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Timing of Prophylactic Antibiotics for Cesarean Sections

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ClinicalTrials.gov Identifier: NCT00330278
Recruitment Status : Completed
First Posted : May 26, 2006
Last Update Posted : September 27, 2007
Sponsor:
Information provided by:
Medical University of South Carolina

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Endometritis Wound Infection Drug: Cefazolin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo Controlled Trial of Cefazolin Given Either 30 Minutes Prior to Cesarean Section or at Cord Clamping
Study Start Date : January 2003
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Combined infectious morbidity - endometritis + wound infection

Secondary Outcome Measures :
  1. Neonatal sepsis
  2. Allergic reactions

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Receiving antibiotics < 18 years old Allergy to cefazolin

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330278


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Scott A Sullivan, MD Medical University of South Carolina
More Information
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ClinicalTrials.gov Identifier: NCT00330278    
Other Study ID Numbers: HR # 11120
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: September 27, 2007
Last Verified: January 2006
Keywords provided by Medical University of South Carolina:
Cesarean section
Antibiotic prophylaxis
Cefazolin
Additional relevant MeSH terms:
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Wound Infection
Endometritis
Infection
Pelvic Inflammatory Disease
Adnexal Diseases
 Genital Diseases, Female
Uterine Diseases
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents