Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis

Not Recruiting

Trial ID: NCT00879190


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.
Natali Aziz, M.D., M.S.

Clinical Associate Professor, Obstetrics & Gynecology - Maternal Fetal Medicine

Yasser El-Sayed, Professor
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
Maurice L. Druzin

Professor of Obstetrics and Gynecology (Maternal Fetal Medicine) and, by courtesy, of Pediatrics


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

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


drug: Unasyn

drug: Ampicillin/Gentamicin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mara Greenberg