Methods |
Randomized placebo-controlled trial; 2 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: not reported. |
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Setting: Jeddah, Saudi Arabia. |
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Inclusion criteria: women undergoing CS (both elective and emergency) |
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Exclusions: use of antibiotics, fever or signs of infection; allergy to penicillin or cephalosporin |
Interventions |
Cefazolin 1 g after clamping of the cord (N = 221) vs matching placebo (N = 220) |
Outcomes |
Febrile morbidity (> 38°C twice 4 hours apart after first 24 hours); endometritis (fever, uterine tenderness and abnormal lochia); wound infection (fever, cellulitis or exudate with positive culture); UTI (fever and positive urine culture); pneumonia, bacteraemia, pelvic abscess, unexplained fever, therapeutic antibiotics, length of post-operative stay |
Notes |
Definition of emergency section (unscheduled) did not correspond to the definition of non-elective section used in this review; these patients have been analysed in the “both or not-defined” group. Women undergoing elective section included women with scheduled section and with intact membranes and have been analysed in the “elective” group. |
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There were no significant differences in the fetal outcomes reported (definitions not consistent with those for this review; no serious side effects with cefazolin |
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Class of antibiotic: first generation cephalosporin. |
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Subgroups:
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Yes |
“…computer-generated randomization…” |
Allocation concealment? |
Yes |
“…each indistinguishable minibag was given a code number in the department of pharmaceutical care.” There was, however, no information on how the codes were used and whether there was sequential opening |
Blinding? |
Yes |
Triple blind. “Both the experimental drug and placebo were indistinguishable.” |
All outcomes |
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Incomplete outcome data addressed? |
Yes |
No losses or exclusions were reported. Analysis appeared to be by ITT |
All outcomes |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 2 groups were comparable regarding maternal characteristics and emergency and elective CS. Insufficient information overall |
Overall low risk of bias? |
Yes |
Mostly low risk of bias. |