PPROM Erythromycin Versus Azithromycin (PEACE)
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.
Preterm Premature Rupture of Membranes
|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|
- 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.
|Study Start Date:||September 2011|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Azithromycin 1gm PO once
Erythromycin 250mg IV Q 6hrs x 48 hours followed by 500 mg PO Q 8 hours x 5 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431248
|Principal Investigator:||Eric Knudtson, MD||University of Oklahoma|