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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 RCT; 2 parallel groups.
Unit of randomization: individual.

Participants Dates of data collection: June - September 1979.
Setting: National Women’s Hospital, Auckland, New Zealand.
Inclusion criteria: all women undergoing CS (8/73 were repeat)
Exclusion: already on antibiotics.

Interventions Metronidazole 500 mg IV prior to incision and metronidazole 2 g suppository at end of surgery (N = 35) vs matching placebo infusion and suppository (N = 38)

Outcomes Fever (> 37.9°C within 14 days of delivery); wound infection, endometritis, UTI, major complication (return to theatre or hospitalised >10 days because of post-operative morbidity); need for antibiotic therapy (treatment 13 vs placebo 10); fever index (257 degree hours vs 165 hours)

Notes 1 major complication (not infectious) in each group (bleeding from lower segment in 1, major deep vein thrombosis extending into iliac veins in another)
Drug class: nitroimidazole (metronidazole).
Subgroups:
  • type of CS unclear;

  • before cord clamping.


Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Unclear “Randomized.”
No additional information.

Allocation concealment? Unclear No information was provided.

Blinding? Yes Double-blind, placebo-controlled.
All outcomes

Incomplete outcome data addressed? Yes No losses to follow up reported.
All outcomes No participants excluded.
ITT analysis.

Free of selective reporting? Unclear Insufficient information to judge.

Free of other bias? Unclear The groups were comparable regarding age and weight. There was insufficient other information which to judge

Overall low risk of bias? Unclear Mostly unclear.
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