NCT00185991

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

June 15, 2011

Status Verified

June 1, 2011

Enrollment Period

2.3 years

First QC Date

September 12, 2005

Last Update Submit

June 13, 2011

Conditions

Chorioamnionitis

Outcome Measures

Primary Outcomes (1)

  • Afebrile at 24 hours and no endometritis

    24 hours after delivery

Secondary Outcomes (1)

  • Neonatal outcomes

    Time of delivery to time of discharge

Study Arms (2)

Once daily Gentamicin

ACTIVE COMPARATOR
Drug: gentamicin

Every eight hour Gentamicin

ACTIVE COMPARATOR
Drug: gentamicin

Interventions

gentamicinDRUG

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).

Every eight hour GentamicinOnce daily Gentamicin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- clinical diagnosis of chorioamnionitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related 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):344-349. doi: 10.1097/AOG.0b013e3181cb5c0e.

    PMID: 20093909RESULT

MeSH Terms

Conditions

Chorioamnionitis

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal Membranes, Premature RuptureObstetric Labor ComplicationsPlacenta DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Yasser Yehia El-Sayed

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

June 1, 2004

Primary Completion

October 1, 2006

Study Completion

February 1, 2010

Last Updated

June 15, 2011

Record last verified: 2011-06

Locations

US(1)