Actively Recruiting
Azithromycin and Ampicillin for Late PPROM
Led by Sheba Medical Center · Updated on 2025-12-18
311
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Azithromycin and Ampicillin for Late PPROM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal age 18 to 50 years
- Premature rupture of membranes between 34.0 and 36.4 weeks of pregnancy
- Singleton pregnancy
You will not qualify if you...
- Multiple pregnancies (twins or more)
- Active labor defined as cervical dilation of 3 cm or more with 80% or greater effacement, or regular uterine contractions more than 4 in 10 minutes
- Presence of meconium-stained amniotic fluid
- Non-reassuring fetal heart rate or fetal status
- Maternal or fetal indications for labor including suspected chorioamnionitis, placental abruption, or maternal morbidity requiring labor
- Cervical cerclage in place
- Major fetal malformations or known chromosomal abnormalities
- Stillbirth
- Known allergy or sensitivity to macrolide antibiotics
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sheba medical center
Ramat Gan, Israel, Israel
Actively Recruiting
Research Team
N
Noa Gonen, MD
CONTACT
M
Michal Fishel - Bartal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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