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

Mansueto 1989.

Methods RCT. Individual women. 2‐arm study.
Participants Inclusion criteria
  • Women undergoing non‐elective CS.

  • N = 48.


Exclusion criteria
  • Allergy to penicillin or cephalosporin; impaired renal and/or liver function; fever (> 38 ºC and/or clinical signs of infection); antibiotic therapy 48 hours prior to the surgical procedure.

Interventions Intervention: B‐lactam (F).
  • Imipenem.

  • 500 mg IV after cord clamped.

  • N = 22.


Comparison: cephalosporin (B3).
  • Cefotamine.

  • 1 g IV after cord clamped and 3 additional doses every 12 hours.

  • N = 26.

Outcomes Infective complications after the CS (endometritis, infection of the wound, peritonitis, urinary infections, other causes, fever morbidity).
Notes Dates: 1 January 1988 to 30 September 1988.
Setting: Umberto I Hospital, Frosinone, Italy.
Subgroups
  1. Non‐elective CS.

  2. After cord clamping.

  3. Systemic ‐ IV.

  4. Single dose vs multiple doses.

  • Comparison 14.

  • Translated from Italian.

  • No information about funding source of study.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Women reported to be divided randomly into two groups.
Allocation concealment (selection bias) Unclear risk No information.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No loss to follow‐up.
Selective reporting (reporting bias) Unclear risk We did not assess trial protocol.
Other bias Unclear risk No differences in baseline characteristics for: age, parity, length of PROM and number of vaginal examination between two groups. Other possible biases were unclear. No information about funding source of study.