Methods |
Randomized, placebo-controlled trial; 4 parallel groups (3 treatment, 1 placebo) |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: October 1986 to February 1987. |
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Setting: Prince ofWales Hospital, Hong Kong; mostly suburban or rural Chinese women of lower or middle class |
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Inclusion criteria: all women undergoing CS. |
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Exclusion criteria: receiving antibiotics; pyrexia >37.4°C; diagnosed infection; increased risk of infection, e.g. diabetes; known sensitivity to the antibiotics |
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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 |
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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) |
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Notes |
Only moderate or prolonged febrile morbidity (as defined) included |
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Class of antibiotic: Aminopenicillin (ampicillin), nitroimidazole (metronidazole), beta-lactam/beta-lactamase inhibitor |
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Subgroups: |
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type of CS unclear;
before cord clamping.
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Risk of bias |
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Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Unclear |
“list of random numbers consulted by nurse.” |
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No additional information. |
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Allocation concealment? |
Unclear |
“list of random numbers consulted by nurse.” |
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Blinding? |
Yes |
Double blind’ randomized trial (the anesthetist was not blind) |
All outcomes |
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Placebo (normal saline). |
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“All doctors and nurses looking after the patients were ignorant of the drug given until the end of the study.” |
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Incomplete outcome data addressed? |
Yes |
No loss to follow up |
All outcomes |
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No participants excluded |
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ITT analysis |
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Free of selective reporting? |
Unclear |
Insufficient information to judge |
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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 |
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Overall low risk of bias? |
Unclear |
Sequence generation and concealment allocation are unclear. |