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. Author manuscript; available in PMC: 2014 May 2.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007482. doi: 10.1002/14651858.CD007482.pub2
Methods Randomized, double blind, placebo-controlled; 2 parallel groups
Unit of randomization: individual.
Participants Dates of data collection: December 1983 to June 1985.
Setting: Chogoria Hospital, Kenya.
Inclusion criteria: all patients undergoing CS.
Exclusion criteria: clinical infection.
Interventions Metronidazole 1 g rectal suppository 10-45 minutes before and 8 hours after procedure (N = 91) vs placebo suppository (N = 91)
Outcomes Fever (> 37.9°C on at least 1 occasion); wound infection; mean febrile days (0.56 for treatment vs 1.23 for control), hospital days, any antibiotic use (18/91 vs 23/91)
Notes Elective CS not defined.
No adverse events on mother or babies noted.
There was 1 grade 3 wound (defined as deep pelvic abscess or evidence of local or generalized peritonitis) in the treatment group as compared with 3 in the placebo group (classified as serious infectious morbidity)
Class of antibiotic: nitroimidazole (metronidazole).
Subgroups:
  • type of CS unclear;

  • before cord clamping.

Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear “…randomized…”
Allocation concealment? Unclear No information was provided.
Blinding? Yes Double-blind.
All outcomes
Incomplete outcome data addressed? Unclear 7/189 patients initially randomized were not included in analysis because suppositories were incorrectly administered As treated analysis performed.
All outcomes
Free of selective reporting? Unclear Insufficient information to judge.
Free of other bias? Unclear The 2 groups were comparable regarding age, parity, duration of labor, duration ruptured membranes, number of vaginal examinations, etc. There was insufficient other information to judge
Overall low risk of bias? Unclear Mostly unclear.
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