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

Saltzman 1986.

Methods RCT. Individual women. 3‐arm study.
Participants Inclusion criteria
  • Women undergoing primary CS at high risk of developing post‐operative infectious morbidity.

  • In active labour and/or had had membrane rupture > 6 hours; predominately women receiving private practice care.

  • N = 158 but data on 151.


Exclusion criteria
  • Women with clinical signs of active infection; oral temp > 38 ºC within 24 hours; systemic antimicrobial used within 3 days prior to CS; known hypersensitivity to penicillin or cephalosporin.

Interventions Intervention: cephalosporin (B2).
  • Cefoxitin.

  • 12 mg total, 4 mg each dose, 3 doses, at cord clamping and at 4 hours and 8 hours.

  • N = 49.


Comparison 1: penicillin (A3).
  • Mezlocillin.

  • 4 mg, 1 dose, at cord clamping.

  • N = 51.


Comparison 2: penicillin (A3).
  • Mezlocillin.

  • 6 mg total, 3 doses, 2 mg every 4 hours from cord clamping.

  • N = 51.

Outcomes Febrile morbidity (temperature > 38 x 2, 8 hours apart, excluding first 24 hours post‐operatively; endometritis (temperature > 38 plus foul lochia or uterine tenderness); wound infection (wound surrounded by cellulitis and/or draining purulent material); UTI.
Notes Dates: October 1982 to April 1983.
Setting: Virginia, US.
Subgroups
  1. Non‐elective CS.

  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. Mixture of single and multiple doses.

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

  • Single and multiple doses were pooled for the comparison between B2 and A3 (Comparison 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 “...randomly assigned...”.
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 of whether assessors were blinded or not.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 7 out of 158 women (4.4%) were removed for failure to fulfil the study criteria.
Selective reporting (reporting bias) Unclear risk The study protocol was unavailable.
Other bias Unclear risk Baseline characteristics similar on: age; parity; gestation. However other aspects of potential bias were unclear. No information about funding source of study.