Azithromycin and Ampicillin for Late PPROM

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorSheba Medical Center

About this trial

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 criteria

Qualifiers

Maternal age 18-50

Premature rupture of membranes

Gestational age 34.0 and 36.4 weeks

Singleton pregnancy

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intravenous Ampicillin followed by Oral Amoxicillin
  • Ampicillin/Amoxicillin plus single-dose PO Azithromycin

Treatment groups

311 Participants
are divided into 2 treatment groups

Sponsors and collaborators