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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, placebo-controlled trial; 3 parallel groups.
Unit of randomization: individual.

Participants Dates of data collectin: no reported.
Setting: 5 centres in Canada.
Inclusion criteria: all women in labor or with ruptured membranes (duration of ruptured membranes not stated; mean duration 9.97 hours; included in both category)

Interventions Cefoxitin 2 g (N = 124) vs cefazolin 1 g (N = 120) vs placebo (N = 117) infused IV immediately after cord clamped and 6 and 12 hours later. Results of both treatment groups combined

Outcomes Febrile morbidity (oral temperature > 37.9°C twice at least 6 hours apart after first 24 hours); wound infection (redness, induration, tenderness and/or purulent discharge from the incision line); endometritis/parametritis (uterine and/or adnexal tenderness with fever) UTI (dysuria or pyuria and positive culture); need for antibiotic therapy (11% for treatment groups vs 27% for placebo); maternal length of stay (7.3 and 7.4 days for treatment groups vs 7.9 for placebo)

Notes Side effects documented: 2 infusion-related hypotensive episodes (1 with cefazolin, 1 with placebo that necessitated withdrawal from study); 6 episodes of phlebitis (5 in treated, 1 in placebo group); 1 episode of angioedema (placebo patient). Data provided on antibiotic resistance in wound isolates and screening cervical cultures. 1 episode of bacteraemia (in placebo group); 1 episode of septic shock (in cefazolin-treated group); both outcomes included as serious morbidity.
Follow up at 6 weeks.
Class of antibiotic: first generation cephalosporin or second generation cephalosporin
Subgroups:
  • both elective and non-elective CS;

  • after cord clamping.


Risk of bias


Item Authors’ judgement Description

Adequate sequence generation? Unclear “Randomily assigned.”
No additional information.

Allocation concealment? Unclear No information provided.

Blinding? Unclear Described as “double-blind”.
All outcomes No details provided on placebo.

Incomplete outcome data addressed? Unclear No loss to follow up reported.
All outcomes 7 women (1 in treatment, 6 in placebo group) initially randomized but results not included, 6 because they failed to receive all 3 doses, 1 because of hypotensive episode with first dose As-treated analysis performed.

Free of selective reporting? Unclear Insufficient information to judge.

Free of other bias? Unclear The 3 groups were comparable regarding age, parity, gravidity, etc.There was insufficient other information which to judge

Overall low risk of bias? Unclear All unclear.
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