Methods |
RCT; 3 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: September 1982-September 1983. |
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Setting: University of Mississippi Medical Center, |
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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) |
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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) |
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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’. |
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The outcome of serious morbidity included endomyometritis and is classified as endometritis in this review |
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Class of antibiotic: second generation cephalosporin. |
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Subgroups:
type CS unclear;
after cord clamping.
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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 |
|
|
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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. |