Timing of Prophylactic Antibiotics for Cesarean Sections

September 26, 2007 updated by: Medical University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

Receiving antibiotics < 18 years old Allergy to cefazolin

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Combined infectious morbidity - endometritis + wound infection

Secondary Outcome Measures

Outcome Measure
Neonatal sepsis
Allergic reactions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

May 25, 2006

First Submitted That Met QC Criteria

May 25, 2006

First Posted (Estimate)

May 26, 2006

Study Record Updates

Last Update Posted (Estimate)

September 27, 2007

Last Update Submitted That Met QC Criteria

September 26, 2007

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR # 11120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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