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. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3

Fugere 1983.

Methods Randomized, placebo‐controlled trial; 3 parallel groups.
Unit of randomization: individual.
Participants Dates of data collection: September 1980 to November 1981.
Setting: Hopital Saint‐Luc, Montreal, Canada.
Inclusion criteria: women undergoing non‐elective CS. N = 89.
Exclusion criteria: not in labor with intact membranes, allergy to cephalosporins, antibiotic use within 48 hrs, fever, ruptured membranes for > 36 hrs.
Interventions Intervention:
  • cefoxitin 2 g IV;

  • N = 30.


Intervention:
  • cefazolin 1 g IV;

  • N = 30.


Comparison: placebo:
  • placebo;

  • N = 29.


At clamping of the cord and at 6 and 12 hrs later.
Placebo group was divided 1/2 and for comparison with the 2 treatment groups.
Outcomes Endometritis, wound infection, UTI (symptoms or 2 successive positive cultures) septicemia, pelvic abscess, pelvic thrombophlebitis. Follow‐up at 6 weeks. No side effects observed.
Notes There were no serious infections in any of the groups.
 In the placebo and cefazolin groups there was no increase in aerobic bacterial colonization of the cervix after 4 days but there was an increase in colonization by anaerobes; the opposite occurred in the group receiving cefoxitin.
Class of antibiotic: 1st generation cephalosporin vs cefamycin (2nd generation cephalosporin).
Subgroups:
  • non‐elective CS;

  • after cord clamping.


The groups were comparable regarding demographic characters.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomized".
Comment: no description of sequence generation process.
Allocation concealment (selection bias) Unclear risk Quote: "A number (1 to 90) identified the boxes. The number was allocated randomly to a box".
Comment: an envelope containing the randomization code was available in case of adverse reactions.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: no loss to follow‐up; 1 patient in the control group was excluded from analysis as no cultures were performed; as‐treated analysis performed.
Selective reporting (reporting bias) Unclear risk Comment: insufficient information to judge.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "double blind"..... "vitamin solution with a similar colour as the other preparations".
Comment: placebo‐controlled.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: insufficient information to judge.
Other bias Low risk Comment: no other sources of bias identified.