Maurice L. Druzin
Comparison of ampicillin / sulbactam vs. ampicillin / gentamicin for treatment of intrapartum chorioamnionitis: a randomized controlled trial
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Unasyn
- Drug: Ampicillin/Gentamicin
Phase:
Phase 2/Phase 3Eligibility
Ages Eligible for Study:
18 years to 55 yearsGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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
baseling >160), purulent amniotic fluid, uterine tendernesss.
Key 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
Additional Study Details
Official Title:
Comparison of ampicillin / sulbactam vs. ampicillin / gentamicin for treatment of intrapartum chorioamnionitis: a randomized controlled trialAnticipated start date:
5/1/2009Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Proportion of patients in each arm experiencing treatment failure as indicated by resolution of maternal infection
Secondary Outcomes:
- Cost
- Maternal adverse effects including side effects, labor abnormalities, type of delivery, blood loss, post partum infectious complication.
- Neonatal adverse outcomes.
Total Number to be Enrolled:
282Total Number to be Enrolled at Stanford:
282More Information
Secondary ID(s):
- 15562
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/27/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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