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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 Randomized, placebo-controlled trial; 4 parallel groups (3 treatment, 1 placebo)
Unit of randomization: individual.

Participants Dates of data collection: October 1986 to February 1987.
Setting: Prince ofWales Hospital, Hong Kong; mostly suburban or rural Chinese women of lower or middle class
Inclusion criteria: all women undergoing CS.
Exclusion criteria: receiving antibiotics; pyrexia >37.4°C; diagnosed infection; increased risk of infection, e.g. diabetes; known sensitivity to the antibiotics

Interventions IV at time of induction of anesthesia: ampicillin 1 g (N = 96); ampicillin 1 g and metronidazole 500 mg (N = 104); ampicillin 1 g and sulbactam 500 mg (N = 99), vs placebo (normal saline) (N = 101). Results of the 3 treatment groups combined

Outcomes Febrile morbidity (oral temperature of more than 38°C at least twice after day 1); wound infection (induration, serosanguinous discharge or dehiscence with purulent discharge) ; UTI (positive culture); genital tract infection (pain and uterine tenderness, purulent uterine discharge with microbiological confirmation); any infection anywhere (antibiotic 75/299 vs placebo 28/101); post-operative antibiotic use (22/299 vs 9/101)

Notes Only moderate or prolonged febrile morbidity (as defined) included
Class of antibiotic: Aminopenicillin (ampicillin), nitroimidazole (metronidazole), beta-lactam/beta-lactamase inhibitor
Subgroups:
  • type of CS unclear;

  • before cord clamping.


Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Unclear “list of random numbers consulted by nurse.”
No additional information.

Allocation concealment? Unclear “list of random numbers consulted by nurse.”

Blinding? Yes Double blind’ randomized trial (the anesthetist was not blind)
All outcomes
Placebo (normal saline).
“All doctors and nurses looking after the patients were ignorant of the drug given until the end of the study.”

Incomplete outcome data addressed? Yes No loss to follow up
All outcomes No participants excluded
ITT analysis

Free of selective reporting? Unclear Insufficient information to judge

Free of other bias? Unclear The groups were comparable regarding age, parity, primary CS, indication for CS, urinary catheterization and vaginal examination before operation. There was insufficient other information which to judge

Overall low risk of bias? Unclear Sequence generation and concealment allocation are unclear.
HHS Vulnerability Disclosure