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Comparison 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
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chorioamnionitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
September 12, 2005
Last Updated
June 13, 2011
Sponsor
Stanford University
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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

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Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis

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