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PPROM Erythromycin Versus Azithromycin (PEACE)

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ClinicalTrials.gov Identifier: NCT01431248
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : January 16, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Preterm Premature Rupture of Membranes

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.

Study Design

Study Type : Observational
Actual Enrollment : 7 participants
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
Study Start Date : September 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. Time to delivery [ Time Frame: 2 years ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431248


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

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01431248     History of Changes
Other Study ID Numbers: PEACE
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

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

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