Actively Recruiting

Phase 3
Age: 18Years - 50Years
FEMALE
NCT06273891

Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

Led by Inova Health Care Services · Updated on 2025-09-18

140

Participants Needed

2

Research Sites

133 weeks

Total Duration

On this page

Sponsors

I

Inova Health Care Services

Lead Sponsor

E

Eastern Virginia Medical School

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM.

CONDITIONS

Official Title

Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant between 22 weeks 0 days and 32 weeks 6 days of gestation
  • Water break confirmed by biochemical testing
  • Membrane rupture occurred within the past 36 hours
  • Cervical dilation 3 cm or less and 4 or fewer contractions within 60 minutes at admission
  • Female aged 18 years or older and younger than 50 years
Not Eligible

You will not qualify if you...

  • Non-reassuring fetal heart tracing, vaginal bleeding, chorioamnionitis, or need for delivery at admission
  • Allergy to penicillin, erythromycin, or azithromycin
  • Multiple pregnancies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Inova Fairfax Medical Campus

Falls Church, Virginia, United States, 22042

Actively Recruiting

2

Eastern Viriginia Medical School

Norfolk, Virginia, United States, 23507

Actively Recruiting

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Research Team

A

Antonio Saad, MD, MBA

CONTACT

E

Ellen M Murrin, DO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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