PPROM Erythromycin Versus Azithromycin

NCT01431248 | Completed

• 1 other identifier: PEACE
• Study Type: observational
• Target: 7
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preterm Premature Rupture of Membranes

Keywords

Preterm Premature Rupture of Membranes; Erythromycin; Azithromycin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• Indiana University School of Medicine: collaborator

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Study Officials

• Eric Knudtson, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 16, 2013

Record last verified: 2013-01