NCT07183462 Azithromycin and Ampicillin for Late PPROM
| NCT ID | NCT07183462 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sheba Medical Center |
| Condition | Pregnancy Complications, Infectious |
| Study Type | INTERVENTIONAL |
| Enrollment | 311 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 311 participants in total. It began in 2025-09-10 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Maternal age 18-50 * Premature rupture of membranes * Gestational age 34.0 and 36.4 weeks * Singleton pregnancy Exclusion Criteria: * 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
Contact & Investigator
Noa Gonen, MD
STUDY CHAIR
Sheba Medical Center
Frequently Asked Questions
Who can join the NCT07183462 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Pregnancy Complications, Infectious. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07183462 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07183462 currently recruiting?
Yes, NCT07183462 is actively recruiting participants. Contact the research team at gonen.noa7@gmail.com for enrollment information.
Where is the NCT07183462 trial being conducted?
This trial is being conducted at Ramat Gan, Israel.
Who is sponsoring the NCT07183462 clinical trial?
NCT07183462 is sponsored by Sheba Medical Center. The principal investigator is Noa Gonen, MD at Sheba Medical Center. The trial plans to enroll 311 participants.