Timing of Prophylactic Antibiotics for Cesarean Sections

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT00330278
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 9.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2003
• Actual Study Completion Date: Jan 1, 2006

Outcome Measures

Primary Outcome Measures

1. Combined infectious morbidity - endometritis + wound infection []

Secondary Outcome Measures

1. Neonatal sepsis []

2. Allergic reactions []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

• Principal Investigator: Scott A Sullivan, MD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00330278
• Other Study ID Numbers: HR # 11120
• First Posted: May 26, 2006
• Last Update Posted: Sep 27, 2007
• Last Verified: Jan 1, 2006

• Keywords provided by , ,: Cesarean section; Antibiotic prophylaxis; Cefazolin
• Additional relevant MeSH terms: Wound Infection; Endometritis; Cefazolin

Study Results

No Results Posted as of Sep 27, 2007