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

Elective Cesarean Section Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248078
• Other study ID #: 226/2003
• Status: Completed
• Phase: N/A
• First received: November 24, 2010
• Last updated: November 24, 2010
• Start date: March 2004
• Est. completion date: January 2010

Study information

• Verified date: November 2010
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1112
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Elective Cesarean Section

Intervention

Drug:
• Keflex
2g of i.v. cefazolin singleshot administered before skin incision
• Keflex
2g of i.v. cefazolin singleshot administered after umbilical cord clamping
• saline solution
100cc administered before skin incision

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative infectious morbidity