Status:
COMPLETED
PPROM Erythromycin Versus Azithromycin
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Indiana University School of Medicine
Conditions:
Preterm Premature Rupture of Membranes
Eligibility:
FEMALE
18-50 years
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...
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01431248
Start Date
September 1 2011
End Date
January 1 2013
Last Update
January 16 2013
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