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. 2014 Nov 17;2014(11):CD008726. doi: 10.1002/14651858.CD008726.pub2

van der Linden 1993.

Methods RCT. Individual women. 2‐arm study, stratified by type of operation, CS or hysterectomy. We only report on women having CS here.
Participants Inclusion criteria
  • Women undergoing vaginal hysterectomy without cysto/rectocoele repair or secondary CS.

  • Secondary CS is defined as CS performed after onset of labour.

  • N = 83 in CS group.


Exclusion criteria
  • Hypersensitivity to any of the study drugs, antibiotic treatment within 48 hours prior to surgery, previously scheduled antibiotic treatment during the post‐operative period of 72 hours or longer, impaired renal function, hepatic dysfunction, haematological and neurological disorders, or the presence of serious underlying disease or infection.

Interventions Intervention: cephalosporin (B2) combination.
  • Cefuroxime (750 mg) plus metronidazole (500 mg, which gives anaerobic cover).

  • The first dose was given IV at the induction of anaesthesia, followed by the same dose 8 and 16 hours later.

  • In women undergoing CS, medication was started immediately after clamping the umbilical cord.

  • N = 42.


Comparison: penicillin (A4) combination.
  • Amoxicillin + clavulanic acid (which gives anaerobic cover).

  • Single dose of 2200 mg IV at the induction of anaesthesia.

  • In women undergoing CS, medication was started immediately after clamping the umbilical cord.

  • N = 41.

Outcomes UTI; febrile temperature; abdominal wound infection; endometritis and infiltrates at the top of the vaginal vault.
Notes Dates: 1 August 1988 to 15 December 1989.
Setting: Leyenburg Hospital, Netherlands.
Subgroups
  1. Non‐elective CS.

  2. After cord clamping.

  3. IV administration.

  4. Single and multiple doses.

  • Comparisons: 1 (subgroup 4); 2; 3; 4; 8.

  • "This study was sponsored by Smith Kline and Beecham Pharmaceuticals."

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Women were “randomly allocated to one of two treatment regimes”.
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information provided.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information provided.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 16 out of 215 (7.4%) women were excluded from the analysis.
Selective reporting (reporting bias) Unclear risk The study protocol was unavailable.
Other bias High risk Baseline characteristics were similar on: age and weight. Other possible biases were unclear. The study was sponsored by Smith Kline and Beecham Pharmaceuticals.