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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 RCT; 3 parallel groups.
Unit of randomization: individual.

Participants Dates of data collection: July 1980 to June 1981.
Setting: Mount Sinai Hospital, Toronto, Canada.
Inclusion criteria: women undergoing CS (at ‘high’ risk because of ruptured membranes in active labor); classified as ‘non-elective’
Exclusion criteria: febrile, antibiotic use in prior 24 hours; allergy to penicillin or cephalosporin; significant hepatic or renal disease
Predominantly private, middle-class and in their late 20s.

Interventions Cefoxitin 2 g IV at time of cord clamping (N = 64) vs cefoxitin 2 g at time of cord clamping and at 4 and 8 hours post-operatively (N = 60) vs identical-appearing placebo; both treatment groups combined in this analysis

Outcomes Febrile morbidity (> 38°C twice at least 8 hours apart, after first post-operative day); endometritis (fever, foul, excessive lochia or uterine tenderness); UTI (fever and positive culture); wound infection (fever, cellulitis or exudate with positive cultures)

Notes No adverse drug reactions in cefoxitin groups, no septicemia in any group; 4 patients in placebo group were considered seriously ill (although do not fit the criteria for serious morbidity in this review) compared to none in treatment groups
Antibiotic class: Second generation cephalosporin (cefamycin)
Subgroups:
  • non-elective CS;

  • after cord clamping.


Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Unclear “…randomized.”
Method not described.

Allocation concealment? Yes “…randomly packaged in identical vials coded from 1 to 200.”

Blinding? Yes “…double-blinded, placebo-controlled.” “The medication and an identical appearing placebo were prepared prior to the study and … packaged in identical vials….The attending physician was unaware of what regimen his patient received and the code numbers were revealed only after the study was completed.”
All outcomes

Incomplete outcome data addressed? No No loss of participants to follow up.
All outcomes 7 patients were excluded after having entered the study. 1 patient was excluded because of an error in mixing and administering the IV injections; 6 patients were excluded because they became febrile within 8 hours of operation and required immediate antibiotic therapy Not ITT analysis. Data from excluded patients could not be re-included in the analysis

Free of selective reporting? Unclear Insufficient information to judge.

Free of other bias? Unclear The 3 groups were comparable regarding age, parity, gestational age, duration of labor, duration of ruptured membranes, number of vaginal examinations, use of internal fetal monitoring or post-operative haemoglobin.There was insufficient other information which to judge

Overall low risk of bias? Unclear Mostly unclear.
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