 36.6 weeks of pregnancy. The main question it aims to answer is: Does the combination of ampicillin and azithromycin lower the risk of serious neonatal health problems compared to ampicillin alone? Researchers will compare two antibiotic regimens: Ampicillin alone, which is the current standard care Ampicillin with azithromycin, a broader regimen that may better prevent infections and prolong pregnancy Participants will: Receive one of the two antibiotic treatments during hospitalization. Be monitored until delivery for signs of infection and labor All participants will stay in the hospital until delivery. The study also looks at how the antibiotic choice may affect the time between membrane rupture and delivery, maternal infections, and the need for neonatal intensive care.

NCT Number	NCT07183462
Lead Sponsor	Sheba Medical Center
Conditions	Pregnancy Complications, Infectious, Premature Birth, Neonatal Diseases and Abnormalities, Antibiotic Prophylaxis, Latency Period, Prematurity
Enrollment	311 participants
Start Date	2025-09-10
Primary Completion	2029-06-30 (estimated)
Study Completion	2029-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-18