Methods |
RCT; 3 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: July 1980 to June 1981. |
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Setting: Mount Sinai Hospital, Toronto, Canada. |
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Inclusion criteria: women undergoing CS (at ‘high’ risk because of ruptured membranes in active labor); classified as ‘non-elective’ |
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Exclusion criteria: febrile, antibiotic use in prior 24 hours; allergy to penicillin or cephalosporin; significant hepatic or renal disease |
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Predominantly private, middle-class and in their late 20s. |
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Interventions |
Cefoxitin 2 g IV at time of cord clamping (N = 64) vs cefoxitin 2 g at time of cord clamping and at 4 and 8 hours post-operatively (N = 60) vs identical-appearing placebo; both treatment groups combined in this analysis |
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Outcomes |
Febrile morbidity (> 38°C twice at least 8 hours apart, after first post-operative day); endometritis (fever, foul, excessive lochia or uterine tenderness); UTI (fever and positive culture); wound infection (fever, cellulitis or exudate with positive cultures) |
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Notes |
No adverse drug reactions in cefoxitin groups, no septicemia in any group; 4 patients in placebo group were considered seriously ill (although do not fit the criteria for serious morbidity in this review) compared to none in treatment groups |
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Antibiotic class: Second generation cephalosporin (cefamycin) |
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Subgroups: |
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non-elective CS;
after cord clamping.
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Risk of bias |
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Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Unclear |
“…randomized.” |
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Method not described. |
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Allocation concealment? |
Yes |
“…randomly packaged in identical vials coded from 1 to 200.” |
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Blinding? |
Yes |
“…double-blinded, placebo-controlled.” “The medication and an identical appearing placebo were prepared prior to the study and … packaged in identical vials….The attending physician was unaware of what regimen his patient received and the code numbers were revealed only after the study was completed.” |
All outcomes |
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|
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Incomplete outcome data addressed? |
No |
No loss of participants to follow up. |
All outcomes |
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7 patients were excluded after having entered the study. 1 patient was excluded because of an error in mixing and administering the IV injections; 6 patients were excluded because they became febrile within 8 hours of operation and required immediate antibiotic therapy Not ITT analysis. Data from excluded patients could not be re-included in the analysis |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
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Free of other bias? |
Unclear |
The 3 groups were comparable regarding age, parity, gestational age, duration of labor, duration of ruptured membranes, number of vaginal examinations, use of internal fetal monitoring or post-operative haemoglobin.There was insufficient other information which to judge |
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Overall low risk of bias? |
Unclear |
Mostly unclear. |