Erythromycin Versus Azithromycin in Preterm Premature Rupture of Membranes
Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Preterm Premature Ruptured Membranes
Intervention: Azithromycin (Drug); Erythromycin (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Indiana University Official(s) and/or principal investigator(s): David M Haas, MD, MS, Principal Investigator, Affiliation: IU School of Medicine
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.
Clinical Details
Official title: Preterm Premature Rupture of Membranes: Erythromycin Versus Azithromycin a Randomized Trial Comparing Their Efficacy to Prolong Latency (PEACE Trial)
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Time to delivery
Detailed description:
Preterm, premature rupture of membranes complicates 140,000 pregnancies annually in the
United States and is a major contributor to pre-term births and resultant neonatal morbidity
and mortality. Typically, a brief period of latency exists after PPROM, with 70-80% of women
delivering within the 1st week of membrane rupture. It has been shown through numerous
well-conducted trials that antibiotics can prolong this latency time to delivery. Mercer and
et al., demonstrated that the administration of ampicillin with erythromycin prolonged the
median time to delivery, in comparison to placebo, from 2. 9 to 6. 1 days. This regimen has
now become the standard protocol of treatment in PPROM patients. However, this protocol
requires a multi-day dosing regimen of erythromycin and it has been known to have untoward
gastrointestinal side effects leading to decreased patient compliance. To overcome these
challenges, azithromycin, a newer 2nd generation macrolide, is now commonly being used as a
substitution on many of our labor and delivery units nationwide. Azithromycin has a long
intracellular half-life, which allows for a more patient friendly one-time dosing regimen;
in addition many of the unwanted side effects seen with erythromycin are not seen or greatly
reduced with azithromycin, making it an attractive alternative. Despite its popular use,
there is a lack of evidence in the literature to support azithromycin as an agent to prolong
latency. The purpose of this study is to demonstrate that there is no difference in the
clinical effectiveness of azithromycin and erythromycin for prolonging latency in PPROM
patients. This trial will be a prospective randomized trial performed in singleton
pregnancies with PPROM between 24 0/7 - 32 0/7 weeks gestation. The protocol will enroll
250 eligible women who will then be randomized to receive either azithromycin 1 gm orally at
enrollment or erythromycin 250mg IV every 6 hours for 48 hours followed by 500mg orally
every 8hours for 5 days. All women will also receive the standard ampicillin 2gm IV every 6
hours followed by amoxicillin 250mg orally every 8 hours for 5 days. The primary outcome
measure is the time of latency between the two groups. Secondary outcomes of neonatal
death, need for oxygen supplementation, ventilation, and neonatal infection, will also be
reviewed. In addition, side effect profiles between the two will be assessed in a post
treatment patient survey.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
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 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.
Locations and Contacts
Indiana University School of Medicine, Indianapolis, Indiana 46202, United States
Additional Information
Starting date: April 2010
Last updated: March 4, 2014
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