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

Inclusion Criteria4

  • Maternal age 18-50
  • Premature rupture of membranes
  • Gestational age 34.0 and 36.4 weeks
  • Singleton pregnancy

Exclusion Criteria12

  • Multiple gestations
  • Individuals in active labor (defined as 3 cm dilatation and 80% effacement or more. or regular uterine construction of more than 4 in 10 minutes)
  • Meconium stain amniotic fluid
  • Non-reassuring fetal heart rate or status
  • Maternal or fetal indication for labor:
  • Suspected Chorioamnionitis
  • Suspected placental abruption
  • Any maternal morbidity requiring labor
  • Cervical cerclage in place.
  • Major fetal malformation or known chromosomal abnormalities.
  • Stillbirth.
  • Sensitivity to Macrolides Antibiotics

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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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