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

Stage 1982.

Methods Randomized, placebo‐controlled trial; 2 parallel groups (2:1 active:placebo randomization).
Unit of randomization: individual.
Part of a larger study looking at prophylaxis also in gynecologic surgery.
Participants Dates of data collection: July 1976 to June 1978.
Setting: 14 US centers.
Inclusion criteria: all women undergoing CS (46% in labor). N = 199.
 Exclusion criteria: infection, allergy to penicillin or cephalosporins.
Interventions Intervention: 1st generation cephalosporin:
  • cephradine 1 g IV;

  • N = 133.


Comparison: placebo:
  • placebo;

  • N = 66.


Within 1 hr prior to surgery, repeated at 4 hrs.
Outcomes Febrile morbidity (oral temperature > 37.7oC twice 4 hrs apart, after 1st 48 hrs); endometritis (uterine tenderness, fever and purulent discharge), wound infection (increased local tenderness, redness or swelling); UTI (positive culture); maternal length of stay (treatment 5.8 days vs placebo 7.57 days; P < 0.05, variance not given).
Notes Class of antibiotic: 1st generation cephalosporin.
Subgroups:
  • type of CS undefined;

  • before cord clamping.


The 2 groups were comparable regarding age and other risk factors.
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: investigator provided with Individually. randomized block of patient numbers.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: dropouts in CS women not stated (overall: 11/319 from treated group, 8/172 from placebo group. As‐treated analysis performed.
Selective reporting (reporting bias) Unclear risk Comment: insufficient information to judge.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: placebo‐controlled; patients and investigators blind to allocation throughout the study.
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.