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

Tracking Information

First Received Date ^ICMJE

September 7, 2011

Last Updated Date

January 15, 2013

Start Date ^ICMJE

September 2011

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01431248 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

PPROM Erythromycin Versus Azithromycin

Official Title ^ICMJE

Preterm Premature Rupture of Membranes: Erythromycin Versus Azithromycin. A Randomized Trial Comparing Their Efficacy to Prolong Latency

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.

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

Preterm Premature Rupture of Membranes

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01431248

Other Study ID Numbers ^ICMJE

PEACE

Has Data Monitoring Committee

Responsible Party

University of Oklahoma

Study Sponsor ^ICMJE

University of Oklahoma

Collaborators ^ICMJE

Indiana University School of Medicine

Investigators ^ICMJE

Principal Investigator:

Eric Knudtson, MD

University of Oklahoma

Information Provided By

University of Oklahoma

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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