RECRUITING

Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-08
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06273891

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnancy at 22 weeks 0 days to 32 weeks 6 days of gestation.
  2. * Rupture of membranes confirmed by biochemical testing.
  3. * Membrane rupture within the past 36 hours.
  4. * Cervical dilation 3 cm or less and 4 or fewer contractions within 60-minutes at the time of admission.
  5. * Age ≥18 and \<50 years.
  1. * Non-reassuring fetal heart tracing, vaginal bleeding, chorioamnionitis or any indication for delivery at admission.
  2. * Allergy to penicillin, erythromycin, or azithromycin.
  3. * Multiple gestations.

Contacts and Locations

Study Contact

Antonio Saad, MD, MBA
CONTACT
7037766040
antonio.saad@inova.org
Ellen M Murrin, DO
CONTACT
7037766040
ellen.murrin@inova.org

Principal Investigator

Antonio Saad, MD, MBA
PRINCIPAL_INVESTIGATOR
Inova Health Systems
Ellen M Murrin, DO
PRINCIPAL_INVESTIGATOR
Inova Health Systems

Study Locations (Sites)

Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
United States
Eastern Viriginia Medical School
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Inova Fairfax Hospital

  • Antonio Saad, MD, MBA, PRINCIPAL_INVESTIGATOR, Inova Health Systems
  • Ellen M Murrin, DO, PRINCIPAL_INVESTIGATOR, Inova Health Systems

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-08
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2024-03-08
Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

  • pprom
  • latency antibiotics
  • prom

Additional Relevant MeSH Terms

  • Premature Rupture of Membrane