Methods |
RCT; 3 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: November 1981-March 1982. |
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Setting: University of Parma, Parma, Italy. |
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Inclusion criteria: women undergoing emergency CS (58/60 women in spontaneous labor; classified as non-elective) |
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Exclusion criteria: allergy to penicillin or cephalosporins; severe renal disease, history of pelvic infections |
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Interventions |
Cefuroxime 750 mg IM 30-60 minutes before surgery and 8 and 16 hours after (short term)(N = 20) vs 750 mg 3 times a day for 5 days (first dose being given post-operatively after the woman had returned to the ward) (long term) (N = 20) vs no treatment (N = 20). The results of both treatment groups have been combined |
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Outcomes |
Fever (> 100.3°F twice 6 hr apart); endometritis (fever and uterine tenderness); maternal stay (treatment 7.1 vs control 7.9 days, no variance given) |
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Notes |
Note: the group given long-term prophylaxis received the first dose after return to the ward |
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Class of antibiotic: second generation cephalosporin. |
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Subgroups: |
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Risk of bias |
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Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Unclear |
Randomly assigned. |
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No further information. |
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Allocation concealment? |
Unclear |
No information was provided. |
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Blinding? |
Unclear |
Not placebo controlled. |
All outcomes |
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Incomplete outcome data addressed? |
Unclear |
No losses to follow up reported. |
All outcomes |
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1 woman was excluded because of an allergic reaction to cefuroxime |
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Could not be re-included in ITT 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.There was insufficient other information which to judge |
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Overall low risk of bias? |
Unclear |
All sections unclear. |