Comparing Erythromycin and Azithromycin for Treating Premature Rupture of Membranes
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes: A Cluster Randomized Comparative Effectiveness Trial
This study is testing whether azithromycin or erythromycin works better with standard care to help pregnant people with premature rupture of membranes keep their pregnancy going longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Inova Health Care Services Academic / other |
| Locations | 2 sites (Falls Church, Virginia and 1 other locations) |
| Trial ID | NCT06273891 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the most effective antibiotic treatment for pregnant individuals experiencing premature rupture of membranes (PPROM). Participants diagnosed with PPROM will be randomly assigned to receive either azithromycin or erythromycin, alongside standard care with ampicillin and amoxicillin, to see which antibiotic combination better prolongs pregnancy. The study is crucial as it addresses a gap in existing research regarding the optimal antibiotic choice for this condition. By comparing these two treatments, the study seeks to improve outcomes for both mothers and their babies.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals between 22 and 32 weeks gestation who have experienced a confirmed rupture of membranes within the last 36 hours.
Not a fit: Patients with non-reassuring fetal heart tracings, chorioamnionitis, or those requiring immediate delivery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved antibiotic treatment protocols that prolong pregnancies and reduce complications for both mothers and infants.
How similar studies have performed: While observational studies have shown no significant difference between azithromycin and erythromycin, this study is novel as it is the first randomized controlled trial to directly compare these two antibiotics in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnancy at 22 weeks 0 days to 32 weeks 6 days of gestation. * Rupture of membranes confirmed by biochemical testing. * Membrane rupture within the past 36 hours. * Cervical dilation 3 cm or less and 4 or fewer contractions within 60-minutes at the time of admission. * Age ≥18 and \<50 years. Exclusion Criteria: * Non-reassuring fetal heart tracing, vaginal bleeding, chorioamnionitis or any indication for delivery at admission. * Allergy to penicillin, erythromycin, or azithromycin. * Multiple gestations.
Where this trial is running
Falls Church, Virginia and 1 other locations
- Inova Fairfax Medical Campus — Falls Church, Virginia, United States (Recruiting)
- Eastern Viriginia Medical School — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Antonio Saad, MD, MBA — Inova Health Care Services
- Study coordinator: Antonio Saad, MD, MBA
- Email: antonio.saad@inova.org
- Phone: 7037766040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.