PPROM Erythromycin Versus Azithromycin
Information source: University of Oklahoma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Preterm Premature Rupture of Membranes
Phase: N/A
Status: Completed
Sponsored by: University of Oklahoma Official(s) and/or principal investigator(s): Eric Knudtson, MD, Principal Investigator, Affiliation: University of Oklahoma
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.
Clinical Details
Official title: Preterm Premature Rupture of Membranes: Erythromycin Versus Azithromycin. A Randomized Trial Comparing Their Efficacy to Prolong Latency
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Time to delivery
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
- 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.
Locations and Contacts
Additional Information
Starting date: September 2011
Last updated: January 15, 2013
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