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Timing of Prophylactic Antibiotics for Cesarean Sections

Primary Purpose

Endometritis, Wound Infection

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cefazolin

About this trial

This is an interventional prevention trial for Endometritis focused on measuring Cesarean section, Antibiotic prophylaxis, Cefazolin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Pregnant 24-43 weeks gestation > 18 years old Requiring cesarean section - Exclusion Criteria: Receiving antibiotics < 18 years old Allergy to cefazolin -

Sites / Locations

Medical University of South Carolina

Outcomes

Primary Outcome Measures

Combined infectious morbidity - endometritis + wound infection

Secondary Outcome Measures

Neonatal sepsis

Allergic reactions

Full Information

NCT ID

NCT00330278

First Posted

May 25, 2006

Last Updated

September 26, 2007

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT00330278

Brief Title

Timing of Prophylactic Antibiotics for Cesarean Sections

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2006

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of South Carolina

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometritis, Wound Infection

Keywords

Cesarean section, Antibiotic prophylaxis, Cefazolin

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

350 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Cefazolin

Primary Outcome Measure Information:

Title

Combined infectious morbidity - endometritis + wound infection

Secondary Outcome Measure Information:

Title

Neonatal sepsis

Title

Allergic reactions

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pregnant 24-43 weeks gestation > 18 years old Requiring cesarean section - Exclusion Criteria: Receiving antibiotics < 18 years old Allergy to cefazolin -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott A Sullivan, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

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Timing of Prophylactic Antibiotics for Cesarean Sections

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