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

September 12, 2005
June 13, 2011
June 2004
October 2006   (final data collection date for primary outcome measure)
Afebrile at 24 hours and no endometritis [ Time Frame: 24 hours after delivery ] [ Designated as safety issue: Yes ]
Afebrile at 24 hours and no endometritis
Complete list of historical versions of study NCT00185991 on ClinicalTrials.gov Archive Site
Neonatal outcomes [ Time Frame: Time of delivery to time of discharge ] [ Designated as safety issue: Yes ]
Neonatal outcomes
Not Provided
Not Provided
 
Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis

To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chorioamnionitis
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: Once daily Gentamicin
    Intervention: Drug: gentamicin
  • Active Comparator: Every eight hour Gentamicin
    Intervention: Drug: gentamicin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
February 2010
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

- clinical diagnosis of chorioamnionitis

Exclusion Criteria:

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

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00185991
80104
Not Provided
Yasser Yehia El-Sayed, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Yasser Yehia El-Sayed Stanford University
Stanford University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP