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. Author manuscript; available in PMC: 2014 May 2.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007482. doi: 10.1002/14651858.CD007482.pub2
Methods RCT, 2 parallel groups.
Unit of randomization: individual.

Participants Dates of data collection: Sept 2003 - April 2004.
Setting: New Halfa Teaching Hospital, Eastern Sudan.
Inclusion criteria: planned elective CS (categorized as elective)
Exclusion criteria: antibiotics within 2 weeks; any visible infection; elevated temperature; allergic to antimicrobials; did not wish to participate

Interventions Ceftriaxone 1 g IV at anesthetic induction vs no treatment.

Outcomes Post-operative febrile morbidity (oral temperature ≥ 38 °C twice at least 4 hours apart after first 24 hours
Post-operative infections (endometritis, wound infection, pelvic abscess, peritonitis, other febrile morbidity (UTI, chest infection, malaria)
2 perinatal deaths: 1 in each group due to respiratory distress and septicaemia due to imperforate anus

Notes Developing country.
Class of antimicrobial: third generation cephalosporin.
Subgroups:
  • elective CS;

  • before cord clamping.


Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Unclear “Patients were randomized.”
No additional details.

Allocation concealment? Unclear No information.

Blinding? No No blinding.
All outcomes Not placebo-controlled.

Incomplete outcome data addressed? Yes No loss of participants to follow up.
All outcomes No participant excluded after randomization.
ITT analysis.

Free of selective reporting? Unclear Insufficient information to judge.

Free of other bias? Unclear “The 2 groups were well matched at enrolment and there were no statistical differences in the admission variables.”
There was insufficient other information which to judge.

Overall low risk of bias? No Very little information provided, particularly around allocation concealment and it appears not placebo controlled
HHS Vulnerability Disclosure