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Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
Not Recruiting
Trial ID: NCT00879190
Purpose
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.
Official Title
Comparison of Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Intrapartum Chorioamnionitis: a Randomized Controlled Trial
Stanford Investigator(s)
Natali Aziz, M.D., M.S.
Clinical Associate Professor, Obstetrics & Gynecology - Maternal Fetal Medicine
Yasser El-Sayed, Professor
Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery
Maurice L. Druzin
Professor of Obstetrics and Gynecology (Maternal Fetal Medicine) and, by courtesy, of Pediatrics
Eligibility
Inclusion Criteria:
1. Pregnant women in labor or undergoing induction of labor
2. Greater than or equal to 18 years of age
3. 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 Criteria:
1. Allergy or adverse reaction to penicillin or ampicillin, gentamicin, or sulbactam
2. Having received antibiotics for the treatment of preterm premature rupture of
membranes or other condition within the last 7 days
3. Acute or chronic renal disease or insufficiency (creatinine >1.0)
4. Hearing loss
5. Major fetal congenital anomalies or intrauterine fetal demise
6. Neutropenia
7. HIV
8. Myasthenia gravis or other neuromuscular disorder
Intervention(s):
drug: Unasyn
drug: Ampicillin/Gentamicin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mara Greenberg
4158672051