PPROM Erythromycin Versus Azithromycin

Preterm Premature Rupture of Membranes Clinical Trial

— PEACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431248
• Other study ID #: PEACE
• Status: Completed
• Phase: N/A
• First received: September 7, 2011
• Last updated: January 15, 2013
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membranes
• Rupture

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Indiana University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to delivery	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.	2 years	No