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. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3

Ross 1984.

Methods RCT; 2 parallel groups.
Unit of randomization: individual.
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.
Interventions Intervention: nitroimidazole:
  • metronidazole 500 mg;

  • N = 57.


Comparison: placebo:
  • placebo;

  • N = 58.


IV infusion at start of procedure; post‐operatively metronidazole or placebo suppository twice daily for 5 days.
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:
  • non‐elective CS;

  • before cord clamping.


Comparison of the 2 groups showed similar risk factors.
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.