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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: January 1970 to June 1980.
Setting: Washington, DC. US.
Inclusion criteria: women undergoing CS who were not in labor and did not have ruptured membranes (elective)
Interventions Ampicillin 1 g 30 min prior to surgery and at 4 and 8 hours post-operatively (N = 42) vs placebo solution (N = 40)
Outcomes Febrile morbidity (> 100.4 °F twice 6 hours apart after the first 24 hours); endomy-ometritis (fever, uterine and adnexal tenderness, purulent lochia); UTI; wound infection (induration, erythema and warmth with purulent drainage); need for antibiotics (treatment 1/42 vs placebo 6/40); maternal hospital stay (4.3 vs 4.6; no variance given)
Notes No life-threatening infection related complications nor bacteremic episodes in either group
Class of antibiotic: aminopenicillin (ampicillin).
Subgroups:
  • elective CS;

  • before cord clamping.

Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear Randomized.
No further information.
Allocation concealment? Unclear No information was provided.
Blinding? Unclear Described as “double-blind”. Placebo-controlled: “placebo solution”.
All outcomes
Incomplete outcome data addressed? Yes No loss to follow up.
All outcomes No participant excluded.
ITT analysis.
Free of selective reporting? Unclear Insufficient information to judge.
Free of other bias? Unclear The 2 groups were comparable regarding age, race, gravidity, parity and socioeconomic status. There was insufficient other information which to judge
Overall low risk of bias? Unclear Mostly unclear.
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