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Clinical Trials/NCT01248078
NCT01248078
Completed
Not Applicable

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

Medical University of Vienna1 site in 1 country1,112 target enrollmentMarch 2004

Overview

Phase
Not Applicable
Intervention
Keflex
Conditions
Elective Cesarean Section
Sponsor
Medical University of Vienna
Enrollment
1112
Locations
1
Primary Endpoint
postoperative infectious morbidity
Status
Completed
Last Updated
15 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
March 2004
End Date
January 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Arms & Interventions

Cefazolin A

administered before skin incision

Intervention: Keflex

Cefazolin B

after umbilical cord clamping

Intervention: Keflex

saline solution

administered before skin incision

Intervention: saline solution

Outcomes

Primary Outcomes

postoperative infectious morbidity

Study Sites (1)

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