Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

Description

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

Premature Rupture of Membrane

Study Overview

Study Details

Study overview

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.

Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes: A Cluster Randomized Comparative Effectiveness Trial

Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

Condition
Premature Rupture of Membrane
Intervention / Treatment

-

Contacts and Locations

Falls Church

Inova Fairfax Medical Campus, Falls Church, Virginia, United States, 22042

Norfolk

Eastern Viriginia Medical School, Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pregnancy at 22 weeks 0 days to 32 weeks 6 days of gestation.
  • * Rupture of membranes confirmed by biochemical testing.
  • * Membrane rupture within the past 36 hours.
  • * Cervical dilation 3 cm or less and 4 or fewer contractions within 60-minutes at the time of admission.
  • * Age ≥18 and \<50 years.
  • * Non-reassuring fetal heart tracing, vaginal bleeding, chorioamnionitis or any indication for delivery at admission.
  • * Allergy to penicillin, erythromycin, or azithromycin.
  • * Multiple gestations.

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Inova Fairfax Hospital,

Antonio Saad, MD, MBA, PRINCIPAL_INVESTIGATOR, Inova Health Systems

Ellen M Murrin, DO, PRINCIPAL_INVESTIGATOR, Inova Health Systems

Study Record Dates

2025-10-01