Back to resultsComparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
Primary Purpose
Chorioamnionitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gentamicin
Sponsored by
About this trial
This is an interventional treatment trial for Chorioamnionitis
Eligibility Criteria
Inclusion Criteria: - clinical diagnosis of chorioamnionitis Exclusion Criteria: - maternal renal disease, intrauterine fetal death, allergy to gentamicin
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Once daily Gentamicin
Every eight hour Gentamicin
Arm Description
Outcomes
Primary Outcome Measures
Afebrile at 24 hours and no endometritis
Secondary Outcome Measures
Neonatal outcomes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00185991
Brief Title
Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
Official Title
Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chorioamnionitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Once daily Gentamicin
Arm Type
Active Comparator
Arm Title
Every eight hour Gentamicin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
gentamicin
Intervention Description
Daily gentamicin (5 mg/kg intravenously, then placebo doses IV after 8 and 16 hours).
Eight hour gentamicin (2 mg/kg intravenously, then 1.5 mg/kg IV after 8 and 16 hours).
Primary Outcome Measure Information:
Title
Afebrile at 24 hours and no endometritis
Time Frame
24 hours after delivery
Secondary Outcome Measure Information:
Title
Neonatal outcomes
Time Frame
Time of delivery to time of discharge
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of chorioamnionitis
Exclusion Criteria:
- maternal renal disease, intrauterine fetal death, allergy to gentamicin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser Yehia El-Sayed
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20093909
Citation
Lyell DJ, Pullen K, Fuh K, Zamah AM, Caughey AB, Benitz W, El-Sayed YY. Daily compared with 8-hour gentamicin for the treatment of intrapartum chorioamnionitis: a randomized controlled trial. Obstet Gynecol. 2010 Feb;115(2 Pt 1):344-349. doi: 10.1097/AOG.0b013e3181cb5c0e.
Results Reference
result
Learn more about this trial
Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
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