Erythromycin Versus Azithromycin in Preterm Premature Rupture of Membranes (PEACE)
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|ClinicalTrials.gov Identifier: NCT01556334|
Recruitment Status : Withdrawn (Terminated before starting due to need for IND determined by FDA.)
First Posted : March 16, 2012
Last Update Posted : March 5, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Preterm Premature Ruptured Membranes||Drug: Azithromycin Drug: Erythromycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preterm Premature Rupture of Membranes: Erythromycin Versus Azithromycin a Randomized Trial Comparing Their Efficacy to Prolong Latency (PEACE Trial)|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Azithromycin 1g po
Azithromycin 1g po
Other Name: amp/azithro
Active Comparator: Erythromycin
Erythromycin IV followed by po for a total of 5 days.
Erythromycin IV then PO
Other Name: amp/erythro
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556334
|United States, Indiana|
|Indiana University School of Medicine|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||David M Haas, MD, MS||IU School of Medicine|
|Responsible Party:||Indiana University|
|Other Study ID Numbers:||
|First Posted:||March 16, 2012 Key Record Dates|
|Last Update Posted:||March 5, 2014|
|Last Verified:||March 2014|
premature ruptured membranes
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Female Urogenital Diseases and Pregnancy Complications
Wounds and Injuries
Protein Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action