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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: August 1970 - January 1971.
Setting: Johns Hopkins University, Baltimore, US;
Inclusion criteria: women undergoing CS (criteria not specified)
Exclusion criteria: evidence of clinical infection, history of penicillin allergy

Interventions Cephalothin 1 g IV on call to operating room, further 2 g IV intra-operatively and every 6 hours for 48 hours, then 500 mg IM for additional 72 hours (N = 5) vs placebo (N = 7)

Outcomes Morbidity (temperature > 100.9°F twice, 6 hours apart after first 48 hours or other clinical signs of infection); not separated. For this review, the authors’ definition of morbidity has been classified as fever

Notes Part ofa larger randomized trial ofprophylactic antibiotics in gynecologic surgery; most patients (87%) were undergoing hysterectomy; only 12/300 patients enrolled underwent CS
Class of antibiotic: first generation cephalosporin.
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? Yes Randomized list ofplacebo or drug, kept in hospital pharmacy; code not broken until after patient classified as ‘morbid’ or ‘non-morbid’

Blinding? Yes Described as “double-blind”.
All outcomes Placebo-controlled.

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

Free of selective reporting? Unclear Insufficient information to judge.

Free of other bias? Unclear No information was provided.

Overall low risk of bias? Unclear Insufficient information to judge.
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