NCT01248078

Brief Summary

In this prospective, randomized, placebo controlled trial the investigators were able to demonstrate the usefulness of prophylactic cefazolin in elective caesarean section versus placebo, irrespective of the timing of administration, ie before skin incision or after umbilical cord clamping

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,112

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 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

March 1, 2004

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
Last Updated

November 25, 2010

Status Verified

November 1, 2010

Enrollment Period

5.8 years

First QC Date

November 24, 2010

Last Update Submit

November 24, 2010

Conditions

Elective Cesarean Section

Keywords

elective cesarean sectionantibiotic prophylaxiscefazolinewound infection

Outcome Measures

Primary Outcomes (1)

  • postoperative infectious morbidity

Study Arms (3)

Cefazolin A

ACTIVE COMPARATOR

administered before skin incision

Drug: Keflex

Cefazolin B

ACTIVE COMPARATOR

after umbilical cord clamping

Drug: Keflex

saline solution

PLACEBO COMPARATOR

administered before skin incision

Drug: saline solution

Interventions

KeflexDRUG

2g of i.v. cefazolin singleshot administered before skin incision

Cefazolin A
saline solutionDRUG

100cc administered before skin incision

saline solution

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Elective cesarean section at term Patientin \>18 years Informed consent NO known allergy to cefazolin NO exposure to any antibiotic agent within 1 week prior to delivery

You may not qualify if:

  • \- cesarean section before week 37 cephalosporin allergy age less than 18 years exposure to any antibiotic agent within 1 week prior to delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • Witt A, Doner M, Petricevic L, Berger A, Germann P, Heinze G, Tempfer C. Antibiotic prophylaxis before surgery vs after cord clamping in elective cesarean delivery: a double-blind, prospective, randomized, placebo-controlled trial. Arch Surg. 2011 Dec;146(12):1404-9. doi: 10.1001/archsurg.2011.725.

    PMID: 22184305DERIVED

MeSH Terms

Conditions

Wound Infection

Interventions

CephalexinSaline Solution

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 25, 2010

Study Start

March 1, 2004

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

November 25, 2010

Record last verified: 2010-11

Locations

AU(1)