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