Methods |
Randomized, controlled trial; 2 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: not stated. |
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Setting: Pittsburgh, Pennsylvania, US. |
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Inclusion criteria: women undergoing CS after labor or rupture of membranes (method section unclear as to duration of ruptured membranes; it has been assumed that all women were in labor) |
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Exclusion criteria: elective CS without labor; already receiving antibiotics; fever or other evidence of infection; allergy to penicillin or cephalosporins; requiring endocarditis prophylaxis |
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Interventions |
Cefoxitin 2 g IV after cord clamping, and at 6 and 12 hours after initial dose (N = 196) vs matching mannitol and riboflavin placebo (N = 196) |
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Outcomes |
Febrile morbidity (fever > 37.9°C twice at least 4 hours apart after first post-operative day); endomyometritis (fever > 38°C with uterine tenderness, maternal white blood cell count > 15000/cu mm, malodorous lochia and no apparent cause for fever); UTI; incision infection (purulent drainage with induration and tenderness); additional antibiotic therapy (treatment 26/196 vs placebo 68/190) |
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Notes |
Increase in enterococci and decrease in Staphylococcus aureus, various streptococci, E. coli and a variety of anaerobes from infected sites in prophylactic group compared with placebo |
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Class of antibiotics: 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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No further information. |
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Allocation concealment? |
Yes |
“The hospital pharmacy prepared coded vials.” |
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Blinding? |
Yes |
Double-blind, identical appearing placebo. |
All outcomes |
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Incomplete outcome data addressed? |
No |
Insufficient information to judge. |
All outcomes |
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Free of selective reporting? |
Unclear |
No loss to follow up reported. 14/400 women initially randomized not included in final analysis (errors in protocol, 2 allergic to penicillin after first dose given and 2, who received cefoxitin, for infusion-related reactions); insufficient data provided to perform ITT analysis |
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Free of other bias? |
Unclear |
The 2 groups were comparable regarding demographic and obstetric variables and indications for CS. There was insufficient other information which to judge |
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Overall low risk of bias? |
Unclear |
Mostly unclear. |