RecruitingPhase 4NCT05345457

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

Enrollment

88 participants

Start Date

Jan 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Amoxicillin Pill and a drug called Azithromycin Pill for people with prom (pregnancy), prom, preterm (pregnancy), and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzithromycin 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).

DRUGAmoxicillin 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

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NCT05345457


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