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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01248078
First received: November 24, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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


Condition Intervention
Elective Cesarean Section
Drug: Keflex
Drug: saline solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • postoperative infectious morbidity

Enrollment: 1112
Study Start Date: March 2004
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cefazolin A
administered before skin incision
Drug: Keflex
2g of i.v. cefazolin singleshot administered before skin incision
Active Comparator: Cefazolin B
after umbilical cord clamping
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01248078

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Armin Witt, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01248078     History of Changes
Other Study ID Numbers: 226/2003
Study First Received: November 24, 2010
Last Updated: November 24, 2010
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Vienna:
elective cesarean section
antibiotic prophylaxis
cefazoline
wound infection

Additional relevant MeSH terms:
Pharmaceutical Solutions
Cefazolin
Cephalexin
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 01, 2014