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

Kristensen 1990.

Methods RCT; 2 parallel groups.
Unit of randomization: individual.
Participants Dates of data collection: February 1987 to March 1988.
Setting: Odense University Hospital, Denmark.
Inclusion criteria: women undergoing non‐elective CS (58/201 without labor; 65/201 without ruptured membranes). N = 201.
Exclusion: fever, antibiotics within 7 days, penicillin or cephalosporin allergy.
Interventions Intervention: 2nd generation cephalosporin:
  • cefuroxime 750 mg IV after cord clamping;

  • N = 102.


Comparison: no treatment:
  • no treatment;

  • N = 99.

Outcomes Febrile morbidity (> 37.9oC twice at least 6 hrs apart after 1st post‐operative day); endometritis (fever, uterine tenderness and abnormal lochia); wound infection (fever, cellulitis and/or purulent discharge); UTI; cost of post‐operative antibiotics (treatment $US0.69 vs control $US7.47); maternal hospital stay (treatment 8.1 vs control 8.0, no variance given).
Notes No woman had a severe infection such as pelvic abscess or septic pelvic thrombophlebitis.
Class of antibiotic: 2nd generation cephalosporin.
Subgroups:
  • type of CS unclear;

  • after cord clamping.


The 2 groups were comparable regarding epidemiologic and obstetric data.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "...randomly..".
Comment: no description of sequence generation process.
Allocation concealment (selection bias) Unclear risk Quote: "envelopes containing empty vial or vial containing treatment".
Comment: insufficient information to judge.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no losses or exclusions were reported. The analysis appears to be by ITT.
Selective reporting (reporting bias) Unclear risk Insufficient information to judge.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "Patients, attending physicians, and study coordinators were blind with regard to group assignments".
Comment: not placebo‐controlled; insufficient information to judge.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: insufficient information to judge.
Other bias Low risk Comment: no other sources of bias identified.