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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 Date of data collection: November 1983 and December 1984.
Setting: University Hospital, New Jersey; ; lower socioeconomic class (90% black)
Inclusion criteria: women < 21 years old undergoing CS.
Exclusion: antibiotic use within 2 weeks; active infection or fever at delivery; penicillin or sulfa allergy; internal fetal monitoring
Interventions Trimethoprim 240 mg and sulfamethoxazole 1200 mg IV after clamping of cord (N = 29) vs placebo (N = 28)
Outcomes Endomyometritis (fever [> 100.3°F twice within 24 hours after first day], uterine tenderness, absence of another focus); UTI (fever and positive culture); wound infection (fever, abnormal appearing wound with cellulitis or a wound draining purulent material)
Notes Authors’ definition of high risk not comparable with that used in this review.
The incidence of UTI and wound infection was similar between the groups (numbers not given)
Class of antibiotic: sulfonamide/trimethoprim.
Subgroups:
  • type of CS unclear;

  • after cord clamping.

Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear ‘Randomly divided.’
No further details provided.
Allocation concealment? Unclear No information provided.
Blinding? Unclear Placebo-controlled.
All outcomes No further information.
Incomplete outcome data addressed? Yes No loss 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 2 groups were comparable regarding age, gravidity, vaginal examinations, duration of labor and duration of rupture of membranes, elective repeat CS. There was insufficient other information which to judge
Overall low risk of bias? Unclear Mostly unclear.
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