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

NCT ID: NCT00185991

Last Updated: 2011-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2010-02-28

Brief Summary

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

Detailed Description

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Conditions

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Chorioamnionitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Once daily Gentamicin

Group Type ACTIVE_COMPARATOR

gentamicin

Intervention Type DRUG

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 Gentamicin

Group Type ACTIVE_COMPARATOR

gentamicin

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- clinical diagnosis of chorioamnionitis

Exclusion Criteria

\- maternal renal disease, intrauterine fetal death, allergy to gentamicin
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Stanford University School of Medicine

Principal Investigators

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Yasser Yehia El-Sayed

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20093909 (View on PubMed)

Other Identifiers

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80104

Identifier Type: -

Identifier Source: org_study_id

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