Adding azithromycin to ampicillin for late PPROM
Official title: Azithromycin and Ampicillin for Late PPROM
Run by Sheba Medical Center · NCT07183462 · Data updated 2026-11-12
This test sees if adding a single dose of azithromycin to the usual ampicillin/amoxicillin treatment helps newborns when membranes break early between 34.0 and 36.6 weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 311 (estimated) |
| Sponsor | Sheba Medical Center Government |
| Locations | 1 site (Ramat Gan, Israel) |
| Status | Recruiting |
| Started | September 10, 2025 |
| Main results expected | June 30, 2029 |
| Study ends | July 31, 2029 |
| Registry record updated | December 18, 2025 |
| Trial ID | NCT07183462 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant people aged 18–50 with a singleton pregnancy and PPROM between 34.0 and 36.6 weeks who are not in active labor and have no macrolide allergy are ideal candidates.
✕Probably not a fit
Those in active labor, with multiple gestation, suspected chorioamnionitis, fetal compromise, major fetal anomalies, or macrolide sensitivity would not be expected to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 4 interventional trial enrolls pregnant people with singleton preterm premature rupture of membranes (PPROM) between 34.0 and 36.6 weeks to compare two antibiotic regimens. Participants are randomized to receive standard intravenous ampicillin followed by oral amoxicillin alone or the same regimen plus a single oral dose of azithromycin, and they remain hospitalized until delivery. Investigators monitor maternal signs of infection, time from membrane rupture to delivery (latency), and neonatal outcomes including serious morbidity and need for NICU support. The trial aims to determine whether broader antibiotic coverage in the late preterm period reduces neonatal complications or prolongs latency compared with current standard care.
Why it matters
Potential benefit: If successful, adding azithromycin could reduce serious neonatal infections and respiratory complications and lower NICU admissions by preventing ascending infection or prolonging pregnancy.
How similar studies have gone: Large randomized trials in earlier preterm PPROM (<32 weeks) showed benefit from combining ampicillin with a macrolide like erythromycin or azithromycin, but randomized evidence specifically in the late preterm window (34.0–36.6 weeks) is limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Sheba medical center
Ramat Gan, Israel, Israel Recruiting
Study contacts
- Study coordinator: Noa Gonen, MD
- Email: gonen.noa7@gmail.com
- Phone: 972-54-3955584
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.