Antibiotic Prophylaxis Before Surgery Versus After Cord Clamping in Elective Cesarean Delivery - a Double-blind, Prospective, Randomized Placebo-controlled Trial

November 24, 2010 updated by: Medical University of Vienna
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background. Perioperative antibiotic prophylaxis during elective cesarean section at term to reduce postoperative maternal infectious morbidity is generally used but may not be efficient based on the available data. Also, the optimal timing of prophylactic antibiotic administration is unclear.

Methods. The investigators compared the effectiveness of cefazolin, administered before skin incision versus after umbilical cord clamping versus placebo in a three-arm randomized trial. The primary endpoint of the study was postoperative infectious morbidity, defined as wound infection, endometritis, or urinary tract infection. Results: The primary outcome was observed in 18/370 women in group 1 (4.9%) and in 14/371 women in group 2 (3.8%), whereas it was noted in 45/371 women in group 3 (12.1%; p<0.001 for group 1 vs. group 3; p<0.001 for group 2 vs. group 3; p<0.001 for group 1 vs. group 2 vs. group 3). The number needed to treat to avoid one primary outcome was 13. Comparing groups 1 and 2, there was no statistically significant difference regarding the primary outcome (p=0.6).

Conclusions. 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.

Study Type

Interventional

Enrollment (Actual)

1112

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

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

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 to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cefazolin A
administered before skin incision
Drug: Keflex
2g of i.v. cefazolin singleshot administered before skin incision
Drug: Keflex
2g of i.v. cefazolin singleshot administered after umbilical cord clamping
Active Comparator: Cefazolin B
after umbilical cord clamping
Drug: Keflex
2g of i.v. cefazolin singleshot administered before skin incision
Drug: Keflex
2g of i.v. cefazolin singleshot administered after umbilical cord clamping
Placebo Comparator: saline solution
administered before skin incision
Drug: saline solution
100cc administered before skin incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
postoperative infectious morbidity

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2004

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Estimate)

November 25, 2010

Last Update Submitted That Met QC Criteria

November 24, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 226/2003

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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