Methods |
Randomized, placebo controlled trial; 2 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: July-December 1976. |
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Setting: Naval Regional Medical Center, Portmouth, Virginia, US |
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Inclusion criteria: all women undergoing CS (46/122 were a repeat section). The authors’ definition of primary and repeat do not correspond to definitions of elective and non-elective used in this review (repeat sections included women in labor with ruptured membranes). The results for these two categories have been combined in this review |
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Exclusion criteria: allergy to penicillin or cephalosporin, infection or receiving antibiotics |
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Interventions |
Cefazolin 500 mg IV 30 minutes before and 500 mg at 2 and 1 g at 8 hours after delivery (N = 61) vs matching placebo (N = 61) |
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Outcomes |
Endometritis (fever and uterine tenderness or fever and pathogenic organism); UTI (fever and symptoms, or positive culture); wound infection (fever, cellulitis and exudate) ; maternal hospital stay (treatment 5.5 days vs placebo 5.7 days, no variance given) |
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Notes |
2 women developed serious complications as stated by the authors: 1 in treatment group developed septic pelvic thrombophlebitis; 1 given placebo developed pneumonia and endoparametritis (both included in outcome of serious morbidity) |
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Class of antibiotic: first 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.” |
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No further information. |
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Allocation concealment? |
Yes |
“All preparations supplied had a code number known only by the pharmacy.” |
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Blinding? |
Yes |
Described as double-blind. |
All outcomes |
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“All materials appeared similar in solution.” |
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Incomplete outcome data addressed? |
Unclear |
No loss to follow up reported. 8 women excluded for mistakes in protocol (no further details) could not be included in ITT analysis |
All outcomes |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
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Free of other bias? |
Unclear |
The 2 groups were comparable regarding age, height, weight, etc. There was insufficient other information which to judge |
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Overall low risk of bias? |
Unclear |
Mostly unclear. |