Methods |
Double blind, 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: Athens, Greece. |
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Inclusion criteria: women undergoing elective or non-elective CS. Age range 17-40 years Exclusion criteria: allergy to metronidazole, amnionitis, and pyrexia |
Interventions |
Metronidazole 500 mg IV 2 hours or immediately preoperatively, 500 mg intraopera-tively, 1000 mg 8 hours post-operatively (N = 50), vs placebo (N = 50) |
Outcomes |
Wound infection; endometritis; inadequate wound healing (metronidazole 1/50 vs placebo 8/50); mean temperature (36.8°C SD 1.02 vs 37.6, 1.03); duration of hospital stay. |
Notes |
Although the authors are not identical and the presentation of the data makes direct comparisons difficult, the description of the 2 studies cited is so similar that it is presumed the 2 citations refer to the same patient population |
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Translated from Bulgarian. |
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Class of antibiotic: nitroimidazole (metronidazole). |
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Subgroups:
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
Women were divided into 2 groups; no further details available |
Allocation concealment? |
Unclear |
No information provided. |
Blinding? |
Unclear |
Placebo given to control group; described as “double blind”. |
All outcomes |
|
Incomplete outcome data addressed? |
Unclear |
No information available (pending full translation). |
All outcomes |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
There was no significant difference in parity and age between the groups. There was insufficient other information which to judge |
Overall low risk of bias? |
Unclear |
Unclear. |