Methods |
Quasi-RCT; 2 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: not reported. |
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Setting: New York Medical College, New York, US. |
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Inclusion criteria: all women undergoing CS (divided into “no labor” and “labor” groups which correspond to the definitions of elective/non-elective used in this review |
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Exclusion criteria: fever, antibiotic use within 2 weeks, ruptured membranes > 2 hours, major penicillin allergy |
Interventions |
Cephalothin 2 g IV and kanamycin 1 g IM at induction of anesthesia, then cephalothin 2 g IV q6hrs × 8 doses and kanamycin 500 mg IM q12 hr × 4 doses (N = 47) vs no treatment (N = 53) |
Outcomes |
Febrile morbidity (temperature greater that 100.4°F orally on 2 consecutive days, excluding the first post-operative day); endometritis (fever, uterine tenderness and positive culture or fever and pathogenic organism); UTI, wound infection (fever and cellulitis or exudate). Data available on elective (defined as no labor) and non-elective (defined as presence of labor) |
Notes |
No difference in average duration of hospital stay between groups (data not shown). |
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1 woman (treatment group) developed endometritis with organism resistant to cephalothin and kanamycin |
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Class of antibiotic: first generation cephalosporin and animoglycoside |
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Subgroups:
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
No |
Randomized “…using the last digit of their hospital chart number” to treatment or no treatment |
Allocation concealment? |
No |
“…using the last digit of their hospital chart number.” |
Blinding? |
No |
Not placebo controlled. |
All outcomes |
|
No further information provided. |
Incomplete outcome data addressed? |
Yes |
No loss to follow up. |
All outcomes |
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No participants excluded. |
|
|
ITT analysis. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 2 groups were comparable regarding age, parity, ethnic background or type of anesthesia. There was insufficient other information which to judge |
Overall low risk of bias? |
No |
Quasi-RCT suggests high risk of bias. |