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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185991
First Posted: September 16, 2005
Last Update Posted: June 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Stanford University
  Purpose
To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.

Condition Intervention
Chorioamnionitis Drug: gentamicin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

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

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

Estimated Enrollment: 126
Study Start Date: June 2004
Study Completion Date: February 2010
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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

Publications:
Responsible Party: Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00185991     History of Changes
Other Study ID Numbers: 80104
First Submitted: September 12, 2005
First Posted: September 16, 2005
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