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.
Maternal age 18-50
Premature rupture of membranes
Gestational age 34.0 and 36.4 weeks
Singleton pregnancy
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
Parallel
Intravenous Ampicillin followed by Oral Amoxicillin
DrugThis 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
Ampicillin/Amoxicillin plus single-dose PO Azithromycin
DrugThis 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
A composite of neonatal adverse outcomes
A composite of neonatal adverse outcomes defined as the occurrence of one or more of the following events within 72 hours after birth: use of continuous positive airway pressure (CPAP) or high-flow nasal cannula, supplemental oxygen with a fraction of inspired oxygen (FiO2) ≥0.30 for ≥4 continuous hours, extracorporeal membrane oxygenation (ECMO), mechanical ventilation, neonatal sepsis (defined as positive blood culture), hypoglycemia requiring treatment, hyperbilirubinemia requiring phototherapy, stillbirth, or neonatal death within 72 hours after delivery The composite will be reported as the number of infants who experience at least one of the listed adverse outcomes. Unit of Measure: Number of infants with ≥1 adverse outcome
Number of Infants With Severe Respiratory Morbidity
Includes infants requiring CPAP or high-flow nasal cannula for ≥12 hours or mechanical ventilation, or neonatal death
Number of Infants Requiring Resuscitation at Birth
Any newborn requiring active resuscitation immediately after birth
Number of Infants Diagnosed With Respiratory Distress Syndrome
Based on clinical signs, FiO₂ \>0.21, and characteristic chest X-ray findings
Number of Infants Receiving Surfactant Therapy
Administration of surfactant during hospitalization
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