Ross 1984.
Methods | RCT; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: not reported. Setting: Addenbrooke's Hospital, Cambridge, UK. Inclusion criteria: women undergoing emergency CS (in active labor with membrane rupture). N = 115. Exclusion criteria: pyrexia; antibiotic use within 2 weeks. |
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Interventions |
Intervention: nitroimidazole:
Comparison: placebo:
IV infusion at start of procedure; post‐operatively metronidazole or placebo suppository twice daily for 5 days. |
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Outcomes | Pyrexia (> 38oC twice 4 hrs apart after 1st 24 hrs); 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.
Length of admission not significantly different between the 2 groups (mean 7.4, SD 2.3 days).
No adverse reactions occurred. Class of antibiotic: nitroimidazole (metronidazole). Subgroups:
Comparison of the 2 groups showed similar risk factors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomized, sequential basis". Comment: insufficient description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Quote: "Antibiotic ... was provided without access to the 'trial code". Comment: insufficient information to judge. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no loss to follow‐up; no participant excluded. ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: double‐blind, placebo‐controlled. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to judge. |
Other bias | Low risk | Comment: no other sources of bias identified. |