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CompletedNCT00185991Updated Jun 15, 2011

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

An interventional study of gentamicin in Chorioamnionitis, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-15.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Chorioamnionitis

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03

In context

Chorioamnionitis

39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.

This study's planned enrollment of 126 is below the median of 157 across 22 interventional studies indexed under Chorioamnionitis.

Browse Chorioamnionitis studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • clinical diagnosis of chorioamnionitis

Exclusion criteria

Exclusion Criteria:

  • maternal renal disease, intrauterine fetal death, allergy to gentamicin
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
126 participants (estimated)

Study arms

  • Active comparator
    Once daily Gentamicin

    Drug: gentamicin

  • Active comparator
    Every eight hour Gentamicin

    Drug: gentamicin

Interventions

  • 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).

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What researchers measure

Primary outcomes

  1. Afebrile at 24 hours and no endometritis

    Time frame: 24 hours after delivery

Secondary outcomes

  1. Neonatal outcomes

    Time frame: Time of delivery to time of discharge

07

Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
08

References and documents

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):344-349. doi: 10.1097/AOG.0b013e3181cb5c0e. PubMed 20093909 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00185991
First posted
Sep 16, 2005
Start date
Jun 2004
Primary completion
Oct 2006
Completion
Feb 2010
Last update
Jun 15, 2011

Study contacts

Yasser Yehia El-Sayed
principal investigator · Stanford University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Gentamicins

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