Methods |
Quasi-RCT, 3 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: Jan 1979 - May 1980. |
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Setting: Riverside Osteopathic Hospital, Michigan, USA. |
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Inclusion criteria: women at high risk (defined as presence of labor) undergoing CS |
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Exclusion criteria: oral temperature > 38° C any time prior to surgery; antibiotic use within 2 weeks prior to admission; refusal to participate; repeat elective CS; compelling indication for antibiotics in the judgement of the physician |
Interventions |
Either cefazolin (N = 28) 1 G IV within 1 hour prior to surgery, then 5 and 12 hours after operation for total of 3 doses, or carbenicillin (N = 34) 2G IV within 1hr prior to surgery then 6 and 12 hours after operation for a total of 3 doses or no treatment |
Outcomes |
Febrile morbidity (oral temperature > 38 °C twice at least 6 hours apart after the first 24 hours); wound infection (fever, cellulitis, and/or exudate); endometritis (fever, uterine tenderness and foul discharge, or fever and a positive culture with uterine tenderness and no other apparent cause); UTI (fever, urinary tract symptoms and/or positive culture >100,000 organisms/ml if pre-operative culture negative); pulmonary infection (fever with abnormal chest x-ray and/or physical signs of consolidation); undetermined (persistent fever with no discernible signs of infection) |
Notes |
Results of 2 antibiotic groups reported together. |
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Class ofantimicrobial: first generation cephalosporin vs carboxypenicillin (carbenicillin) |
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Subgroups:
non-elective CS;
before cord clamping.
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
No |
“By random distribution of the last digit of their hospital number.” |
Allocation concealment? |
No |
Allocation based on case record number. |
Blinding? |
No |
No blinding. |
All outcomes |
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Not placebo controlled. |
Incomplete outcome data addressed? |
Yes |
No loss of participants to follow up. |
All outcomes |
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No participant excluded after randomization. |
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ITT analysis. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
“Lack of any significant differences between the two groups confirmed adequate randomization.” |
|
|
Insufficient other information to judge. |
Overall low risk of bias? |
No |
Quasi-RCT give high risk of bias. |