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NCT00330278 Clinical Trial

Timing of Prophylactic Antibiotics for Cesarean Sections

Wound Infection Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo Controlled Trial of Cefazolin Given Either 30 Minutes Prior to Cesarean Section or at Cord Clamping

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00330278
Other study ID # HR # 11120
Secondary ID
Status Completed
Phase N/A
First received May 25, 2006
Last updated September 26, 2007
Start date January 2003
Est. completion date January 2006

Study information
Verified date January 2006
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blinded placebo controlled trial of cefazolin timing before cesarean section fo infection prophylaxis. Subjects are randomized to cefazolin either 30 minutes prior to skin incision or at time of cord-clamping. Primary outcome is infectious morbidity including wound infections and endometritis.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

Pregnant 24-43 weeks gestation > 18 years old Requiring cesarean section -

Exclusion Criteria:

Receiving antibiotics < 18 years old Allergy to cefazolin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Cefazolin

Locations
Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (1)
Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Combined infectious morbidity - endometritis + wound infection
Secondary Neonatal sepsis
Secondary Allergic reactions
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