Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Chorioamnionitis
In brief
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 routinely treated with antibiotics given to the mother both before and after the baby is born. Currently it is not known what is the best choice of antibiotics to treat this type of infection, but commonly used treatments include Unasyn (ampicillin/sulbactam) or ampicillin/gentamicin. We plan to compare these two different antibiotic regimens to see if one is better than the other at treating and preventing bad outcomes from chorioamnionitis in women and babies.
Key facts
- Study ID
- NCT00879190
- Run by
- Stanford University
- People needed
- 92
- Starts
- 2009-05-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2018-05-18
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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