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

June 13, 2011 updated by: Stanford University
To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- clinical diagnosis of chorioamnionitis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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).

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

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Yasser Yehia El-Sayed, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

June 15, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

June 1, 2011

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Subscribe