Methods |
RCT; 2 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: not reported. |
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Setting: Addenbrooke’s Hospital, Cambridge, UK. |
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Inclusion criteria: women undergoing emergency CS (in active labor with membrane rupture) |
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Exclusion criteria: pyrexia; antibiotic use within 2 weeks. |
Interventions |
Metronidazole 500 mg (N = 57) vs placebo (N = 58) IV infusion at start of procedure; post-operatively metronidazole or placebo suppository twice daily for 5 days |
Outcomes |
Pyrexia (> 38°C twice 4 hours apart after first 24 hours); wound infection; endometritis (heavy, offensive lochia and pyrexia); UTI; antibiotic use (15/57 in treatment group vs 20/58 in control group) |
Notes |
1 woman in the control group developed a pelvic abscess. |
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Length of admission not significantly different between the 2 groups (mean 7.4, SD 2. 3 days). |
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No adverse reactions occurred. |
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Class of antibiotic: Nitroimidazole (metronidazole). |
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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? |
Unclear |
“Randomized, sequential basis.” |
|
|
No further information. |
Allocation concealment? |
Unclear |
No information provided. |
Blinding? |
Yes |
Double-blind, placebo controlled. |
All outcomes |
|
“Antibiotic … was provided without access to the ‘trial code.”’ |
Incomplete outcome data addressed? |
Yes |
No loss to follow up. |
All outcomes |
|
No participant excluded. |
|
|
ITT analysis. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
Comparison of the 2 groups showed similar risk factors.There was insufficient other information which to judge |
Overall low risk of bias? |
Unclear |
Mostly unclear. |