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

Saltzman 1985.

Methods RCT. Individual women. 2‐arm study.
Participants Inclusion criteria
  • Women who underwent primary CS for cephalopelvic disproportion.

  • N = 147 with data on 129.


Exclusion criteria
  • Women with clinical signs of active infection, an oral temperature of 100.4 oF (38.0 oC) or more within 24 hours preceding surgery, systemic antimicrobial use within 3 days prior to CS, or known hypersensitivity to penicillin or cephalosporins.

Interventions Intervention: cephalosporin (B2).
  • Cefoxitin.

  • 2 g each dose, with 3 doses given.

  • First dose of each drug was given immediately after the umbilical cord was clamped, with the second and third doses administered 4 and 8 hours afterward.

  • N = 68.


Comparison: penicillin (A3) combination.
  • Ticarcillin + clavulanic acid.

  • 3 g of ticarcillin and 100 mg of clavulanic acid, 3 doses given.

  • First dose of each drug was given immediately after the umbilical cord was clamped, with the second and third doses administered 4 and 8 hours afterward.

  • N = 61.

Outcomes Febrile morbidity; endometritis; UTI.
Notes Setting: Virginia, US.
Subgroups
  1. Type of CS not defined.

  2. After cord clamping.

  3. IV administration. Although route of administration not specified the administration of doses 4 and 8 hours after birth indicated lavage was not used.

  4. Multiple doses.

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

  • Long‐term follow‐up: reported no infections at 6 weeks post‐operatively.

  • No information about funding source of study.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk “...randomly assigned...”.
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind study.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Double‐blind study but no mention about whether assessors were blinded or not.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 18 out of 147 women (12.2%) were excluded from the analysis.
Selective reporting (reporting bias) Unclear risk Study protocol unavailable.
Other bias Unclear risk No information on baseline characteristics. Other possible biases were unclear. No information about funding source of study.