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RECRUITING
NCT05345457
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

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