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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: September 1982-September 1983.
Setting: University of Mississippi Medical Center,
Inclusion criteria: women undergoing non-elective CS (including prolonged ruptured membranes and prolonged labor, as well as general risk factors such as poor nutrition and poverty)
Exclusion: current antibiotics, known infectious process, allergy to cephalosporins
Interventions Cefamandole 2 g in 800 ml saline irrigation during the procedure (N = 84) vs saline irrigation (N = 86) vs no treatment (N = 92)
As the objective of this review is to compare antibiotic with no antibiotic, rather than the effect of irrigation, the 2 irrigation groups are compared
Outcomes Febrile morbidity (> 100.6°F twice 6 hours apart after first post-operative day); serious morbidity (fever and endomyometritis or abscess requiring IV antibiotics for resolution)
Notes Authors’ definition of high risk does not correspond to that used for non-elective in this review, classified as ‘both’.
The outcome of serious morbidity included endomyometritis and is classified as endometritis in this review
Class of antibiotic: second generation cephalosporin.
Subgroups:
  • type CS unclear;

  • after cord clamping.

Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? No Randomized by last digit ofhospital admission number to no irrigation, antibiotic irrigation or saline irrigation
Allocation concealment? No No additional information provided.
Blinding? Unclear Placebo-controlled (normal saline irrigation).
All outcomes No further information provided.
Incomplete outcome data addressed? No No loss to follow up or exclusion ofpartici-pants reported, but follow up given for only 77/84 of treatment and 53/86 of placebo group for outcome of serious infection, without explanation
All outcomes
No evidence ITT analysis was performed.
Free of selective reporting? Unclear Insufficient information to judge.
Free of other bias? Unclear The 3 groups were comparable regarding operative indicators, duration of labor, etc.
There was insufficient other information which to judge
Overall low risk of bias? No Quasi-RCT gives high risk of bias.
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