NCT00330278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2006

Completed
Last Updated

September 27, 2007

Status Verified

January 1, 2006

First QC Date

May 25, 2006

Last Update Submit

September 26, 2007

Conditions

EndometritisWound Infection

Keywords

Cesarean sectionAntibiotic prophylaxisCefazolin

Outcome Measures

Primary Outcomes (1)

  • Combined infectious morbidity - endometritis + wound infection

Secondary Outcomes (2)

  • Neonatal sepsis

  • Allergic reactions

Interventions

CefazolinDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Receiving antibiotics \< 18 years old Allergy to cefazolin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

EndometritisWound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Pelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine DiseasesGenital DiseasesInfections

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Scott A Sullivan, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2006

First Posted

May 26, 2006

Study Start

January 1, 2003

Study Completion

January 1, 2006

Last Updated

September 27, 2007

Record last verified: 2006-01

Locations

US(1)