NCT05345457View on ClinicalTrials.gov

Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age

PHASE4RecruitingINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

January 13, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

Conditions
Pregnancy PretermPregnancy PromPROM, Preterm (Pregnancy)PROM (Pregnancy)Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/LaborPremature Birth
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.

Trial Locations (3)

44106

NOT_YET_RECRUITING

University Hospitals, Cleveland

44109

RECRUITING

MetroHealth, Cleveland

44111

NOT_YET_RECRUITING

Cleveland Clinic, Cleveland

All Listed Sponsors
collaborator

MetroHealth Medical Center

OTHER

collaborator

The Cleveland Clinic

OTHER

lead

University Hospitals Cleveland Medical Center

OTHER