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Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Sponsor: Inova Health Care Services
Summary
The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM.
Official title: Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes: A Cluster Randomized Comparative Effectiveness Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2024-03-08
Completion Date
2026-10-01
Last Updated
2025-09-18
Healthy Volunteers
No
Conditions
Interventions
Erythromycin
Erythromycin 250 mg IV every 6 hours for 48 hours, followed by 250 mg PO or 333 mg PO every 8 hours for 5 days in addition to Ampicillin 2 gm IV every 6 hours for 2 days followed by Amoxicillin 250 mg PO every 8 hours for 5 days
Azithromycin
Azithromycin 1 gm PO once or 500 mg PO followed by 250 mg PO daily for a total of 5 days in addition to Ampicillin 2 gm IV every 6 hours for 2 days followed by Amoxicillin 250 mg PO every 8 hours for 5 days
Locations (2)
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Eastern Viriginia Medical School
Norfolk, Virginia, United States