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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: July 1978-October 1980.
Setting: Brigham and Women’s Hospital, Boston, Massachusetts, US
Inclusion criteria: all women undergoing CS (other than repeat section); criteria do not correspond with our definition of non-elective
Exclusion: active infection, fever, membranes ruptured > 36 hours, antibiotic therapy within 2 weeks, renal disease, allergy to penicillin or cephalosporin

Interventions Cefazolin 2 g after cord clamped (N = 146) and at 4 and 8 hours after first dose vs matching placebo (N = 132)

Outcomes Fever (oral temperature > 100.3 degrees Fahrenheit on any of 2 of first 10 post-operative days); UTI, wound infection (only pus-draining included in outcome of wound infection); endometritis (fever, tenderness on pelvic examination, abnormal discharge) ; pelvic abscess; septic pelvic thrombophlebitis, bacteraemia; subsequent antibiotic use (23% for placebo vs 12% for treatment)

Notes Outcome of fever and minor wound infection combined (11/146 for treatment vs 13/ 132 for placebo).
4 episodes of bacteraemia, all in placebo group.
1 episode of rash and 1 episode of phlebitis reported in treatment group vs none in control.
Data collected at 6 weeks on 259/266 patients; 35% of infections diagnosed after discharge
Class of antibiotic: first generation cephalosporin.
Subgroups:
  • type CS undefined;

  • after cord clamping.


Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Unclear “Randomly allocated.”
No further information.

Allocation concealment? Unclear No information provided.

Blinding? Yes Double blind; placebo-controlled.
All outcomes “Participants, their physicians and all investigators were unaware of the assignment throughout the study.”

Incomplete outcome data addressed? Unclear 12 participants withdrawn (8 treatment, 4 placebo) and started on therapeutic antibiotics by the surgeon because the operation had been prolonged or was complicated or the preoperative specimen of urine disclosed significant bacteriuria Results on participants excluded could not be re-included in ITT analysis
All outcomes

Free of selective reporting? Unclear Insufficient information to judge.

Free of other bias? Unclear The 2 groups were comparable regarding age, body mass index, proportion on private service, etc. There was insufficient other information which to judge

Overall low risk of bias? Unclear Mostly unclear.
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