Timing of Prophylactic Antibiotics for Cesarean Sections

This study has been completed.

First Received on May 25, 2006. Last Updated on September 26, 2007 History of Changes

Sponsor:	Medical University of South Carolina
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00330278

Purpose

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	Intervention
Endometritis Wound Infection	Drug: Cefazolin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Cesarean Section

Drug Information available for: Cefazolin Cefazolin sodium

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Combined infectious morbidity - endometritis + wound infection

Secondary Outcome Measures:

Neonatal sepsis
Allergic reactions

Estimated Enrollment:	350
Study Start Date:	January 2003
Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330278

Locations

United States, South Carolina
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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00330278 History of Changes
Other Study ID Numbers:	HR # 11120
Study First Received:	May 25, 2006
Last Updated:	September 26, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:

Cesarean section
Antibiotic prophylaxis
Cefazolin

Additional relevant MeSH terms:

Endometritis
Wound Infection
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Infection

Wounds and Injuries
Anti-Bacterial Agents
Cefazolin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012