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PPROM Erythromycin Versus Azithromycin (PEACE)

This study has been completed.
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01431248
First received: September 7, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in stomach upset in some patients, causing them to stop taking the medication. Therefore, azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach upset is not seen or greatly reduced. The goal of this study is to see if there is a difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The working hypothesis is that there is no difference in the clinical effectiveness between antibiotic regimens containing te macrolides azithromycin and erythromycin for prolonging latency in PPROM.


Condition
Preterm Premature Rupture of Membranes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preterm Premature Rupture of Membranes: Erythromycin Versus Azithromycin. A Randomized Trial Comparing Their Efficacy to Prolong Latency

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Time to delivery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To compare the mean time to delivery, using azithromycin versus erythromycin to prolong latency in PPROM patients. The working hypothesis for this aim is that there is no difference in the clinical effectiveness between antibiotic regimens containing the macrolides azithromycin and erythromycin for prolonging latency in PPROM.


Enrollment: 7
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Azithromycin
Azithromycin 1gm PO once
Erythromycin 250mg
Erythromycin 250mg IV Q 6hrs x 48 hours followed by 500 mg PO Q 8 hours x 5 days.

Detailed Description:

The current standard regimen for PPROM patients between the gestational age of 24 0/7 and 32 0/7 weeks, is to administer ampicillin 2gm IV every 6hours for 48hrs followed by amoxicillin 250mg orally every 8 hours for 5 days, with erythromycin 250mg IV for 48hours followed by 500mg orally every 8hours for 5 days. Our study design would be a prospective randomized trial. Consented, eligible women will be randomized to receive ampicillin as above plus either azithromycin 1 gm orally at enrollment or erythromycin 250mg IV every 6 hours for 48hours followed by 500mg orally every 8hours for 5 days. Those who are unable to tolerate the 1gm of azithromycin within the first 30 minutes of administration, a 1000mg powder suspension will be given. In conjunction with standard protocol, a course of steroids for fetal lung maturity will be administered upon the treating staff's discretion, and all Group B Beta Streptococcus positive patients will be treated.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pregnant women with the diagnosis of PPROM will be enrolled in this protocol.

Criteria

Inclusion Criteria:

  • Pregnant women at least 18 years old
  • Gestational age of 24 0/7 to 32 0/7 weeks
  • Singleton gestation
  • Randomization within 36 hours of rupture of membranes.
  • Cervical dilation less than or equal to 4 cm.

Exclusion Criteria:

  • Known lethal fetal anomaly
  • Vaginal bleeding
  • Maternal or fetal indication for delivery
  • Diagnosis of chorioamnionitis on admission
  • Cervical cerclage in place
  • Placenta previa or other known placental anomalies
  • Use of antibiotic therapy within 5 days.
  • Allergy or other contraindications to erythromycin/azithromycin or steroid use.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431248

Sponsors and Collaborators
University of Oklahoma
Indiana University School of Medicine
Investigators
Principal Investigator: Eric Knudtson, MD University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01431248     History of Changes
Other Study ID Numbers: PEACE
Study First Received: September 7, 2011
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Preterm Premature Rupture of Membranes
Erythromycin
Azithromycin

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Erythromycin stearate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
 Azithromycin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 16, 2013