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

Chorioamnionitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185991
• Other study ID #: 80104
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: June 13, 2011
• Start date: June 2004
• Est. completion date: February 2010

Study information

• Verified date: June 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: February 2010
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of chorioamnionitis

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chorioamnionitis

Intervention

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).

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.0b — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Afebrile at 24 hours and no endometritis		24 hours after delivery	Yes
Secondary	Neonatal outcomes		Time of delivery to time of discharge	Yes