RecruitingPhase 4NCT07183462

Azithromycin and Ampicillin for Late PPROM


Sponsor

Sheba Medical Center

Enrollment

311 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ampicillin/Amoxicillin plus single-dose PO Azithromycin and a drug called Intravenous Ampicillin followed by Oral Amoxicillin for people with antibiotic prophylaxis, latency period, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntravenous Ampicillin followed by Oral Amoxicillin

This intervention consists of intravenous Ampicillin 2 grams every 6 hours for 48 hours, followed by oral Amoxicillin 500 mg every 8 hours for 5 days

DRUGAmpicillin/Amoxicillin plus single-dose PO Azithromycin

This intervention includes intravenous Ampicillin 2 grams every 6 hours for 48 hours, followed by oral Amoxicillin 500 mg every 8 hours for 5 days, plus a single dose of oral Azithromycin 1 gram administered once at the start of treatment


Locations(1)

Sheba medical center

Ramat Gan, Israel, Israel

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NCT07183462


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