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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; 5 parallel groups (4 treatment, 1 control)
Unit of randomization: individual.
Participants Dates of data collection: December 1982 to May 1984.
Setting: Madigan Army Medical Centre, Tacoma, Washington, USA
Inclusion criteria: all women undergoing CS.
Exclusion criteria: penicillin or cephalosporin allergy; antibiotic therapy; known infectious process
Interventions Irrigation during CS with 2 g of either cephapirin sodium (N = 79), cefamandole nafate (N = 70), moxalactam disodium (N = 64) or ampicillin sodium (N = 70), vs saline (N = 77). A vitamin was added to each solution for disguise. The antibiotic groups have been considered together in this review
Outcomes Fever (>38°C twice 6 hours apart, excluding the first 24 hours); endomyometritis (pyrexia >37.8°C, uterine tenderness and pelvic peritoneal irritation without other localising signs of irritation; UTI (positive culture); wound infection; fever index; all infection-related morbidity; therapeutic antibiotics; mean post-operative days (variance not given)
Notes 3 episodes of pelvic thrombophlebitis (all in treated groups).
Results were given for all women and women in labor, both high risk (corresponding to the category of non-elective deliveries) and all labor. The data for elective deliveries were deduced from these
Class of antibiotic: first generation cephalosporin vs second generation cephalosporin vs carbapenem vs aminopenicillin (ampicillin)
Subgroups:
  • both elective and non-elective CS - data separated by elective and non-elective;

  • after cord clamping.

Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Computer-generated numbers using the mixed congruential method
Allocation concealment? Yes “The pharmacy to assign each patient to 1 of 5 groups.”
Blinding? Yes Double blind placebo controlled trial. A vitamin was added to each solution for disguise
All outcomes
Incomplete outcome data addressed? Yes No loss to follow up.
All outcomes No participant excluded.
ITT analysis.
Free of selective reporting? Unclear Insufficient information to judge.
Free of other bias? Unclear The mean level of gravidity of the placebo group was higher than that of the cephapirin group. There was insufficient other information which to judge
Overall low risk of bias? Yes The most important aspects are with low risk of bias.
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