Methods |
Randomized, placebo-controlled trial; 5 parallel groups (4 treatment, 1 control) |
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Unit of randomization: individual. |
Participants |
Dates of data collection: December 1982 to May 1984. |
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Setting: Madigan Army Medical Centre, Tacoma, Washington, USA |
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Inclusion criteria: all women undergoing CS. |
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Exclusion criteria: penicillin or cephalosporin allergy; antibiotic therapy; known infectious process |
Interventions |
Irrigation during CS with 2 g of either cephapirin sodium (N = 79), cefamandole nafate (N = 70), moxalactam disodium (N = 64) or ampicillin sodium (N = 70), vs saline (N = 77). A vitamin was added to each solution for disguise. The antibiotic groups have been considered together in this review |
Outcomes |
Fever (>38°C twice 6 hours apart, excluding the first 24 hours); endomyometritis (pyrexia >37.8°C, uterine tenderness and pelvic peritoneal irritation without other localising signs of irritation; UTI (positive culture); wound infection; fever index; all infection-related morbidity; therapeutic antibiotics; mean post-operative days (variance not given) |
Notes |
3 episodes of pelvic thrombophlebitis (all in treated groups). |
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Results were given for all women and women in labor, both high risk (corresponding to the category of non-elective deliveries) and all labor. The data for elective deliveries were deduced from these |
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Class of antibiotic: first generation cephalosporin vs second generation cephalosporin vs carbapenem vs aminopenicillin (ampicillin) |
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Subgroups:
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Yes |
Computer-generated numbers using the mixed congruential method |
Allocation concealment? |
Yes |
“The pharmacy to assign each patient to 1 of 5 groups.” |
Blinding? |
Yes |
Double blind placebo controlled trial. A vitamin was added to each solution for disguise |
All outcomes |
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Incomplete outcome data addressed? |
Yes |
No loss to follow up. |
All outcomes |
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No participant excluded. |
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ITT analysis. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The mean level of gravidity of the placebo group was higher than that of the cephapirin group. There was insufficient other information which to judge |
Overall low risk of bias? |
Yes |
The most important aspects are with low risk of bias. |