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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, placebo-controlled trial; 2 parallel groups.
Unit of randomization: individual.
Participants Dates of data collection: May 1982-August 1983.
Setting: South Saimaa Central Hospital, Lappeenranta, Finland
Inclusion criteria: initially all women undergoing CS (N = 80); thereafter women undergoing non-elective (ruptured membranes) section (N = 72)
Interventions Tinidazole 500 mg IV at cord clamping (N = 75) vs identical placebo (N = 77)
Outcomes Febrile morbidity (> 38°C on 2 post-operative days, excluding the first); endometritis (fever, foul lochia or uterine tenderness); wound infection (fever, cellulitis or exudate); UTI (fever and positive culture)
Notes Authors’ definition of non-elective (ruptured membranes) and elective (unruptured membranes) not consistent with the definitions used in this review; classified in this review as ‘both’.
Newborn infants observed for effects of tinidazole (although data not given)
Class of antibiotic: nitroimidazole (tinidazole).
Subgroups:
  • both elective and non-elective CS;

  • after cord clamping.

Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear ‘Randomized according to a code.’
Allocation concealment? Yes “Identical vials … coded from 1 to 160.”
Blinding? Yes Placebo-controlled, double blind.
All outcomes “The code was first opened when the study was completed.”
Incomplete outcome data addressed? Unclear No loss to follow up reported.
All outcomes 8 women excluded: 4 because they were febrile before the operation, 4 because of mistakes in administration; data not provided to perform ITT analysis
Free of selective reporting? Unclear Insufficient information to judge.
Free of other bias? Unclear The 2 groups were comparable regarding age, weight, gestational age, etc. There was insufficient other information which to judge
Overall low risk of bias? Unclear Mostly unclear.
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