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

This study has been completed.

Sponsor:

Information provided by:

Stanford University

ClinicalTrials.gov Identifier:

NCT00185991

First received: September 12, 2005

Last updated: June 13, 2011

Last verified: June 2011

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Gentamicin Gentamicin sulfate

Genetic and Rare Diseases Information Center resources: Placenta Disorder

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Afebrile at 24 hours and no endometritis [ Time Frame: 24 hours after delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Neonatal outcomes [ Time Frame: Time of delivery to time of discharge ] [ Designated as safety issue: Yes ]


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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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):344-9. doi: 10.1097/AOG.0b013e3181cb5c0e.


Responsible Party:	Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00185991 History of Changes
Other Study ID Numbers:	80104
Study First Received:	September 12, 2005
Last Updated:	June 13, 2011
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016

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