Erythromycin Versus Azithromycin in Preterm Premature Rupture of Membranes

• Status: Withdrawn
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

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 the macrolides azithromycin and erythromycin for prolonging latency in PPROM.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Treatments: Azithromycin; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate

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 not associated with labor

• 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.