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

Lewis 1990.

Methods RCT. Individual women. Study in 2 parts.
Study 1: compared a penicillin vs placebo (so not included in this review).
Study 2: compared a cephalosporin vs a penicillin.
Participants Inclusion criteria
  • Women having CS.

  • N = 396, 9 excluded as charts not available, leaving 383 for analysis.


Exclusion criteria
  • Women who had antibiotics within 2 weeks of CS and those allergic to penicillin.

Interventions Intervention: cephalosporin (B2).
  • Cefoxitin.

  • 2 g in 1.5 L, by irrigation.

  • N = 186.


Comparison: penicillin (A3).
  • Ticarcillin.

  • 5 g in 1.2 L, by irrigation.

  • N = 197.

Outcomes Endometritis; wound infection (criteria not specified): UTI (criteria not specified): sepsis.
Notes Setting: Louisiana State University Hospital, US.
Subgroups
  1. Both elective and non‐elective CS. Data reported separately but randomisation not stratified.

  2. After cord clamping.

  3. Irrigation/lavage.

  4. Single lavage dose but

  • Comparisons: 1 (subgroup 1): 2; 3; 4; 7.

  • No information about funding source of study.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk “...random double‐blind fashion...”.
Allocation concealment (selection bias) Unclear risk “...random double‐blind fashion...”.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind study.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Although a double‐blind study, it is unclear whether the outcome assessors might have not know allocation.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 396 women were reported to be included with 383 providing data, 186 in cephalosporin group and 197 in penicillin group (loss of 13/396 = 3.3%).
Selective reporting (reporting bias) Unclear risk We did not assess trial protocol.
Other bias Unclear risk Baseline characteristics were similar for age; gestation; gravidity; parity; length of labour. However, other potential biases were unclear. No information about funding source of study.