Timing of Prophylactic Antibiotics for Cesarean Sections | NCT00330278

Studies
Timing of Prophylactic Antibiotics for Cesarean Sections

NCT00330278

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Sep 27, 2007Estimated

Enrollment

350

Phase

Not Applicable

Conditions

Endometritis
Wound Infection

Interventions

Cefazolin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Jan 2006Actual

First Submitted Date

May 25, 2006

First Submission Date that Met QC Criteria

May 25, 2006

First Posted Date

May 26, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2007

Last Update Posted Date

Sep 27, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350

Name	Type	Description	Arm Group Labels	Other Names
Cefazolin	Drug

Measure	Description	Time Frame
Combined infectious morbidity - endometritis + wound infection

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott A Sullivan, MD	Medical University of South Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina		Charleston	South Carolina	29425	United States

Condition Browse Module

MeSH Terms

ID	Term
D004716	Endometritis
D014946	Wound Infection

Ancestor Terms

ID	Term
D000292	Pelvic Inflammatory Disease
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002437	Cefazolin

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Neonatal sepsis
Allergic reactions