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. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3

Polk 1982.

Methods RCT; 2 parallel groups.
Unit of randomization: individual.
Participants Dates of data collection: July 1978 to 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. N = 278.
Exclusion: active infection, fever, membranes ruptured > 36 hrs, antibiotic therapy within 2 weeks, renal disease, allergy to penicillin or cephalosporin.
Interventions Intervention: 1st generation cephalosporin:
  • cefazolin 2 g after cord clamped and at 4 and 8 hrs after 1st dose;

  • N = 146.


Comparison: placebo:
  • matching placebo;

  • N = 132.

Outcomes Fever (oral temperature > 100.3oF on any of 2 of 1st 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, bacteremia; 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 bacteremia, 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: 1st generation cephalosporin.
Subgroups:
  • type CS undefined;

  • after cord clamping.


The 2 groups were comparable regarding age, BMI, proportion on private service, etc.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomly allocated".
Comment: no description of sequence generation process.
Allocation concealment (selection bias) Unclear risk Comment: no information provided.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: 12 participants withdrawn (8 treatment, 4 placebo) and started on therapeutic antibiotics by the surgeon because the operation had been prolonged or was complicated or the pre‐operative specimen of urine disclosed significant bacteriuria; results on participants excluded could not be re‐included in ITT analysis.
Selective reporting (reporting bias) Unclear risk Comment: insufficient information to judge.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Participants, their physicians and all investigators were unaware of the assignment throughout the study".
Comment: double‐blind, matching placebo.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: probably outcome assessment was blinded.
Other bias Low risk Comment: no other sources of bias identified.