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Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
Sponsor: University Hospitals Cleveland Medical Center
Summary
A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2023-01-13
Completion Date
2027-06
Last Updated
2025-04-22
Healthy Volunteers
Yes
Conditions
Interventions
Azithromycin Pill
Azithromycin will be dosed as single 500 mg dose (2-250mg oral tablets) administered immediately following randomization, yet prior to discharge to home, followed with 1-250mg oral tablet daily for 4 additional days (for a total of 5 days).
Amoxicillin Pill
Amoxicillin will be dosed as a single-500mg oral tablet three times daily for 7 days with first dose also being given prior to discharge home.
Locations (3)
University Hospitals
Cleveland, Ohio, United States
MetroHealth
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States