Status:
COMPLETED
Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
Lead Sponsor:
Stanford University
Conditions:
Chorioamnionitis
Eligibility:
FEMALE
18-55 years
Phase:
PHASE2
PHASE3
Brief Summary
Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters) surrounding the baby inside of a pregnant woman prior to delivery. This infection is somewhat common and is rout...
Detailed Description
Patients who meet inclusion criteria will be approached upon admission to Labor and Delivery. A study staff member will describe the study and offer participation. If a patient agrees to participate, ...
Eligibility Criteria
Inclusion
- Pregnant women in labor or undergoing induction of labor
- Greater than or equal to 18 years of age
- Diagnosed with chorioamnionitis as defined by maternal temperature \> or = 38.0 degrees Centigrade plus at least one of the following: maternal tachycardia (heart rate \>110), fetal tachycardia (fetal heart rate baseline \>160), purulent amniotic fluid, uterine tenderness.
Exclusion
- Allergy or adverse reaction to penicillin or ampicillin, gentamicin, or sulbactam
- Having received antibiotics for the treatment of preterm premature rupture of membranes or other condition within the last 7 days
- Acute or chronic renal disease or insufficiency (creatinine \>1.0)
- Hearing loss
- Major fetal congenital anomalies or intrauterine fetal demise
- Neutropenia
- HIV
- Myasthenia gravis or other neuromuscular disorder
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00879190
Start Date
May 1 2009
End Date
June 1 2012
Last Update
May 18 2018
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305