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Azithromycin and Ampicillin for Late PPROM

NCT07183462 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Pregnancy Complications, Infectious
  • Premature Birth
  • Neonatal Diseases and Abnormalities
  • Antibiotic Prophylaxis
  • Latency Period
  • Prematurity

Interventions

DRUG

Intravenous 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

DRUG

Ampicillin/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

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Noa Gonen, MD · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2029-06-30
Completion
2029-07-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07183462 on ClinicalTrials.gov