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. Author manuscript; available in PMC: 2014 May 2.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007482. doi: 10.1002/14651858.CD007482.pub2
Methods Randomized, controlled trial; 2 parallel groups.
Unit of randomization: individual.

Participants Dates of data collection: not stated.
Setting: Pittsburgh, Pennsylvania, US.
Inclusion criteria: women undergoing CS after labor or rupture of membranes (method section unclear as to duration of ruptured membranes; it has been assumed that all women were in labor)
Exclusion criteria: elective CS without labor; already receiving antibiotics; fever or other evidence of infection; allergy to penicillin or cephalosporins; requiring endocarditis prophylaxis

Interventions Cefoxitin 2 g IV after cord clamping, and at 6 and 12 hours after initial dose (N = 196) vs matching mannitol and riboflavin placebo (N = 196)

Outcomes Febrile morbidity (fever > 37.9°C twice at least 4 hours apart after first post-operative day); endomyometritis (fever > 38°C with uterine tenderness, maternal white blood cell count > 15000/cu mm, malodorous lochia and no apparent cause for fever); UTI; incision infection (purulent drainage with induration and tenderness); additional antibiotic therapy (treatment 26/196 vs placebo 68/190)

Notes Increase in enterococci and decrease in Staphylococcus aureus, various streptococci, E. coli and a variety of anaerobes from infected sites in prophylactic group compared with placebo
Class of antibiotics: second generation cephalosporin (cefamycin)
Subgroups:
  • non-elective CS;

  • after cord clamping.


Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Unclear “Randomized.”
No further information.

Allocation concealment? Yes “The hospital pharmacy prepared coded vials.”

Blinding? Yes Double-blind, identical appearing placebo.
All outcomes

Incomplete outcome data addressed? No Insufficient information to judge.
All outcomes

Free of selective reporting? Unclear No loss to follow up reported. 14/400 women initially randomized not included in final analysis (errors in protocol, 2 allergic to penicillin after first dose given and 2, who received cefoxitin, for infusion-related reactions); insufficient data provided to perform ITT analysis

Free of other bias? Unclear The 2 groups were comparable regarding demographic and obstetric variables and indications for CS. There was insufficient other information which to judge

Overall low risk of bias? Unclear Mostly unclear.
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