NCT05345457

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy Preterm
• Pregnancy Prom
• PROM, Preterm (Pregnancy)
• PROM (Pregnancy)
• Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor
• Premature Birth

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-13
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2022-04-26
• Last updated: 2025-04-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study