MedTrace Logo

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

NCT05345457 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-04-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • MetroHealth Medical Center

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • David Hackney, MD · University Hospitals Cleveland Medical Center

  • Justin Lappen, MD · The Cleveland Clinic

  • Brian Mercer, MD · MetroHealth Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-13
Primary Completion
2026-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05345457 on ClinicalTrials.gov