- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00185991
Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- clinical diagnosis of chorioamnionitis
Exclusion Criteria:
- maternal renal disease, intrauterine fetal death, allergy to gentamicin
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Once daily Gentamicin
|
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). |
Active Comparator: Every eight hour Gentamicin
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Afebrile at 24 hours and no endometritis
Time Frame: 24 hours after delivery
|
24 hours after delivery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neonatal outcomes
Time Frame: Time of delivery to time of discharge
|
Time of delivery to time of discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yasser Yehia El-Sayed, Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 80104
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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