PPROM Erythromycin Versus Azithromycin

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.

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Key information

Conditions

Preterm Premature Rupture of Membranes Preterm Premature Rupture of the Membranes

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

Indiana University

Registry information

Official study title

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

Acronym: PEACE

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 9, 2011
Registry last updated: Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed