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

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ClinicalTrials.gov Identifier: NCT00185991
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:
Stanford University

Study Description
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Brief Summary:
To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.

Condition or disease Intervention/treatment Phase
Chorioamnionitis Drug: gentamicin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
Study Start Date : June 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : February 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Once daily Gentamicin Drug: 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 Drug: 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).


Outcome Measures
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Primary Outcome Measures :
  1. Afebrile at 24 hours and no endometritis [ Time Frame: 24 hours after delivery ]

Secondary Outcome Measures :
  1. Neonatal outcomes [ Time Frame: Time of delivery to time of discharge ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- clinical diagnosis of chorioamnionitis

Exclusion Criteria:

- maternal renal disease, intrauterine fetal death, allergy to gentamicin

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185991


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Yasser Yehia El-Sayed Stanford University
More Information
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Publications of Results:

Responsible Party: Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00185991     History of Changes
Other Study ID Numbers: 80104
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Chorioamnionitis
Fetal Diseases
Pregnancy Complications
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases
 Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action