drugset / Trial / NCT00879190

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

NCT00879190

Phase 2/3 Completed 92 enrolled Stanford University
RandomizedParallel-groupQuadruple-blindTreatment

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 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.

Timeline

Start
2009-05
Primary completion
2012-06
Completion
2012-06

Publications

  • Results Greenberg, Mara et al. Comparison of ampicillin/sulbactam versus ampicillin/gentamicin for treatment of intrapartum chorioamnionitis: a randomized controlled trial. American Journal of Obstetrics & Gynecology , Volume 212 , Issue 1 , S145

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ampicillin Unknown 2 g Intravenous
Comparator Gentamicin Small molecule 1.5 mg/kg Intravenous
Comparator ampicillin/sulbactam Unknown 3 g Intravenous

Indications