Methods |
Randomized, placebo-controlled trial; 3 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collectin: no reported. |
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Setting: 5 centres in Canada. |
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Inclusion criteria: all women in labor or with ruptured membranes (duration of ruptured membranes not stated; mean duration 9.97 hours; included in both category) |
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Interventions |
Cefoxitin 2 g (N = 124) vs cefazolin 1 g (N = 120) vs placebo (N = 117) infused IV immediately after cord clamped and 6 and 12 hours later. Results of both treatment groups combined |
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Outcomes |
Febrile morbidity (oral temperature > 37.9°C twice at least 6 hours apart after first 24 hours); wound infection (redness, induration, tenderness and/or purulent discharge from the incision line); endometritis/parametritis (uterine and/or adnexal tenderness with fever) UTI (dysuria or pyuria and positive culture); need for antibiotic therapy (11% for treatment groups vs 27% for placebo); maternal length of stay (7.3 and 7.4 days for treatment groups vs 7.9 for placebo) |
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Notes |
Side effects documented: 2 infusion-related hypotensive episodes (1 with cefazolin, 1 with placebo that necessitated withdrawal from study); 6 episodes of phlebitis (5 in treated, 1 in placebo group); 1 episode of angioedema (placebo patient). Data provided on antibiotic resistance in wound isolates and screening cervical cultures. 1 episode of bacteraemia (in placebo group); 1 episode of septic shock (in cefazolin-treated group); both outcomes included as serious morbidity. |
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Follow up at 6 weeks. |
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Class of antibiotic: first generation cephalosporin or 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 |
“Randomily assigned.” |
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No additional information. |
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Allocation concealment? |
Unclear |
No information provided. |
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Blinding? |
Unclear |
Described as “double-blind”. |
All outcomes |
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No details provided on placebo. |
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Incomplete outcome data addressed? |
Unclear |
No loss to follow up reported. |
All outcomes |
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7 women (1 in treatment, 6 in placebo group) initially randomized but results not included, 6 because they failed to receive all 3 doses, 1 because of hypotensive episode with first dose As-treated analysis performed. |
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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, gravidity, etc.There was insufficient other information which to judge |
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Overall low risk of bias? |
Unclear |
All unclear. |